Transcription of 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Page 1 of 73 NEW ZEALAND DATA SHEET 1 PRODUCT NAME KEYTRUDAP P 50 mg powder for solution for infusion. KEYTRUDAP P 100 mg/4 mL (25 mg/mL) concentrate for solution for infusion. 2 qualitative and quantitative composition CAS No.: 1374853-91-4 KEYTRUDA 50 mg powder for solution for infusion One vial contains 50 mg of pembrolizumab. After reconstitution, 1 mL of solution contains 25 mg of pembrolizumab. KEYTRUDA 100 mg/4 mL (25 mg/mL) concentrate for solution for infusion One vial contains 100 mg of pembrolizumab in 4 mL of solution. Pembrolizumab is a selective humanized monoclonal antibody designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Pembrolizumab is an IgG4 kappa immunoglobulin with an approximate molecular weight of 149 kDa.
Dose modification . Immune-mediated pneumonitis . Moderate (Grade 2) Withhold until adverse reactions recover to Grade 0-1* Severe or life-threatening
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