देश: यूरोपीय संघ
भाषा: अंग्रेज़ी
स्रोत: EMA (European Medicines Agency)
filgrastim
Teva GmbH
L03AA02
filgrastim
Immunostimulants,
Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Tevagrastim 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.Tevagrastim 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 Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Tevagrastim 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: 18
Authorised
2008-09-15
49 B. PACKAGE LEAFLET 50 PACKAGE LEAFLET: INFORMATION FOR THE USER TEVAGRASTIM 30 MIU/0.5 ML SOLUTION FOR INJECTION/INFUSION TEVAGRASTIM 48 MIU/0.8 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, 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 Tevagrastim is and what it is used for 2. What you need to know before you use Tevagrastim 3. How to use Tevagrastim 4. Possible side effects 5. How to store Tevagrastim 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 TEVAGRASTIM IS AND WHAT IT IS USED FOR WHAT TEVAGRASTIM IS Tevagrastim is a white blood cell growth factor (granulocyte colony-stimulating factor) and belong 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. Tevagrastim works by encouraging the bone marrow to produce more white blood cells. WHAT TEVAGRASTIM IS USED FOR A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection. Tevagrastim stimulates the bone marrow to produce new white cells quickly. Tevagrastim 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 chemo पूरा दस्तावेज़ पढ़ें
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tevagrastim 30 MIU/0.5 mL solution for injection/infusion Tevagrastim 48 MIU/0.8 mL solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection/infusion contains 60 million international units [MIU] (600 µg) of filgrastim. Tevagrastim 30 MIU/0.5 mL solution for injection/infusion Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 mL solution for injection/ infusion. Tevagrastim 48 MIU/0.8 mL solution for injection/infusion Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8 mL solution for injection/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/infusion Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tevagrastim 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. Tevagrastim 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 Tevagrastim is indicated to increase neutrophi पूरा दस्तावेज़ पढ़ें