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Store below 30°C.
Do not refrigerate.
For storage conditions after dilution of the medicinal product, see Shelf-Life as follows.
Shelf-Life: After opening: The concentrate and solvent vials must be used immediately. If not used immediately, in‑use storage times and conditions are the responsibility of the user.
After initial dilution of the concentrate with the solvent: Chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature (15°C - 30°C). From a microbiological point of view, the concentrate‑solvent mixture should be used immediately. If not used immediately, in-use storage times and conditions 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.
After final dilution in the infusion bag/bottle: Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (including the 1-hour infusion time) and for 48 hours at refrigerated conditions (including the 1-hour infusion time).
From a microbiological point of view, the infusion solution should be used immediately. If not used immediately, in-use storage times and conditions 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.
