CSC Pharmaceuticals International




Neulastim Injection


Neulastim Injection

Neulastim
®
DS 140205
1
Data Sheet
Neulastim
®
Pegfilgrastim 6 mg in 0.6 mL (pre-filled syringe), solution for injection
Description
Therapeutic/Pharmacologic Class of Medicine
Haematopoietic growth factor
Pharmacotherapeutic group: Cytokines, ATC Code: L03AA13
Type of Dosage Form
Solution for injection in a pre-filled syringe.
Route of Administration
Subcutaneous injection.
Sterile/Radioactive Statement
Sterile.
Q
ualitative and
Q
uantitative
C
omposition
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




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