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Zarzio (filgrastim) – Package leaflet - L03AA02

Updated on site: 11-Oct-2017

Medication nameZarzio
ATC CodeL03AA02
Substancefilgrastim
ManufacturerSandoz GmbH

Package leaflet: Information for the user

Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe

Filgrastim

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, pharmacist or nurse.

-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.

What is in this leaflet:

1.What Zarzio is and what it is used for

2.What you need to know before you use Zarzio

3.How to use Zarzio

4.Possible side effects

5.How to store Zarzio

6.Contents of the pack and other information

1.What Zarzio is and what it is used for

Zarzio is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of proteins called cytokines. Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine. Zarzio works by encouraging the bone marrow to produce more white blood cells.

A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection. Zarzio stimulates the bone marrow to produce new white cells quickly.

Zarzio can be used:

to increase the number of white blood cells after treatment with chemotherapy to help prevent infections;

to increase the number of white blood cells after a bone marrow transplant to help prevent infections;

before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment. These can be taken from you or from a donor. The stem cells will then go back into the bone marrow and produce blood cells;

to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections;

in patients with advanced HIV infection which will help reduce the risk of infections.

2.What you need to know before you use Zarzio

Do not use Zarzio

-if you are allergic 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 Zarzio.

Take special care with Zarzio if you have ever had an allergic reaction to latex.

Please tell your doctor before starting treatment if you have:

-osteoporosis (bone disease);

-sickle cell anaemia, as Zarzio may cause sickle cell crisis.

Please tell your doctor immediately during treatment with Zarzio, 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 an enlarged spleen (splenomegaly), or possibly rupture of the spleen],

-notice unusual bleeding or bruising [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 on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing as these could be signs of a severe allergic reaction.

-experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.

Loss of response to filgrastim

If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralise filgrastim’s activity.

Your doctor may want to monitor you closely, see section 4 of the package leaflet.

If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome [MDS]). You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done. If you develop or are likely to develop cancers of the blood, you should not use Zarzio unless instructed by your doctor.

If you are a stem cell donor, you must be aged between 16 and 60 years.

Take special care with other products that stimulate white blood cells.

Zarzio is one of a group of products that stimulate the production of white blood cells. Your healthcare professional should always record the exact product you are using.

Other medicines and Zarzio

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

Zarzio has not been tested in pregnant or breast-feeding women.

It is important to tell your doctor if you:

are pregnant;

think you may be pregnant; or

are planning to have a baby.

If you become pregnant during Zarzio treatment, please inform your doctor.

Unless your doctor directs you otherwise, you must stop breast feeding if you use Zarzio.

Driving and using machines

Zarzio should not affect your ability to drive and use machines. However, it is advisable to wait and see how you feel after taking Zarzio and before driving or operating machinery.

Zarzio contains sorbitol

Zarzio contains sorbitol (E420), if you have been told by your doctor that you have a reaction to some sugars, contact your doctor before taking this medicinal product.

3.How to use Zarzio

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How is Zarzio given and how much should I take?

Zarzio is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection). It can also be given as a daily slow injection into the vein (known as an intravenous infusion). The usual dose varies depending on your illness and weight. Your doctor will tell you how much Zarzio you should take.

Patients having a bone marrow transplant after chemotherapy:

You will normally receive your first dose of Zarzio at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.

You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home. However, you should not attempt this unless you have been properly trained first by your health care provider.

How long will I have to take Zarzio?

You will need to take Zarzio until your white blood cell count is normal. Regular blood tests will be taken to monitor the number of white blood cells in your body. Your doctor will tell you how long you will need to take Zarzio.

Use in children

Zarzio is used to treat children who are receiving chemotherapy or who suffer from severe low white blood cell count (neutropenia). The dosing in children receiving chemotherapy is the same as for adults.

If you use more Zarzio than you should

Do not increase the dose your doctor has given you. If you think you have injected more than you should, contact your doctor as soon as possible.

If you forget to use Zarzio

If you have missed an injection, or injected too little, contact your doctor as soon as possible. Do not take a double dose to make up for any missed doses.

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

4.Possible side effects

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

Please 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 Acute Respiratory Distress Syndrome (ARDS). ARDS is uncommon in patients with cancer;

if you get left upper belly (abdominal) pain, pain below the left rib cage or pain at the tip of your shoulder, as there may be a problem with your spleen [enlargement of the spleen (splenomegaly) or rupture of the spleen].

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 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 (may affect up to 1 in 100 people) condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body and needs urgent medical attention.

• if you experience kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received filgrastim. Call your doctor right away if you experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual.

A very frequent side effect of filgrastim 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 or 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 cell 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.

Very common side effects (may affect more than 1 in 10 people who take Zarzio)

in cancer patients

changes in blood chemistry

increase of certain enzymes in the blood

decreased appetite

headache

pain in your 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)

generalised 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)

pain

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

enlargement 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 (may affect up to 1 in 10 people taking Zarzio)

in cancer patients

allergic reaction (drug hypersensitivity)

low blood pressure (hypotension)

pain when 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

rupture of the spleen

decrease of 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

damage to the tiny filters inside your kidneys (glomerulonephritis)

in HIV patients

enlargement of the spleen (splenomegaly)

Uncommon side effects (may affect up to 1 in 100 people taking Zarzio)

in cancer patients

rupture of the spleen

enlargement of the spleen (splenomegaly)

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)

abnormal x-rays of the lungs (lung infiltration)

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

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

worsening of rheumatoid arthritis

unusual change in the 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

damage to the tiny filters inside your kidneys (glomerulonephritis)

in normal stem cell donors

rupture of the spleen

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

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

damage to the tiny filters inside your kidneys (glomerulonephritis)

in severe chronic neutropenia patients

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

excess protein in the urine (proteinuria)

in HIV patients

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

Not known side effects (frequency cannot be estimated from the available data):

• damage to the tiny filters inside your kidneys (glomerulonephritis)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Zarzio

Keep this medicine out of the sight and reach of children.

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

Store in a refrigerator (2°C - 8°C).

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

Accidental freezing will not harm Zarzio.

The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 72 hours (but not above 25°C). At the end of this period, the product should not be put back in the refrigerator and should be disposed of.

Do not use this medicine if you notice discolouration, cloudiness or particles, it should be a clear, colourless to slightly yellowish liquid.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Zarzio contains

-The active substance is filgrastim.

Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 30 MU filgrastim in 0.5 ml, corresponding to 60 MU/ml.

Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 48 MU filgrastim in 0.5 ml, corresponding to 96 MU/ml

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

-The needle cap of the syringe may contain dry rubber (latex).

What Zarzio looks like and contents of the pack

Zarzio is a clear, colourless to slightly yellowish solution for injection or infusion in pre-filled syringe.

Zarzio is available in packs containing 1, 3, 5 or 10 pre-filled syringes with injection needle and with or without a needle safety guard.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

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

België/Belgique/Belgien

Lietuva

Sandoz nv-sa

Sandoz Pharmaceuticals d.d filialas

Tél/Tel: +32 2 722 97 97

Tel: +370 5 2636 037

България

Luxembourg/Luxemburg

Търговско представителство Сандоз д.д.

Sandoz GmbH

Тел.: +359 2 970 47 47

Tel: +43 5338 200

Česká republika

Magyarország

Sandoz s.r.o.

Sandoz Hungária Kft.

Tel: +420 221 421 611

Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige

Malta

Sandoz A/S

Sandoz GmbH

Tlf/Sími /Tel: +45 63 95 10 00

Tel: +43 5338 200

Deutschland

Nederland

Hexal AG

Sandoz B.V.

Tel: +49 8024 908 0

Tel: +31 36 52 41 600

Eesti

Österreich

Sandoz d.d. Eesti filiaal

Sandoz GmbH

Tel: +372 665 2400

Tel: +43 5338 2000

Ελλάδα

Polska

Novartis (Hellas) A.E.B.E.

Sandoz Polska Sp. z o.o.

Τηλ: +30 210 281 17 12

Tel.: +48 22 209 70 00

ή

 

DEMO Ανώνυμος Βιομηχανική και Εμπορική

 

Εταιρεία

 

Тел.: +30 210 816 18 02

 

España

Portugal

Sandoz Farmacéutica, S.A.

Sandoz Farmacêutica Lda.

Tlf: +34 900 456 856

Tel: +351 21 924 19 11

France

România

Sandoz SAS

S.C. Sandoz Pharma Services S.R.L.

Tél: +33 1 49 64 48 00

Tel: +40 21 4075160

Hrvatska

Slovenija

Sandoz d.o.o.

Lek farmacevtska družba d.d.

Tel: +385 1 23 53 111

Tel: +386 1 580 21 11

Ireland

Slovenská republika

Novartis Ireland Limited

Sandoz d.d. - organizačná zložka

Tel: +353 1 260 12 55

Tel: +421 2 48 200 600

Italia

Suomi/Finland

Sandoz S.p.A.

Sandoz A/S

Tel: +39 02 96541

Puh/Tel: +358 10 6133 415

Κύπρος

United Kingdom

P.T.Hadjigeorgiou co ltd

Sandoz Ltd

Τel: +357 25372425

Tel: +44 1276 69 8020

Latvija

 

Sandoz d.d. Pārstāvniecība Latvijā

 

Tel: +371 67 892 006

 

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

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Instructions on how to inject yourself

This section contains information on how to give yourself an injection of Zarzio. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. Zarzio is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse. If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.

1.Wash your hands.

2.Remove one syringe from the pack and remove the protective cap from the injection needle. Syringes are embossed with graduation rings in order to enable partial use if required. Each graduation ring corresponds to a volume of 0.1 ml. If partial use of a syringe is required, remove unwanted solution before injection.

3.Clean the skin at the injection site using an alcohol wipe.

4.Form a skin fold by pinching the skin between thumb and forefinger.

5.Insert the needle into the skin fold with a quick, firm action. Inject the Zarzio solution as you have been shown by your doctor. You should check with your doctor or pharmacist if you are not sure.

Pre-filled syringe without needle safety guard

6.Always keeping your skin pinched, depress the plunger slowly and evenly.

7.After injecting the liquid, remove the needle and let go of your skin.

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

Pre-filled syringe with needle safety guard

6.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!

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

8.Let go of the plunger. The needle safety guard will rapidly move to cover the needle.

9.Discard any unused product or waste material. Only use each syringe for one injection.

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The following information is intended for healthcare professionals only:

The solution should be visually inspected prior to use. Only clear solutions without particles should be used. Accidental exposure to freezing temperatures does not adversely affect the stability of Zarzio.

Zarzio contains no preservative: In view of the possible risk of microbial contamination, Zarzio syringes are for single use only.

The needle cap of the syringe may contain dry rubber (latex), which should not be handled by persons sensitive to this substance.

Dilution prior to administration (optional)

If required, Zarzio may be diluted in glucose 50 mg/ml (5%) solution. Zarzio must not be diluted with sodium chloride solutions.

Dilution to a final concentration < 0.2 MU/ml (2 μg/ml) is not recommended at any time.

For patients treated with filgrastim diluted to concentrations < 1.5 MU/ml (15 μg/ml), human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.

Example: In a final volume of 20 ml, total doses of filgrastim less than 30 MU (300 μg) should be given with 0.2 ml of human serum albumin 200 mg/ml (20%) solution Ph. Eur. added.

When diluted in glucose 50 mg/ml (5%) solution, filgrastim is compatible with glass and a variety of plastics including polyvinylchloride, polyolefin (a copolymer 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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