Entyvio

Entyvio Storage

vedolizumab

Manufacturer:

Takeda

Distributor:

Zuellig Pharma
Full Prescribing Info
Storage
Store in a refrigerator (2°C-8°C). Keep the vial in the outer carton in order to protect from light.
Shelf life: 3 years (up to 36 months).
Stability of reconstituted vedolizumab solution in vial: In-use stability of the reconstituted solution in the vial has been demonstrated for 8 hours at 2°C-8°C.
Stability of diluted vedolizumab solution in 0.9% sodium chloride solution: In-use stability of the diluted solution in 0.9% sodium chloride solution 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 0.9% sodium chloride is a total of 12 hours at 20°C-25°C or 24 hours at 2°C-8°C. This hold time may include up to 8 hours at 2°C-8°C in the vial. Do not freeze the reconstituted solution in the vial or the diluted solution in the infusion bag.
Stability of the diluted vedolizumab solution in Lactated Ringer's solution: In-use stability of the diluted solution in Lactated Ringer's solution in the infusion bag has been demonstrated for 8 hours at 2°C-8°C.
The combined in-use stability of vedolizumab in the vial and infusion bag diluted with Lactated Ringer's solution is a total of 8 hours at 2°C-8°C. Do not freeze the reconstituted solution in the vial or the diluted solution in the infusion bag. (See Table 6.)

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