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Each single dose vial contains 100 mg of infliximab in a 15 mL vial. After reconstitution with 10 mL of Sterile Water for Injection, each mL contains 10 mg of infliximab.
Infliximab, the active ingredient in IXIFI, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions) specific for human tumor necrosis factor-alpha (TNFα), with an identical amino acid sequence for the variable and constant regions and identical primary structure with Remicade (infliximab), the reference product. It has a molecular weight of approximately 149 kilodaltons. The manufacturing process for infliximab drug substance uses a recombinant Chinese hamster ovary (CHO) cell line that contains the DNA encoding the sequence for infliximab and is grown in suspension culture using chemically-defined (CD), animal-derived component-free (ACF) media.
Excipients/Inactive Ingredients: Disodium succinate hexahydrate, Polysorbate 80, Succinic acid, Sucrose.
