Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
filgrastim
Hexal AG
L03AA02
filgrastim
Immunostimulants,
Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
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 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.Mobilisation of peripheral blood progenitor cells (PBPCs).In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 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.Treatment of persistent neutropenia (ANC ≤ 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.in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
Revision: 24
Authorised
2009-02-06
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER FILGRASTIM HEXAL 30 MU/0.5 ML SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE FILGRASTIM HEXAL 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 Filgrastim HEXAL is and what it is used for 2. What you need to know before you use Filgrastim HEXAL 3. How to use Filgrastim HEXAL 4. Possible side effects 5. How to store Filgrastim HEXAL 6. Contents of the pack and other information 1. WHAT FILGRASTIM HEXAL IS AND WHAT IT IS USED FOR Filgrastim HEXAL 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. Filgrastim HEXAL 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. Filgrastim HEXAL stimulates the bone marrow to produce new white cells quickly. Filgrastim HEXAL 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 cel Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Filgrastim HEXAL 30 MU/0.5 mL solution for injection or infusion in pre-filled syringe Filgrastim HEXAL 48 MU/0.5 mL solution for injection or infusion in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Filgrastim HEXAL 30 MU/0.5 mL solution for injection or infusion in pre-filled syringe Each mL of solution contains 60 million units (MU) (equivalent to 600 micrograms [mcg]) filgrastim*. Each pre-filled syringe contains 30 MU (equivalent to 300 mcg) filgrastim in 0.5 mL. Filgrastim HEXAL 48 MU/0.5 mL solution for injection or infusion in pre-filled syringe Each mL of solution contains 96 million units (MU) (equivalent to 960 micrograms [mcg]) filgrastim*. Each pre-filled syringe contains 48 MU (equivalent to 480 mcg) filgrastim in 0.5 mL. * recombinant methionylated human granulocyte-colony stimulating factor (G-CSF) produced in _E. coli_ by recombinant DNA technology. Excipient with known effect Each mL of solution contains 50 mg sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or infusion in pre-filled syringe (injection or infusion). Clear, colourless to slightly yellowish solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - 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 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. - Mobilisation of peripheral blood progenitor cells (PBPCs). - In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (A Lire le document complet