CoronaVac Suspension for Injection COVID-19 Vaccine (Vero Cell) Inactivated

Country: Malaysia

Language: English

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

Active ingredient:

Inactivated SARS-CoV-2 virus (CZ02 strain) (Vero cell)

Available from:

PHARMANIAGA LIFESCIENCE SDN. BHD.

INN (International Name):

Inactivated SARS-CoV-2 virus (CZ02 strain) (Vero cell)

Units in package:

1.0 ml x 5 Vials; 0.5 ml x 10 Vials; 0.5 ml x 40 Vials; 1.0 ml x 40 Vials; 1.0 ml x 10 Vials

Manufactured by:

PHARMANIAGA LIFESCIENCE SDN. BHD.

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.
CORONAVAC
SUSPENSION
FOR
INJECTION
COVID-19 VACCINE (VERO CELL), INACTIVATED
COVID-19 Vaccine (Vero Cell), Inactivated (600 SU equivalent to 3µg)
CONFIDENTIAL
Page No. 1 of 4
WHAT IS IN THIS LEAFLET
1.
What CoronaVac is used for
2.
How CoronaVac works
3.
Before you use CoronaVac
4.
How to use CoronaVac
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
CoronaVac
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT CORONAVAC IS USED FOR
CoronaVac is a vaccine used to
prevent
COVID-19
caused
by
coronavirus (SARS-CoV-2).
CoronaVac is given to adults and
children from 5 years of age and
older.
A
booster
dose
of
CoronaVac
may be administered at least 3-6
months after the second dose in
individuals 18 years of age and
older.
HOW CORONAVAC WORKS
The
vaccine
stimulates
the
immune
system
(the
body’s
natural defences) 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 CORONAVAC
-
_When you must not use it _
DO NOT TAKE CORONAVAC
:
-
if
you
are
allergic
to
CoronaVac
or
any
of
the
other
ingredients
of
CoronaVac
(see
section
_Product Description_
). Signs
of an allergic reaction may
include
itchy
skin
rash,
shortness
of
breath
and
swelling
of
the
face
or
tongue. Contact your doctor
or go to the
nearest hospital
emergency
immediately
if
you
have
an
allergic
reaction
-
if
you
have
a
history
of
allergic
reactions
to
other
vaccines
-
if
you
have
any
severe
neurological
conditions
such
as
spinal
cord
inflammation and Guillain-
Barré syndrome
-
if
you
have
uncontrolled
severe chronic illnesses
-
if you have an infection with
high
feve

Summary of Product characteristics

CoronaVac Suspension for Injection COVID-19
Vaccine (Vero Cell), Inactivated
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.
COMPOSITION
Each dose (0.5 mL) contains 600 SU (equivalent
to 3µg) of inactivated SARS-CoV-2 antigen.
Excipient:
Aluminium
hydroxide,
disodium
hydrogen
phosphate,
monosodium
dihydrogen
phosphate, sodium chloride and water for injection.
There is no preservative in this product.
DESCRIPTION
CoronaVac
is
a
milky-white
(opalescent)
suspension. Stratified precipitate may form which
can be dispersed by shaking.
CoronaVac
is
available
in
the
following
presentations:

Single-dose (1 dose) vial of 0.5 mL

Multi-dose (2 doses) vial of 1.0 mL
INDICATION
CoronaVac is indicated for active immunization to
prevent COVID-19 caused by SARS-CoV-2 virus,
in individuals 5 years of age and older.
The use of this vaccine should be in accordance
with official recommendations.
RECOMMENDED DOSAGE
Individuals 18 years of age and older
Two doses should be administered for primary
immunization. The second dose is preferably given
14 - 28 days after the first dose. 0.5 mL per dose.
A booster dose (0.5ml) may be administered at
least 3-6 months after the second dose when the
potential benefits outweigh any potential risks.
The decision when and for whom to implement a
booster dose of the vaccine should be made based
on available vaccine effectiveness data, taking into
account limited safety data (see clinical data).
Children and adolescent 5 years to 17 years of age
Two doses should be admin