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Concentrate for solution for infusion (sterile concentrate): Clear to slightly opalescent, colourless to slightly brownish-yellow solution.
Each vial contains 450 mg spesolimab in 7.5 mL.
Each mL of concentrate for solution for infusion contains 60 mg spesolimab.
After dilution, each mL of the solution contains 9 mg spesolimab (see Special precautions for disposal and other handling under Cautions for Usage).
Spesolimab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Excipients/Inactive Ingredients: Sodium acetate trihydrate (E262), Glacial acetic acid (E260) (for pH adjustment), Sucrose, Arginine hydrochloride, Polysorbate 20 (E432), Water for injections.
