INFLECTRA (infliximab for Injection) Dosage Forms, Strengths, Composition And Packaging

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Canada
 

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To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.

Table – Dosage Forms, Strengths, Composition and Packaging

Route of Administration

Dosage Form / Strength/Composition

Non-medicinal Ingredients

Intravenous Infusion

Powder for Solution / 100 mg/vial

Di-sodium hydrogen phosphate dihydrate, polysorbate 80, sodium dihydrogen phosphate monohydrate, sucrose

INFLECTRA® (infliximab for injection) is supplied as a sterile white lyophilized powder for intravenous infusion. Each vial contains 100 mg infliximab, 500 mg sucrose, 0.5 mg polysorbate 80, 2.2 mg sodium dihydrogen phosphate monohydrate and 6.1 mg di-sodium hydrogen phosphate dihydrate. No preservatives are present.

INFLECTRA® (infliximab for injection) lyophilized concentrate for IV injection is supplied in individually boxed single-use vials in the following strength: 100 mg infliximab.

Vial stopper is free of natural rubber latex.