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Powder and solvent for solution for injection: 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).
Omalizumab is a humanized monoclonal antibody manufactured from a mammalian cell line.
Xolair 150 mg powder: contained in a 6 ml vial with rubber stopper and an aluminium seal with plastic flip-off cap to be reconstituted with 1.4 ml water for injection.
The water for injections is clear, colourless, odourless liquid in a 2 ml One Point Cut Ampoules of colourless glass.
Solution for injection in prefilled syringe: Each pre-filled syringe of 1 mL contains 150 mg of omalizumab.
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 prefilled syringe: L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, polysorbate 20, water for injection.
