Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Sucrose
((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) Tris (hydroxymethyl) aminomethane hydrochloride (Tris HCl)
Cholesterol
1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
Tromethamine (Tris base)
2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
Water for injection

6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products.
6.3   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.

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 2-year 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.
Opened vial

Chemical and physical in-use stability has been demonstrated for 12 hours at 2 ºC to 30 ºC, 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.

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.

For storage conditions after thawing and first opening, see section 6.3.

6.5   Nature and contents of container
Comirnaty TRIS 30 is supplied in a 2 mL clear vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a grey flip-off plastic cap with aluminium seal.

One multidose vial (2.25 mL) contains 6 doses of 0.3 mL, see sections 4.2 and 6.6.

Pack sizes: 10 vials or 195 vials.
Not all pack sizes may be marketed.

6.6   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.

VIAL VERIFICATION OF COMIRNATY TRIS 30 (12 YEARS AND OLDER)
• Verify that the vial has a grey plastic cap and a grey border around the label and the product name is Comirnaty
Grey cap            TRIS 30.
• If the vial has a purple plastic cap,
please make reference to Comirnaty label.
• If the vial has an orange plastic cap,
please make reference to Comirnaty
Do not dilute
TRIS 10 label.



30 mcg


 HANDLING PRIOR TO USE OF COMIRNATY TRIS 30 (12 YEARS AND OLDER)
• If the 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.
A 10-vial pack of multidose vials may take 6 hours to thaw.
• Upon moving vials to 2 °C to 8 °C
Store for up to   storage, update the expiry date on the
10 weeks at      carton.
2 °C to 8 °C,  • Unopened vials can be stored for up to update expiry     10 weeks at 2 °C to 8 °C; not exceeding on carton.      the printed expiry date (EXP).
• 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.


Gently × 10


PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY TRIS 30 (12 YEARS AND OLDER)
• 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.

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
0.3 mL vaccine                             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.