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Clear to slightly opalescent, colourless to slightly yellowish or slightly brownish solution with a pH between 4.9 and 5.5 and an osmolality of 245-345 mOsmol/kg.
Each pre-filled syringe contains 60 mg of denosumab in 1 mL of solution (60 mg/mL).
Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (Chinese hamster ovary cells) by recombinant DNA technology.
Excipients/Inactive Ingredients: Glacial acetic acid*, Sorbitol (E 420), Polysorbate 20, Sodium hydroxide (for pH adjustment)*, Hydrochloric acid (for pH adjustment), Water for injections.
* Acetate buffer is formed by mixing acetic acid with sodium hydroxide.
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