Država: Izrael
Jezik: angleščina
Source: Ministry of Health
FILGRASTIM
AMGEN EUROPE B.V.
L03AA02
SOLUTION FOR INJECTION
FILGRASTIM 48 MU / 0.5 ML
I.V, S.C
Required
AMGEN EUROPE B.V., NETHERLANDS
FILGRASTIM
FILGRASTIM
Neupogen 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 Neupogen are similar in adults and children receiving cytotoxic chemotherapy.Neupogen 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 × 109/l, and a history of severe or recurrent infections, long term administration of Neupogen is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Neupogen is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 × 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.
2022-06-30
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only. Neupogen 30 MU Pre-filled syringe Neupogen 48 MU Pre-filled syringe Neupogen 30 MU Vials for intravenous/subcutaneous administration Composition: Each Neupogen 30 MU syringe contains 30 million units (300 micrograms (mcg)) of filgrastim in 0.5 ml (0.6 mg/ml). Each Neupogen 48 MU syringe contains 48 million units (480 micrograms (mcg)) of filgrastim in 0.5 ml (0.96 mg/ml). Each Neupogen 30 MU vial contains 30 million units (300 micrograms (mcg)) of filgrastim in 1 ml (0.3 mg/ml). For inactive ingredients and allergens in the medicine – see section 6 “Further information”. Read all of this leaflet carefully and until the end before using this medicine. This leaflet contains concise information about the medicine. If you have further questions, contact your doctor, nurse or pharmacist. • Keep this leaflet. You may need to read it again. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. • 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. Important information for your attention • You can inject Neupogen 30 MU pre-filled syringe, Neupogen 48 MU pre-filled syringe yourself in your home after receiving instructions from your healthcare professional. Please carefully read the instructions for self-injection of Neupogen pre-filled syringe that appear at the end of this leaflet. • Injecting Neupogen 30 MU vials is done by a healthcare professional staff only. • Strict adherence to the doctor’s instructions (dosage, injection times and duration of treatment) increases the chance of treatment success. In any case, do not discontinue the treatment without consulting the attending doctor. Please read sections 2 and 4 for expanded safety i Preberite celoten dokument
1 Neupogen Filgrastim 1. NAME OF THE MEDICINAL PRODUCT Neupogen 30 MU vials (0.3 mg/ml) solution for injection in vials Neupogen 30 MU pre-filled syringe (0.6 mg/ml) solution for injection in a pre-filled syringe Neupogen 48 MU pre-filled syringe (0.96 mg/ml) solution for injection in a pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Neupogen 30 MU vials: Each vial contains 30 million units (300 micrograms (µg)) of filgrastim in 1 ml (0.3 mg/ml). Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced by r-DNA technology in _E. coli_ (K12). Excipient with known effect: Each ml of solution contains 50 mg sorbitol. Neupogen 30 MU pre-filled syringe: Each pre-filled syringe contains 30 million units (MU)/300 micrograms (µg) of filgrastim in 0.5 ml (0.6 mg/ml). Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced by r-DNA technology in _E. coli_ (K12). _ _ Excipient with known effect: Each pre-filled syringe contains 25 mg (or 50 mg/ml) of sorbitol. Neupogen 48 MU pre-filled syringe: Each pre-filled syringe contains 48 million units (MU)/480 micrograms (µg) of filgrastim in 0.5 ml (0.96 mg/ml). Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor) is produced by r-DNA technology in _E. coli_ (K12). Excipient with known effect: Each pre-filled syringe contains 25 mg (or 50 mg/ml) of sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Neupogen 30 MU vials: Solution for injection in a vial. Concentrate for solution for infusion in a vial. Neupogen 30 MU and 48 MU pre-filled syringe: Solution for injection in a pre-filled syringe. Concentrate for solution for infusion in a pre-filled syringe. 2 Clear, colorless solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Neupogen 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 o Preberite celoten dokument