COMIRNATY ORIGINALOMICRON BA.4-5 DISPERSION FOR INJECTION 1515 MICROGRAMSDOSE (MULTI-DOSE VIAL)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Famtozinameran; Tozinameran

Available from:

BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.

ATC code:

J07BN01

Pharmaceutical form:

INJECTION

Composition:

Famtozinameran 15 μg/dose; Tozinameran 15 μg/dose

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Pfizer Manufacturing Belgium NV

Authorization status:

ACTIVE

Authorization date:

2023-09-07

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION
15/15 MICROGRAMS/DOSE (MULTI-DOSE VIAL) (SIN16855P)
COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION
15/15 MICROGRAMS/DOSE (SINGLE-DOSE VIAL) (SIN16856P)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What COMIRNATY (Bivalent) is and what it is used for
2.
What you need to know before you receive COMIRNATY (Bivalent)
3.
How COMIRNATY (Bivalent) is given
4.
Possible side effects
5.
How to store COMIRNATY (Bivalent)
6.
Contents of the pack and other information
1.
WHAT COMIRNATY (BIVALENT) IS AND WHAT IT IS USED FOR
COMIRNATY Original/Omicron BA.4-5 15/15 micrograms per dose Dispersion
for Injection,
COVID-19 mRNA Vaccine (nucleoside modified) is called COMIRNATY
(Bivalent) (For 12 Years
of Age and Older) (Vials with Grey Cap).
COMIRNATY (Bivalent) is a vaccine used for preventing COVID-19 caused
by SARS-CoV-2 virus.
COMIRNATY (Bivalent) (For 12 Years of Age and Older) (Vials with Grey
Cap) is given to adults
and adolescents from 12 years of age and older who have been
previously vaccinated with
COMIRNATY or COMIRNATY (Bivalent) (For 12 Years of Age and Older)
(Vials with Grey Cap).
The vaccine causes the immune system (the body’s natural defences)
to produce antibodies and blood
cells that work against the virus, so giving protection against
COVID-19.
As COMIRNATY (Bivalent) does not contain the virus to produce
immunity, it cannot give you
COVID-19.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE COMIRNATY (BIVALENT)
COMIRNATY (BIVALENT) SHOULD NOT BE GIVEN
•
if you are allergic to the active substance or any of

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION
15/15 MICROGRAMS/DOSE (MULTI-DOSE VIAL) (SIN16855P)
COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION
15/15 MICROGRAMS/DOSE (SINGLE-DOSE VIAL) (SIN16856P)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a single dose or a multidose vial. One single dose vial
contains one dose of 0.3 mL (see
sections 4.2 and 6.6). One multidose vial (2.25 mL) contains 6 doses
of 0.3 mL (see sections 4.2 and
6.6).
One dose (0.3 mL) contains 15 micrograms of tozinameran and 15
micrograms of famtozinameran, a
COVID-19 mRNA Vaccine (embedded in lipid nanoparticles).
COMIRNATY (BIVALENT)
(FOR 12 YEARS OF AGE AND OLDER)
(VIALS WITH GREY CAP)
AGE
12 years of age and older
PHARMACEUTICAL FORM
Dispersion for injection
STRENGTH
15/15 micrograms/dose
CAP COLOUR
Grey
DILUTION
Do not dilute
PRESENTATION
Tris/Sucrose
Tozinameran 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
SARS-CoV-2 (Original). Famtozinameran 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 SARS-CoV-2 (Omicron BA.4-5).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersion for injection
The vaccine is a white to off-white frozen dispersion (pH: 6.9 - 7.9).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COMIRNATY (Bivalent) (For 12 Years of Age and Older) (Vials with Grey
Cap) is indicated for
active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in
individuals 12 years of
age and older.
The use of this vaccine should be in accordance with official
recommendations.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Booster dose in individuals 12 years of age and older_
A booster dose of COMIRNATY (Bivalent) (For 12 Years of Ag