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Powder and solvent for solution for injection: Powder: white to off-white lyophilizate in a glass vial.
Solvent: clear and colorless solution in a glass ampoule.
One vial of Xolair 150 mg powder and solvent for solution for injection delivers 150 mg of omalizumab. Reconstituted Xolair contains 125 mg/mL of omalizumab (150 mg in 1.2 mL).
Solution for injection in pre-filled syringe: Clear to slightly opalescent, colorless to pale brownish-yellow solution in a pre-filled syringe.
Each pre-filled syringe of 1 mL contains 150 mg of omalizumab.
Active substance: Omalizumab is a humanized monoclonal antibody manufactured from a mammalian cell line.
Excipients/Inactive Ingredients: Powder and solvent for solution for injection: Powder: Sucrose, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20.
Solvent: Water for injection.
Solution for injection in pre-filled syringe: L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, polysorbate 20, water for injection.
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