Jcovden (previously COVID-19 Vaccine Janssen)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S)

Available from:

Janssen-Cilag International NV

ATC code:

J07BN02

INN (International Name):

COVID-19 vaccine (Ad26.COV2-S [recombinant])

Therapeutic group:

Vaccines

Therapeutic area:

COVID-19 virus infection

Therapeutic indications:

Jcovden 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.

Product summary:

Revision: 30

Authorization status:

Authorised

Authorization date:

2021-03-11

Patient Information leaflet

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
JCOVDEN SUSPENSION FOR INJECTION
COVID-19 vaccine (Ad26.COV2-S [recombinant])
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED BECAUSE
IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What JCOVDEN is and what it is used for
2.
What you need to know before you are given JCOVDEN
3.
How JCOVDEN is given
4.
Possible side effects
5.
How to store JCOVDEN
6.
Contents of the pack and other information
1.
WHAT JCOVDEN IS AND WHAT IT IS USED FOR
JCOVDEN is a vaccine used for preventing COVID-19 caused by the
SARS-CoV-2 virus.
JCOVDEN is given to adults aged 18 years and older.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN JCOVDEN
DO NOT HAVE THE VACCINE IF

You are allergic to the active substance or any of the other
ingredients of this vaccine (listed in
section 6).

You have had 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).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given JCOVDEN
if:

yo

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
JCOVDEN suspension for injection
COVID-19 vaccine (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
JCOVDEN 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
JCOVDEN is administered as a single-dose of 0.5 mL by intramuscular
injection only.
3
Booster dose
A booster dose (second dose) of 0.5 mL of JCOVDEN may be administered
intramuscularly at least
2 months after the primary vaccination in individuals 18 years of age
and older (see also sections 4.4,
4.8 and 5.1).
A booster dose of JCOVDEN (0.5 mL) may be administered in individuals
18 years of age and older
as a heterologous booster dose following completion of primary
vaccination with an mRNA COVID-
19 vaccine or an adenoviral vector-based COVID-19 vaccine. The dosing
interval for the