COMIRNATY 10mcg Concentrate for Dispersion for Injection

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

Tozinameran

Dostupné s:

PFIZER (MALAYSIA) SDN. BHD.

INN (Mezinárodní Name):

Tozinameran

Jednotky v balení:

10 Vials

Výrobce:

BioNTech Manufacturing GmbH

Informace pro uživatele

_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 10 MCG CONCENTRATE FOR
DISPERSIONFOR INJECTION
COVID-19 mRNA Vaccine (10 mcg)
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 is a vaccine used for
preventing COVID-19 caused by
SARS-CoV-2 virus.
COMIRNATY 10mcg Concentrate
for Dispersion for Injection is given
to children aged 5 to 11 years (i.e. 5
to less than 12 years of age).
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 active
substance or any of the other
ingredients of COMIRNATY.
_Pregnancy and lactation_
If your child is pregnant, tell your
doctor, nurse or pharmacist before
your child receives this vaccine.
COMIRNATY can be used during
pregnancy. A large amount of
information from pregnant women
vaccinated with COMIRNATY
during the second and third
trimester have not shown negative
effects on the pregnancy or the
newborn baby. While information
on effects on pregnancy or the
newborn baby after vaccination
during the first trimester is limited,
no change to the risk for
miscarriage has been seen.
COMIRNATY can be given during
breast feeding.
_Children_
COMIRNATY 10 mcg Concentrate
for Dispersion for Injection should
be used only for children

Charakteristika produktu

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]
17 July 2023
Dear Healthcare Professionals,
CONDITIONAL REGISTRATION OF COMIRNATY 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 10 mcg Concentrate for Dispersion for Injection
REGISTRATION NUMBER
MAL22016037AZ
_ _
STRENGTH OF ACTIVE
INGREDIENTS
10 MCG/DOSE
(children 5 to 11 years)
PACK SIZE
10 multidose vials with 1.3mL filling
(After dilution, each vial contains
10 DOSES OF 0.2 ML
)
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
4.
Pfizer Malaysia will submit label update to the National
Pharmaceutical Regulatory Authority
(NPRA) if there are any label updates in the future.
Thank you.
Yours since