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Vials: Store vials in a refrigerator at 2°C-8°C.
Keep vial in the outer carton in order to protect from light.
Do not freeze. Do not shake.
Shelf-Life: As registered locally.
Shelf-Life of the solution for infusion containing the product: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C followed by 24 hours at ambient temperature (≤30°C) followed by an infusion taking no longer than 24 hours.
From a microbiological point of view, the prepared infusion solution 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°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
GAZYVA does not contain antimicrobial preservatives. Therefore care must be taken to ensure that the solution for infusion is not microbiologically compromised during preparation.
