COMIRNATY (TrisSucrose) 30 mcg Solution for Injection

Страна: Малайзия

Язык: английский

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

Активный ингредиент:

Tozinameran

Доступна с:

PFIZER (MALAYSIA) SDN. BHD.

ИНН (Международная Имя):

Tozinameran

Штук в упаковке:

10 Vials

Производитель:

BioNTech Manufacturing GmbH

тонкая брошюра

_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 (TRIS/SUCROSE) 30 MCG SOLUTION
FOR INJECTION
COVID-19 mRNA Vaccine (30 mcg)
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.
COMIRNATY (Tris/Sucrose) 30 mcg
Solution for Injection is given to
adults and adolescents from 12 years
of age and older.
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 you COVID-19.
BEFORE YOU USE COMIRNATY
-
_When you must not use it_
DO NOT TAKE COMIRNATY
If you are allergic to the active
substance or any of the other
ingredients of COMIRNATY.
_Pregnancy and lactation_
If you are pregnant or think you
may be pregnant, tell your doctor,
nurse or pharmacist before you
receive 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 (Tris/Sucrose)
30 mcg Solution for Injection is not
recommended for children aged
under 12 years.

Характеристики продукта

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 (Tris/Sucrose) 30 mcg Solution for Injection_
_ _
REGISTRATION NUMBER
MAL22016036AZ
_ _
STRENGTH OF ACTIVE
INGREDIENTS
30 MCG/DOSE
(adults and adolescents from 12 years)
PACK SIZE
10 multidose vials with 2.25 mL filling
(Each grey cap vial contains
6 DOSES OF 0.3 ML
– no dilution)
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 fut