Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
FILGRASTIM
TEVA ISRAEL LTD
L03AA02
SOLUTION FOR INJECTION / INFUSION
FILGRASTIM 0.6 MG/ML
I.V, S.C
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
FILGRASTIM
FILGRASTIM
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 Tevagrastim are similar in adults and children receiving cytotoxic chemotherapy. Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic PBPC). In patients children or adults with severe congenital neutropenia cyclic or idiopathic neutropenia with an absolute nuetrophil count (ANC) less than or equal to 0.5 x 1000000000 /l and a history of severe or recurrent infections long term administration of Tevagrastim is indicated to increase neutophil count and to reduce the incidence and duration of infection-related events. Tevagrastim in indicated for the treatment of persistent neutopenia (ANC less than or equal to 1.0 x 1000000000/l ) in patients with advanced HIV infection in order to reduce the risk of bacterial infections when other options to manage neutopenia are inappropriate.
2015-03-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY TEVAGRASTIM ® 30 MIU/0.5 ML Solution for injection or infusion Pre-filled syringe with needle safety guard TEVAGRASTIM ® 48 MIU/0.8 ML Solution for injection or infusion Pre-filled syringe with needle safety guard COMPOSITION: Filgrastim 30 million IU (300 micrograms) in 0.5 ml Filgrastim 48 million IU (480 micrograms) in 0.8 ml For information about inactive ingredients and allergens see section 2 ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. PLEASE NOTE THAT, every time you get this medicine at the pharmacy, it is important to confirm that you have been given the same medicine that your specialist has prescribed you. If the medicine you are given looks different from what you usually get, or if the instructions for use have changed, please consult your pharmacist immediately to make sure you received the correct medicine. Only your specialist can switch your medicine or change the dosage of a medicine that contains filgrastim (the active ingredient in this medicine). Please check that the medicine that your specialist prescribed you has the same brand name as the medicine you got from the pharmacist. 1. WHAT IS THIS MEDICINE INTENDED FOR? Treating decreased white blood cell count (neutropenia) caused by chemotherapy, after bone marrow transplantation, in patients with severe chronic neutropenia, in AIDS (HIV) patients, and for mobilization of stem cells to the peripheral blood in case of cell transplantation. Filgras Citiți documentul complet
TevaGrastim ME 09/2023 Minor changes SUMMARY OF PRODUCT CHARACTERISTICS TEVAGRASTIM 30 MIU/0.5 ML SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE TEVAGRASTIM 48 MIU/0.8 ML SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE SUBCUTANEOUS INJECTION / INTRAVENOUS INFUSION 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. Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 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 ME 09/2023 Minor changes Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neu Citiți documentul complet