6.1 List of excipients
2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Water for injections
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
9 months at -90 °C to -60 °C
Within the 9 month shelf life unopened vials may be stored and transported at -25 °C to -15 °C for a single period of up to 2 weeks and can be returned to -90 °C to -60 °C.
1 month at 2 °C to 8 °C
Within the 1 month shelf-life at 2 °C to 8 °C, up to 12 hours may be used for transportation.
Prior to use, the unopened vaccine can be stored for up to 2 hours at temperatures up to 30 °C.
Once thawed, the vaccine should not be re-frozen.
Handling of temperature excursions once removed from the freezer
Stability data indicate that the unopened vial is stable for up to:
- 24 hours when stored at temperatures from -3 °C to 2 °C
- a total of 4 hours when stored at temperatures from 8 °C to 30 °C; this includes the 2 hours at up to 30 °C detailed above
This information is intended to guide healthcare professionals only in case of temporary temperature excursion.
Transfers of frozen vials stored at ultra-low temperature(< -60 °C)
- Closed-lid vial trays containing 195 vials removed from ultra-low temperature frozen storage (< -60 °C) may be at temperatures up to 25 °C for up to 5 minutes.
- Open-lid vial trays, or vial trays containing less than 195 vials, removed from ultra-low temperature frozen storage (< -60 °C) may be at temperatures up to 25 °C for up to 3 minutes.
- After vial trays are returned to frozen storage following temperature exposure up to 25 °C, they must remain in frozen storage for at least 2 hours before they can be removed again.
Transfers of frozen vials stored at -25 °C to -15 °C
- Closed-lid vial trays containing 195 vials removed from frozen storage (-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 3 minutes.
- Open-lid vial trays, or vial trays containing less than 195 vials, removed from frozen storage (-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 1 minute.
Once a vial is removed from the vial tray, it should be thawed for use.
Diluted medicinal product
Chemical and physical in-use stability, including during transportation, 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, 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.
6.4 Special precautions for storage
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.
Thawed vials can be handled in room light conditions.
For storage conditions after thawing and dilution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a flip-off plastic cap with aluminium seal. Each vial contains 6 doses, see section 6.6.
Pack size: 195 vials
6.6 Special precautions for disposal and other handling
Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
|THAWING PRIOR TO DILUTION|
|PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY|
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.