NEW
Comirnaty復必泰

Comirnaty Storage

Manufacturer:

BioNTech

Distributor:

Pharmason

Marketer:

Fosun Pharma
Full Prescribing Info
Storage
Store at -90°C to -60°C.
Store in the original package in order to protect from light.
During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Thawed vials can be handled in room light conditions.
When ready to thaw or use the vaccine: Open-lid vial trays, or vial trays containing less than 195 vials removed from frozen storage (< -60 °C) may be at room temperature (< 25 °C) for up to 3 minutes to remove vials or for transfer between ultra-low-temperature environments.
Once a vial is removed from the vial tray, it should be thawed for use.
After vial trays are returned to frozen storage following room temperature exposure, they must remain in frozen storage for at least 2 hours before they can be removed again.
For storage conditions after thawing and dilution of the medicinal product, see Shelf life as follows.
Shelf life: Unopened vial: 6 months at -90 °C to -60 °C.
Once removed from the freezer, the unopened vaccine can be stored for up to 5 days at 2 °C to 8 °C, and up to 2 hours at temperatures up to 30 °C, prior to use.
Once thawed, the vaccine should not be re-frozen.
Closed-lid vial trays containing 195 vials removed from frozen storage (< -60 °C) may be at room temperature (< 25 °C) for up to 5 minutes for transfer between ultra-low-temperature environments. After vial trays are returned to frozen storage following room temperature exposure, they must remain in frozen storage for at least 2 hours before they can be removed again.
Diluted medicinal product: Chemical and physical in-use stability has been demonstrated for 6 hours at 2 ºC to 30 ºC after dilution 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.
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