Comirnaty OriginalOmicron BA.4-5 (55 micrograms)dose Concentrate for Dispersion for Injection

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

Famtozinameran; Tozinameran

Tilgjengelig fra:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

Famtozinameran; Tozinameran

Enheter i pakken:

10 Vials; 195 Vials

Produsert av:

BioNTech Manufacturing GmbH

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DISCLAIMER: THIS PRODUCT IS APPROVED UNDER MALAYSIA CONDITIONAL
REGISTRATION FOR
PHARMACEUTICAL PRODUCTS DURING DISASTER GUIDELINE. THE ADMINISTRATION
OF THE
PRODUCT IS PURELY BASED ON INDIVIDUAL’S PREFERENCE.
COMIRNATY ORIGINAL/BA.4-5 (5MCG/5MCG)
CONCENTRATE FOR DISPERSION FOR INJECTION
COVID-19 mRNA Vaccine (BA.4-5 5mcg/5mcg)
1
WHAT IS IN THIS LEAFLET
1.
What COMIRNATY is used for
2.
How COMIRNATY works
3.
Before you use COMIRNATY
4.
How to use COMIRNATY
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
COMIRNATY
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT COMIRNATY IS USED FOR
COMIRNATY Original/BA.4-5
(5mcg/5mcg) Concentrate for
Dispersion for Injection is a vaccine
used for preventing COVID-19
caused by SARS-CoV-2. It is given
to children from 5 to 11 years of age.
COMIRNATY Original/BA.4-5
(5mcg/5mcg) Concentrate for
Dispersion for Injection is only for
individuals who have previously
received at least a primary
vaccination (BNT162b2) course
against COVID-19.
HOW COMIRNATY WORKS
The vaccine causes the immune
system (the body’s natural defenses)
to produce antibodies and blood cells
that work against the virus, so giving
protection against COVID-19.
As COMIRNATY does not contain
the virus to produce immunity, it
cannot give your child COVID-19.
BEFORE YOU USE COMIRNATY
-
_When you must not use it_
DO NOT TAKE COMIRNATY
If your child is allergic to the active
substance or any of the other
ingredients of COMIRNATY.
_Pregnancy and lactation_
If your child is pregnant, tell your
child’s doctor, nurse or pharmacist
before your child receives this
vaccine.
No data are available yet regarding
the use of COMIRNATY
Original/BA.4-5 (5mcg/5mcg)
Concentrate for Dispersion for
Injection during pregnancy.
However, a large amount of
information from pregnant women
vaccinated with the initially
approved Comirnaty vaccine
during the second and third
trimester have not shown negativ

Preparatomtale

Pfizer (Malaysia) Sdn Bhd 197801003134 (40131-T)
Level 10 & 11, Wisma Averis, Tower 2
Avenue 5, Bangsar South, No. 8 Jalan Kerinchi
59200 Kuala Lumpur, Malaysia
Tel: [phone] Fax: [phone]
29 Aug 2023,
Dear Healthcare Professionals,
CONDITIONAL REGISTRATION OF COMIRNATY CONCENTRATE FOR DISPERSION FOR
INJECTION COVID-19 MRNA VACCINE WITH EU LABEL ON PRODUCT CARTON
With regards to the matter above, Pfizer would like to inform that the
label on the product carton
is the label approved by European Medicines Agency (EMA). During
pandemic supply period, the
approved label by EMA will be used for stocks supply to the rest of
world including Malaysia. There will
not be country-specific packs for Malaysia until commercial supply
stage which has not been determined
yet.
2.
The name and address for the Marketing Authorization Holder (MAH) in
EU information is
reflected on the product carton, BioNTech Manufacturing GmbH with the
address of An der Goldgrube 12,
55131 Mainz, Germany. The batch release site information will not be
reflected on the product label.
3.
Enclosed are product information approved in Malaysia for your
reference.
PRODUCT INFORMATION
Details
FULL NAME OF PRODUCT
Comirnaty Original/BA.4-5 (5mcg/5mcg) Concentrate for
Dispersion for Injection
COVID-19 mRNA Vaccine (nucleoside modified)
REGISTRATION NUMBER
STRENGTH OF ACTIVE
INGREDIENTS
5 micrograms of tozinameran and 5 micrograms of famtozinameran,
a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles)
MANUFACTURER AND
BATCH RELEASER (FOR
MALAYSIA)
BATCH RELEASE SITE:
Pfizer Manufacturing Belgium NV, Rijksweg 12, Puurs, 2870,
Belgium
BATCH RELEASE SITE:
BioNTech Manufacturing GmbH, Kupferbergterrasse 17-19, 55116
Mainz, Germany
PRH NAME AND
ADDRESS
Pfizer Malaysia Sdn. Bhd. Level 10 & 11, Wisma Averis (Tower 2),
Bangsar South, No.8, Jalan Kerinchi, 59200 Kuala Lumpur,
Malaysia
STORAGE CONDITION
Store in a freezer at -90°C to -60°C
PACK SIZE
10 vials or 195 vials
4.
Pfizer Malaysia will submit label update to the National
Pharmaceutical Regulato