Janssen COVID-19 Vaccine Suspension for Injection

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

rAd26.COV2-S

Disponible depuis:

JOHNSON & JOHNSON SDN BHD

DCI (Dénomination commune internationale):

rAd26.COV2-S

Unités en paquet:

10 Vials

Fabriqué par:

JANSSEN PHARMACEUTICA N.V.

Notice patient

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.
JANSSEN COVID-19 VACCINE SUSPENSION FOR
INJECTION
Ad26.COV2-S (recombinant) (not less than 8.92 log
10
infectious units (Inf.U)/0.5mL)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Janssen COVID-19 Vaccine is
used for
2.
How Janssen COVID-19 Vaccine
works
3.
Before you use Janssen COVID-19
Vaccine
4.
How to use Janssen COVID-19
Vaccine
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Janssen
COVID-19 Vaccine
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT JANSSEN COVID-19 VACCINE IS
USED FOR
Janssen COVID-19 Vaccine is a vaccine
used for preventing COVID-19 caused by
the SARS-CoV-2 virus.
Janssen COVID-19 Vaccine is given to
adults aged 18 years and older.
HOW JANSSEN COVID-19 VACCINE WORKS
The vaccine causes the immune system
(the body’s natural defences) to produce
antibodies and specialised white blood
cells that work against the virus, so giving
protection against COVID-19.
None of the ingredients in this vaccine can
cause COVID-19.
BEFORE YOU USE JANSSEN COVID-19
VACCINE
-
_When you must not use it _
Do not have the vaccine if:
•
You are allergic to the active
substance or any of the other
ingredients of this vaccine.
•
You have a blood clot occurring at the
same time as having low levels of
blood platelets (thrombosis with
thrombocytopenia syndrome, TTS)
after receiving any COVID-19
Vaccine.
•
You have a previous diagnosis of
capillary leak syndrome, (a condition
causing fluid leakage from small
blood vessels).
-
_Before you start to use it _
Talk to your doctor, pharmacist or nurse
before you are given Janssen COVID-19
Vaccine if:
•
you have ever had a severe allergic
reaction after injection of any other
vaccine,
•
you have ever fainted following any
needle injecti

Résumé des caractéristiques du produit

1
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 required to report
all suspected adverse reactions.
This product information will be updated on a regular basis as further
data and safety reports become
available.
1.
NAME OF THE MEDICINAL PRODUCT
Janssen COVID-19 Vaccine Suspension for Injection (Ad26.COV2-S
(recombinant))
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a multi-dose vial which contains 5 doses of 0.5 mL.
One dose (0.5 mL) contains:
Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein*
(Ad26.COV2-S), not less than
8.92 log
10
infectious units (Inf.U).
*
Produced in the PER.C6 TetR Cell Line and by recombinant DNA
technology.
The product contains genetically modified organisms (GMOs).
Excipients with known effect
Each dose (0.5 mL) contains approximately 2 mg of ethanol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection (injection).
Colourless to slightly yellow, clear to very opalescent suspension (pH
6-6.4).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Janssen COVID-19 Vaccine is indicated for active immunisation 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Individuals 18 years of age and older _
Primary vaccination
COMMENTED [TZW[1]:
Align with EU PI vDec2021
2
Janssen COVID-19 Vaccine is administered as a single-dose of 0.5 mL by
intramuscular injection
only.
Homologous booster dose
A booster dose (second dose) of 0.5 mL of Janssen COVID-19 Vaccine may
be administered
intramuscularly at least 2 months after the primary vaccination in
individuals 18 y