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White to slightly yellow opaque isotonic liposomal dispersion.
One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
One ml of concentrate contains 4.3 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation).
The concentrate has a pH of 7.2 and an osmolality of 295 mOsm/kg.
Excipient with known effect: One ml of concentrate contains 0.144 mmol (3.31 mg) sodium.
Excipients/Inactive Ingredients: Liposome forming lipids: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), Cholesterol, N-(carbonyl-methoxypolyethylene glycol-2000)-1, 2-distearoly-sn-glycero-3-phosphoethanolamine (MPEG-2000-DSPE).
Other excipients: Sucrose octasulphate, 2-[4-(2-Hydroxyethyl)piperazin-1-yl] ethanesulfonic acid (HEPES buffer), Sodium chloride, Water for injections.
