Comirnaty Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: Handling instructions: COMIRNATY should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
Vials: Handling instructions prior to use: Frozen vials must be completely thawed prior to use. Frozen vials should be transferred to 2°C to 8°C to thaw. Thaw times for 10-vial packs are noted in table as follows. (See Table 39.)

Click on icon to see table/diagram/image

Upon moving frozen vaccine to 2°C to 8°C storage, update the expiry date on the carton. The updated expiry date should reflect 10 weeks from the date of transfer to refrigerated conditions (2°C to 8°C) and not exceeding the expiry date (EXP).
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30°C for immediate use.
If the vaccine is received at 2°C to 8°C it should continue to be stored at 2°C to 8°C. Check that the carton has been previously updated to reflect the 10-week refrigerated expiry date.
Unopened vials can be stored for up to 12 hours at temperatures up to 30°C. Total storage time between 8°C to 30°C, inclusive of storage before and after puncture, should not exceed 24 hours.
Preparation for administration: Vial verification: Prior to administration, check the name and strength of the vaccine on the vial label and the colour of the vial cap and vial label border to ensure it is the intended presentation. Check whether the vial is a single dose vial or a multidose vial and check if the vial requires dilution.
COMIRNATY (Omicron JN.1) (Do Not Dilute) (For 12 Years of Age and Older) (Vials with Grey Cap); COMIRNATY (Omicron JN.1) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap): Instructions applicable to both single dose and multidose vials: Check appearance of vaccine prior to mixing and administration.
Grey cap vials: Prior to mixing, the vaccine is a while to off-white dispersion and may contain white to off-white opaque amorphous particles.
Blue cap vials: Prior to mixing, the vaccine is a clear to slightly opalescent dispersion and may contain white to off-white opaque amorphous particles
Gently invert the vial 10 times. Do not shake.
Do not use the vaccine if particulates or discolouration are present after mixing.
Preparation of individual doses: Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
Withdraw a 0.3 mL single dose.
For Dark Grey or Dark Blue cap multidose vials (6 doses per vial): After first puncture, record appropriate date and time on the vial and store at 2°C to 30°C for up to 12 hours. Do not re-freeze.
Each dose must contain 0.3 mL of vaccine. Low dead-volume syringes and/or needles should be used in order to extract all doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.
If the amount of vaccine remaining in the vial cannot provide a full dose, discard the vial and any excess volume.
COMIRNATY (Omicron JN.1) (Dilute Before Use) (For Age 6 Months to <5 Years) (Vials with Yellow Cap): Prior to dilution: After the thawed vial has reached room temperature, gently invert it 10 times prior to dilution. Do not shake.
Check appearance of vaccine.
Yellow cap vials: Prior to dilution, the vaccine is a clear to slightly opalescent dispersion and may contain white to off-white opaque amorphous particles.
Dilution instructions: Thawed vaccine must be diluted in its original vial with sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques. Volume of sodium chloride 9 mg/mL (0.9%) required are noted as follows: Yellow cap vials: 1.1 mL of sodium chloride 9 mg/mL.
Equalise vial pressure before removing the needle from the vial stopper by withdrawing air into the empty diluent syringe. Volume of air required are noted as follows: Yellow cap vials: 1.1 mL of air.
Gently invert the diluted dispersion 10 times. Do not shake.
Check appearance of vaccine after dilution.
Yellow cap vials: After mixing, the vaccine should present as a clear to slightly opalescent dispersion with no particulates visible. Do not use the vaccine if particulates or discolouration are present.
After dilution, mark vial with appropriate date/time, store at 2°C to 30°C and use within 12 hours. Do not re-freeze
Preparation of individual doses: Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
Withdraw a single dose.
Yellow cap vials (3 doses per vial): Each dose must contain 0.3 mL of vaccine. Standard syringes can be used.
If the amount of vaccine remaining in the vial cannot provide a full dose, discard the vial and any excess volume.
Pre-filled syringes: Preparation and administration of individual doses of the refrigerated storage only, glass pre-filled syringes: Prior to use, the pre-filled syringes can be stored for up to 12 hours at temperatures between 8°C to 30°C and can be handled in room light conditions.
Do not shake.
Remove tip cap by slowly turning the cap counterclockwise while holding the luer lock.
Attach a needle appropriate for intramuscular injection and administer the entire volume.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.