البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
filgrastim
AbZ-Pharma GmbH
L03AA02
filgrastim
Colony stimulating factors
Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Revision: 8
Withdrawn
2008-09-15
56 B. PACKAGE LEAFLET Medicinal product no longer authorised 57 PACKAGE LEAFLET: INFORMATION FOR THE USER BIOGRASTIM 30 MIU/0.5 ML SOLUTION FOR INJECTION OR INFUSION BIOGRASTIM 48 MIU/0.8 ML SOLUTION FOR INJECTION OR INFUSION 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 Biograstim is and what it is used for 2. What you need to know before you use Biograstim 3. How to use Biograstim 4. Possible side effects 5. How to store Biograstim 6. Contents of the pack and other information 7. Information for injecting yourself 8. The following information is intended for healthcare professionals only 1. WHAT BIOGRASTIM IS AND WHAT IT IS USED FOR WHAT BIOGRASTIM IS Biograstim contains the active substance filgrastim. Filgrastim is a protein produced by biotechnology in bacteria called _Escherichia coli_ . 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 blood cells, especially certain types of white cells. White cells are important as they help your body fight infection. WHAT BIOGRASTIM IS USED FOR Your doctor has prescribed Biograstim for you to help your body make more white blood cells. Your doctor will tell you why you are being treated with Biograstim. Biograstim is useful in several different conditions, which are: - chemotherapy; - bone marrow transplantation; - اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Biograstim 30 MIU/0.5 mL solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection or infusion contains 60 million international units [MIU] (600 µg) of filgrastim. Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 mL solution for injection or infusion. Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced in _Escherichia coli_ K802 by recombinant DNA technology. _Excipient with known effect _ Each mL of solution contains 50 mg of sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or infusion Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 10 9 /L, and a history of severe or recurrent infections, long term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 10 9 /L) in patients with advanced HIV infection, in or اقرأ الوثيقة كاملة