Each pre-filled syringe contains 6 mg of lipegfilgrastim* in 0.6 ml solution.
Each ml of solution for injection contains 10 mg of lipegfilgrastim.
The active substance is a covalent conjugate of filgrastim** with methoxy polyethylene glycol (PEG) via a carbohydrate linker.
*This is based on protein content only. The concentration is 20.9 mg/ml (i.e. 12.6 mg per pre-filled syringe) if the PEG moiety and the carbohydrate linker are included.
**Filgrastim (recombinant methionyl human granulocyte-colony stimulating factor [G-CSF]) is produced in Escherichia coli cells by recombinant DNA technology.
The potency of this medicinal product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. For more information, see Pharmacology: Pharmacodynamics under Actions.
Excipients with known effect: Each pre-filled syringe contains 30 mg sorbitol; Sodium.
Excipients/Inactive Ingredients: Glacial acetic acid, Sodium hydroxide (for pH adjustment), Sorbitol (E420), Polysorbate 20, Water for injections.
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