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Shelf life: Unopened vial: 2 years.
Reconstituted concentrate in vial: Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C when reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Diluted infusion solution: Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Micafungin NIKP for injection contains no preservatives. From a microbiological point of view, the reconstituted and diluted solutions should be used immediately. If not used 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 to 8°C, unless the reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Special precautions for storage: Unopened vials: Store below 30°C. Protect from light.
This medicinal product does not require any special storage conditions.
For storage conditions after reconstitution and dilution of the medicinal product, see Shelf life as previously mentioned.
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