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Soln for inj: Pre-filled Syringe: 45 mg/0.5 mL: Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
90 mg/mL: Each pre-filled syringe contains 90 mg of ustekinumab per mL.
Conc soln for IV infusion: Single-use vial: 130 mg/25 mL: Each vial contains 130 mg of ustekinumab in 26 mL.
Ustekinumab is a fully human IgG1κ monoclonal antibody with an approximate molecular weight of 148600 daltons. Ustekinumab is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses. Ustekinumab is prepared from a cell line from murine myeloma origin. No adjuvants are being used.
Excipients/Inactive ingredients: Soln for inj: The excipients are L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, Sucrose and Water for injection.
Conc soln for IV infusion: The excipients are EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80 and Sucrose.
