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Humalog (insulin lispro) – Package leaflet - A10AC04

Updated on site: 07-Oct-2017

Medication nameHumalog
ATC CodeA10AC04
Substanceinsulin lispro
ManufacturerEli Lilly Nederland B.V.

Article Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog 100 units/ml solution for injection in vial insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog is and what it is used for

2.What you need to know before you use Humalog

3.How to use Humalog

4.Possible side effects

5.How to store Humalog

6.Contents of the pack and other information

1.What Humalog is and what it is used for

Humalog is used to treat diabetes. Humalog works more quickly than normal human insulin because the insulin molecule has been changed slightly.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally use Humalog within 15 minutes of a meal.

Your doctor may tell you to use Humalog as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

Humalog is suitable for use in adults and children. Humalog may be used in children, when an advantage is expected compared to soluble insulin, for example, in the timing of the injection in relation to meals.

2. What you need to know before you use Humalog

Do NOT use Humalog

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need).

-if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog

Always check the pack and the vial label for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog that your doctor has told you to use.

Always use Humalog exactly as your doctor has told you. You should check with your doctor if you are not sure.

Dosage

You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog under the skin. You should only inject it into a muscle if your doctor has told you to.

Preparing Humalog

Humalog is already dissolved in water, so you do not need to mix it. But you must use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time you inject yourself.

Injecting Humalog

First wash your hands.

Before you make an injection, clean your skin as you have been instructed. Clean the rubber stopper on the vial, but do not remove the stopper.

Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of Humalog you want. Your doctor or clinic will tell you how to do this. Do not share your needles and syringes.

Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will still work quicker than soluble human insulin.

Your doctor will tell you if you have to mix Humalog with one of the human insulins. For example if you do need to inject a mixture, draw the Humalog into the syringe before the long acting insulin. Inject the liquid as soon as you have mixed it. Do the same thing every time. You should not normally mix Humalog with one of the mixtures of human insulins. You should never mix Humalog with insulins produced by other manufacturers or animal insulins.

You must not administer Humalog by the intravenous route. Inject Humalog as your physician or nurse has taught you. Only your physician can administer Humalog by the intravenous route. He will only do this under special circumstances such as surgery or if you are ill and your glucose levels are too high.

Using Humalog in an infusion pump

Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing insulin lispro, the manufacturers instructions should be studied to ascertain the suitability or otherwise for the particular pump. Read and follow the instructions in the product literature supplied with the infusion pump.

Be sure to use the correct reservoir and catheter for your pump.

Changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.

In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe low blood glucose levels occur, notify your doctor or clinic and consider the need to reduce or stop your insulin infusion.

A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify your doctor or clinic.

When used with an insulin infusion pump, Humalog should not be mixed with any other insulin.

If you take more Humalog than you need

If you take more Humalog than you need, a low blood sugar may occur. Check your blood sugar. If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog

If you take less Humalog than you need, a high blood sugar may occur. Check your blood sugar.

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog.

If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Humalog can cause side effects, although not everybody gets them.

Local allergy is common (≥ 1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (≥ 1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating.

If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon (≥ 1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Common problems of diabetes

A.Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat.

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B.Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

C.Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog

Before the first use store your Humalog in a refrigerator (2°C – 8°C). Do not freeze. Keep your vial in use in a refrigerator (2°C – 8°C) or at room temperature up to 30°C and discard after 28 days. Do not put it near heat or in the sun.

Keep out of the reach and sight of children.

Do not use Humalog after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use Humalog, if it is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog 100 units/ml solution for injection in vial contains

-The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

-The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7 H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog looks like and contents of the pack

Humalog 100 units/ml, solution for injection is a sterile, clear, colourless, aqueous solution and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. Each vial contains 1000 units (10 millilitres). Humalog 100 units/ml, solution for injection in vial comes in a pack of 1 vial, 2 vials or a multipack of 5 x 1 vial. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Humalog 100 units/ml, solution for injection in vial is made by:

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog 100 units/ml solution for injection in cartridge insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog is and what it is used for

2.What you need to know before you use Humalog

3.How to use Humalog

4.Possible side effects

5.How to store Humalog

6.Contents of the pack and other information

1.What Humalog is and what it is used for

Humalog is used to treat diabetes. Humalog works more quickly than normal human insulin because the insulin molecule has been changed slightly.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally use Humalog within 15 minutes of a meal.

Your doctor may tell you to use Humalog as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

Humalog is suitable for use in adults and children. Humalog may be used in children, when an advantage is expected compared to soluble insulin, for example, in the timing of the injection in relation to meals.

2. What you need to know before you use Humalog

Do NOT use Humalog

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need).

-if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

If the 40 units/ml vial is the product normally prescribed, do not take insulin from a 100 units/ml cartridge using a 40 units/ml syringe.

Other medicines and Humalog

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog

The 3 ml cartridge is only for use in 3ml pens. It is not for use in 1.5 ml pens.

Always check the pack and the cartridge label for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog that your doctor has told you to use.

Always use Humalog exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if the needle on the delivery device is changed.

Dosage

You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog under the skin. You should only inject it into a muscle if your doctor has told you to.

Preparing Humalog

Humalog is already dissolved in water, so you do not need to mix it. But you must use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time you inject yourself.

Getting the pen ready to use

First wash your hands. Disinfect the rubber membrane of the cartridge.

You must only use Humalog cartridges in compatible CE marked pens. Please make sure that Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. The 3 ml cartridge only fits the 3 ml pen.

Follow the instructions that come with the pen. Put the cartridge into the pen.

You will set the dose to 1 or 2 units. Then hold the pen with the needle pointing up and tap the side of the pen so that any bubbles float to the top. With the pen still pointing up, press the injection mechanism. Do this until a drop of Humalog comes out of the needle. There may still be some small air bubbles left in the pen. These are harmless, but if the air bubble is too big, it may make the dose of your injection less accurate.

Injecting Humalog

Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will still work quicker than soluble human insulin.

You must not administer Humalog by the intravenous route. Inject Humalog as your physician or nurse has taught you. Only your physician can administer Humalog by the intravenous route. He will only do this under special circumstances such as surgery or if you are ill and your glucose levels are too high.

After injecting

As soon as you have done the injection, take the needle off the pen using the outer needle cap. This will keep the Humalog sterile and prevent leaking. It will also stop air going back into the pen and the needle clogging up. Do not share your needles. Do not share your pen. Replace the cap on your pen. Leave the cartridge in the pen.

Further injections

Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing up until a drop of Humalog comes out of the needle. You can see how much Humalog is left by looking at the gauge on the side of the cartridge. The distance between each mark on the gauge is about 20 units. If there is not enough for your dose, change the cartridge.

Do not mix any other insulin in a Humalog cartridge. Once the cartridge is empty, do not use it again.

Using Humalog in an infusion pump

Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing insulin lispro, the manufacturers instructions should be studied to ascertain the suitability or otherwise for the particular pump. Read and follow the instructions in the product literature supplied with the infusion pump.

Be sure to use the correct reservoir and catheter for your pump.

Changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.

In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe low blood glucose levels occur, notify your doctor or clinic and consider the need to reduce or stop your insulin infusion.

A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify your doctor or clinic.

When used with an insulin infusion pump, Humalog should not be mixed with any other insulin.

If you take more Humalog than you need

If you take more Humalog than you need, a low blood sugar may occur. Check your blood sugar. If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog

If you take less Humalog than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog, or a spare pen and cartridges, in case you lose your pen or cartridges or they get damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog.

If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Humalog can cause side effects, although not everybody gets them.

Local allergy is common (≥ 1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (≥ 1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon (≥ 1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

Common problems of diabetes

A.Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat.

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B.Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick.

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

C.Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog

Before the first use store your Humalog in a refrigerator (2°C – 8°C). Do not freeze.

Keep your cartridge in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen with the inserted cartridge should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use Humalog after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use Humalog, if it is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog 100 units/ml solution for injection in cartridge contains

-The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

-The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7 H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog looks like and contents of the pack

Humalog 100 units/ml, solution for injection is a sterile, clear, colourless, aqueous solution and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. Each cartridge contains 300 units (3 millilitres). The cartridges come in packs of 5 or10 cartridges. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Humalog 100 units/ml, solution for injection in cartridge is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog Mix25 100 units/ml suspension for injection in vial insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog Mix25 is and what it is used for

2.What you need to know before you use Humalog Mix25

3.How to use Humalog Mix25

4.Possible side effects

5.How to store Humalog Mix25

6.Contents of the pack and other information

1.What Humalog Mix25 is and what it is used for

Humalog Mix25 is used to treat diabetes. Humalog Mix25 is a premixed suspension. Its active substance is insulin lispro. 25% of the insulin lispro in Humalog Mix25 is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly. 75% of the insulin lispro in Humalog Mix25 is available in a suspension together with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the long term. Humalog Mix25 works very quickly and longer than soluble insulin. You should normally use Humalog Mix25 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix25 as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

2. What you need to know before you use Humalog Mix25

Do NOT use Humalog Mix25

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix25than you need).

-if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog Mix25

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog Mix25

Always check the pack and the vial label for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog Mix25 that your doctor has told you to use.

Always use Humalog Mix25 exactly as your doctor has told you. You should check with your doctor if you are not sure.

Dosage

You should normally inject Humalog Mix25 within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog Mix25 under the skin. You should not administer it using a different administration route. Under no circumstances should Humalog Mix25 be given intravenously.

Preparing Humalog Mix25

Vials containing Humalog Mix25 should be rotated in the palms of the hands before use to resuspend insulin until it appears uniformly cloudy or milky. Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The vials should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the vial, giving it a frosted appearance. Check each time you inject yourself.

Injecting Humalog Mix25

First wash your hands.

Before you make an injection, clean your skin as you have been instructed. Clean the rubber stopper on the vial, but do not remove the stopper.

Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of Humalog Mix25 you want. Your doctor or clinic will tell you how to do this. Do not share your needles and syringes.

Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught.

If you take more Humalog Mix25 than you need

If you take more Humalog Mix25 than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix25

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog Mix25.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix25.

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Humalog Mix25 can cause side effects, although not everybody gets them.

Local allergy is common (≥ 1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (≥ 1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog Mix25, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon (≥ 1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

Common problems of diabetes

A.Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog Mix25 or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness •

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B.Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

C.Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog Mix25

Before the first use store your Humalog Mix25 in a refrigerator (2°C – 8°C). Do not freeze. Keep your vial in use in a refrigerator (2°C – 8°C) or at room temperature up to 30°C and discard after 28 days. Do not put it near heat or in the sun.

Keep out of the reach and sight of children.

Do not use Humalog Mix25 after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use Humalog Mix25, if clumps of material are present or if solid white particles stick to the bottom or wall of the vial, giving it a frosted appearance. Check each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog Mix25 100 units/ml suspension for injection in vial contains

-The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

-The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog Mix25 100 units/ml suspension for injection in vial looks like and contents of the pack

Humalog Mix25 100 units/ml suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 25% of the insulin lispro in Humalog Mix25 is dissolved in water. 75% of the insulin lispro in Humalog Mix25 is available in a suspension together with protamine sulphate. Each vial contains 1000 units (10 millilitres). Humalog Mix25 100 units/ml suspension for injection in vial comes in a pack of 1 vial.

Marketing Authorisation Holder and Manufacturer

Humalog Mix25 100 units/ml suspension for injection in vial is made by:

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog Mix25 100 units/ml suspension for injection in cartridge insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog Mix25 is and what it is used for

2.What you need to know before you use Humalog Mix25

3.How to use Humalog Mix25

4.Possible side effects

5.How to store Humalog Mix25

6.Contents of the pack and other information

1.What Humalog Mix25 is and what it is used for

Humalog Mix25 is used to treat diabetes. Humalog Mix25 is a premixed suspension. Its active substance is insulin lispro. 25% of the insulin lispro in Humalog Mix25 is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly. 75% of the insulin lispro in Humalog Mix25 is available in a suspension together with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the long term. Humalog Mix25 works very quickly and longer than soluble insulin. You should normally use Humalog Mix25 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix25 as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

2. What you need to know before you use Humalog Mix25

Do NOT use Humalog Mix25

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix25 than you need).

-if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog Mix25

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog Mix25

The 3 ml cartridge is only for use in 3ml pens. It is not for use in 1.5 ml pens.

Always check the pack and the cartridge label for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog Mix25 that your doctor has told you to use.

Always use Humalog Mix25 exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if the needle on the delivery device is changed.

Dosage

You should normally inject Humalog Mix25 within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog Mix25 under the skin. You should not administer it using a different administration route. Under no circumstances should Humalog Mix25 be given intravenously.

Preparing Humalog Mix25

Cartridges containing Humalog Mix25 should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Getting the pen ready to use

First wash your hands. Disinfect the rubber membrane of the cartridge.

You must only use Humalog Mix25 cartridges in compatible CE marked pens. Please make sure that Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. The 3 ml cartridge only fits the 3 ml pen.

Follow the instructions that come with the pen. Put the cartridge into the pen.

You will set the dose to 1 or 2 units. Then hold the pen with the needle pointing up and tap the side of the pen so that any bubbles float to the top. With the pen still pointing up, press the injection mechanism. Do this until a drop of Humalog Mix25 comes out of the needle. There may still be some small air bubbles left in the pen. These are harmless, but if the air bubble is too big, it may make the dose of your injection less accurate.

Injecting Humalog Mix25

Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught.

After injecting

As soon as you have done the injection, take the needle off the pen using the outer needle cap. This will keep the Humalog Mix25 sterile and prevent leaking. It will also stop air going back into the pen and the needle clogging up. Do not share your needles. Do not share your pen.

Replace the cap on your pen. Leave the cartridge in the pen.

Further injections

Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing up until a drop of Humalog Mix25 comes out of the needle. You can see how much Humalog is left by looking at the gauge on the side of the cartridge. The distance between each mark on the gauge is about 20 units. If there is not enough for your dose, change the cartridge.

Do not mix any other insulin in a Humalog Mix25 cartridge. Once the cartridge is empty, do not use it again.

If you take more Humalog Mix25 than you need

If you take more Humalog Mix25 than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix25

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog Mix25, or a spare pen and cartridges, in case you lose your pen or cartridges or they get damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix25.

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Humalog Mix25 can cause side effects, although not everybody gets them.

Local allergy is common (1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog Mix25, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon (≥ 1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

Common problems of diabetes

A.Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog Mix25 or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B.Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

C.Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog Mix25

Before the first use store your Humalog Mix25 in a refrigerator (2°C – 8°C). Do not freeze.

Keep your cartridge in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen with the inserted cartridge should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use Humalog Mix25 after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use Humalog Mix25, if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog Mix25 100 units/ml suspension for injection in cartridge contains

-The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

-The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog Mix25 100 units/ml suspension for injection in cartridge looks like and contents of the pack

Humalog Mix25 100 units/ml suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 25% of the insulin lispro in Humalog Mix25 is dissolved in water. 75% of the insulin lispro in Humalog Mix25 is available in a suspension together with protamine sulphate. Each cartridge contains 300 units (3 millilitres). The cartridges come in packs of 5 or 10 cartridges. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Humalog Mix25 100 units/ml suspension for injection in cartridge is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

 

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog Mix50 100 units/ml suspension for injection in cartridge insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog Mix50 is and what it is used for

2.What you need to know before you use Humalog Mix50

3.How to use Humalog Mix50

4.Possible side effects

5.How to store Humalog Mix50

6.Contents of the pack and other information

1.What Humalog Mix50 is and what it is used for

Humalog Mix50 is used to treat diabetes. Humalog Mix50 is a premixed suspension. Its active substance is insulin lispro. 50% of the insulin lispro in Humalog Mix50 is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly. 50% of the insulin lispro in Humalog Mix50 is available in a suspension together with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog Mix50 is a substitute for your own insulin and is used to control glucose in the long term. Humalog Mix50 works very quickly and longer than soluble insulin. You should normally use Humalog Mix50 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix50 as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

2. What you need to know before you use Humalog Mix50

Do NOT use Humalog Mix50

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix50 than you need).

-if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog Mix50

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog Mix50

The 3 ml cartridge is only for use in 3ml pens. It is not for use in 1.5 ml pens.

Always check the pack and the cartridge label for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog Mix50 that your doctor has told you to use.

Always use Humalog Mix50 exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if the needle on the delivery device is changed.

Dosage

You should normally inject Humalog Mix50 within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog Mix50 under the skin. You should not administer it using a different administration route. Under no circumstances should Humalog Mix50 be given intravenously.

Preparing Humalog Mix50

Cartridges containing Humalog Mix50 should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Getting the pen ready to use

First wash your hands. Disinfect the rubber membrane of the cartridge.

You must only use Humalog Mix50 cartridges in compatible CE marked pens. Please make sure that Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. The 3 ml cartridge only fits the 3 ml pen.

Follow the instructions that come with the pen. Put the cartridge into the pen.

You will set the dose to 1 or 2 units. Then hold the pen with the needle pointing up and tap the side of the pen so that any bubbles float to the top. With the pen still pointing up, press the injection mechanism. Do this until a drop of Humalog Mix50 comes out of the needle. There may still be some small air bubbles left in the pen. These are harmless, but if the air bubble is too big, it may make the dose of your injection less accurate.

Injecting Humalog Mix50

Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught.

After injecting

As soon as you have done the injection, take the needle off the pen using the outer needle cap. This will keep the Humalog Mix50 sterile and prevent leaking. It will also stop air going back into the pen and the needle clogging up. Do not share your needles. Do not share your pen.

Replace the cap on your pen. Leave the cartridge in the pen.

Further injections

Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing up until a drop of Humalog Mix50 comes out of the needle. You can see how much Humalog is left by looking at the gauge on the side of the cartridge. The distance between each mark on the gauge is about 20 units. If there is not enough for your dose, change the cartridge.

Do not mix any other insulin in a Humalog Mix50 cartridge. Once the cartridge is empty, do not use it again.

If you take more Humalog Mix50 than you need

If you take more Humalog Mix50 than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix50

If you take less Humalog Mix50 than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog Mix50, or a spare pen and cartridges, in case you lose your pen or cartridges or they get damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix50.

If you take less Humalog Mix50 than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Humalog Mix50 can cause side effects, although not everybody gets them.

Local allergy is common (1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog Mix50, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon (≥ 1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

Common problems of diabetes

A.Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog Mix50 or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B.Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

C.Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog Mix50

Before the first use store your Humalog Mix50 in a refrigerator (2°C – 8°C). Do not freeze.

Keep your cartridge in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen with the inserted cartridge should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use Humalog Mix50 after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use Humalog Mix50, if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog Mix50 100 units/ml suspension for injection in cartridge contains

-The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

-The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog Mix50 100 units/ml suspension for injection in cartridge looks like and contents of the pack

Humalog Mix50 100 units/ml suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 50% of the insulin lispro in Humalog Mix50 is dissolved in water. 50% of the insulin lispro in Humalog Mix50 is available in a suspension together with protamine sulphate. Each cartridge contains 300 units (3 millilitres). The cartridges come in packs of 5 or 10 cartridges. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Humalog Mix50 100 units/ml suspension for injection in cartridge is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

 

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog BASAL 100 units/ml suspension for injection in cartridge insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog BASAL is and what it is used for

2.What you need to know before you use Humalog BASAL

3.How to use Humalog BASAL

4.Possible side effects

5.How to store Humalog BASAL

6.Contents of the pack and other information

1.What Humalog BASAL is and what it is used for

Humalog BASAL is used to treat diabetes. Its active substance is insulin lispro. The insulin lispro in Humalog BASAL is available in a suspension together with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog BASAL is a substitute for your own insulin and is used to control glucose in the long term. Humalog BASAL has a prolonged mode of action compared to soluble insulin.

Your doctor may tell you to use Humalog BASAL as well as a fast-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

2. What you need to know before you use Humalog BASAL

Do NOT use Humalog BASAL

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Humalog BASAL than you need).

-if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog BASAL

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog BASAL

The 3 ml cartridge is only for use in 3ml pens. It is not for use in 1.5 ml pens.

Always check the pack and the cartridge label for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog BASAL that your doctor has told you to use.

Always use Humalog BASAL exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if the needle on the delivery device is changed.

Dosage

You should normally inject Humalog BASAL as your basal insulin. Your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog BASAL under the skin. You should not administer it using a different administration route. Under no circumstances should Humalog BASAL be given intravenously.

Preparing Humalog BASAL

Cartridges containing Humalog BASAL should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Getting the pen ready to use

First wash your hands. Disinfect the rubber membrane of the cartridge.

You must only use Humalog BASAL cartridges in compatible CE marked pens. Please make sure that Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. The 3 ml cartridge only fits the 3 ml pen.

Follow the instructions that come with the pen. Put the cartridge into the pen.

You will set the dose to 1 or 2 units. Then hold the pen with the needle pointing up and tap the side of the pen so that any bubbles float to the top. With the pen still pointing up, press the injection mechanism. Do this until a drop of Humalog BASAL comes out of the needle. There may still be some small air bubbles left in the pen. These are harmless, but if the air bubble is too big, it may make the dose of your injection less accurate.

Injecting Humalog BASAL

Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught.

After injecting

As soon as you have done the injection, take the needle off the pen using the outer needle cap. This will keep the Humalog BASAL sterile and prevent leaking. It will also stop air going back into the pen and the needle clogging up. Do not share your needles. Do not share your pen.

Replace the cap on your pen. Leave the cartridge in the pen.

Further injections

Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing up until a drop of Humalog BASAL comes out of the needle. You can see how much

Humalog is left by looking at the gauge on the side of the cartridge. The distance between each mark on the gauge is about 20 units. If there is not enough for your dose, change the cartridge.

Do not mix any other insulin in a Humalog BASAL cartridge. Once the cartridge is empty, do not use it again.

If you take more Humalog BASAL than you need

If you take more Humalog BASAL than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog BASAL

If you take less Humalog BASAL than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog BASAL, or a spare pen and cartridges, in case you lose your pen or cartridges or they get damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog BASAL.

If you take less Humalog BASAL than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Humalog BASAL can cause side effects, although not everybody gets them.

Local allergy is common (≥ 1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (≥ 1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog BASAL, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon (≥ 1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

Common problems of diabetes

A.Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog BASAL or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B.Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

C.Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog BASAL

Before the first use store your Humalog BASAL in a refrigerator (2°C – 8°C). Do not freeze.

Keep your cartridge in use at room temperature (15° - 30°C) and discard after 21 days. Do not put it near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen with the inserted cartridge should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use Humalog BASAL after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use Humalog BASAL, if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog BASAL 100 units/ml suspension for injection in cartridge contains

-The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

-The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog BASAL 100 units/ml suspension for injection in cartridge looks like and contents of the pack

Humalog BASAL 100 units/ml suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. The insulin lispro in Humalog BASAL is available in a suspension together with protamine sulphate. Each cartridge contains 300 units (3 millilitres). The cartridges come in packs of 5 or 10 cartridges. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Humalog BASAL 100 units/ml suspension for injection in cartridge is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog 100 units/ml KwikPen, solution for injection insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog KwikPen is and what it is used for

2.What you need to know before you use Humalog KwikPen

3.How to use Humalog KwikPen

4.Possible side effects

5.How to store Humalog KwikPen

6.Contents of the pack and other information

1.What Humalog KwikPen is and what it is used for

Humalog KwikPen is used to treat diabetes. It works more quickly than normal human insulin because the insulin molecule has been changed slightly.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally use Humalog within 15 minutes of a meal.

Your doctor may tell you to use Humalog KwikPen as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

Humalog is suitable for use in adults and children. Humalog may be used in children, when an advantage is expected compared to soluble insulin, for example, in the timing of the injection in relation to meals.

2. What you need to know before you use Humalog KwikPen

Do NOT use Humalog KwikPen

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need).

-if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog KwikPen

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog KwikPen

Always check the pack and the label of the pre-filled pen for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog KwikPen that your doctor has told you to use.

Always use Humalog KwikPen exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used by you only, even if the needle is changed.

Dosage

You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog under the skin. You should only inject it into a muscle if your doctor has told you to.

Preparing Humalog KwikPen

Humalog is already dissolved in water, so you do not need to mix it. But you must use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time you inject yourself.

Getting the KwikPen ready to use (Please see user manual)

First wash your hands.

Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions carefully. Here are some reminders.

Use a clean needle. (Needles are not included).

Prime your KwikPen before each use. This checks that insulin comes out and clears the air bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these are harmless. But if the air bubbles are too large it may affect the insulin dose.

Injecting Humalog

Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will still work quicker than soluble human insulin.

You must not administer Humalog by the intravenous route. Inject Humalog as your physician or nurse has taught you. Only your physician can administer Humalog by the intravenous route. He will only do this under special circumstances such as surgery or if you are ill and your glucose levels are too high.

After injecting

As soon as you have done the injection, unscrew the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen and your needle clogging. Do not share your needles. Do not share your pen. Replace the cap on your pen.

Further injections

Every time you use a KwikPen you must use a new needle. Before every injection, clear any air bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing up. The scale on the cartridge shows about how many units you have left.

Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do this.

Using Humalog in an infusion pump

Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing insulin lispro, the manufacturers instructions should be studied to ascertain the suitability or otherwise for the particular pump. Read and follow the instructions in the product literature supplied with the infusion pump.

Be sure to use the correct reservoir and catheter for your pump.

Changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.

In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe low blood glucose levels occur, notify your doctor or clinic and consider the need to reduce or stop your insulin infusion.

A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions in the product literature and if appropriate, notify your doctor or clinic.

When used with an insulin infusion pump, Humalog should not be mixed with any other insulin.

If you take more Humalog than you need

If you take more Humalog than you need, a low blood sugar may occur. Check your blood sugar. If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog

If you take less Humalog than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog, or a spare pen and cartridges, in case you lose your KwikPen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog.

If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Humalog can cause side effects, although not everybody gets them.

Local allergy is common (≥ 1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (≥ 1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon (≥ 1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

Common problems of diabetes

A.Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B.Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

C.Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog KwikPen

Before the first use store your Humalog KwikPen in a refrigerator (2°C – 8°C). Do not freeze.

Keep your Humalog KwikPen in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge. The KwikPen should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use Humalog KwikPen after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use Humalog KwikPen, if the solution is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog 100 units/ml KwikPen solution for injection contains

-The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

-The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7 H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog KwikPen looks like and contents of the pack

Humalog 100 units/ml KwikPen, solution for injection is a sterile, clear, colourless, aqueous solution and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. Each Humalog KwikPen contains 300 units (3 millilitres). The Humalog KwikPen comes in a pack of 5 pre-filled pens or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog in your pre-filled pen is the same as the Humalog, which comes in separate Humalog cartridges. The KwikPen simply has a built in cartridge. When the pre-filled pen is empty you cannot use it again.

Marketing Authorisation Holder and Manufacturer

Humalog 100 units/ml KwikPen, solution for injection is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

 

USER MANUAL

 

Please see manual text later.

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog Mix25 100 units/ml KwikPen, suspension for injection insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog Mix25 KwikPen is and what it is used for

2.What you need to know before you use Humalog Mix25 KwikPen

3.How to use Humalog Mix25 KwikPen

4.Possible side effects

5.How to store Humalog Mix25 KwikPen

6.Contents of the pack and other information

1.What Humalog Mix25 KwikPen is and what it is used for

Humalog Mix25 KwikPen is used to treat diabetes. It is a premixed suspension. Its active substance is insulin lispro. 25% of the insulin lispro in Humalog Mix25 KwikPen is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly. 75% of the insulin lispro in Humalog Mix25 KwikPen is available in a suspension together with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the long term. Humalog Mix25 works very quickly and longer than soluble insulin. You should normally use Humalog Mix25 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix25 KwikPen as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

2. What you need to know before you use Humalog Mix25 KwikPen

Do NOT use Humalog Mix25 KwikPen

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix25 than you need).

-if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog Mix25 KwikPen

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog Mix25 KwikPen

Always check the pack and the label of the pre-filled pen for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog Mix25 KwikPen that your doctor has told you to use.

Always use Humalog Mix25 KwikPen exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used by you only, even if the needle is changed.

Dosage

You should normally inject Humalog Mix25 within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog Mix25 under the skin. You should not administer it using a different administration route. Under no circumstances should Humalog Mix25 be given intravenously.

Preparing Humalog Mix25 KwikPen

The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Getting the KwikPen ready to use (Please see user manual)

First wash your hands.

Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions carefully. Here are some reminders.

Use a clean needle. (Needles are not included).

Prime your KwikPen before each use. This checks that insulin comes out and clears the air bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these are harmless. But if the air bubbles are too large it may affect the insulin dose.

Injecting Humalog Mix25

Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from where you last injected and that you ‘rotate’ the places you inject, as you have been taught.

After injecting

As soon as you have done the injection, unscrew the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen and your needle clogging. Do not share your needles. Do not share your pen. Replace the cap on the pen.

Further injections

Every time you use a KwikPen you must use a new needle. Before every injection, clear any air bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing up. The scale on the cartridge shows about how many units you have left.

Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do this.

If you take more Humalog Mix25 than you need

If you take more Humalog Mix25 than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix25

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog Mix25, or a spare pen and cartridges, in case you lose your KwikPen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix25.

If you take less Humalog Mix25 than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Humalog Mix25 can cause side effects, although not everybody gets them.

Local allergy is common (1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog Mix25, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon (1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

Common problems of diabetes

A.Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog Mix25 or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B.Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

C.Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog Mix25 KwikPen

Before the first use store your Humalog Mix25 KwikPen in a refrigerator (2°C – 8°C). Do not freeze.

Keep your Humalog Mix25 KwikPen in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge. The KwikPen should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use Humalog Mix25 KwikPen after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use Humalog Mix25 KwikPen, if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog Mix25 100 units/ml KwikPen, suspension for injection contains

-The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

-The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog Mix25 100 units/ml KwikPen, suspension for injection looks like and contents of the pack

Humalog Mix25 100 units/ KwikPen, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 25% of the insulin lispro in Humalog Mix25 is dissolved in water. 75% of the insulin lispro in Humalog Mix25 is available in a suspension together with protamine sulphate. Each Humalog Mix25 KwikPen contains 300 units (3 millilitres). The Humalog Mix25 KwikPen comes in a pack of 5 prefilled pens or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog Mix25 in your KwikPen is the same as the Humalog Mix25, which comes in separate Humalog Mix25 cartridges. The KwikPen simply has a built in cartridge. When the KwikPen is empty you cannot use it again.

Marketing Authorisation Holder and Manufacturer

Humalog Mix25 100 units/ml KwikPen, suspension for injection is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

 

USER MANUAL

 

Please see manual text later.

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog Mix50 100 units/ml KwikPen, suspension for injection insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog Mix50 KwikPen is and what it is used for

2.What you need to know before you use Humalog Mix50 KwikPen

3.How to use Humalog Mix50 KwikPen

4.Possible side effects

5.How to store Humalog Mix50 KwikPen

6.Contents of the pack and other information

1.What Humalog Mix50 KwikPen is and what it is used for

Humalog Mix50 KwikPen is used to treat diabetes. It is a premixed suspension. Its active substance is insulin lispro. 50% of the insulin lispro in Humalog Mix50 KwikPen is dissolved in water and it works more quickly than normal human insulin because the insulin molecule has been changed slightly. 50% of the insulin lispro in Humalog Mix50 KwikPen is available in a suspension together with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog Mix50 is a substitute for your own insulin and is used to control glucose in the long term. Humalog Mix50 works very quickly and longer than soluble insulin. You should normally use Humalog Mix50 within 15 minutes of a meal.

Your doctor may tell you to use Humalog Mix50 KwikPen as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

2. What you need to know before you use Humalog Mix50 KwikPen

Do NOT use Humalog Mix50 KwikPen

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix50 than you need).

-if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog Mix50 KwikPen

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog Mix50 KwikPen

Always check the pack and the label of the pre-filled pen for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog Mix50 KwikPen that your doctor has told you to use.

Always use Humalog Mix50 KwikPen exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used by you only, even if the needle is changed.

Dosage

You should normally inject Humalog Mix50 within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog Mix50 under the skin. You should not administer it using a different administration route. Under no circumstances should Humalog Mix50 be given intravenously.

Preparing Humalog Mix50 KwikPen

The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Getting the KwikPen ready to use (Please see user manual)

First wash your hands.

Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions carefully. Here are some reminders.

Use a clean needle. (Needles are not included).

Prime your KwikPen before each use. This checks that insulin comes out and clears the air bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these are harmless. But if the air bubbles are too large it may affect the insulin dose.

Injecting Humalog Mix50

Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from where you last injected and that you ‘rotate’ the places you inject, as you have been taught.

After injecting

As soon as you have done the injection, unscrew the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen and your needle clogging. Do not share your needles. Do not share your pen. Replace the cap on the pen.

Further injections

Every time you use a KwikPen you must use a new needle. Before every injection, clear any air bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing up. The scale on the cartridge shows about how many units you have left.

Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do this.

If you take more Humalog Mix50 than you need

If you take more Humalog Mix50 than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog Mix50

If you take less Humalog Mix50 than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog Mix50, or a spare pen and cartridges, in case you lose your KwikPen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog Mix50.

If you take less Humalog Mix50 than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Humalog Mix50 can cause side effects, although not everybody gets them.

Local allergy is common (1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog Mix50, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon (1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

Common problems of diabetes

A.Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog Mix50 or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B.Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

C.Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog Mix50 KwikPen

Before the first use store your Humalog Mix50 KwikPen in a refrigerator (2°C – 8°C). Do not freeze.

Keep your Humalog Mix50 KwikPen in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge. The KwikPen should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use Humalog Mix50 KwikPen after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use Humalog Mix50 KwikPen, if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog Mix50 100 units/ml KwikPen, suspension for injection contains

-The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

-The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog Mix50 100 units/ml KwikPen, suspension for injection looks like and contents of the pack

Humalog Mix50 100 units/ml KwikPen, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 50% of the insulin lispro in Humalog Mix50 is dissolved in water. 50% of the insulin lispro in Humalog Mix50 is available in a suspension together with protamine sulphate. Each Humalog Mix50 KwikPen contains 300 units (3 millilitres). The Humalog Mix50 KwikPen comes in a pack of 5 prefilled pens or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog Mix50 in your KwikPen is the same as the Humalog Mix50, which comes in separate Humalog Mix50 cartridges. The KwikPen simply has a built in cartridge. When the KwikPen is empty you cannot use it again.

Marketing Authorisation Holder and Manufacturer

Humalog Mix50 100 units/ml KwikPen, suspension for injection is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

 

USER MANUAL

 

Please see manual text later.

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Humalog BASAL 100 units/ml KwikPen, suspension for injection insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog BASAL KwikPen is and what it is used for

2.What you need to know before you use Humalog BASAL KwikPen

3.How to use Humalog BASAL KwikPen

4.Possible side effects

5.How to store Humalog BASAL KwikPen

6.Contents of the pack and other information

1.What Humalog BASAL KwikPen is and what it is used for

Humalog BASAL KwikPen is used to treat diabetes. Its active substance is insulin lispro. The insulin lispro in Humalog BASAL KwikPen is available in a suspension together with protamine sulphate, so that its action is prolonged.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog BASAL is a substitute for your own insulin and is used to control glucose in the long term. Humalog BASAL has a prolonged mode of action compared to soluble insulin

Your doctor may tell you to use Humalog BASAL as well as a fast-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin.

2.What you need to know before you use Humalog BASAL KwikPen

Do NOT use Humalog BASAL KwikPen

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see Section 3: If you take more Humalog BASAL than you need).

-if you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising them, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

The amount of insulin you need may also change if you drink alcohol.

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog BASAL KwikPen

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics,

acetyl salicylic acid,

sulpha antibiotics,

octreotide,

“beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),

beta-blockers, or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol,

some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and

angiotensin II receptor blockers.

Please tell your doctor, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog BASAL KwikPen BASAL KWIKPEN

Always check the pack and the label of the pre-filled pen for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog BASAL KwikPen that your doctor has told you to use.

Always use Humalog BASAL KwikPen exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used by you only, even if the needle is changed.

Dosage

You should normally inject Humalog BASAL as your basal insulin. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog BASAL under the skin. You should not administer it using a different administration route. Under no circumstances should Humalog BASAL be given intravenously.

Preparing Humalog BASAL KwikPen

The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The cartridges should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Getting the KwikPen ready to use (Please see user manual)

First wash your hands.

Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions carefully. Here are some reminders.

Use a clean needle. (Needles are not included).

Prime your KwikPen before each use. This checks that insulin comes out and clears the air bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these are harmless. But if the air bubbles are too large it may affect the insulin dose.

Injecting Humalog BASAL

Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from where you last injected and that you ‘rotate’ the places you inject, as you have been taught.

After injecting

As soon as you have done the injection, unscrew the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen and your needle clogging. Do not share your needles. Do not share your pen. Replace the cap on the pen.

Further injections

Every time you use a KwikPen you must use a new needle. Before every injection, clear any air bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing up. The scale on the cartridge shows about how many units you have left.

Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do this.

If you take more Humalog BASAL than you need

If you take more Humalog BASAL than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog BASAL

If you take less Humalog BASAL than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even death (see A and B in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always keep spare syringes and a spare vial of Humalog BASAL, or a spare pen and cartridges, in case you lose your KwikPen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog BASAL.

If you take less Humalog BASAL than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, Humalog BASAL can cause side effects, although not everybody gets them.

Local allergy is common (1/100 to <1/10). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Systemic allergy is rare (1/10,000 to <1/1,000). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog BASAL, tell your doctor at once.

Lipodystrophy (thickening or pitting of the skin) is uncommon (1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

Common problems of diabetes

A.Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog BASAL or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B.Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

C.Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog BASAL KwikPen

Before the first use store your Humalog BASAL KwikPen in a refrigerator (2°C – 8°C). Do not freeze.

Keep your Humalog BASAL KwikPen in use at room temperature (15° - 30°C) and discard after 21 days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge. The KwikPen should not be stored with the needle attached.

Keep out of the reach and sight of children.

Do not use Humalog BASAL KwikPen after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use Humalog BASAL KwikPen, if clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog BASAL 100 units/ml KwikPen, suspension for injection contains

-The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

-The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog BASAL 100 units/ml KwikPen, suspension for injection looks like and contents of the pack

Humalog BASAL 100 units/ml KwikPen, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. The insulin lispro in Humalog BASAL is available in a suspension together with protamine sulphate. Each Humalog BASAL KwikPen contains 300 units (3 millilitres). The Humalog BASAL KwikPen comes in a pack of 5 pre-filled pens or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog BASAL in your KwikPen is the same as the Humalog BASAL, which comes in separate Humalog BASAL cartridges. The KwikPen simply has a built in cartridge. When the KwikPen is empty you cannot use it again.

Marketing Authorisation Holder and Manufacturer

Humalog BASAL 100 units/ml KwikPen, suspension for injection is made by:

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France

The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

 

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

USER MANUAL

Please see manual text later.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

USER MANUAL KwikPen pre-filled insulin pen

100 units/ml

PLEASE READ THIS USER MANUAL BEFORE USE

Read the User Manual before you start taking your insulin and each time you get another KwikPen. There may be new information. This information does not take the place of talking to your healthcare professional about your medical condition or your treatment.

KwikPen (“Pen”) is a disposable pre-filled pen containing 3ml (300 units, 100 units/ml) of insulin. You can give yourself multiple doses using one Pen. The Pen dials 1 unit at a time. You can give from 1 to 60 units in a single injection. If your dose is more than 60 units, you will need to give yourself more than one injection. The plunger only moves a little with each injection, and you may not notice that it moves. The plunger will only reach the end of the cartridge when you have used all 300 units in the Pen.

Do not share your pen with other people, even if the needle has been changed. Do not reuse or share needles with other people. You may give an infection to them or get an infection from them.

This Pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the Pen.

 

 

KwikPen Parts

 

 

 

 

Cartridge

 

 

Cap Clip

Holder

Label

Dose Indicator

 

 

 

 

Dose Knob

Pen

Rubber

Plunger

Pen

Dose

Cap

Seal

 

Body

Window

Pen Needle Parts

(Needles Not Included)

Paper Tab

Outer Needle

Inner Needle

Needle

Shield

Shield

 

How to recognize your KwikPen:

 

Humalog

Humalog

Humalog

Humalog

 

Mix25

Mix50

Basal

 

 

 

Solution

Suspension

Suspension

Suspension

 

 

(cloudy insulin)

(cloudy insulin)

(cloudy insulin)

 

 

 

 

 

Pen colour:

Blue

Blue

Blue

Blue

 

 

 

 

 

Dose Knob:

 

 

 

 

 

Burgundy

Yellow

Red

Green

 

 

 

 

 

Labels:

White with

White with

White with

White with

 

Burgundy

Yellow

Red

Green Colour

 

Colour Bar

Colour Bar

Colour Bar

Bar

Supplies needed to give your injection:

KwikPen containing your insulin

KwikPen compatible Needle (BD [Becton, Dickinson and Company] Pen Needles recommended)

Alcohol swab

Needles and alcohol swab are not included.

Preparing your Pen

Wash your hands with soap and water.

Check the Pen to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.

Do not use your Pen past the expiration date printed on the Label. After you start using the Pen, throw your Pen away after the in-use time specified in the Package Leaflet.

Always use a new Needle for each injection to help prevent infections and blocked Needles.

Step 1:

Pull the Pen Cap straight off.

Do not remove the Pen Label.

Wipe the Rubber Seal with an alcohol swab.

Step 2:

(For HUMALOG suspensions cloudy insulins only)

Gently roll the Pen 10 times.

AND

Invert the Pen 10 times.

Mixing is important to make sure you get the right dose.

The insulin should look evenly mixed.

Step 3:

Check the appearance of the insulin.

HUMALOG solution should look clear and colourless. Do not use if it is cloudy, coloured, or has particles or clumps in it.

HUMALOG suspensions - cloudy insulins - should look white after mixing. Do not use if it looks clear or contains any clumps or particles.

Step 4:

Select a new Needle.

Pull off the Paper Tab from the Outer Needle Shield.

Step 5:

Push the capped Needle straight onto the Pen and twist the Needle on until it is tight.

Step 6:

Pull off the Outer Needle Shield. Do not throw it away.

Pull off the Inner Needle Shield and throw it away.

Priming your Pen

Prime before each injection.

Priming your Pen means removing the air from the Needle and Cartridge that may collect

during normal use and ensures that the Pen is working correctly.

If you do not prime before each injection, you may get too much or too little insulin.

Step 7:

To prime your Pen, turn the Dose Knob to select 2 units.

Step 8:

Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top

Step 9:

Continue holding your Pen with Needle pointing up. Push the Dose Knob in until it stops, and “0” is seen in the Dose Window. Hold the Dose Knob in and count to 5 slowly.

You should see insulin at the tip of the Needle.

If you do not see insulin, repeat the priming steps, but not more than 4 times.

If you still do not see insulin, change the Needle and repeat the priming steps.

Small air bubbles are normal and will not affect your dose.

Selecting your dose

You can give from 1 to 60 units in a single injection.

If your dose is more than 60 units, you will need to give more than one injection.

If you need help deciding how to divide up your dose, ask your healthcare professional.

You should use a new Needle for each injection and repeat the priming step.

Step 10:

Turn the Dose Knob to select the number of units you need to inject. The Dose Indicator should line up with your dose.

The Pen dials 1 unit at a time.

The Dose Knob clicks as you turn it.

DO NOT dial your dose by counting the clicks because you may dial the wrong dose.

The dose can be corrected by turning the Dose Knob in either direction until the correct dose lines up with the Dose Indicator.

The even numbers are printed on the dial.

The odd numbers, after the number 1, are shown as full lines.

Always check the number in the Dose Window to make sure you have dialled the correct dose.

(Example: 12 units shown in the Dose Window)

(Example: 25 units shown in the Dose Window)

The Pen will not let you dial more than the number of units left in the Pen.

If you need to inject more than the number of units left in the Pen, you may either:

inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or

get a new Pen and inject the full dose.

It is normal to see a small amount of insulin left in the Pen that you cannot inject.

Giving your injection

Inject your insulin as your healthcare professional has shown you.

Change (rotate) your injection site for each injection.

Do not try to change your dose while injecting.

Step 11:

Choose your injection site.

Your insulin is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.

Wipe your skin with an alcohol swab, and let the injection site dry before you inject your dose.

Step 12:

Insert the Needle into your skin.

Push the Dose Knob all the way in.

Continue to hold the Dose

Knob in and slowly count

to 5 before removing the 5 sec Needle.

Do not try to inject your insulin by turning the Dose Knob. You will NOT receive your insulin by turning the Dose Knob.

Step 13:

Pull the Needle out of your skin.

A drop of insulin at the Needle tip is normal. It will not affect your dose.

Check the number in the Dose Window

If you see “0” in the Dose window, you have received the full amount you dialled.

If you do not see “0” in the Dose window, do not redial. Insert the needle into your skin and finish your injection.

If you still do not think you received the full amount you dialled for your injection, do not start over or repeat that injection. Monitor your blood glucose as instructed by your healthcare professional.

If you normally need to give 2 injections for your full dose, be sure to give your second injection.

The plunger only moves a little with each injection, and you may not notice that it moves.

If you see blood after you take the Needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.

After your injection

Step 14:

Carefully replace the Outer Needle Shield.

Step 15:

Unscrew the capped Needle and dispose of it as described below (see Disposing of Pens and Needles section).

Do not store the Pen with the Needle attached to prevent leaking, blocking the Needle, and air from entering the Pen.

Step 16:

Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

Disposing of pens and needles

Put used Needles in a sharps container or a hard plastic container with a secure lid. Do not throw needles directly into your household waste.

The used Pen may be discarded in your household waste after you have removed the Needle.

Do not recycle the filled sharps container.

Ask your healthcare professional about options to dispose of the sharps container properly.

The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.

Storing your pen

Unused pens

Store unused Pens in the refrigerator at 2°C to 8°C.

Do not freeze your insulin. Do not use if it has been frozen.

Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept in the refrigerator.

In-use Pen

Store the Pen you are currently using at room temperature up to 30°C and away from heat and light.

Throw away the Pen you are using after the time specified in the Package Leaflet, even if it still has insulin left in it.

General information about the safe and effective use of your pen

Keep your Pen and Needles out of the sight and reach of children.

Do not use your Pen if any part looks broken or damaged.

Always carry an extra Pen in case yours is lost or damaged.

Troubleshooting

If you cannot remove the Pen Cap, gently twist the cap back and forth, and then pull the cap straight off.

If the Dose Knob is hard to push:

Pushing the Dose Knob more slowly will make it easier to inject.

Your Needle may be blocked. Put on a new Needle and prime the Pen.

You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen.

If you have any questions or problems with your KwikPen, call your healthcare professional for help or contact your local Lilly affiliate

Document Revision Date:

Package leaflet: Information for the user Humalog 200 units/ml, solution for injection in pre-filled pen

insulin lispro

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Humalog 200 units/ml KwikPen is and what it is used for

2.What you need to know before you use Humalog 200 units/ml KwikPen

3.How to use Humalog 200 units/ml KwikPen

4.Possible side effects

5.How to store Humalog 200 units/ml KwikPen

6.Contents of the pack and other information

1.What Humalog 200 units/ml KwikPen is and what it is used for

Humalog 200 units/ml KwikPen is used to treat diabetes. Humalog works more quickly than normal human insulin because insulin lispro has been changed slightly in comparison to human insulin. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas.

You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally use Humalog within 15 minutes of a meal.

Your doctor may tell you to use Humalog 200 units/ml KwikPen as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to.

Humalog 200 units/ml KwikPen should be reserved for the treatment of adults with diabetes requiring daily doses of more than 20 units of rapid-acting insulin.

2.What you need to know before you use Humalog 200 units/ml KwikPen

Do NOT use Humalog 200 units/ml KwikPen

-if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in section 6).

-if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see section 3: If you take more Humalog than you need).

Warnings and precautions

The Humalog 200 units/ml solution for injection in your pre-filled pen (the KwikPen) should ONLY be injected with this pre-filled pen. Do not transfer the insulin lispro from your Humalog 200 units/ml KwikPen to a syringe. The markings on the insulin syringe will not measure your dose correctly. A severe overdose can result, causing low blood sugar which may put your life in danger. Do not transfer insulin from your Humalog 200 units/ml KwikPen to any other insulin delivery devices like insulin infusion pumps.

Do NOT mix the Humalog 200 units/ml solution for injection in your pre-filled pen (the KwikPen) with any other insulin or any other medicine. The Humalog 200 units/ml solution for injection should not be diluted.

If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed in section 4 of this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often.

A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.

If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse

-Have you recently become ill?

-Do you have trouble with your kidneys or liver?

-Are you exercising more than usual?

You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Other medicines and Humalog 200 units/ml KwikPen

Your insulin needs may change if you are taking

the contraceptive pill,

steroids,

thyroid hormone replacement therapy,

oral hypoglycaemics, (e.g. metformin, acarbose, sulphonylurea agents, pioglitazone, empagliflozin, DPP-4-inhibitors like sitagliptin or saxagliptine, ),

acetyl salicylic acid,

sulpha antibiotics,

somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too much growth hormone),

“beta2 stimulants”such as salbutamol or terbutaline to treat asthma, or ritodrine used to stop premature labor,

beta-blockers – to treat high blood pressure., or

some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),

danazol (medicine acting on ovulation),

some angiotensin converting (ACE) inhibitors, used to treat certain heart conditions or high blood pressure (for example captopril, enalapril), and

specific medicines to treat high blood pressure, kidney damage due to diabetes, and some heart problems (angiotensin II receptor blockers).

Please tell your doctor, if you are taking, have recently taken or might take any other medicines. (see also section “Warnings and precautions”).

Humalog with alcohol

Your blood sugar levels may either rise or fall if you drink alcohol. Therefore the amount of insulin needed may change.

Pregnancy and breast-feeding

Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. Ask your doctor for advice.

Driving and using machines

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines). You should contact your doctor about the advisability of driving if you have:

frequent episodes of hypoglycaemia

reduced or absent warning signs of hypoglycaemia

3.How to use Humalog 200 units/ml KwikPen

Always check the pack and the label of the pre-filled pen for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Humalog 200 units/ml KwikPen that your doctor has told you to use.

Always use this medicine exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used by you only, even if the needle is changed.

Humalog 200 units/ml KwikPen is for patients taking more than 20 units of rapid-acting insulin a day.

Do not transfer insulin from your Humalog 200 units/ml KwikPen to a syringe. The markings on the insulin syringe will not measure your dose correctly. A severe overdose can result, causing low blood sugar which may put your life in danger.

Do not use Humalog 200 units/ml KwikPen solution for injection in an insulin infusion pump.

Dosage

You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly.

If you change the type of insulin you use (for example from a human or animal insulin to a Humalog product), you may have to take more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months.

Inject Humalog under the skin (subcutaneously).

Preparing Humalog 200 units/ml KwikPen

Humalog is already dissolved in water, so you do not need to mix it. But you must use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time you inject yourself.

Getting the KwikPen ready to use (Please see user manual)

First wash your hands.

Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions carefully. Here are some reminders.

Use a clean needle. (Needles are not included).

Prime your KwikPen before each use. This checks that insulin comes out and clears the air bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these are harmless. But if the air bubbles are too large it may affect the insulin dose.

Injecting Humalog

Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. After your injection, leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will still work quicker than soluble human insulin.

Do not inject Humalog 200 units/ml KwikPen solution for injection directly into a vein (intravenously).

After injecting

As soon as you have done the injection, unscrew the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen and your needle clogging. Do not share your needles. Do not share your pen. Replace the cap on your pen.

Further injections

Every time you use a KwikPen you must use a new needle. Before every injection, clear any air bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing up.

Once the KwikPen is empty, do not use it again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do this.

If you take more Humalog than you need

If you take more Humalog than you need, a low blood sugar may occur. Check your blood sugar.

If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.

If you forget to use Humalog

If you take less Humalog than you need, a high blood sugar may occur. Check your blood sugar

If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids (dehydration), unconsciousness, coma or even death (see section 4 “Possible side effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

Always carry a spare pen in case you lose your KwikPen or it gets damaged.

Always carry something to show you are diabetic.

Always carry sugar with you.

If you stop using Humalog.

If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows:

rash over the whole body

blood pressure dropping

difficulty in breathing

heart beating fast

wheezing

sweating

If you think you are having this sort of insulin allergy with Humalog, contact a doctor at once.

Local allergy is common (may affect up to 1 in 10 people). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.

Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people). If you notice your skin thickening or pitting at the injection site, tell your doctor.

Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

Common problems of diabetes

Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

you take too much Humalog or other insulin;

you miss or delay meals or change your diet;

you exercise or work too hard just before or after a meal;

you have an infection or illness (especially diarrhoea or vomiting);

there is a change in your need for insulin; or

you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels (see section 2).

The first symptoms of low blood sugar usually come on quickly and include the following:

tiredness

rapid heartbeat

nervousness or shakiness

feeling sick

headache

cold sweat

While you are not confident about recognising your warning symptoms, avoid situations such as driving a car, in which you or others would be put at risk by hypoglycaemia.

Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

not taking your Humalog or other insulin;

taking less insulin than your doctor tells you to;

eating a lot more than your diet allows; or

fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

feeling sleepy

 

no appetite

flushed face

fruity smell on the breath

thirst

feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.

Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

5.How to store Humalog 200 units/ml KwikPen

Keep this medicine out of the sight and reach of children.

Do not use Humalog 200 units/ml KwikPen after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Before the first use store your Humalog 200 units/ml KwikPen in a refrigerator (2°C – 8°C). Do not freeze.

Keep your Humalog 200 units/ml KwikPen in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge. The KwikPen should not be stored with the needle attached.

Do not use Humalog 200 units/ml KwikPen, if the solution is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.Contents of the pack and other information

What Humalog 200 units/ml KwikPen solution for injection contains

-The active substance is insulin lispro. Each ml of solution contains 200 units (U) of insulin lispro. Each pre-filled pen (3 ml) contains 600 units (U) of insulin lispro.

-The other ingredients are metacresol, glycerol, trometamol, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

What Humalog 200 units/ml KwikPen looks like and contents of the pack

Humalog 200 units/ml KwikPen, solution for injection is a sterile, clear, colourless, aqueous solution and contains 200 units of insulin lispro in each millilitre (200 units/ml) solution for injection. Each Humalog 200 units/ml KwikPen contains 600 units (3 millilitres). The Humalog 200 units/ml KwikPen comes in a pack of 1, 2 or 5 pre-filled pens or multipacks of 2 x 5 pre-filled pens. Not all

pack sizes may be marketed. The KwikPen simply has a built in cartridge. When the pre-filled pen is empty you cannot use it again.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,

Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

Eli Lilly Benelux S.A./N.V.

Eli Lilly Holdings Limited atstovybė

Tél/Tel: + 32-(0)2 548 84 84

Tel. +370 (5) 2649600

България

Luxembourg/Luxemburg

ТП "Ели Лили Недерланд" Б.В. - България

Eli Lilly Benelux S.A./N.V.

тел. + 359 2 491 41 40

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

Magyarország

ELI LILLY ČR, s.r.o.

Lilly Hungária Kft.

Tel: + 420 234 664 111

Tel: + 36 1 328 5100

Danmark

Malta

Eli Lilly Danmark A/S

Charles de Giorgio Ltd.

Tlf: +45 45 26 6000

Tel: + 356 25600 500

Deutschland

Nederland

Lilly Deutschland GmbH

Eli Lilly Nederland B.V.

Tel. + 49-(0) 6172 273 2222

Tel: + 31-(0) 30 60 25 800

Eesti

Norge

Eli Lilly Holdings Limited Eesti filiaal

Eli Lilly Norge A.S.

Tel: +372 6817 280

Tlf: + 47 22 88 18 00

Ελλάδα

Österreich

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Eli Lilly Ges. m.b.H.

Τηλ: +30 210 629 4600

Tel: + 43-(0) 1 711 780

España

Polska

Lilly S.A.

Eli Lilly Polska Sp. z o.o.

Tel: + 34-91 663 50 00

Tel: +48 22 440 33 00

France

Portugal

Lilly France S.A.S.

Lilly Portugal - Produtos Farmacêuticos, Lda

Tél: +33-(0) 1 55 49 34 34

Tel: + 351-21-4126600

Hrvatska

România

Eli Lilly Hrvatska d.o.o.

Eli Lilly România S.R.L.

Tel: +385 1 2350 999

Tel: + 40 21 4023000

Ireland

Slovenija

Eli Lilly and Company (Ireland) Limited

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 353-(0) 1 661 4377

Tel: +386 (0) 1 580 00 10

Ísland

Slovenská republika

Icepharma hf.

Eli Lilly Slovakia, s.r.o.

Sími + 354 540 8000

Tel: + 421 220 663 111

Italia

Suomi/Finland

Eli Lilly Italia S.p.A.

Oy Eli Lilly Finland Ab

Tel: + 39- 055 42571

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Sverige

Phadisco Ltd

Eli Lilly Sweden AB

Τηλ: +357 22 715000

Tel: + 46-(0) 8 7378800

Latvija

United Kingdom

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Eli Lilly and Company Limited

Tel: +371 67364000

Tel: + 44-(0) 1256 315000

This leaflet was last revised in

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

USER MANUAL

Humalog 200 units/ml solution for injection in pre-filled pen insulin lispro

PLEASE READ THIS USER MANUAL BEFORE USE

USE ONLY IN THIS PEN, OR

SEVERE OVERDOSE CAN RESULT

Read the User Manual before you start taking Humalog 200 units/ml KwikPen solution for injection and each time you get another Humalog 200 units/ml KwikPen. There may be new information. This information does not take the place of talking to your healthcare professional about your medical condition or your treatment.

Humalog 200 units/ml KwikPen (“Pen”) is a disposable pre-filled pen containing 3 ml (600 units, 200 units/ml) of insulin lispro solution for injection. You can give yourself multiple doses using one Pen. The Pen dials 1 unit at a time. You can inject from 1 to 60 units in a single injection. If your dose is more than 60 units, you will need to give yourself more than one injection. The plunger only moves a little with each injection, and you may not notice that it moves. The plunger will only reach the end of the cartridge when you have used all 600 units in the Pen.

This pen is designed to allow you to give more doses than other pens you may have used in the past. Dial your usual dose as instructed by your healthcare professional.

Humalog KwikPen is available in two strengths, 100 units/ml and 200 units/ml. Inject Humalog 200 units/ml ONLY with your Pen. DO NOT transfer insulin from your Pen to another insulin delivery device. Syringes and insulin pumps will not dose 200 units/ml insulin correctly. A severe overdose can result, causing very low blood sugar which may put your life in danger.

Do not share your Pen with other people, even if the needle has been changed. Do not reuse or share needles with other people.. You may give an infection to them or get an infection from them.

This Pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the Pen.

KwikPen Parts

Pen Cap

Cartridge Holder Label

Dose Indicator

Cap

 

 

Rubber Seal

 

Clip

 

Pen Needle Parts

(Needles Not Included)

Needle

USE ONLY IN THIS PEN OR

 

 

 

 

 

 

SEVERE OVERDOSE CAN RESULT

 

 

 

 

 

 

 

 

 

 

 

 

Dose

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Dose

Plunger

Pen Body

Knob

Window

 

 

 

 

 

 

Dose Knob with burgundy ring

Outer Needle

Inner

Paper Tab

Shield

Needle

 

 

Shield

 

How to recognize your Humalog 200 units/ml KwikPen:

-

Pen colour:

Dark grey

-

Dose Knob:

Dark grey with burgundy ring on the end

-

Labels:

Burgundy, “200 units/ml” in yellow box.

 

 

Yellow warning on cartridge holder

Supplies needed to give your injection:

Humalog 200 units/ml KwikPen

KwikPen compatible Needle (BD [Becton, Dickinson and Company] Pen Needles recommended)

Alcohol swab

Needles and alcohol swab are not included.

Preparing your Pen

Wash your hands with soap and water.

Check the Pen to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.

Do not use your Pen past the expiration date printed on the Label or for more than 28 days after you first start using the Pen.

Always use a new Needle for each injection to help prevent infections and blocked Needles.

Step 1:

Pull the Pen Cap straight off.

• Do not remove the Pen Label.

Wipe the Rubber Seal with an alcohol swab.

Humalog 200 units/ml solution for injection should look clear and colourless. Do not use if it is cloudy, coloured, or has particles or clumps in it.

USE ONLY IN THIS PEN OR

SEVERE OVERDOSE CAN RESULT

Step 2:

Select a new Needle.

Pull off the Paper Tab from the Outer Needle Shield.

Step 3:

Push the capped Needle straight onto the Pen and twist the Needle on until it is tight.

Step 4:

Pull off the Outer Needle Shield. Do not throw it away.

Pull off the Inner Needle Shield and throw it away.

Priming your Pen

Prime before each injection.

Priming your Pen means removing the air from the Needle and Cartridge that may collect during normal use and ensures that the Pen is working correctly.

If you do not prime before each injection, you may get too much or too little insulin.

Step 5:

To prime your Pen, turn the Dose Knob to select 2 units.

Step 6:

Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.

Step 7:

Continue holding your Pen with Needle pointing up. Push the Dose Knob in until it stops, and “0” is seen in the Dose Window. Hold the Dose Knob in and count to 5 slowly.

You should see insulin at the tip of the Needle.

If you do not see insulin, repeat the priming steps, but not more than

8 times.

If you still do not see insulin, change the Needle and repeat the priming steps.

Small air bubbles are normal and will not affect your dose.

Selecting your dose

This pen has been designed to deliver the dose that is shown in the window. Dial your usual dose as instructed by your healthcare professional.

You can give from 1 to 60 units in a single injection.

If your dose is more than 60 units, you will need to give more than one injection.

-If you need help deciding how to divide up your dose, ask your healthcare professional.

-You should use a new Needle for each injection and repeat the priming step.

Step 8:

Turn the Dose Knob to select the number of units you need to inject. The Dose Indicator should line up with your dose.

The Pen dials 1 unit at a time.

The Dose Knob clicks as you turn it.

DO NOT dial your dose by counting the clicks because you may dial the wrong dose.

The dose can be corrected by turning the Dose Knob in either direction until the correct dose lines up with the Dose Indicator.

The even numbers are printed on the dial.

The odd numbers, after the number 1, are shown as full lines.

Always check the number in the Dose Window to make sure you have dialled the correct dose.

(Example: 12 units shown in the Dose Window)

(Example: 25 units shown in the Dose Window)

The Pen will not let you dial more than the number of units left in the Pen.

If you need to inject more than the number of units left in the Pen, you may either:

-inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or

-get a new Pen and inject the full dose.

Giving your injection

Inject your insulin as your healthcare professional has shown you.

Change (rotate) your injection site for each injection.

Do not try to change your dose while injecting.

Step 9:

Choose your injection site.

Humalog 200 units/ml solution for injection is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.

Wipe your skin with an alcohol swab, and let your skin dry before you inject your dose.

Step 10:

Insert the Needle into your skin.

Push the Dose Knob all the way in.

Continue to hold the Dose Knob in and slowly count to 5 before removing the Needle.

Do not try to inject your insulin by turning the Dose Knob. You will NOT receive your insulin by turning the Dose Knob.

Step 11:

Pull the Needle out of your skin.

A drop of insulin at the Needle tip is normal. It will not affect your dose.

Check the number in the Dose Window.If you see “0” in the Dose Window, you have received the full amount you dialled.

If you do not see “0” in the Dose Window, do not redial. Insert the needle into your skin and finish your injection.

If you still do not think you received the full amount you dialled for your injection, do not start over or repeat that injection. Monitor your blood glucose as instructed by your healthcare professional.

The plunger only moves a little with each injection and you may not notice that it moves.

If you see blood after you take the Needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.

After your injection

Step 12:

Carefully replace the Outer Needle Shield.

Step 13:

Unscrew the capped Needle and dispose of it as described below (see Disposing of Pens and Needles section).

Do not store the Pen with the Needle attached to prevent leaking, blocking the Needle, and air from entering the Pen.

Step 14:

Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

Disposing of Pens and Needles

Put used Needles in a sharps container or hard plastic container with a secure lid. Do not throw needles directly into your household waste.

The used Pen may be discarded in your household waste after you have removed the Needle.

Do not recycle the filled sharps container.

Ask your healthcare professional about options to dispose of the sharps container properly.

The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.

Storing your Pen

Unused Pens

Store unused Pens in the refrigerator at 2°C to 8°C.

Do not freeze Humalog 200 units/ml solution for injection. Do not use if it has been frozen.

Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept in the refrigerator.

In-use Pen

Store the Pen you are currently using at room temperature (up to 30°C) and away from heat and light.

Throw away the Pen you are using after 28 days, even if it still has insulin left in it.

General information about the safe and effective use of your Pen

Keep your Pen and Needles out of the sight and reach of children.

Do not use your Pen if any part looks broken or damaged.

Always carry an extra Pen in case yours is lost or damaged.

Troubleshooting

If you cannot remove the Pen Cap, gently twist the cap back and forth, and then pull the cap straight off.

If the Dose Knob is hard to push;

-Pushing the Dose Knob more slowly will make it easier to inject.

-Your Needle may be blocked. Put on a new Needle and prime the Pen.

-You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen.

Do not transfer insulin from the Pen to a syringe or an insulin pump. Severe overdose can result.

If you have any questions or problems with your Humalog 200 units/ml KwikPen, call your healthcare professional for help or contact your local Lilly affiliate.

Document revision date:

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