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Comirnaty

Comirnaty Storage

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Storage
3 mcg/10 mcg: Store in a freezer 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.
For storage conditions after thawing and first opening/dilution, see Shelf Life as follows.
30 mcg: Vials: Store single dose vials and multidose vials in a freezer at -90°C to -60°C.
Glass pre-filled syringes: Store glass pre-filled syringes at 2°C to 8°C. DO NOT FREEZE.
Vials and pre-filled syringes: 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.
For storage conditions after thawing and first opening, see Shelf Life as follows.
Shelf Life: Unopened vial: Frozen vial: 18 months when stored at -90°C to -60°C.
The vaccine will be received frozen at -90°C to -60°C. Frozen vaccine can be stored either at -90°C to -60°C or 2°C to 8°C upon receipt.
Single dose vials: When stored frozen at -90°C to -60°C, 10-vial packs of single dose vials of the vaccine can be thawed at 2°C to 8°C for 2 hours or individual vials can be thawed at room temperature (up to 30°C) for 30 minutes.
Multidose vials: When stored frozen at -90°C to -60°C, 10-vial packs of multidose vials of the vaccine can be thawed at 2°C to 8°C for 6 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
Thawed vial: 10 weeks storage and transportation at 2°C to 8°C within the 18-month shelf life.
Upon moving the vaccine to 2°C to 8°C storage, the updated expiry date must be written on the outer carton and the vaccine should be used or discarded by the updated expiry date. The original expiry date should be crossed out.
If the vaccine is received at 2°C to 8°C it should be stored at 2°C to 8°C. The expiry date on the outer carton should have been updated to reflect the refrigerated expiry date and the original expiry date should have been crossed out.
Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8°C and 30°C.
Thawed vials can be handled in room light conditions.
Once thawed, the vaccine should not be re-frozen.
Handling of temperature excursions during refrigerated storage: Stability data indicate that the unopened vial is stable for up to 10 weeks when stored at temperatures from -2°C to 2°C, within the 10-week storage period between 2°C and 8°C.
Stability data indicate the vial can be stored for up to 24 hours at temperatures of 8°C to 30°C, including up to 12 hours following first puncture.
This information is intended to guide healthcare professionals only in case of temporary temperature excursion.
3 mcg: Diluted medicinal product: Chemical and physical in-use stability has been demonstrated for 12 hours at 2ºC to 30ºC, after dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, which includes up to 6 hours transportation time. From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
10 mcg/30 mcg: Opened vial: Chemical and physical in-use stability has been demonstrated for 12 hours at 2°C to 30°C, which includes up to 6 hours transportation time. From a microbiological point of view, unless the method of opening precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
30 mcg: Pre-filled syringes: Glass pre-filled syringes: The vaccine will be received and stored at 2°C to 8°C (refrigerated only).
8 months when stored at 2°C to 8°C.
Prior to use, pre-filled syringes can be stored for up to 12 hours at temperatures between 8°C and 30°C and can be handled in room light conditions.
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