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Accofil (filgrastim) – Package leaflet - L03AA02

Updated on site: 11-Jul-2017

PACKAGE LEAFLET: INFORMATION FOR THE USER

Accofil 30 MU/0.5 ml (0.6 mg/ml) solution for injection or infusion in pre-filled syringe filgrastim

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side-effects you may get. See the end of section 4 for how to report side effects.

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, nurse 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet

1.What Accofil is and what it is used for

2.What you need to know before you use Accofil

3.How to use Accofil

4.Possible side effects

5.How to store Accofil

6.Contents of the pack and other information

1. What Accofil is and what it is used for

What Accofil is

Accofil contains the active ingredient filgrastim. Filgrastim is a protein produced in bacteria called Escherichia coli by recombinant DNA technology. It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body. Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells that help fight infection.

What Accofil is used for

Your doctor has prescribed Accofil for you to help your body make more white blood cells. Your doctor will tell you why you are being treated with Accofil. Accofil is useful in several different conditions which are:

-chemotherapy

-bone marrow transplantation

-severe chronic neutropenia (low number of a type of white blood cells)

-neutropenia (low number of a type of white blood cells) in patients with HIV infection

-peripheral blood stem cell mobilisation (to stimulate stem cells to enter the blood stream to be collected and used in bone marrow transplantation).

2. What you need to know before you use Accofil

Do not use Accofil

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Accofil:

Please tell your doctor before starting treatment if you have:

Sickle cell anaemia, accofil may cause sickle cell crisis.

Osteoporosis (bone disease)

Please tell your doctor immediately during treatment with Accofil, if you:

Get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder( these may be symptoms of enlarge spleen or possibly rupture of spleen.

Notice unusual bleeding or bruising that may be (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot.

Have sudden signs of allergy such as rash, itching or hives of skin, swelling of the face, lips,tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be a signs of severe allergic reaction.

You may need to have regular blood tests whilst being treated with Accofil to count the number of neutrophils and other white blood cells in your blood. This will tell your doctor how the treatment is working and will also indicate if treatment needs to be continued.

The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause an allergic reaction.

Other medicines and Accofil

You should not receive Accofil in the 24 hours before and the 24 hours after receiving chemotherapy.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Accofil has not been tested in pregnant women.Your doctor may decide that you should not use this medicine.

It is unknown whether filgrastim passes over into the breast milk. Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding.

Driving and using machines

If you are experiencing fatigue, do not drive a car or operate machines.

Important information about some of the ingredients of Accofil

This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars (fructose), contact your doctor before taking this medicine. This medicine also contains sodium less than 1mmol sodium (0.035 mg) per dose, i.e. essentially ‘sodium-free’.

3.How to use Accofil

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

The amount of Accofil you need will depend on the condition you are taking Accofil for and on your bodyweight.

Dosage

Accofil and neutropenia (low number of a type of white blood cells) associated with chemotherapy

The usual dose is 0.5 million units (5 micrograms) per kilogram of bodyweight each day. For example, if you weigh 60 kilograms your daily dose will be 30 million units (300 micrograms). Your treatment with Accofil will usually last for about 14 days. In some disease types, however, longer treatment lasting up to about one month may be required.

Accofil and bone marrow transplantation

The usual starting dose is 1 million units (10 micrograms) per kilogram of bodyweight each day given as an infusion. For example, if you weigh 60 kilograms your daily dose will be 60 million units (600 micrograms). You will normally receive your first dose of Accofil at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant. Your doctor may then test your blood to see how well the treatment is working and how long it should last.

Accofil and severe chronic neutropenia (low number of a type of white blood cells)

The usual starting dose is between 0.5 million units (5 micrograms) and 1.2 million units (12 micrograms) per kilogram bodyweight each day in a single or divided dose. Your doctor may then test your blood to see how well your treatment with Accofil is working and to find the dose that is best for you. Long-term treatment with Accofil is required for reduction in neutropenia.

Accofil and neutropenia (low number of a type of white blood cells) in patients with HIV infection

The usual starting dose is between 0.1 million units (1 micrograms) and 0.4 million units (4 micrograms) per kilogram bodyweight each day. Your doctor may test your blood at regular intervals to see how well the Accofil treatment is working. Once the number of white cells in your blood has returned to normal it may be possible to reduce the dose frequency to less than once per day. Long term treatment with Accofil may be required to maintain a normal number of white cells in your blood.

Accofil and peripheral blood stem cell transplantation (stem cells collected from the blood to use in bone marrow transplantation)

If you are donating stem cells for yourself, the usual dose is 0.5 million units (5 micrograms) to 1 million units (10 micrograms) per kilogram bodyweight each day. Accofil treatment will last for up to 2 weeks. Your doctor will monitor your blood to determine the best time to collect the stem cells.

If you are acting as a stem cell donor for another person, the usual dose is 1 million units (10 micrograms) per kilogram bodyweight each day. Accofil treatment will last for 4 to 5 days. Your doctor will perform regular blood tests to determine the best time to collect the stem cells.

Method of administration

This medicine is given by injection, either through an intravenous (IV) infusion (drip) or by a subcutaneous (SC) injection into the tissue just under the skin.

If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections. Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Accofil). Do not attempt to self-administer without this training. Some of the information you require is given at the end of this leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.

Information for injecting yourself

This section contains information on how to give yourself an injection of Accofil. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.

How do I inject Accofil myself?

You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection. You will need to have your injections at about the same time every day.

Equipment that you need

To give yourself a subcutaneous injection you will need:

a pre-filled syringe of Accofil;

alcohol swab or similar.

What should I do before I give myself a subcutaneous injection of Accofil?

Ensure the needle cover remains on the syringe until just before you are ready to inject.

a.Take your Accofil pre-filled syringe out of the refrigerator.

b.Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown or if it has been kept outside of the refrigerator for more than 15 days or has otherwise expired.

c.Check the appearance of Accofil. It must be a clear and colourless liquid. If there are particles in it, you must not use it.

d.For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Accofil in any other way (for example, do not warm it in a microwave or in hot water).

e.Wash your hands thoroughly.

f.Find a comfortable, well-lit place and put everything you need where you can reach them (the Accofil pre-filled syringe and alcohol swab).

How do I prepare my Accofil injection?

Before you inject Accofil you must do the following:

1.Hold the syringe and gently take the cover from the needle without twisting. Pull straight as shown in pictures 1 and 2. Do not touch the needle or push the plunger.

2.You may notice a small air bubble in the pre-filled syringe. If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With the syringe pointing upwards, expel all air from the syringe by pushing the plunger upwards.

3.The syringe may contain more liquid than you need. Use the scale on the syringe barrel as follows to set the correct dose of Accofil that your doctor prescribed. Eject unnecessary liquid by pushing the plunger up to the number (mL) on the syringe that matches the prescribed dose.

4.Check again to make sure the correct dose of Accofil is in the syringe.

5.You can now use the pre-filled syringe.

Where should I give my injection?

The most suitable places to inject yourself are:

the top of your thighs; and

the abdomen, except for the area around the navel (see picture 3).

If someone else is injecting you, they can also use the back of your arms (see picture 4)

It is better to change the injection site every day to avoid the risk of soreness at any one site.

How do I give my injection?

a.Disinfect the injection site by using an alcohol swab and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).

Pre-filled syringe without needle safety guard

b.Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).

c.Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.

d.Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger!

e.Inject only the dose your doctor has told you.

f.After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin.

g.Put the used syringe in the disposal container. Use each syringe only for one injection.

Pre-filled syringe with needle safety guard

h.Put the needle fully into the skin as shown by your nurse or doctor (see picture 7).

i.Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.

j.Inject only the dose your doctor has told you following the instructions below.

k.Always keeping your skin pinched, depress the plunger slowly and evenly while grasping the finger flange until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger!

l.After injecting the liquid, remove the needle while keeping the syringe at the same angle and maintaining pressure on the plunger, then let go of your skin. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see picture 8). The needle guard will not activate unless the entire dose has been given.

Remember

If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used syringes

The needle safety guard prevents needle stick injuries after use, so no special precautions for disposal are required. Dispose of the syringe as instructed by your doctor, nurse or pharmacist.

If you use more Accofil than you should

If you use more Accofil than you should, contact your doctor or pharmacist as soon as possible.

If you forget to use Accofil

Do not take a double dose to make up for a forgotten injection. Contact your doctor to discuss when you should inject the next dose.

If you stop using Accofil

Your doctor will tell you when to stop using Accofil. It is quite normal to have a number of courses of treatment with Accofil.

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

4.Possible side effects

Tell your doctor immediately during treatment:

if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face, lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).

Hypersensitivity is common in patients with cancer;

if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Adult Respiratory Distress Syndrome (ARDS). ARDS is uncommon in patients with cancer;

if you get left upper belly (abdonimal) pain, pain below the left rib cage or pain at the tip of your shoulder since this may relate to a problem with your spleen (splenomegaly). This is very common in severe chronic neutropenia patients, common in HIV patients and uncommon in normal stem cell donors.

if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria). Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).

If you have any of the following or a combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally develop in a rapid fashion. These could be symptoms of an uncommon condition (may affect up to 1 in 100 people) called Capillary Leak Syndrome which causes the blood to leak from the small blood vessels into your body and needs urgent medical attention.

A very frequent side effect of Accofil use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics). In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands and soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints. Very commonly seen in normal stem cells donors is increase in white blood cells (leukocytosis) and decrease of platelets which reduces the ability of blood to clot (thrombocytopenia), these will be monitored by your doctor.

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

Very common side effects (seen in more than 1 in 10 people who take Accofil): in cancer patients

changes in blood chemistry

increase in certain enzymes in the blood

decreased apetite

headache

pain in the mouth and throat (oropharyngeal pain)

cough

diarrhoea

vomiting

constipation

nausea

skin rash

unusual hair loss or thinning (alopecia)

pain in your muscles or bones (musculoskeletal pain)

generalized weakness (asthenia)

tiredness (fatigue)

soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucosal inflammation)

shortness of breath (dyspnoea)

in normal stem cell donors

decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)

increase in white blood cells (leukocytosis)

headache

pain in your muscles or bones (musculoskeletal pain)

in severe chronic neutropenia patients

enlargement of the spleen (splenomegaly)

low red blood cell count (anaemia)

changes in blood chemistry

increase of certain enzymes in the blood

headache

nose bleeds (epistaxis)

diarrhoea

enlargment of the liver (hepatomegaly)

skin rash

pain in your muscles or bones (musculoskeletal pain)

joint pain (arthralgia)

in HIV patients

pain in your muscles or bones (musculoskeletal pain)

Common side effects (seen in more than 1 in 100 people taking Accofil): in cancer patients

allergic reaction (drug hypersensitivity)

low blood pressure (hypotension)

pain while passing urine (dysuria)

chest pain

coughing up blood (haemoptysis)

in normal stem cell donors

increase of certain enzymes in the blood

shortness of breath (dyspnoea)

enlargement of the spleen (splenomegaly)

in severe chronic neutropenia patients

decrease in platelets which reduces the ability of blood to clot (thrombocytopenia)

changes in blood chemistry

inflammation of the blood vessels in the skin (cutaneous vasculitis)

unusual hair loss or thinning (alopecia)

disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)

blood in the urine (haematuria)

injection site pain

in HIV patients

enlargement of the spleen (splenomegaly)

Uncommon side effects (seen in more than 1 in 1000 people taking Accofil): in cancer patients

severe pain in the bones, chest, gut or joints (sickle cell crisis)

rejection of transplanted bone marrow (graft versus host disease)

pain and swelling of the joints, similar to gout (pseudogout)

severe lung inflammation causing difficulty in breathing (acute respiratory distress syndrome)

lungs do not function as they should, causing breathlessness (respiratory failure)

swelling and/or fluid in the lungs (pulmonary oedema)

inflammation of the lungs (interstitial lung disease)

adnormal x-rays of the lungs (lung infiltration)

plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with fever (Sweets syndrome)

inflammation of the blood vessels in the skin (cutaneous vasculitits)

worsening of rheumatoid arthritis

unusual change in urine

pain

liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)

bleeding from the lung (pulmonary haemorrhage)

a change in how your body regulates fluids within your body and may result in puffiness

in normal stem cell donors

rupture of the spleen

sudden life-threatening allergic reaction (anaphylactic reaction)

changes in blood chemistry

bleeding in the lung (pulmonary haemorrhage)

coughing up blood (haemoptysis)

abnormal x-rays of the lung (lung infiltration)

lack of absorption of oxygen in the lung (hypoxia)

increase of certain enzymes in the blood

worsening of rheumatoid arthritis

in severe chronic neutropenia patients

excess protein in the urine (proteinuria)

rupture of the spleen

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor. 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.

5.How to store Accofil

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP. The expiry date refers to the last day of the month.

Store in a refrigerator (2°C - 8°C). Do not freeze.

The syringe can be removed from the refrigerator and left at room temperature (not above 25°C) for a single period, that ends within the labelled expiry date, of up to a maximum of 15 days. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.

Keep the pre-filled syringe in the carton in order to protect from light.

Do not use Accofil if you notice it is cloudy, or there is discoloration or there are particles in it.

Do not put the cover back on used needles, as you may accidentally prick 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 Accofil contains

-The active substance is filgrastim. Each pre-filled syringe contains 30 MU (300 micrograms) filgrastim in 0.5 ml, corresponding to 0.6 mg/ml.

-The other ingredients are acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80 and water for injections.

What Accofil looks like and contents of the pack

Accofil is a clear colourless solution for injection or infusion in a pre-filled syringe marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel, with an injection needle. Each pre-filled syringe contains 0.5 ml of solution.

Accofil is available in packs containing 1, 3, 5, 7 and 10 pre-filled syringes, with prefixed needle safety guard in individual blister pack or without needle safety guard / blister and alcohol swabs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow,

Middlesex, HA1 4HF

United Kingdom

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

AT / BE / BG / CY / CZ / DE / DK /

FR

 

EE / EL / FI / HR / HU / IS / LT /

Arrow Génériques

LV / LX/ MT / NL / NO / PT /

Tél: +33

4 72 72 60 72

PL / RO / SE / SI / SK / UK

 

 

Accord Healthcare Limited

 

 

Tel : +44 (0)208 863 1427

 

 

ES

IT

 

Accord Healthcare S.L.U.

Accord Healthcare Limited

Tel: +34 93 301 00 64

Tel: +39

02 94323700

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

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The following information is intended for medical or healthcare professionals only:

Accofil does not contain any preservative. In view of the possible risk of microbial contamination, Accofil syringes are for single use only.

Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Accofil. If exposure has been greater than 24 hours or frozen more than once then Accofil should NOT be used.

In order to improve traceability of granulocyte-colony stimulating factors, the product name (Accofil) and batch number of the administered product should be clearly recorded in the patient file

Accofil should not be diluted with sodium chloride solution. This medicinal product must not be mixed with other medicinal products except those mentioned below. Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.

If required, Accofil may be diluted in 5% glucose. Dilution to a final concentration less than 0.2 MU (2 µg) per ml is not recommended at any time.

The solution should be visually inspected prior to use. Only clear solutions without particles should be used.

For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ml. Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MU (300 µg) should be given with 0.2 ml of 200 mg/ml (20%) human albumin solution added.

When diluted in 5% glucose, Accofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.

After dilution:

Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Using the pre-filled syringe with a needle safety guard

The needle safety guard covers the needle after injection to prevent needle stick injury. This does not affect normal operation of the syringe. Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. While maintaining pressure on the

plunger, remove the syringe from the patient. The needle safety guard will cover the needle when releasing the plunger.

Using the pre-filled syringe without a needle safety guard

Administer the dose as per standard protocol.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Accofil 48 MU/0.5 ml (0.96 mg/ml) solution for injection or infusion in pre-filled syringe filgrastim

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side-effects you may get. See the end of section 4 for how to report side effects.

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, nurse 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet

1.What Accofil is and what it is used for

2.What you need to know before you use Accofil

3.How to use Accofil

4.Possible side effects

5.How to store Accofil

6.Contents of the pack and other information

1. What Accofil is and what it is used for What Accofil is

Accofil contains the active ingredient filgrastim. Filgrastim is a protein produced in bacteria called Escherichia coli by recombinant DNA technology. It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body. Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more white blood cells that help fight infection.

What Accofil is used for

Your doctor has prescribed Accofil for you to help your body make more white blood cells. Your doctor will tell you why you are being treated with Accofil. Accofil is useful in several different conditions which are:

-chemotherapy

-bone marrow transplantation

-severe chronic neutropenia (low number of a type of white blood cells)

-neutropenia (low number of a type of white blood cells) in patients with HIV infection

-peripheral blood stem cell mobilisation (to stimulate stem cells to enter the blood stream to be collected and used in bone marrow transplantation).

2. What you need to know before you use Accofil

Do not use Accofil

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

Warnings and precautions

Talk to your doctor before using Accofil:

Talk to your doctor, pharmacist or nurse before using Accofil:

Please tell your doctor before starting treatment if you have:

Sickle cell anaemia, accofil may cause sickle cell crisis.

Osteoporosis (bone disease)

Please tell your doctor immediately during treatment with Accofil, if you:

Get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder( these may be symptoms of enlarge spleen or possibly rupture of spleen.

Notice unusual bleeding or bruising that may be (these may be symptoms of a decrease in blood platelets(thrombocytopenia), with a reduced ability of your blood to clot.

Have sudden signs of allergy such as rash, itching or hives of skin, swelling of the face, lips,tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be a signs of severe allergic reaction.

You may need to have regular blood tests whilst being treated with Accofil to count the number of neutrophils and other white blood cells in your blood. This will tell your doctor how the treatment is working and will also indicate if treatment needs to be continued.

The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause an allergic reaction.

Other medicines and Accofil

You should not receive Accofil in the 24 hours before and the 24 hours after receiving chemotherapy.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Accofil has not been tested in pregnant women.Your doctor may decide that you should not use this medicine.

It is unknown whether filgrastim passes over into the breast milk. Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding.

Driving and using machines

If you are experiencing fatigue, do not drive a car or operate machines.

Important information about some of the ingredients of Accofil

This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars (fructose), contact your doctor before taking this medicine. This medicine also contains sodium less than 1mmol sodium (0.035 mg) per dose, i.e. essentially ‘sodium-free’.

3. How to use Accofil

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

The amount of Accofil you need will depend on the condition you are taking Accofil for and on your bodyweight.

Dosage

Accofil and neutropenia (low number of a type of white blood cells) associated with chemotherapy

The usual dose is 0.5 million units (5 micrograms) per kilogram of bodyweight each day. For example, if you weigh 60 kilograms your daily dose will be 30 million units (300 micrograms). Your treatment with Accofil will usually last for about 14 days. In some disease types, however, longer treatment lasting up to about one month may be required.

Accofil and bone marrow transplantation

The usual starting dose is 1 million units (10 micrograms) per kilogram of bodyweight each day given as an infusion. For example, if you weigh 60 kilograms your daily dose will be 60 million units (600 micrograms). You will normally receive your first dose of Accofil at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant. Your doctor may then test your blood to see how well the treatment is working and how long it should last.

Accofil and severe chronic neutropenia (low number of a type of white blood cells)

The usual starting dose is between 0.5 million units (5 micrograms) and 1.2 million units (12 micrograms) per kilogram bodyweight each day in a single or divided dose. Your doctor may then test your blood to see how well your treatment with Accofil is working and to find the dose that is best for you. Long-term treatment with Accofil is required for reduction in neutropenia.

Accofil and neutropenia (low number of a type of white blood cells) in patients with HIV infection

The usual starting dose is between 0.1 million units (1 micrograms) and 0.4 million units (4 micrograms) per kilogram bodyweight each day. Your doctor may test your blood at regular intervals to see how well the Accofil treatment is working. Once the number of white cells in your blood has returned to normal it may be possible to reduce the dose frequency to less than once per day. Long term treatment with Accofil may be required to maintain a normal number of white cells in your blood.

Accofil and peripheral blood stem cell transplantation (stem cells collected from the blood to use in bone marrow transplantation)

If you are donating stem cells for yourself, the usual dose is 0.5 million units (5 micrograms) to 1 million units (10 micrograms) per kilogram bodyweight each day. Accofil treatment will last for up to 2 weeks. Your doctor will monitor your blood to determine the best time to collect the stem cells.

If you are acting as a stem cell donor for another person, the usual dose is 1 million units (10 micrograms) per kilogram bodyweight each day. Accofil treatment will last for 4 to 5 days. Your doctor will perform regular blood tests to determine the best time to collect the stem cells.

Method of administration

This medicine is given by injection, either through an intravenous (IV) infusion (drip) or by a subcutaneous (SC) injection into the tissue just under the skin.

If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections. Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Accofil). Do not attempt to self-administer without this training. Some of the information you require is given at the end of this leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor.

Information for injecting yourself

This section contains information on how to give yourself an injection of Accofil. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.

How do I inject Accofil myself?

You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection. You will need to have your injections at about the same time every day.

Equipment that you need

To give yourself a subcutaneous injection you will need:

a pre-filled syringe of Accofil;

alcohol swab or similar.

What should I do before I give myself a subcutaneous injection of Accofil?

Ensure the needle cover remains on the syringe until just before you are ready to inject.

a.Take your Accofil pre-filled syringe out of the refrigerator.

b.Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passedthe last day of the month shown or if it has been kept outside of the refrigerator for more than 15 days or has otherwise expired.

c.Check the appearance of Accofil. It must be a clear and colourless liquid. If there are particles in it, you must not use it.

d.For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Accofil in any other way (for example, do not warm it in a microwave or in hot water).

e.Wash your hands thoroughly.

f.Find a comfortable, well-lit place and put everything you need where you can reach them (the Accofil pre-filled syringe and alcohol swab).

How do I prepare my Accofil injection?

Before you inject Accofil you must do the following:

1.Hold the syringe and gently take the cover from the needle without twisting. Pull straight as shown in pictures 1 and 2. Do not touch the needle or push the plunger.

2.You may notice a small air bubble in the pre-filled syringe. If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With the syringe pointing upwards, expel all air from the syringe by pushing the plunger upwards.

3.The syringe may contain more liquid than you need. Use the scale on the syringe barrel as follows to set the correct dose of Accofil that your doctor prescribed. Eject unnecessary liquid by pushing the plunger up to the number (mL) on the syringe that matches the prescribed dose.

4.Check again to make sure the correct dose of Accofil is in the syringe.

5.You can now use the pre-filled syringe.

Where should I give my injection?

The most suitable places to inject yourself are:

the top of your thighs; and

the abdomen, except for the area around the navel (see picture 3).

If someone else is injecting you, they can also use the back of your arms (see picture 4).

It is better to change the injection site every day to avoid the risk of soreness at any one site.

How do I give my injection?

a.Disinfect the injection site by using an alcohol swab and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).

Pre-filled syringe without needle safety guard

b.Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).

c.Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.

d.Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger!

e.Inject only the dose your doctor has told you.

f.After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin.

g.Put the used syringe in the disposal container. Use each syringe only for one injection.

Pre-filled syringe with needle safety guard

h.Put the needle fully into the skin as shown by your nurse or doctor (see picture 7).

i.Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.

j.Inject only the dose your doctor has told you following the instructions below.

k.Always keeping your skin pinched, depress the plunger slowly and evenly while grasping the finger flange until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger!

l.After injecting the liquid, remove the needle while keeping the syringe at the same angle and maintaining pressure on the plunger, then let go of your skin. The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see picture 8). The needle guard will not activate unless the entire dose has been given.

Remember

If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used syringes

The needle safety guard prevents needle stick injuries after use, so no special precautions for disposal are required. Dispose of the syringe as instructed by your doctor, nurse or pharmacist.

If you use more Accofil than you should

If you use more Accofil than you should, contact your doctor or pharmacist as soon as possible.

If you forget to use Accofil

Do not take a double dose to make up for a forgotten injection. Contact your doctor to discuss when you should inject the next dose.

If you stop using Accofil

Your doctor will tell you when to stop using Accofil. It is quite normal to have a number of courses of treatment with Accofil.

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

4. Possible side effects

Tell your doctor immediately during treatment:

if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face, lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).

Hypersensitivity is common in patients with cancer;

if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Adult Respiratory Distress Syndrome (ARDS). ARDS is uncommon in patients with cancer;

if you get left upper belly (abdonimal) pain, pain below the left rib cage or pain at the tip of your shoulder since this may relate to a problem with your spleen (splenomegaly). This is very common in severe chronic neutropenia patients, common in HIV patients and uncommon in normal stem cell donors.

if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria). Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).

If you have any of the following or a combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally develop in a rapid fashion. These could be symptoms of an uncommon condition (may affect up to 1 in 100 people) called Capillary Leak Syndrome which causes the blood to leak from the small blood vessels into your body and needs urgent medical attention.

A very frequent side effect of Accofil use is pain in your muscles or bones (musculoskeletal pain), which can be helped by taking standard pain relief medicines (analgesics). In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands and soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints. Very commonly seen in normal stem cells donors is increase in white blood cells (leukocytosis) and decrease of platelets which reduces the ability of blood to clot (thrombocytopenia), these will be monitored by your doctor.

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

Very common side effects (seen in more than 1 in 10 people who take Accofil): in cancer patients

changes in blood chemistry

increase in certain enzymes in the blood

decreased apetite

headache

pain in the mouth and throat (oropharyngeal pain)

cough

diarrhoea

vomiting

constipation

nausea

skin rash

unusual hair loss or thinning (alopecia)

pain in your muscles or bones (musculoskeletal pain)

generalized weakness (asthenia)

tiredness (fatigue)

soreness and swelling of the digestive tract lining which runs from the mouth to the anus (mucosal inflammation)

shortness of breath (dyspnoea)

in normal stem cell donors

decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)

increase in white blood cells (leukocytosis)

headache

pain in your muscles or bones (musculoskeletal pain)

in severe chronic neutropenia patients

enlargement of the spleen (splenomegaly)

low red blood cell count (anaemia)

changes in blood chemistry

increase of certain enzymes in the blood

headache

nose bleeds (epistaxis)

diarrhoea

enlargment of the liver (hepatomegaly)

skin rash

pain in your muscles or bones (musculoskeletal pain)

joint pain (arthralgia)

in HIV patients

pain in your muscles or bones (musculoskeletal pain)

Common side effects (seen in more than 1 in 100 people taking Accofil): in cancer patients

allergic reaction (drug hypersensitivity)

low blood pressure (hypotension)

pain while passing urine (dysuria)

chest pain

coughing up blood (haemoptysis)

in normal stem cell donors

increase of certain enzymes in the blood

shortness of breath (dyspnoea)

enlargement of the spleen (splenomegaly)

in severe chronic neutropenia patients

decrease in platelets which reduces the ability of blood to clot (thrombocytopenia)

changes in blood chemistry

inflammation of the blood vessels in the skin (cutaneous vasculitis)

unusual hair loss or thinning (alopecia)

disease which causes bones to become less dense, making them weaker, more brittle and likely to break (osteoporosis)

blood in the urine (haematuria)

injection site pain

in HIV patients

enlargement of the spleen (splenomegaly)

Uncommon side effects (seen in more than 1 in 1000 people taking Accofil): in cancer patients

severe pain in the bones, chest, gut or joints (sickle cell crisis)

rejection of transplanted bone marrow (graft versus host disease)

pain and swelling of the joints, similar to gout (pseudogout)

severe lung inflammation causing difficulty in breathing (acute respiratory distress syndrome)

lungs do not function as they should, causing breathlessness (respiratory failure)

swelling and/or fluid in the lungs (pulmonary oedema)

inflammation of the lungs (interstitial lung disease)

adnormal x-rays of the lungs (lung infiltration)

plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with fever (Sweets syndrome)

inflammation of the blood vessels in the skin (cutaneous vasculitits)

worsening of rheumatoid arthritis

unusual change in urine

pain

liver damage caused by blocking of the small veins within the liver (veno-occlusive disease)

bleeding from the lung (pulmonary haemorrhage)

a change in how your body regulates fluids within your body and may result in puffiness

in normal stem cell donors

rupture of the spleen

sudden life-threatening allergic reaction (anaphylactic reaction)

changes in blood chemistry

bleeding in the lung (pulmonary haemorrhage)

coughing up blood (haemoptysis)

abnormal x-rays of the lung (lung infiltration)

lack of absorption of oxygen in the lung (hypoxia)

increase of certain enzymes in the blood

worsening of rheumatoid arthritis

in severe chronic neutropenia patients

excess protein in the urine (proteinuria)

rupture of the spleen

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor. 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.

5. How to store Accofil

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP. The expiry date refers to the last day of the month.

Store in a refrigerator (2°C - 8°C). Do not freeze.

The syringe can be removed from the refrigerator and left at room temperature (not above 25°C) for a single period, that ends within the labelled expiry date, of up to a maximum of 15 days. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.

Keep the pre-filled syringe in the carton in order to protect from light.

Do not use Accofil if you notice it is cloudy, or there is discoloration or there are particles in it.

Do not put the cover back on used needles, as you may accidentally prick 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 Accofil contains

-The active substance is filgrastim. Each pre-filled syringe contains 48 MU (480 micrograms) filgrastim in 0.5 ml, corresponding to 0.96 mg/ml.

-The other ingredients are acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80 and water for injections.

What Accofil looks like and contents of the pack

Accofil is a clear colourless solution for injection or infusion in a pre-filled syringe marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel, with an injection needle. Each pre-filled syringe contains 0.5 ml of solution.

Accofil is available in packs containing 1, 3, 5, 7 and 10 pre-filled syringes, with prefixed needle safety guard in individual blister pack or without needle safety guard / blister and alcohol swabs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow,

Middlesex, HA1 4HF

United Kingdom

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

AT / BE / BG / CY / CZ / DE / DK /

FR

 

EE / EL / FI / HR / HU / IS / LT /

Arrow Génériques

LV / LX/ MT / NL / NO / PT /

Tél: +33

4 72 72 60 72

PL / RO / SE / SI / SK / UK

 

 

Accord Healthcare Limited

 

 

Tel : +44 (0)208 863 1427

 

 

ES

IT

 

Accord Healthcare S.L.U.

Accord Healthcare Limited

Tel: +34 93 301 00 64

Tel: +39

02 94323700

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

---------------------------------------------------------------------------------------------------------------

The following information is intended for medical or healthcare professionals only:

Accofil does not contain any preservative. In view of the possible risk of microbial contamination, Accofil syringes are for single use only.

Accidental exposure to freezing temperatures for up to 24 hours does not affect the stability of Accofil. If exposure has been greater than 24 hours or frozen more than once then Accofil should NOT be used.

In order to improve traceability of granulocyte-colony stimulating factors, the product name (Accofil) and batch number of the administered product should be clearly recorded in the patient file

Accofil should not be diluted with sodium chloride solution. This medicinal product must not be mixed with other medicinal products except those mentioned below. Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.

If required, Accofil may be diluted in 5% glucose. Dilution to a final concentration less than 0.2 MU (2 µg) per ml is not recommended at any time.

The solution should be visually inspected prior to use. Only clear solutions without particles should be used.

For patients treated with filgrastim diluted to concentrations below 1.5 MU (15 µg) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ml. Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MU (300 µg) should be given with 0.2 ml of 200 mg/ml (20%) human albumin solution added.

When diluted in 5% glucose, Accofil is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.

After dilution:

Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Using the pre-filled syringe with a needle safety guard

The needle safety guard covers the needle after injection to prevent needle stick injury. This does not affect normal operation of the syringe. Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. While maintaining pressure on the plunger, remove the syringe from the patient. The needle safety guard will cover the needle when releasing the plunger.

Using the pre-filled syringe without a needle safety guard

Administer the dose as per standard protocol.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

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