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Unopened vials: Store below 30°C.
Reconstituted suspension: For storage conditions after reconstitution of the medicinal product, see Shelf life as follows.
Shelf life: Unopened powder vial: 2 years.
After reconstitution: When Azacitidine for injection is reconstituted using water for injections that has not been refrigerated, chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 25°C for 1 hour and at 2°C to 8°C for 8 hours.
The shelf life of the reconstituted medicinal product can be extended by reconstituting with refrigerated (2°C to 8°C) water for injections. When Azacitidine for injection is reconstituted using refrigerated (2°C to 8°C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2°C to 8°C for 22 hours.
From a microbiological point of view, the reconstituted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than 8 hours at 2°C to 8°C when reconstituted using water for injections that has not been refrigerated or not longer than 22 hours when reconstituted using refrigerated (2°C to 8°C) water for injections.
