Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
FILGRASTIM
AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
L03AA02
48 mu/0.5 ml
INJECTION
FILGRASTIM 48 mu/0.5 ml
INTRAVENOUS, SUBCUTANEOUS
Prescription Only
Amgen Manufacturing Limited
ACTIVE
1999-03-01
1 NEULASTIM® Pegfilgrastim 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Hematopoietic growth factor Pharmacotherapeutic group: Cytokines, ATC Code: L03AA13 1.2 TYPE OF DOSAGE FORM Solution for injection in pre-filled syringe. 1.3 ROUTE OF ADMINISTRATION Subcutaneous injection. 1.4 STERILE / RADIOACTIVE STATEMENT Sterile. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml*) solution for injection. * Based on protein only. The concentration is 20mg/ml if the PEG moiety is included. Pegfilgrastim is composed of filgrastim (recombinant methionyl human G-CSF) with a 20 kDa polyethylene glycol (PEG) molecule covalently bound to the N-terminal methionine residue. Filgrastim is produced by recombinant DNA technology in E. coli (K12). Excipients: Sodium acetate** Sorbitol, Polysorbate 20, Water for injections. **Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). 2.2 DOSAGE AND ADMINISTRATION Adults (≥ 18 years): One 6 mg dose (a single pre-filled syringe) of pegfilgrastim is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy. Neulastim therapy should be initiated and supervised by physicians experienced Perskaitykite visą dokumentą
1 NEUPOGEN ® Filgrastim 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Haematopoietic growth factor (Cytokines) ATC code: L03AA02 1.2 TYPE OF DOSAGE FORM _Single-use vials _ Neupogen vial of 1.0 ml or 1.6 ml solution for injection. _Single-use pre-filled syringes _ Neupogen solution for injection in pre-filled syringe of 0.5 ml. 1.3 ROUTE OF ADMINISTRATION Intravenous infusion or subcutaneous injection. 1.4 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient:_ filgrastim (recombinant-methionyl human granulocyte-colony stimulating factor, r-metHuG-CSF, from _E. coli_ K12). Filgrastim is a highly purified non-glycosylated protein comprising 175 amino acids. Filgrastim is produced in a laboratory strain of _Escherichia coli_ bacteria which has been genetically altered by the addition of a gene for the granulocyte-colony stimulating factor. _Vials _ 1 vial of Neupogen of 1.0 ml injection solution contains 30 MU (= 300 g) of filgrastim. 1 vial of Neupogen of 1.6 ml injection solution contains 48 MU (= 480 g) of filgrastim. _Pre-filled syringes _ 1 pre-filled syringe of Neupogen of 0.5 ml contains 30 MU (= 300 g) of filgrastim. 1 pre-filled syringe of Neupogen of 0.5 ml contains 48 MU (= 480 g) of filgrastim. Excipients: sodium acetate*, sorbitol, polysorbate 80, water for injection. *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) _Established cytotoxic chemotherapy _ Neupogen is indicated for 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 and its clinical sequelae in patients undergoing myeloablative therapy 2 followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia (see section 2.5.3 Paediatric Use). _Perip Perskaitykite visą dokumentą