البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
filgrastim
Pfizer Europe MA EEIG
L03AA02
filgrastim
Immunostimulants,
Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Filgrastim 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.Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).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 filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Filgrastim is indicated for the treatment of persistent neutropenia (ANC ≤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: 27
Authorised
2010-06-07
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER NIVESTIM 12 MU/0.2 ML SOLUTION FOR INJECTION/INFUSION NIVESTIM 30 MU/0.5 ML SOLUTION FOR INJECTION/INFUSION NIVESTIM 48 MU/0.5 ML SOLUTION FOR INJECTION/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, 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. WHAT IS IN THIS LEAFLET 1. What Nivestim is and what it is used for 2. What you need to know before you use Nivestim 3. How to use Nivestim 4. Possible side effects 5. How to store Nivestim 6. Contents of the pack and other information 1. WHAT NIVESTIM IS AND WHAT IT IS USED FOR Nivestim is a white blood cell growth factor (granulocyte-colony stimulating factor) and belongs to a group of medicines 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. Nivestim 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. Nivestim stimulates the bone marrow to produce new white cells quickly. Nivestim 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 اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nivestim 12 MU/0.2 ml solution for injection/infusion Nivestim 30 MU/0.5 ml solution for injection/infusion Nivestim 48 MU/0.5 ml solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nivestim 12 MU/0.2 ml solution for injection/infusion Each ml of solution for injection or infusion contains 60 million units [MU] (600 micrograms [mcg]) of filgrastim*. Each pre-filled syringe contains 12 million units (MU) (120 micrograms [mcg]) of filgrastim in 0.2 ml (0.6 mg/ml). Nivestim 30 MU/0.5 ml solution for injection/infusion Each ml of solution for injection or infusion contains 60 million units [MU] (600 micrograms [mcg]) of filgrastim*. Each pre-filled syringe contains 30 million units (MU) (300 micrograms [mcg]) of filgrastim in 0.5 ml (0.6 mg/ml). Nivestim 48 MU/0.5 ml solution for injection/infusion Each ml of solution for injection or infusion contains 96 million units [MU] (960 micrograms [mcg]) of filgrastim*. Each pre-filled syringe contains 48 million units (MU) (480 micrograms [mcg]) of filgrastim in 0.5 ml (0.96 mg/ml). *recombinant methionyl granulocyte colony-stimulating factor G-CSF produced in _Escherichia coli_ (BL21) _ _ by recombinant DNA technology. Excipient with known effect Each ml of solution contains 50 mg of sorbitol (E420) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion (injection/infusion). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Filgrastim 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 prolo اقرأ الوثيقة كاملة