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Each mL of concentrate for solution for infusion contains 20 mg of tremelimumab.
One vial of 1.25 mL of concentrate contains 25 mg of tremelimumab.
One vial of 15 mL of concentrate contains 300 mg of tremelimumab.
Tremelimumab is a human anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) immunoglobulin G2 IgG2a monoclonal antibody produced in murine myeloma cells by recombinant DNA technology.
Concentrate for solution for infusion (sterile concentrate) (IV).
Clear to slightly opalescent, colourless to slightly yellow solution, free from or practically free from visible particles. The solution has a pH of approximately 5.5 and an osmolality of approximately 285 mOsm/kg.
Excipients/Inactive Ingredients: Histidine, Histidine hydrochloride monohydrate, Trehalose dihydrate, Disodium edetate dihydrate, Polysorbate 80, Water for injections.
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