INFLECTRA (infliximab for Injection) Special Handling Instructions

Medical Information
Canada
 

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After Reconstution and Dilution

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at room temperature (25 °C). Diluted INFLECTRA® infusion solution is stable for 48 hours when stored between 5±3 °C and 30±2 °C/65±5% Relative Humidity (RH). This product contains no preservative. Since no preservative is present, it is recommended that the administration of the infusion solution should begin within 3 hours of reconstitution and dilution.

Handling Under Controlled and Validated Aseptic Conditions

Chemical and physical in-use stability of the diluted solution has been demonstrated for up to 28 days at 2 to 8 °C and for an additional 24 hours at 25 °C after removal from refrigeration. From a microbiological point of view, the infusion solution should be administered immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.

 

Control #: 237374
July 6, 2020