Source: Health Products Regulatory Authority (ZA) Revision Year: 2015 Publisher: Amgen South Africa (Pty) Ltd. Building D, Ballyoaks Office Park, 35 Ballyclare Drive, Bryanston Ext. 7, South Africa
NEULASTIM – Injection.
| Pharmaceutical Form |
|---|
|
Pre-filled syringe. A clear and colourless liquid, practically free from particles. |
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0,6 ml (10 mg/ ml) in solution for injection.
Pegfilgrastim is composed of filgrastim (recombinant methionyl human granulocyte colony stimulating factor (G-CSF)) with a 20 kDa polyethylene glycol (PEG) molecule covalently bound to the N-terminal methionine residue. Filgrastim is produced in Escherichia coli cells by recombinant DNA technology.
| Active Ingredient | Description | |
|---|---|---|
| Pegfilgrastim |
Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Pegfilgrastim and filgrastim have been shown to have identical modes of action, causing a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes. |
| List of Excipients |
|---|
|
Sodium acetate, sorbitol, polysorbate 20, water for injections. |
1 ml clear colourless Type I glass pre-filled syringe (containing 0,6 ml) with a stainless steel needle, for single use only. Cartons with 1 or 5 syringes.
Amgen South Africa (Pty) Ltd. Building D, Ballyoaks Office Park, 35 Ballyclare Drive, Bryanston Ext. 7, South Africa
42/8.5/0598
| Drug | Countries | |
|---|---|---|
| NEULASTIM | Brazil, Ecuador, Hong Kong, Israel, New Zealand, Singapore, Turkey, South Africa |
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