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Translucent, clear to yellowish color, pH 7.4 solution.
Each vial of 3 mL contains 300 mg of ravulizumab (100 mg/mL).
Each vial of 11 mL contains 1100 mg of ravulizumab (100 mg/mL).
After dilution, the final concentration of the ULTOMIRIS 100 mg/mL solution to be infused is 50 mg/mL.
ULTOMIRIS is a formulation of ravulizumab which is a long-acting humanized monoclonal IgG2/4K antibody produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology.
Excipient(s) with known effect: Sodium (4.6 mg per 3 mL vial or 16.8 mg per 11 mL vial).
Excipients/Inactive Ingredients: Monobasic sodium phosphate, Dibasic sodium phosphate, Polysorbate 80, L-arginine, Sucrose, Water for injection.
ULTOMIRIS 100 mg/mL contains 4.6 mg of sodium per 3 mL vial or 16.8 mg per 11 mL vial.
This should be taken into consideration by patients on a controlled sodium diet.
