Zarzio 30 MU/0,5 ml. 5 injections

SANDOZ
Zarzio 30 MU/0,5 ml. 5 injections
€ 297.00
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Zarzio 30 MU / 0,5 ml solution for injection or infusion in a pre-filled syringe
Zarzio 48 MU / 0,5 ml solution for injection or infusion in a pre-filled syringe
Filgrastim (Filgrastim)

What Zarzio is and what it is used
Zarzio is a growth factor for white blood cells (granulocyte-colony stimulating factor) and belongs to a group of proteins called cytokines. Growth factors are proteins naturally produced in the body, but can be produced with the assistance of biotechnology for use as a medicine. Zarzio works by stimulating the bone marrow to produce more white blood cells.
Reducing the number of white blood cells (neutropenia) can occur for several reasons and makes the body less able to fight infections. Zarzio stimulates the bone marrow to produce fast new white blood cells.
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 bone marrow transplantation, to help prevent infections;
• before high dose chemotherapy, to stimulate the bone marrow to produce more stem cells that can be taken and returned after your treatment. They can be taken from you or from a donor. Then, stem cells will return in 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 HIV infection in an advanced stage, which will help to reduce the risk of infections.
2. What you need to know before you use Zarzio
Do not use Zarzio
-if you are allergic (hypersensitivity) to filgrastim or any of the other ingredients of Zarzio (listed in section 6).
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Zarzio. Tell your doctor before starting treatment if you have:


-osteoporoza (bone disease);
-alergiya to latex. The needle cover on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions;
-sarpovidnokletachna anemia as Zarzio can cause a crisis of sickle cell anemia.
Tell your doctor immediately during treatment with Zarzio, if:
-usetite pain in the upper left part of the abdomen (abdominal pain), pain in the left sides or the top of the left shoulder [this may be symptoms of an enlarged spleen (splenomegaly), or possible tearing (rupture) of the spleen]
-zabelezhite unusual bleeding or bruising [this may be symptoms of reduction in blood platelets (thrombocytopenia), reduced ability of blood to clot].
Your doctor may want to monitor you closely see. point 4 of the leaflet.
If you have SCN for you may be at risk to develop cancer of the blood (leukemia, myelodysplastic syndrome [MDS]). You should talk to your doctor about the risks that you have to develop cancers of the blood and on what research needs to be done. If you develop or is likely to develop cancers of the blood, you should not use Zarzio, unless your doctor instructs you to use it.
If you are a donor stem cell, 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, you have recently taken or might take any other medicines.
Pregnancy and lactation
Zarzio has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you might be pregnant or planning to become pregnant because the doctor may decide that you should not use this medicine. Filgrastim could affect your ability to become pregnant or stay pregnant.
You should not use this medicine if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Zarzio should not affect the ability to drive and use machines. However, it is advisable to wait and see how you feel after application of Zarzio before driving or operating machinery.
Zarzio contains sorbitol (E420):
How to use Zarzio
Always use Zarzio exactly as your doctor has told you. If you're not sure, ask your doctor, nurse or pharmacist.
How to use Zarzio and how should I take?
Zarzio is usually administered as a daily injection into the tissue just below the skin (known as subcutaneous injection). It can also be administered as a daily slowly applied injection into a vein (known as an intravenous infusion). The usual dose is different depending on your condition and your weight. Your doctor will tell you how much Zarzio should take.
Patients with bone marrow transplant after chemotherapy:
Normally you should receive the first dose of Zarzio at least 24 hours after chemotherapy and at least 24 hours after transplantation of bone marrow.
How long I will have to accept Zarzio?
You have to take Zarzio, while the number of white blood cells become normal. Tracking the number of white blood cells in your body will have regular blood tests. Your doctor will tell you how long you should keep taking Zarzio.
Use in children and adolescents
Zarzio is used to treat children who are receiving chemotherapy or who suffer from severely reduced white blood cell count (neutropenia). Doses for children undergoing chemotherapy are the same as for adults.
How to use Zarzio
Always use this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Your doctor may decide it is more convenient for you to inject Zarzio. Your doctor or nurse will show you how to inject. Do not try to
inject yourself unless you are trained.
Instructions on how to self-inject Zarzio can be found at the end of this leaflet.
If you use more than the amount of Zarzio
If you think you use more than you should, you should contact your doctor as soon as possible.
If you forget to use Zarzio
If you miss an injection, contact your doctor as soon as possible.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
If you stop using Zarzio
Your doctor will tell you when you can stop using Zarzio. It is quite normal to have several courses of treatment with Zarzio.
4. Possible side effects
As with all drugs, this drug may cause side effects, although not everyone gets them.
Please tell your doctor during treatment:
• if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, facial swelling (anaphylaxis), skin rash, itchy rash (hives), swelling of face, lips, mouth, tongue or throat (angioedema) and shortness of breath ( dyspnoea). Hypersensitivity is common in cancer patients;
• have a cough, fever and difficulty breathing (dyspnea), as this may be a sign of acute respiratory distress syndrome (ARDS); ARDS is not common in cancer patients;
• if you experience pain in the left upper abdomen (abdominal pain), pain in the left under the ribs or pain in the upper arm, as it may have a problem with the spleen [enlargement of the spleen (splenomegaly), or rupture of the spleen].
• If you are being treated for severe chronic neutropenia and have blood in the urine (hematuria). Your doctor may regularly examine your urine if you get this side effect, or if you detect protein in the urine (proteinuria).
• if you have any of the following or a combination of the following side reactions:
- swelling or puffiness, which may be associated with less frequent urination,
difficulty breathing, abdominal bloating and a feeling of fullness and a general feeling of fatigue. These symptoms usually develop quickly.
These may be symptoms of uncommonly (may affect up to 1 in 100 people) disease called "syndrome of abnormal capillary permeability", causing leakage of blood from small blood vessels in the body and needs urgent medical attention.
Very common side effect of the use of filgrastim is pain in the muscles or the bones (musculoskeletal pain), which may be alleviated by taking the conventional pain-killers (analgesics). In patients undergoing a procedure of transplantation of stem cells or bone marrow may be obtained graft-versus-host disease, which is a response of donor cells against the patient receiving the transplant; Signs and symptoms include a rash on the palms of the hands or soles of the feet, as well as wounds and ulcerations in the mouth, intestine, liver, skin or eyes, lungs, vagina and your joints. Very common in healthy donors of stem cells is an increase in white blood cell count (leukocytosis) and reduce platelet count, which reduces the ability of blood to clot (thrombocytopenia), these parameters will be monitored by your doctor.
Very common side effects (seen in more than 1 in 10 people who take
Zarzio)
cancer patients
• changes in blood chemistry
• an increase of certain enzymes in the blood
• decreased appetite
•headache
• pain in the mouth and throat (oropharyngeal pain)
• cough
• diarrhea


• vomiting
• constipation
• nausea
• skin rash
• unusual hair loss or thinning hair (alopecia)
• pain in the muscles or the bones (musculoskeletal pain)
• weakness (asthenia)
• tiredness (fatigue)
• tenderness and swelling of the lining of the digestive system (inflammation of the lining)
• shortness of breath (dyspnea)
in healthy donors of stem cells
• decrease of blood platelets, which reduces the ability for blood clotting (thrombocytopenia)
• an increase in white blood cell count (leukocytosis)
•headache
• pain in the muscles or the bones (musculoskeletal pain)
in patients with SCN
• enlargement of the spleen (splenomegaly)
• low number of red blood cells (anemia)
• changes in blood chemistry
• increase of certain enzymes in the blood
•headache
• nose bleeding (epistaxis)
• diarrhea
• enlargement of the liver (hepatomegaly)
• skin rash


• pain in the muscles or the bones (musculoskeletal pain)
• joint pain (arthralgia)
in patients with HIV
• pain in the muscles or the bones (musculoskeletal pain)
Common side effects (seen in more than 1 in 100 people who take Zarzio)
cancer patients
• allergic reaction (drug hypersensitivity)
• Low blood pressure (hypotension)
• pain on urination (dysuria)
• chest pain
• coughing up blood (hemoptysis)
in healthy donors of stem cells
• an increase of certain enzymes in the blood
• shortness of breath (dyspnea)
• enlargement of the spleen (splenomegaly)
in patients with SCN
• rupture of the spleen
• decrease of blood platelets, which reduces the ability for blood clotting (thrombocytopenia)
• changes in blood chemistry
• inflammation of the blood vessels of the skin (cutaneous vasculitis)
• unusual hair loss or thinning hair (alopecia)
• a disease that makes bones less dense, weaker, more fragile and prone to fracture (osteoporosis)
• blood in the urine (hematuria)
• pain at the injection site
in patients with HIV
• enlargement of the spleen (splenomegaly)
Uncommon adverse reactions (occurring in more than 1 in 1000 people who take
Zarzio)
cancer patients
• rupture of the spleen
• enlargement of the spleen (splenomegaly)
• severe bone pain, chest, gut and joints (crisis of sickle cell anemia)
• rejection of transplanted bone marrow (graft versus host)
• pain and swelling of the joints, similar to gout (pseudogout)
• severe lung inflammation causing difficulty in breathing (acute respiratory distress syndrome)
• lung function properly, causing shortness of breath
(respiratory failure)
• swelling and / or fluid in the lungs (pulmonary edema)
• lung inflammation (interstitial lung disease)
• abnormal finding in the X-ray of the lungs (pulmonary infiltration)
• dark violet-colored, raised, painful wounds on the limbs and sometimes the face
Ischia with fever (syndrome Sweet)
• inflammation of the blood vessels in the skin (cutaneous vasculitis)
• worsening of rheumatoid arthritis
• unusual change in urine
• pain
• liver injury caused by a blockage of the small veins in the liver
(Veno-occlusive disease)
• bleeding from the lung (pulmonary bleeding)
• a change in the way the body regulates fluids in the body, which can lead to puffiness
in healthy donors of stem cells
• rupture of the spleen
• sudden life-threatening allergic reaction (anaphylactic reaction)
• changes in blood chemistry
• bleeding in the lungs (pulmonary bleeding)
• coughing up blood (hemoptysis)
• abnormal finding in the X-ray of the lungs (pulmonary infiltration)
• reduced absorption of oxygen in the lung (hypoxia)
• an increase of certain enzymes in the blood
• worsening of rheumatoid arthritis
in patients with SCN
• an increased amount of protein in the urine (proteinuria)
Adverse event reporting
If you get any side effects, contact your doctor or pharmacist or nurse. This includes any possible 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 do your bit for obtaining more information on the safety of this medicine.
5. How to store Zarzio
Keep out of reach of children.
Do not use this medicine after the expiry date 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 to protect from light.
The syringe can be removed from the refrigerator and kept at room temperature for a single period of up to 72 hours (but not more than 25 ° C). At the end of this period, the product should not be put back in the refrigerator and must be discarded.
Do not use Zarzio, if you notice discoloration, cloudiness or particles, it should be clear, colorless liquid.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Zarzio
The active substance is filgrastim
Zarzio 30 MU / 0,5 ml injection or infusion solution in prefilled syringe: Each pre-filled syringe contains 30 MU filgrastim in 0,5 ml, corresponding to 60 MU / ml.
Zarzio 48 MU / 0,5 ml injection or infusion solution in prefilled syringe: Each pre-filled syringe contains 48 MU filgrastim in 0,5 ml, corresponding to 96 MU / ml.
-other substances are glutamic acid, sorbitol (E420), polysorbate 80 and water for injections.
Zarzio looks like and contents of the pack
Zarzio is a clear, colorless to slightly yellowish solution for injection or infusion in a pre-filled syringe.
Zarzio is available in packages of 1, 3, 5 or 10 pre-filled syringes with injection needles with or without a needle guard.
Not all pack sizes may be marketed.
€ 297.00
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