COVAXIN® (Whole Virion Inactivated Coronavirus (SARS-CoV-2) Vaccine) Suspension for Intramuscular Injection

Country: Malaysia

Language: English

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

Active ingredient:

Inactivated whole SARS-CoV-2 virion (strain NIV-2020-770)

Available from:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (International Name):

Inactivated whole SARS-CoV-2 virion (strain NIV-2020-770)

Units in package:

0.5 ml; 2.5 ml; 5 ml; 10 ml

Manufactured by:

BHARAT BIOTECH INTERNATIONAL LIMITED

Patient Information leaflet

_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.
COVAXIN
® (WHOLE VIRION, INACTIVATED
CORONAVIRUS (SARS- COV-2) VACCINE)
SUSPENSION FOR INTRAMUSCULAR INJECTION
Whole Virion, Inactivated (SARS-Cov-2) Antigen (Strain NIV-2020-770)
(6mcg)
__________________________________________________________________________________________
CONFIDENTIAL
Page 1 of 3
WHAT IS IN THIS LEAFLET
1.
What Covaxin® is used for
2.
How Covaxin® works
3.
Before you use Covaxin®
4.
How to use Covaxin®
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Covaxin®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT
COVAXIN®
IS
USED
FOR
Covaxin®
is
a
vaccine
used
to
prevent
COVID-19
caused
by
coronavirus (SARS CoV-2).
Covaxin® is given to adults of age
18 years and older.
HOW COVAXIN® WORKS
The
vaccine
stimulates
the
immune
system
(the
body’s
natural
defenses)
to
produce
its
own
antibodies
and
blood
cells
that work against the virus. This
will
help
to
increase
your
protection against COVID-19.
None
of
the
ingredients
in
this
vaccine can cause COVID-19.
BEFORE YOU USE COVAXIN®
-
_When you must not use it_
DO NOT TAKE COVAXIN®
:
- if you are allergic to
Covaxin® or
any
of
the
other
ingredients
of
Covaxin®
(see
section
_Product _
_Description_
). Contact your doctor
or
go
to
the
nearest
hospital
emergency immediately if
you have an allergic reaction
- if you had a severe allergic reaction
after a previous dose of this vaccine.
- currently having an acute infection or
fever .
_Pregnancy and lactation_
If
you
are
pregnant
or
breastfeeding,
planning
to
breastfeed,
think
you
may
be
pregnant or are planning to
have a
baby, ask your doctor for
advice
before you receive this
vaccine.
There is limited data on the use
of
Covaxin®
in
pregnant
or
breastfe

Summary of Product characteristics

AVERROES PHARMACEUTICALS SDN. BHD.
COVAXIN®
(Whole Virion Inactivated Coronavirus (SARS-CoV-2) Vaccine)
Suspension for Intramuscular Injection
CONTROLLED MEDICINE / UBAT TERKAWAL DISCLAIMER: THIS PRODUCT IS
APPROVED UNDER
MALAYSIAN
CONDITIONAL
REGISTRATION
FOR
PHARMACEUTICAL
PRODUCTS
DURING
DISASTER
GUIDELINE.
THE
ADMINISTRATION
OF
THE
PRODUCT
IS
PURELY
BASED
ON
INDIVIDUAL’S PREFERENCE.
THIS MEDICINAL PRODUCT IS SUBJECT TO ADDITIONAL MONITORING. THIS WILL
ALLOW QUICK IDENTIFICATION OF NEW SAFETY
INFORMATION. HEALTHCARE PROFESSIONALS ARE ASKED TO REPORT ANY
SUSPECTED NEW OR SERIOUS ADVERSE REACTIONS. THIS
PRODUCT INFORMATION WILL BE UPDATED ON A REGULAR BASIS AS FURTHER DATA
AND SAFETY REPORTS BECOME AVAILABLE.
THE INFORMATION STATED ON INNER AND OUTER CARTON LABELS IS BASED ON
THE GLOBAL LABEL. FOR MALAYSIA SPECIFIC
INFORMATION, PLEASE REFER THIS PACKAGE INSERT.
PRODUCT DESCRIPTION
COVAXIN®
(Whole Virion Inactivated Coronavirus (SARS-CoV-2) Vaccine) is a white
to off white, opalescent
suspension free from extraneous particles containing 6 μg of Whole
Virion, Inactivated (SARS-CoV-2) Antigen (strain
NIV-2020-770).
COMPOSITION
ONE DOSE (0.5ML) CONTAINS:
Active ingredient:
6
µg of Inactivated whole SARS-CoV-2 virion (strain NIV-2020-770).
Excipient:
0.25mg Aluminium Hydroxide Gel equivalent to Al, 15 µg TLR7/8
Agonist, 2.5mg of 2- phenoxyethanol and phosphate
buffered saline q.s to 0.5ml.
PHARMACODYNAMIC PROPERTIES
COVID-19 disease is caused due to SARS-CoV-2 virus infection.
COVAXIN
® has been studied in an ongoing Phase
1 and 2 clinical studies for safety and immunogenicity and found to be
safe and immunogenic. In the ongoing Phase 3
trial, COVAXIN® has been shown to prevent COVID 19 following 2 doses
of vaccine given 4 weeks apart based on
the interim analysis showing vaccine efficacy to be 77.8%. The
duration of protection against COVID-19 is currently
unknown.
PHARMACOKINETIC PROPERTIES
Evaluation of pharmacokinetic properties is not required for vaccines.
INDICATION
COVAXIN®
is indicated for active i