Shelf-Life: Unopened Vial: 3 years at 2°C-8°C.
After preparation of infusion solution: Durvalumab (IMFINZI) does not contain a preservative. Administer infusion solution immediately once prepared. If infusion solution is not administered immediately and it needs to be stored, follow the recommendations as follows: Chemical and physical stability of the prepared solution for infusion, in the IV bag, has been demonstrated for up to 30 days at 2°C to 8°C (36°F to 46°F) and for up to 24 hours at room temperature from the time of preparation.
From a microbiological point of view, the prepared solution for infusion, in the IV bag, should be used immediately. If not used immediately, post-dilution storage times and conditions prior to use are the responsibility of the user and the product may be stored for a maximum of 30 days at 2°C to 8°C (36°F to 46°F) or 12 hours at room temperature. If dilution has taken place in controlled and validated aseptic conditions, the product may be stored for the time defined by the chemical and physical stability described previously.
Special precautions for storage: Unopened vial: Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
Do not freeze.
Do not shake.
Diluted Solution: For storage conditions after preparation of the infusion, see Shelf-life as previously mentioned.
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