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) Sodium chloride
Cholesterol
1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
Disodium phosphate dihydrate
2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
Potassium chloride
Potassium dihydrogen phosphate
Water for injections
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)

6.2     Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3     Shelf life

Unopened vial
Frozen vial
2 years when stored at -90 °C to -60 °C.
Within the 2-year 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.

When stored frozen at -90 °C to -60 °C, 195-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 3 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.

Thawed vial

1 month at 2 °C to 8 °C within the 2-year shelf life.
Within the 1-month shelf life at 2 °C to 8 °C, up to 48 hours may be used for transportation.
Prior to use, the unopened vial can be stored for up to 2 hours at temperatures up to 30 °C.
Thawed vials can be handled in room light conditions.
Once thawed, the vaccine should not be re-frozen.
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.

For storage conditions after thawing and dilution of the medicinal product, see section 6.3.

6.5     Nature and contents of container
0.45 mL concentrate in a 2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a purple 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
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 (12 YEARS AND OLDER)
• Verify that the vial has a purple plastic
Purple cap         cap.
• If the vial has a grey plastic cap,
please make reference to Comirnaty
TRIS 30 label.
• If the vial has an orange plastic cap,
please make reference to Comirnaty
TRIS 10 label.
After Dilution



30 mcg
 THAWING PRIOR TO DILUTION OF COMIRNATY
• The multidose vial is stored frozen and must be thawed prior to dilution. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a
195-vial pack may take 3 hours to thaw.
Alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 30 °C for immediate use.
• The unopened vial can be stored for up to 1 month at 2 °C to 8 °C; not exceeding the printed expiry date (EXP).
Within the 1-month shelf life at 2 °C to
8 °C, up to 48 hours may be used for transportation.
• Allow the thawed vial to come to room temperature. Prior to use, the unopened vial can be stored for up to 2 hours at temperatures up to 30 °C. Thawed vials can be handled in room light conditions.
• Gently invert the vial 10 times prior to dilution. Do not shake.
• Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
DILUTION OF COMIRNATY
• The thawed vaccine must be diluted in its original vial with 1.8 mL of 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 1.8 mL air into the empty diluent syringe.

                                                 •   Gently invert the diluted dispersion
10 times. Do not shake.
•   The diluted vaccine should present as an off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present.



Gently × 10
•   The diluted vials should be marked with the appropriate date and time.
•   After dilution, store at 2 ºC to 30 ºC and use within 6 hours, including any transportation time.
•   Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
Discard Time



Record appropriate date and time.
Use within 6 hours after dilution.

 PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY
• After dilution, the vial contains
2.25 mL from which 6 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.

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.
•   Discard any unused vaccine within
6 hours after dilution.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.