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Ultratard (insulin human) – Package leaflet - A10AE01

Updated on site: 10-Oct-2017

Medication nameUltratard
ATC CodeA10AE01
Substanceinsulin human
ManufacturerNovo Nordisk A/S

Article Contents

Ultratard

Read all of this leaflet carefully before you start using your insulin. Keep this leaflet. You may

DK-2880 Bagsværd, Denmark.

authorised

need to read it again.

 

If you have further questions, please ask your doctor, diabetes nurse or pharmacist. This medicine is prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Ultratard 40 IU/ml Suspension for injection in a vial

Suspension for injection in a vial. Insulin human, rDNA. Ultratard is a zinc suspension consisting of crystalline particles.

The active substance is insulin human made by recombinant biotechnology.

1 ml contains 40 IU of insulin human. 1 vial contains 10 ml equivalent to 400 IU.

Ultratard also contains zinc chloride, sodium chloride, methyl parahydroxy benzoate, sodium actetate, sodium hydroxide, hydrochloric acid and water for injections.

The suspension for injection comes as a white, cloudy suspension in packs of 1 or 5 vials of 10 ml (not all packs may be marketed).

The marketing authorisation holder and manufacturer is Novo Nordisk A/S, Novo Allé,

1 What Ultratard is

Ultratard is human insulin to treat diabetes. It comes in a 10 ml vial that you use to fill a syringe. Ultratard is a very long-acting insulin. This means that it will start to lower your blood sugar about 4 hours after you take it, and the effect will last for approximately 28 hours. Ultratard is often given in

combination with fast-acting insulins.

no

longer

 

 

2 Before you use Ultratard

 

Do not use Ultratard

 

 

 

If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of

 

low blood sugar). See 4 What to do in an emergency for more about hypos

If you have ever had an allergic reaction to this insulin product or any of the ingredients (see

 

box, below left). Some people are allergic to the ingredient methyl parahydroxy benzoate. Look

Take special care with Ultratard

out for the signs of allergyProductin 5 Possible side effects.

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands

If you are drinking alcohol: watch for signs of a hypo

If you are exercising more than usual or if you want to change your usual diet

If you are ill: carry on taking your insulin

If you are going abroad: travelling over time zones may affect your insulin needs

If you are pregnant, or planning a pregnancy: you must be especially careful to control your blood sugar; too much or too little could harm your health and the baby’s

If you are breastfeeding: there’s no risk to the baby, but you may need to adjust your insulin and your diet

If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming

on. Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.Medicinal

Other medicines and Ultratard

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most important medicines which may affect your insulin treatment. Talk to your doctor if you take or change any other medicines, even those not-prescribed.

3 Using Ultratard

Your need for insulin may change if you also take: oral hypoglycaemic agents; monoamine oxidase

inhibitors (MAOI); certain beta-blockers; ACE-inhibitors; acetylsalicylic acid; thiazides;

glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol;

Before using Ultratard

authorised

octreotide and lanreotide.

 

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advice carefully. This leaflet is a general guide.

If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Make sure it is the right type of insulin

Disinfect the rubber membrane with surgical spirit.

Do not use Ultratardlonger

► If the protective cap is loose or missing. Each vial has a protective, tamperproof plastic cap. If it isn’t in perfect condition when you get the vial, return the vial to your supplier

► If it hasn’t been stored correctly or been frozen (see 6 How to store Ultratard) ► If it’s not uniformly white and cloudy after rolling.

How to use this insulin

Ultratard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best place to give yourself an injection is the front of your thighs.no If convenient, the front of your waist

(abdomen), your buttocks or the front of your upper arms may be used.

You should always measure your blood glucose regularly.

Just before injecting this insulin, roll the vial between your hands until the liquid is uniformly

white and cloudy

 

Draw air into the syringe, in the same amount as the dose of insulin you need

Inject the air into the vial: push the needle through the rubber stopper and press the plunger

Turn the vial and syringe upside down

Draw the right dose of insulin into the syringe

Pull the needle out of the vial

Make sure there is no air left in the syringe: point the needle upwards and push the air out

 

Product

Check you have the right dose

Inject straight away.

 

Roll the vial of Ultratard between your hands until the liquid is uniformly white and cloudy

Draw as much air into the syringe as the dose of Ultratard you need. Inject the air into the

Ultratard vial, then pull out the needle

Draw as much air into the syringe as the dose of fast acting insulin you need. Inject the air into

the fast acting insulin vial. Then turn the vial and syringe upside down

Draw the right dose of fast acting insulin into the syringe. Pull the needle out of the vial.

 

Make sure there is no air left in the syringe: point the needle upwards and push the air out.

 

Check the dose

 

MedicinalNow push the needle into the vial of Ultratard. Then turn the vial and syringe upside down

Draw the right dose of Ultratard into the syringe. Pull the needle out of the vial. Make sure there

is no air left in the syringe, and check the dose

• Inject the mixture straight away.

Always mix fast acting and long acting insulin in this order.

authorised

 

Inject the insulin

 

Inject the insulin under the skin. Use the injection technique advised by your doctor or diabetes

nurse

 

Keep the needle under your skin for at least 6 seconds to make sure the full dose has been

 

delivered.

 

4 What to do in an emergency

If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs: eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell people that if you pass out (become unconscious), they should: turn you on your side and get medical help straight away. They should not give you any food or drink. It could choke you.

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.

If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and

 

even death

 

 

longer

 

 

 

 

If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or

 

timing of insulin, food or exercise may need to be adjusted.

Using glucagon

Product

no

 

 

 

 

 

 

 

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

• If you take too much insulin

Medicinal

If you eat too little or miss a meal

If you exercise more than usual.

If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity smell of the breath.

If you get any of these signs: test your blood sugar level; test your urine for ketones if you can; then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of a hyperglycaemia

Having forgotten to take your insulin

Repeatedly taking less insulin than you need

An infection or a fever

Eating more than usual

Less exercise than usual.

5 Possible side effects

Like all medicines, Ultratard can have side effects.

Common side effects (up to 10%)

Low or high blood sugar (hypo or hyperglycaemia). Taking too much or too little Ultratard may cause respectively hypo or hyperglycaemia. See the advice in 4 What to do in an emergency.

Rare side effects (up to 0.1%)

authorised

 

Vision problems. When you first start your insulin treatment, it may disturb your vision, but the reaction usually disappears.

Changes at the injection site. Reactions (redness, swelling, itching) at the injection site may occur and will normally disappear during use. If you inject yourself too often in the same site, lumps may develop underneath. Prevent this by choosing different injection sites each time within the same area.

longer

Signs of allergy. Very rarely, people get redness, swelling or itching around the area of the insulin injection (local allergic reactions). These usually go away after a few weeks of taking your insulin. If

they do not go away, see your doctor.

 

Seek medical advice straight away:

 

If signs of allergy spread to other parts of your body, or

 

no

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

 

Product

 

in breathing; have a rapid heart beat; feel dizzy.

You may have a very rare serious allergic reaction to Ultratard or one of its ingredients (called a systemic allergic reaction). See also the warning in 2 Before you use Ultratard.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon goes away.

If you notice any side effects, also those not mentioned in this leaflet, please inform your doctor or

pharmacist.

6 HowMedicinalto store Ultratard

Keep out of the reach and sight of children.

Ultratard vials that are not being used are to be stored in the fridge at 2°C - 8°C, away from the freezer compartment. Do not freeze.

Ultratard vials that are being used or about to be used are not to be kept in the fridge. You can carry them with you and keep them at room temperature (below 25°C) for up to 6 weeks.

Always keep the vial in the outer carton when you’re not using it in order to protect it from light. Ultratard should be protected from excessive heat and sunlight.

Do not use Ultratard after the expiry date stated on the label and the carton.

Leaflet last approved on

Ultratard

Read all of this leaflet carefully before you start using your insulin. Keep this leaflet. You may

DK-2880 Bagsværd, Denmark.

authorised

need to read it again.

 

If you have further questions, please ask your doctor, diabetes nurse or pharmacist. This medicine is prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Ultratard 100 IU/ml Suspension for injection in a vial

Suspension for injection in a vial. Insulin human, rDNA. Ultratard is a zinc suspension consisting of crystalline particles.

The active substance is insulin human made by recombinant biotechnology.

1 ml contains 100 IU of insulin human. 1 vial contains 10 ml equivalent to 1000 IU.

Ultratard also contains zinc chloride, sodium chloride, methyl parahydroxy benzoate, sodium acetate, sodium hydroxide, hydrochloric acid and water for injections.

The suspension for injection comes as a white, cloudy suspension in packs of 1 or 5 vials of 10 ml (not all packs may be marketed).

The marketing authorisation holder and manufacturer is Novo Nordisk A/S, Novo Allé,

1 What Ultratard is

Ultratard is human insulin to treat diabetes. It comes in a 10 ml vial that you use to fill a syringe. Ultratard is a very long-acting insulin. This means that it will start to lower your blood sugar about 4 hours after you take it, and the effect will last for approximately 28 hours. Ultratard is often given in

combination with fast-acting insulins.

no

longer

 

 

2 Before you use Ultratard

 

Do not use Ultratard

 

 

 

If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of

 

low blood sugar). See 4 What to do in an emergency for more about hypos

If you have ever had an allergic reaction to this insulin product or any of the ingredients (see

 

box, below left). Some people are allergic to the ingredient methyl parahydroxy benzoate. Look

Take special care with Ultratard

out for the signs of allergyProductin 5 Possible side effects.

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands

If you are drinking alcohol: watch for signs of a hypo

If you are exercising more than usual or if you want to change your usual diet

If you are ill: carry on taking your insulin

If you are going abroad: travelling over time zones may affect your insulin needs

If you are pregnant, or planning a pregnancy: you must be especially careful to control your blood sugar; too much or too little could harm your health and the baby’s

If you are breastfeeding: there’s no risk to the baby, but you may need to adjust your insulin and your diet

If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming

on. Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.Medicinal

Other medicines and Ultratard

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most important medicines which may affect your insulin treatment. Talk to your doctor if you take or change any other medicines, even those not-prescribed.

3 Using Ultratard

Your need for insulin may change if you also take: oral hypoglycaemic agents; monoamine oxidase

inhibitors (MAOI); certain beta-blockers; ACE-inhibitors; acetylsalicylic acid; thiazides;

glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol;

Before using Ultratard

authorised

octreotide and lanreotide.

 

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advice carefully. This leaflet is a general guide.

If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Make sure it is the right type of insulin

Disinfect the rubber membrane with surgical spirit.

Do not use Ultratardlonger

► If the protective cap is loose or missing. Each vial has a protective, tamperproof plastic cap. If it isn’t in perfect condition when you get the vial, return the vial to your supplier

► If it hasn’t been stored correctly or been frozen (see 6 How to store Ultratard) ► If it’s not uniformly white and cloudy after rolling.

How to use this insulin

Ultratard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best place to give yourself an injection is the front of your thighs.no If convenient, the front of your waist

(abdomen), your buttocks or the front of your upper arms may be used.

You should always measure your blood glucose regularly.

Just before injecting this insulin, roll the vial between your hands until the liquid is uniformly

white and cloudy

 

Draw air into the syringe, in the same amount as the dose of insulin you need

Inject the air into the vial: push the needle through the rubber stopper and press the plunger

Turn the vial and syringe upside down

Draw the right dose of insulin into the syringe

Pull the needle out of the vial

Make sure there is no air left in the syringe: point the needle upwards and push the air out

 

Product

Check you have the right dose

Inject straight away.

 

Roll the vial of Ultratard between your hands until the liquid is uniformly white and cloudy

Draw as much air into the syringe as the dose of Ultratard you need. Inject the air into the

Ultratard vial, then pull out the needle

Draw as much air into the syringe as the dose of fast acting insulin you need. Inject the air into

the fast acting insulin vial. Then turn the vial and syringe upside down

Draw the right dose of fast acting insulin into the syringe. Pull the needle out of the vial.

 

Make sure there is no air left in the syringe: point the needle upwards and push the air out.

 

Check the dose

 

MedicinalNow push the needle into the vial of Ultratard. Then turn the vial and syringe upside down

Draw the right dose of Ultratard into the syringe. Pull the needle out of the vial. Make sure there

is no air left in the syringe, and check the dose

• Inject the mixture straight away.

Always mix fast acting and long acting insulin in this order.

authorised

 

Inject the insulin

 

Inject the insulin under the skin. Use the injection technique advised by your doctor or diabetes

nurse

 

Keep the needle under your skin for at least 6 seconds to make sure the full dose has been

 

delivered.

 

4 What to do in an emergency

If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs: eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell people that if you pass out (become unconscious), they should: turn you on your side and get medical help straight away. They should not give you any food or drink. It could choke you.

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.

If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and

 

even death

 

 

longer

 

 

 

 

If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or

 

timing of insulin, food or exercise may need to be adjusted.

Using glucagon

Product

no

 

 

 

 

 

 

 

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

• If you take too much insulin

Medicinal

If you eat too little or miss a meal

If you exercise more than usual.

If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity smell of the breath.

If you get any of these signs: test your blood sugar level; test your urine for ketones if you can; then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of a hyperglycaemia

Having forgotten to take your insulin

Repeatedly taking less insulin than you need

An infection or a fever

Eating more than usual

Less exercise than usual.

5 Possible side effects

Like all medicines, Ultratard can have side effects.

Common side effects (up to 10%)

Low or high blood sugar (hypo or hyperglycaemia). Taking too much or too little Ultratard may cause respectively hypo or hyperglycaemia. See the advice in 4 What to do in an emergency.

Rare side effects (up to 0.1%)

authorised

 

Vision problems. When you first start your insulin treatment, it may disturb your vision, but the reaction usually disappears.

Changes at the injection site. Reactions (redness, swelling, itching) at the injection site may occur and will normally disappear during use. If you inject yourself too often in the same site, lumps may develop underneath. Prevent this by choosing different injection sites each time within the same area.

longer

Signs of allergy. Very rarely, people get redness, swelling or itching around the area of the insulin injection (local allergic reactions). These usually go away after a few weeks of taking your insulin. If

they do not go away, see your doctor.

 

Seek medical advice straight away:

 

If signs of allergy spread to other parts of your body, or

 

no

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

 

Product

 

in breathing; have a rapid heart beat; feel dizzy.

You may have a very rare serious allergic reaction to Ultratard or one of its ingredients (called a systemic allergic reaction). See also the warning in 2 Before you use Ultratard.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon goes away.

If you notice any side effects, also those not mentioned in this leaflet, please inform your doctor or

pharmacist.

6 HowMedicinalto store Ultratard

Keep out of the reach and sight of children.

Ultratard vials that are not being used are to be stored in the fridge at 2°C - 8°C, away from the freezer compartment. Do not freeze.

Ultratard vials that are being used or about to be used are not to be kept in the fridge. You can carry them with you and keep them at room temperature (below 25°C) for up to 6 weeks.

Always keep the vial in the outer carton when you’re not using it in order to protect it from light. Ultratard should be protected from excessive heat and sunlight.

Do not use Ultratard after the expiry date stated on the label and the carton.

Leaflet last approved on

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