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Shelf life: In-use stability of the reconstituted solution in the vial has been demonstrated for 8 hours at 2°C - 8°C. In-use stability of the diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection in infusion bag has been demonstrated for 12 hours at 20°C - 25°C or 24 hours at 2°C - 8°C. The combined in-use stability of vedolizumab in the vial and infusion bag with sodium chloride 9 mg/mL (0.9%) solution for injection is a total of 12 hours at 20°C - 25°C or 24 hours at 2°C - 8°C. A 24-hour period may include up to 8 hours at 2°C - 8°C for reconstituted solution in the vial and up to 12 hours at 20°C - 25°C for diluted solution in the infusion bag but the infusion bag must be stored in the refrigerator (2°C - 8°C) for the rest of the 24-hour period. Do not freeze the reconstituted solution in the vial or the diluted solution in the infusion bag. (See Table 8.)
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