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Vial: Powder: white to off-white lyophilisate. Solvent: clear and colourless solution.
One vial contains 150 mg of omalizumab*.
After reconstitution, one vial contains 125 mg/mL omalizumab (150 mg in 1.2 mL).
Pre-filled syringe: Clear to slightly opalescent, colourless to pale brownish-yellow solution.
Each pre-filled syringe of 1 ml solution contains 150 mg of omalizumab*.
*Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
Excipients/Inactive Ingredients: Vial: Powder: Sucrose, L-histidine, L-histidine hydrochloride monohydrate, Polysorbate 20. Solvent: Water for injections.
Pre-filled syringe: L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, Polysorbate 20, Water for injections.
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