Convidecia (Trade Mark) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Solution for Injection

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

rAd5-nCoV

Boleh didapati daripada:

Solution Biologics Sdn. Bhd.

INN (Nama Antarabangsa):

rAd5-nCoV

Unit dalam pakej:

2ml glass vial (0.5mil/vial) in one small box Vials (Quantity) Vials; 2ml glass vial (1.5ml/vial) in one small box Vials; 2ml glass vial (0.5mil/vial) in one small box Vials; 2ml glass vial (1.5ml/vial) in one small box Vials; 2ml glass vial (0.5ml/vial) in one small box Vials; 2ml glass vial (1.5ml/vial) in one small box Vials

Dikeluarkan oleh:

CanSino Biologics Inc

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
_ _
Page
1
of
3
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.
CONVIDECIA
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Solution for Injection
WHAT IS IN THIS LEAFLET
1.
What
CONVIDECIA
is
used for
2.
How CONVIDECIA works
3.
Before
you
use
CONVIDECIA
4.
How to use CONVIDECIA
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
CONVIDECIA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT CONVIDECIA IS USED
FOR
CONVIDECIA is indicated for
active immunization to prevent
COVID-19
caused
by
SARS-
CoV-2, in individuals 18 years of
age and older. The use of this
vaccine should be in accordance
with official recommendations
HOW CONVIDECIA WORKS
CONVIDECIA
stimulates
the
body’s natural defences (immune
system). It causes the body to
produce
its
own
protection
(antibodies)
against
the
virus.
This
will
help
to
protect
you
against COVID-19 in the future.
None of the ingredients in this
vaccine can cause COVID-19.
BEFORE YOU USE CONVIDECIA
_When you must not use it _
DO NOT TAKE CONVIDECIA
if
you have ever had an allergic
reaction to any component of this
vaccine or similar vaccines, (see
_ingredient_
subsection)
of
this
vaccine or similar vaccines.
People
who
have
experienced
severe
allergic
reactions
to
vaccines in the past (such as acute
allergic reactions, angioedema,
•
Those who have been injected
with immune globulin should
vaccinate at an interval of more
than
1
month
to
avoid
decreasing the immune effect.
_ _
_Taking other medicines _
Tell
your
doctor,
pharmacist
or
nurse
if
you
are
taking,
have
recently taken or might take, any
other medicines or vaccines
HOW TO USE CONVIDECIA
_How much to use & when to use _
CONVIDECIA should be injected
into the deltoid muscle of the upper
arm as a single dose. Based o

Ciri produk

CanSino Biologics Inc., 185 South Avenue, TEDAWest District, Tianjin,
China 300462
Page 1 of 11
V4.0
First Approval Date: 16-06-2021
Revision date: 26-12-2022
PACKAGE INSERT
CONVIDECIA (TRADE MARK) RECOMBINANT NOVEL CORONAVIRUS VACCINE
(ADENOVIRUS TYPE 5 VECTOR) SOLUTION FOR INJECTION
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
_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 events. This product information will be updated on a
regular basis as further _
_data and safety reports become available _
1.
DRUG NAME
Proprietary Name: Recombinant Novel Coronavirus Vaccine (Adenovirus
Type 5 Vector)
Trade Name: Convidecia or CONVIDECIA
2.
DESCRIPTION
The final product is sterile liquid injection in 2 ml glass vial of
single dose (0.5 ml per dose) or
three doses per vial (1.5 ml per vial, 0.5 ml per dose). The vaccine
is colorless or slightly white
liquid injection.
ACTIVE INGREDIENT:
Each 0.5mL contains ≥ 4×10
10
viral particles of replication-defective
recombinant human type 5 Adenovirus expressing S protein of
SARS-CoV-2.
CanSino Biologics Inc., 185 South Avenue, TEDAWest District, Tianjin,
China 300462
Page 2 of 11
EXCIPIENTS:
Mannitol, sucrose, sodium chloride, magnesium chloride, polysorbate
80, glycerin,
and
N-(2-Hydroxyethyl)
piperazine-N’-(2-ethanesulfonic
acid)
(HEPES)
and
Water-For-
Injection as solvent.
3.
INDICATIONS AND USAGE
Convidecia is indicated for active immunization to prevent COVID-19
caused by SARS-CoV-
2, in individuals 18 years of age and older.
The use of this vaccine should be in accordance with official
recommendations.
4.
RECOMMENDED DOSAGE
Individuals 18 years of age and older:
Single dose. Each dose contains 0.5 mL liquid injection, supplied in a
single-dose gl