Vaxzevria Solution for Injection

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

AZD1222

זמין מ:

ASTRAZENECA SDN. BHD.

INN (שם בינלאומי):

AZD1222

יחידות באריזה:

10 Vials

תוצרת:

ASTRAZENECA NIJMEGEN B.V.

עלון מידע

_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
VAXZEVRIA
_ _
Solution for Injection
COVID-19 Vaccine (ChAdOx1-S [recombinant]), 5×10
10
viral particles
1
WHAT IS IN THIS LEAFLET
1.
What Vaxzevria is used for
2.
How Vaxzevria works
3.
Before you use Vaxzevria
4.
How to use Vaxzevria
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
Vaxzevria
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT VAXZEVRIA IS USED FOR
Vaxzevria is used for preventing
COVID-19 caused by SARS-CoV-
2 virus.
Vaxzevria is given to adults aged
18 years and older.
HOW VAXZEVRIA WORKS
The vaccine causes the immune
system (the body’s natural
defences) to produce antibodies
and specialised white blood cells
that work against the virus, so
giving protection against COVID-
19. None of the ingredients in this
vaccine can cause COVID-19.
BEFORE YOU USE VAXZEVRIA_ _
_When you must not use it _
THE VACCINE MUST NOT BE GIVEN:
-
If you are allergic to the active
substance or any of the other
ingredients of this vaccine
(see
_Ingredient_
subsection).
-
If you have had a major blood
clot occurring at the same
time as having low levels of
platelets (thrombocytopenia)
after receiving any COVID-19
vaccine.
_Children and adolescents _
Vaxzevria is not recommended for
children aged below 18 years.
Currently there is not enough
information available on the use of
Vaxzevria in children and
adolescents younger than 18 years
of age.
_Before you start to use it _
Tell your doctor, pharmacist or
nurse before vaccination:
•
If you have ever had a severe
allergic reaction after any other
vaccine injection or after you
were given Vaxzevria in the
past;
•
If you have ever fainted
following any needle injection;
•
If you have a severe infection
with a high body temperature

מאפייני מוצר

1
28 APRIL 2023
DEAR HEALTHCARE PROFESSIONAL,
CONDITIONAL REGISTRATION OF VAXZEVRIA SOLUTION FOR INJECTION WITH
EXEMPTIONS FROM
MALAYSIA SPECIFIC LABELLING REQUIREMENTS
With regards to the matter above, AstraZeneca would like to inform
that the approval in Malaysia is
supported by common pack product label and carton to facilitate supply
during pandemic period. In
order to make the artwork acceptable to multiple countries around the
world during the pandemic the
artwork is exempted from a number of country specific labelling
requirements. There will not be
country-specific packs for Malaysia until the post pandemic period
which has not been determined
yet.
2. The name and address for the Marketing Authorization Holder (MAH)
in EU, AstraZeneca AB, SE-151
85 Sodertalje Sweden, is reflected on the product carton.
3. Enclosed are the additional Malaysian local labelling information
for your reference which will not
be included in the artwork during the pandemic period.
IMMEDIATE LABEL
PRODUCT INFORMATION
DETAILS
Product Name
Vaxzevria Solution for Injection
Strength of active substance
1 x 10^11 vp/ml
Name and content of alcohol
Ethanol 2 mg per 0.5 ml dose
OUTER CARTON
PRODUCT INFORMATION
DETAILS
Storage Condition
Store in a refrigerator (2 to 8°C).
Do not freeze.
Keep vials in outer carton in order to protect from light.
Name and content of alcohol
This medicinal product contains 2 mg of alcohol (ethanol) per 0.5
ml dose.
Disposal
Vaxzevria contains genetically modified organisms (GMOs). Any
unused vaccine or waste material should be disposed of in
accordance with local requirements. Spills should be disinfected
with an appropriate antiviral disinfectant.
Keep out of the sight and reach
of children
Jauhi dari pandangan dan jangkauan kanak-kanak
Strength of active substance
1 x 10^11 vp/ml
Batch Releaser
AstraZeneca Nijmegen BV
Lagelandseweg 78
6545 CG Nijmegen
The Netherlands
Local Registration Number (MAL
Number)
MAL21036009ACZ
ASTRAZENECA SDN BHD
The Bousteador, Level 12
No. 10, Jalan PJU 7/6, Mutiara Damansara