国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
Pegfilgrastim
AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
L03AA13
6mg
INJECTION, SOLUTION
Pegfilgrastim 6mg/0.6ml
SUBCUTANEOUS
Prescription Only
Amgen Manufacturing, Limited
ACTIVE
2006-04-20
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 阅读完整的文件
1 NEULASTIM ® Pegfilgrastim 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Haematopoietic 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 20 mg/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 leukaemia 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 in oncology and/or haematology. 2 2.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 1.5. 2.4 WARNINGS AND PRECAUTIONS 2.4.1 GENERAL In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file. Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to 阅读完整的文件