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INFLECTRA®How Supplied/Storage and Handling (infliximab-dyyb)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

INFLECTRA (infliximab-dyyb) for injection is supplied as one single-dose vial individually packaged in a carton (NDC 0069-0809-01 100 mg vial).

Each single-dose vial contains 100 mg of infliximab-dyyb as a sterile, preservative-free, white lyophilized powder for reconstitution and dilution (more than one vial may be needed for a full dose) [see Dosage and Administration (2.11)].

Storage and Handling

Store unopened INFLECTRA® vials in a refrigerator at 2°C to 8°C (36°F to 46°F).

If needed, unopened INFLECTRA vials may be stored at room temperature up to a maximum of 30°C (86°F) for a single period up to 6 months but not exceeding the original expiration date. The new expiration date must be written in the space provided on the carton. Once removed from the refrigerator, INFLECTRA cannot be returned to the refrigerator.

Not made with natural rubber latex.

For storage condition of the reconstituted and diluted product for administration, see Dosage and Administration (2.11).

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