Comirnaty Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products (except those mentioned as follows - for 3 mcg only).
Special Precautions for Disposal and Other Handling: Handling instructions prior to use: Comirnaty JN.1 should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
Instructions Applicable to Both Single and Multidose Vials: Verify that the vial has a yellow (3 mcg)/blue (10 mcg)/grey (30 mcg) plastic cap and the product name is Comirnaty JN.1 (3 micrograms)/dose concentrate for dispersion for injection (infants and children 6 months to 4 years) or (10 micrograms)/dose dispersion for injection (children 5 to 11 years) or (30 micrograms)/dose dispersion for injection (12 years and older).
If the vial has another product name on the label or a different cap colour, make reference to the monograph for that formulation.
If the vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred to an environment of 2°C to 8°C to thaw. Ensure vials are completely thawed prior to use.
Single dose vials: A 10-vial pack of single dose vials may take 2 hours to thaw.
Multidose vials: A 10-vial pack of multidose vials may take 6 hours to thaw.
Upon moving vials to 2°C to 8°C storage, update the expiry date on the carton.
Unopened vials can be stored for up to 10 weeks at 2°C to 8°C.
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30°C.
Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30°C. Thawed vials can be handled in room light conditions.
3 mcg: Dilution for a vial with a yellow cap: Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake.
Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
The thawed vaccine must be diluted in its original vial with 1.1 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.1 mL air into the empty diluent syringe.
Gently invert the diluted dispersion 10 times. Do not shake.
The diluted vaccine should present as a white to off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present.
The diluted vials should be marked with the appropriate discard date and time.
After dilution, store at 2ºC to 30ºC and use within 12 hours.
Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
Preparation of 0.3 mL doses using a vial with a yellow cap: After dilution, the vial contains 1.58 mL from which 3 doses of 0.3 mL can be extracted.
Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
Withdraw 0.3 mL of Comirnaty JN.1 for infants and children aged 6 months to 4 years. Standard syringes and/or needles can be used in order to extract 3 doses from a single vial.
Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Discard any unused vaccine within 12 hours after dilution.
10 mcg/30 mcg: Preparation of 0.3 mL doses: Gently mix by inverting vials 10 times prior to use. Do not shake.
Prior to mixing, the thawed dispersion may contain white to off-white opaque amorphous particles.
After mixing, the vaccine should present as a clear to slightly opalescent (10 mcg) or white to off-white (30 mcg) dispersion with no particulates visible. Do not use the vaccine if particulates or discolouration are present.
Check whether the vial is a single dose vial or a multidose vial and follow the applicable handling instructions as follows: Single dose vials: Withdraw a single 0.3 mL dose of vaccine.
Discard vial and any excess volume.
Multidose vials: Multidose vials contain 6 doses of 0.3 mL each.
Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
Withdraw 0.3 mL of Comirnaty JN.1.
Low dead-volume syringes and/or needles should be used in order to extract 6 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 standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.
Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Record the appropriate date/time on the vial. Discard any unused vaccine 12 hours after first puncture.
30 mcg: Instructions applicable to pre-filled syringes: Glass pre-filled syringes: Prior to use, 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.
Remove tip cap by slowly turning the cap counterclockwise. Do not shake. 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.