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Shelf life: Unopened vial: 4 years (100 mg/4 mL); 4 years (400 mg/16 mL).
Diluted medicinal product: Chemical and physical in-use stability has been demonstrated for a period of up to 60 days at 2°C to 8°C after dilution and a period of up to 7 days at temperatures not exceeding 30°C in sodium chloride 9 mg/mL (0.9%) solution for injection. From a microbiological point of view, the product 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 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Special precautions for storage: Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see Shelf life as previously mentioned.
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