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 (0.5ml/vial) in one box of 40 Vials

Dikeluarkan oleh:

Solution Biologics Sdn. Bhd.

Risalah maklumat

_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.
CONVIDECIA
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Solution for Injection
Page
1
of
3
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 defenses (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,
dyspnea, etc).
People with uncontrolled epilepsy
and other progressive neurological
diseases,
and
the
history
of
Guillain-Barré syndrome.
If you are not sure, talk to your
doctor, pharmacist or nurse.
_Pregnant and lactating women. _
No data are currently available on
the use of CONVINDECIA in
Pregnant and lactating women.
_Before you start to use it _
Caution should be taken when this
vaccine is used in the following
conditions:

For
patients
w

Ciri produk

PACKAGE INSERT
V2.0
First Approval Date: 13-12-2022
Revision date: 05-01-2023
CONVIDECIA (TRADE MARK) RECOMBINANT NOVEL CORONAVIRUS VACCINE
(ADENOVIRUS TYPE 5 VECTOR) SOLUTION FOR INJECTION
CONTROLLED MEDICINE / UBAT TERKAWAL
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). 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.
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 glass vial.
A booster dose (0.5ml) may be administered at least 3-6 months after
the first single dose
when the potential benefits outweigh any potential risks.
The decision when and for whom to implement a booster