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White to light yellow powder or porous mass. The recovered solution - clear to slightly opalescent, colourless to light yellow liquid.
For vial containing 150 mg of trastuzumab: Histidine hydrochloride monohydrate 3.4 mg, Histidine 2.2 mg, Trehalose dihydrate 330.0 mg, Polysorbate 20 0.6 mg.
For vial containing 440 mg of trastuzumab: Histidine hydrochloride monohydrate 9.9 mg, Histidine 6.4 mg, Trehalose dihydrate 968.0 mg, Polysorbate 20 1.8 mg.
Each vial containing 440 mg trastuzumab is reconstituted with 20.0 mL of solvent (supplied) or water for injections (not supplied). Each mL of solvent contains: benzyl alcohol 11.0 mg; water for injections q.s. to make 1 mL.
Each vial contains 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection.
The resulting solution contains approximately 21 mg/mL trastuzumab.
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