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Pharmaceutical form: Solution for injection (injection): Clear to slightly opalescent, colourless to pale yellow sterile solution, which is free from visible particulates, with a pH of approximately 5.9.
Each single-use pre-filled syringe contains 200 mg of dupilumab in 1.14 ml solution (175 mg/ml) or 300 mg of dupilumab in 2 ml solution (150 mg/ml).
Dupilumab is a fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Excipients/Inactive Ingredients: L-arginine monohydrochloride, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sodium acetate trihydrate, glacial acetic acid, sucrose, water for injections.
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