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Shelf life: Unopened vial: 2 years.
Before opening the product may be stored at room temperature (up to 30°C) for a period of up to 3 months. The end of the 3-month storage at room temperature should be recorded on the product carton. This date should never exceed the one initially mentioned on the outer carton. At the end of this period the product shall not be put back in the refrigerator, but shall be used or discarded.
After reconstitution: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature not above 30°C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. Do not refrigerate.
Special precautions for storage: Store refrigerated (2° to 8°C).
Do not freeze.
ADYNOVATE with BAXJECT II Hi-Flow device: Keep the vial in the outer carton in order to protect from light.
ADYNOVATE in BAXJECT III system: Keep the sealed blister in the outer carton in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see Shelf life as previously mentioned.
