COMIRNATY Omicron XBB.1.5 (raxtozinameran) COVID-19 VACCINE 10 micrograms/0.3 mL suspension for injection single dose vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

raxtozinameran, Quantity: 16 microgram

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate); water for injections; cholesterol; 2-((polyethylene glycol)-2000)-N-N-ditetradecylacetamide; sucrose; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride

Administration route:

Intramuscular

Units in package:

10, 195 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 5 years of age to less than 12 years of age.,The use of this vaccine should be in accordance with official recommendations.

Product summary:

Visual Identification: Clear to slightly opalescent solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store between minus 60 - minus 90 degrees; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2023-10-09

Patient Information leaflet

COMIRNATY
® OMICRON XBB.1.5
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about receiving this vaccine, speak to your doctor or pharmacist.
▼
This vaccine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I BEING GIVEN COMIRNATY OMICRON XBB.1.5?
COMIRNATY Omicron XBB.1.5 is a vaccine given to prevent coronavirus
disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults and children
from 5 years of age and older. COMIRNATY Omicron
XBB.1.5 contains the active ingredient raxtozinameran. For more
information, see Section 1. Why am I being given COMIRNATY
Omicron XBB.1.5? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN COMIRNATY OMICRON XBB.1.5?
You should not be given COMIRNATY Omicron XBB.1.5 if you have had an
allergic reaction to any of the ingredients in the vaccine.
See list at the end of the CMI. Check with your doctor if you have
had: a severe allergic reaction or breathing problems after any
other vaccine or after being given COMIRNATY or COMIRNATY Omicron
XBB.1.5 vaccines in the past; fainted following any needle
injection; a severe illness or infection with high fever; a weakened
immune system or are on a medicine that affects your immune
system; a bleeding disorder, bruise easily or are on a blood thinning
medicine. Talk to your doctor if you have any other medical
conditions, take any other medicines, or are pregnant or plan to
become pregnant or are breastfeeding. COMIRNATY Omicron
XBB.1.5 should not be given to children under 5 years. For more
information, see Section 2. What should I know before I am given
COMIRNATY Omicron XBB.1.5? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor or pharmacist if you are taking any other medicines,
including any medicines, vitamins or supplements that you buy
without a prescription. Tell your doctor or pharmacist i

Summary of Product characteristics

Version: pfpcxbbi11023
Supersedes: N/A
Page 1 of 39
This vaccine is subject to additional monitoring
IN AUSTRALIA
. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN
PRODUCT
INFORMATION
–
COMIRNATY
® OMICRON XBB.1.5 (RAXTOZINAMERAN)
COVID-19 VACCINE
1.
NAME OF THE MEDICINE
Raxtozinameran
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Raxtozinameran is a single-stranded, 5’-capped messenger RNA (mRNA)
produced using a
cell-free
_in vitro_
transcription from the corresponding DNA templates, encoding the viral
spike (S) protein of severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2)
(Omicron XBB.1.5).
COMIRNATY OMICRON XBB.1.5
AGE GROUP
12 years and older
5 to <12 years
STRENGTH PER DOSE
30 micrograms
10 micrograms
Each dose contains COVID-19 mRNA Vaccine embedded in lipid
nanoparticles. For the full
list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
AGE GROUP
12 YEARS AND OLDER
5 TO <12 YEARS
AUST R
419330
419371
CAP & LABEL
COLOUR CODE
Dark Grey
Light Blue
PHARMACEUTIC
AL FORM
Suspension for injection
Suspension for injection
STRENGTH PER
DOSE
30 micrograms
(0.3 mL dose)
10 micrograms
(0.3 mL dose)
FILL VOLUME
2.25 mL
0.48 mL
NO. OF DOSES
PER VIAL
6
1
DILUTION
Do not dilute
Do not dilute
COMIRNATY Omicron XBB.1.5 (Dark Grey) is a white to off-white frozen
suspension.
COMIRNATY Omicron XBB.1.5 (Light Blue) is a clear to slightly
opalescent solution.
▼

Version: pfpcxbbi11023
Supersedes: N/A
Page 2 of 39
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunisation to prevent coronavirus disease 2019 (COVID-19)
caused by SARS-CoV-
2, in individuals 5 years of age and older.
The use of this vaccine should be in accordance with official
recommendations.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
STRENGTH AND AGE OF
INDIVIDUAL
VOLUME OF
EACH DOSE
DOSE SCHEDULE FOR PRIMARY SERIES
AND ADDITIONAL DOSE(S)
10 MICROGRAMS PER DOSE
5 to <