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

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Inactivated SARS-CoV-2 virus (19nCoV-CDC-Tan-HB02 strain) (Vero cell)

Boleh didapati daripada:

DUOPHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

Inactivated SARS-CoV-2 virus (19nCoV-CDC-Tan-HB02 strain) (Vero cell)

Unit dalam pakej:

0.5 ml; 0.5 ml

Dikeluarkan oleh:

Beijing Institute of Biological Products Co., Ltd. (BIBP)

Risalah maklumat

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (PIL_)
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.
COVILO SUSPENSION FOR INJECTION COVID-19 VACCINE (VERO CELL),
INACTIVATED
Inactivated SARS-CoV-2 virus (19nCoV-CDC-Tan-HB02 strain) (Vero cell)
1
WHAT IS IN THE LEAFLET
1.
What COVILO is used for
2.
How COVILO works
3.
Before you use COVILO
4.
How to use COVILO
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
COVILO
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT COVILO IS USED FOR
COVILO
is
a
vaccine
used
to
prevent
COVID-19
caused
by
SARS-CoV-2 virus.
COVILO is given to adults of 18 to
59 years of age.
A
booster
dose
(0.5mL)
of
COVILO may be administered at
least 3-6 months after the second
dose.
HOW COVILO 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 COVILO
-
_When you must not use it_
_ _
_ _
Do not take COVILO
•
if
you
have
an
allergy
to
COVILO or any of the other
ingredients listed at the end of
this leaflet.
•
if you have ever had a severe
allergic
reaction
to
other
vaccines in the past.
•
if
you
have
nervous
system
diseases such as uncontrolled
epilepsy
(seizure)
and
Guillain-Barre syndrome.
_Pregnancy and lactation _
If
you
are
pregnant
or
breast-
feeding, think you may be pregnant
or are planning to have a baby, ask
your doctor for advice before you
receive this vaccine.
_Children and adolescents _
COVILO is not recommended for
children aged under 18 years as
limited safety and efficacy data are
available.
_Elderly adults 60 years old and _
_above _
COVILO is not recommended for
elderly
adults
60
years
old
and
above
as
limited

Ciri produk

03 March 2022
DIRECT HEALTHCARE PROFESIONAL COMMUNICATION (DHPC)
PRODUCT NAME
: COVILO SUSPENSION FOR INJECTION COVID-19 VACCINE (VERO CELL), INACTIVATED
REGISTRATION NO.
: MAL21076098AZ
RE
: PRODUCT LABEL NOTICE
Dear Healthcare Professional,
Please be informed that details in the vial label (immediate label)
and outer carton label for COVILO are
based on the global product information issued by the manufacturer,
Beijing Institute of Biological
Products Co. Ltd.
2.
However, product details specified In the Package Insert (PI) and the
Patient Information Leaflet
(PIL) are based on information approved by the Drug Control Authority
(DCA), Malaysia. As such, there
are differences in information in the product vial label, outer
carton, PI and PIL as follows:
DETAILS
GLOBAL LABEL
(VIAL & OUTER CARTON)
LABEL APPROVED BY DCA MALAYSIA
(PI AND PIL)
Product Name
COVID-19
Vaccine
(Vero
Cell)
Inactivated COVILO
COVILO Suspension for Injection COVID-19
Vaccine (Vero Cell), Inactivated
Indication
This
product
is
for
active
immunization to prevent COVID-19
caused
by
SARS-CoV-2
virus
in
individuals from 18 to 59 years of age.
This product is for active immunization to
prevent
COVID-19
caused
by
SARS-CoV2
virus in individuals from 18 to 59 years of
age. The vaccine efficacy of this product for
adults in 18-59-year-old cohort have been
shown based on the interim report of the
international Phase III clinical trial, in which,
the proportion of older adults (
≥
60 years
old) was low (2.01%).
The
use
of
this
vaccine
should
be
in
accordance with official recommendations.
Composition
3.9-10.4U/Single dose x 0.5mL/Vial
Each dose (0.5mL) contains 3.9-10.4 units of
inactivated SARS-CoV-2, 19nCoV-CDC-Tan-
HB02 antigen strain
Dosage Form
Liquid
Suspension for Injection
Registration
No./ MAL
GYZZ S20200030
MAL21076098AZ
Route of
Administration
The recommended administration is
through intramuscular route
Intramuscular route
Dose
Immunization Regimen and Dosage:
Two dose regimens at an interval of
21-28 days, each dose is 0.5mL.
_Immunizati