INFLECTRA (infliximab for Injection) Description

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Canada
 

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INFLECTRA®(infliximab for Injection) is a biosimilar to REMICADE®. It consists of a chimeric immunoglobin G1 (IgG1) monoclonal antibody that binds with high affinity to the human tumour necrosis factor alpha (TNFα).

The INFLECTRA®drug product is formulated as a white lyophilized powder in a type I borosilicate glass vial with a 20 mm, double vent butyl rubber stopper and a 20 mm flip-off seal. The lyophilisate is reconstituted with 10 mL of sterile water for injection to yield a single dose formulation of 10 mg/mL infliximab for Injection, at pH 7.2. Each vial is designed to deliver a single dose of 100 mg infliximab active substance. The components of a single vial of the drug product INFLECTRA® are: infliximab, sucrose, sodium dihydrogen phosphate monohydrate, di-sodium hydrogen phosphate dihydrate, polysorbate 80.