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Xenpozyme

Xenpozyme Storage

Manufacturer:

Sanofi

Distributor:

DKSH
Full Prescribing Info
Storage
Store in a refrigerator (2°C-8°C).
For storage conditions after reconstitution and dilution of the medicinal product, see Shelf life.
Shelf life: Reconstituted medicinal product: After reconstitution with sterile water for injection, chemical, physical and microbiological in-use stability has been demonstrated for up to 24 hours at 2-8°C or 12 hours at room temperature (up to 25°C).
From a microbiological point of view, the reconstituted medicinal product should be used immediately. If not used for dilution immediately, in-use storage times and conditions prior to dilution are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C.
Diluted medicinal product: After dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, chemical, physical and microbiological in-use stability has been demonstrated between 0.1 mg/mL and 3.5 mg/mL for 24 hours at 2-8°C, and up to 12 hours (including infusion time) when stored at room temperature (up to 25°C).
From a microbiological point of view, the diluted medicinal product should be used immediately. If not used immediately after dilution, in-use storage times and conditions are the responsibility of the user and should normally not be longer than 24 hours at 2°C to 8°C followed by 12 hours (including infusion time) at room temperature (up to 25°C).
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