Vexpinem 500 Caution For Usage

Preparation of Solution: Vials: Contents of the vials must be suspended and transferred to 100 mL of infusion solution prior to intravenous infusion.
A suggested procedure is to add approximately 10 mL from the appropriate infusion solution (see list of diluents under Compatibility and Stability as follows) to the vial. Shake well and transfer the resulting suspension to the infusion solution container. Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluents containing benzyl alcohol should not be used when imipenem and cilastatin for injection (I.V.) is constituted for administration to pediatric patients in this age range.
Repeat with an additional 10 mL of infusion solution to ensure complete transfer of vial contents to the infusion solution. The resulting mixture should be agitated until clear. (See Table 4.)

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Compatibility and Stability: Before Reconstitution: The dry powder should be stored at a temperature below 30°C.
Reconstituted Solutions: Solutions of Imipinem and Cilastatin for injection range from colorless to yellow. Variations of color within this range do not affect the potency of the product.
Vials: Imipenem and Cilastatin for Injection, as supplied in single use vials and reconstituted with the following diluents (see Preparation of Solution previously), maintains satisfactory potency for 4 hours at room temperature or for 24 hours under refrigeration (5°C). Solutions of Imipenem and Cilastatin for Injection should not be frozen.