Comirnaty Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products.
Special Precautions for Disposal and Other Handling: Handling instructions: Comirnaty Omicron XBB.1.5 should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion. (See Table 14.)

Click on icon to see table/diagram/image

Instructions Applicable to Both Single and Multidose Vials: Vial verification of Comirnaty Omicron XBB 1.5 (10 micrograms)/dose dispersion for injection (children 5 to 11 years) or (30 micrograms)/dose dispersion for injection (12 years and older): Verify that the vial has a blue (10 mcg)/grey (30 mcg) plastic cap and the product name is Comirnaty Omicron XBB.1.5 (10 micrograms)/dose dispersion for injection.
Check whether the vial is a single dose vial or a multidose vial and follow the applicable handling instructions as follows.
If the vial has another product name on the label, make reference to the monograph for that formulation.
Handling prior to use of Comirnaty Omicron XBB 1.5 (10 micrograms)/dose dispersion for injection (children 5 to 11 years) or (30 micrograms)/dose dispersion for injection (12 years and older): If the single or multidose 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.
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 white to off-white dispersion with no particulates visible. Do not use the vaccine if particulates or discolouration are present.
Preparation of individual 0.3 mL doses of Comirnaty Omicron XBB 1.5 (10 micrograms)/dose dispersion for injection (children 5 to 11 years) or (30 micrograms)/dose dispersion for injection (12 years and older): 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 Omicron XBB.1.5 for children aged 5 to 11 years (10 mcg) or 12 years and older (30 mcg).
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.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.