Страна: Израел
Език: английски
Източник: Ministry of Health
FILGRASTIM
TZAMAL BIO-PHARMA LTD
L03AA02
SOLUTION FOR INJECTION / INFUSION
FILGRASTIM 480 MCG / 0.5 ML
S.C, I.V
Required
INTAS PHARMACEUTICALS LTD., INDIA
FILGRASTIM
Stimofil 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 Stimofil are similar in adults and children receiving cytotoxic chemotherapy.Stimofil 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 less or equal to 0.5 x 109 /L, and a history of severe or recurrent infections, long term administration of Stimofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Stimofil 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.
2020-04-02
1 of 19 STIMOFIL 300 MCG/0.5 ML, 480 MCG/0.5 ML PHYSICIAN'S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT StimoFil 300 mcg/0.5 ml StimoFil 480 mcg/0.5 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION STIMOFIL 300 MCG/0.5 ML: Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of (filgrastim). Each pre-filled syringe contains 30 MU (equivalent to 300 micrograms of filgrastim in 0.5 ml solution for injection or infusion. STIMOFIL 480 MCG/0.5 ML: Each ml of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) of filgrastim. Each pre-filled syringe contains 48 MU (equivalent to 480 micrograms of filgrastim in 0.5 ml solution for injection or infusion. Filgrastim is a recombinant methionyl human granulocyte-colony stimulating factor produced in _Escherichia coli _(BL21) by recombinant DNA technology. Excipient with known effect: Each ml of solution contains 50 mg of D-sorbitol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or infusion Clear, colourless solution StimoFil is a biosimilar medicinal product that has been demonstrated to be similar in quality, safety and efficacy to the reference medicinal product Neupogen. Please be aware of any differences in the indications between the biosimilar medicinal product and the reference medicinal product. Information regarding biosimilar products can be found on the website of the Ministry of Health: https://www.gov.il/he/Departments/General/biosimilar 4. CLINCAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS StimoFil 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 leukemia 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 neutro Прочетете целия документ