ImiCila Caution For Usage

The following information is intended for healthcare professionals only.
ImiCila powder for solution for infusion: Each vial is for single use only.
Reconstitution: Contents of each vial must be transferred to 50ml of an appropriate infusion solution (see Presentation and Description): 0.9% sodium chloride injection, 10% glucose injection, 5% glucose and 0.9% sodium chloride injection, 5% glucose injection with 0.45% saline solution, 5% glucose injection with 0.15% potassium chloride solution, Mannitol 5%, Mannitol 10%.
A suggested procedure is to add approximately 10 ml of the appropriate infusion solution to the vial. Shake well and transfer the resulting mixture to the infusion solution container.
CAUTION: THE MIXTURE IS NOT FOR DIRECT INFUSION.
Repeat with an additional 10ml of infusion solution to ensure complete transfer of vial contents to the infusion solution. The resulting mixture should be agitated until clear.
The concentration of the reconstituted solution following the previously mentioned procedure is approximately 10mg/ml for both imipenem and cilastatin.
Variations of colour, from colourless to yellow, do not affect the potency of the product.
Incompatibility: This medicinal product is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate. However, it can be administered into an I.V system through which a lactate solution is being infused.
This medicinal product must not be mixed with other medicinal products except those mentioned under Reconstitution.
After reconstitution: Diluted solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed 4 hours at 25°C or 24 hours under refrigeration (5°C ± 3°C).
Do not throw away any medicine via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer in use. These measures will help protect the environment.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Refer to the Summary of Product Characteristics (SmPC) for further information about ImiCila powder for solution for infusion.