COVID-19 VACCINE JANSSEN Ad26.COV2.S 5x10^10 VP/0.5mL suspension for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Ad26.COV2.S, Quantity: 50000000000 vp

Available from:

Janssen-Cilag Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: sodium chloride; polysorbate 80; sodium hydroxide; hydroxypropylbetadex; citric acid monohydrate; sodium citrate dihydrate; ethanol absolute; hydrochloric acid; water for injections

Administration route:

Intramuscular

Units in package:

10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

COVID-19 Vaccine Janssen has provisional approval for the indication:,COVID-19 Vaccine Janssen 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. The decision has been made on the basis of short term efficacy and safety data. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

Product summary:

Visual Identification: Colourless to slightly yellow, clear to very opalescent suspension; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 11 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2021-06-25

Patient Information leaflet

COVID-19 Vaccine Janssen
1
COVID-19 VACCINE JANSSEN
This vaccine has PROVISIONAL APPROVAL in Australia for preventing
COVID-19 caused by the SARS-CoV-2 virus in adults aged 18
years and older. This approval has been granted on the basis of short
term efficacy and safety data. Evidence of longer term
efficacy and safety from ongoing clinical trials and vaccination in
the community continues to be gathered and assessed.
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this vaccine, speak to your doctor or pharmacist.

This vaccine is new. Please report side effects. See the full CMI for
further details.
1.
WHY AM I RECEIVING COVID-19 VACCINE JANSSEN?
COVID-19 Vaccine Janssen contains the active ingredient Ad26.COV2.S.
COVID-19 Vaccine Janssen is a vaccine used for preventing COVID-19
caused by the SARS-CoV-2 virus.
COVID-19 Vaccine Janssen is given to adults aged 18 years and older.
For more information, see Section 1. Why am I receiving COVID-19
Vaccine Janssen?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I RECEIVE COVID-19 VACCINE JANSSEN?
Do not receive if:
- you have ever had an allergic reaction to any of the ingredients
listed at the end of the full CMI.
- you have ever had a diagnosis of capillary leak syndrome, a very
rare, serious condition where fluid (plasma) leaks out of the
small blood vessels into the body tissues.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
COVID-19 Vaccine Janssen should not be given to children under 18
years.
For more information, see Section 2. What should I know before I
receive COVID-19 Vaccine Janssen?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with COVID-19 Vaccine Janssen and affect
how it works.
For more information, see Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I RECEIVE COVID-19 VACCINE JANSSEN?
Your doctor, phar

Summary of Product characteristics

This vaccine is subject to additional monitoring in Australia. This
will allow quick identification of new safety
information.
Healthcare
professionals
are
asked
to
report
any
suspected
adverse
events
at
www.tga.gov.au/reporting-problems.
11.220211
Page 1 of 17
COVID-19 JANSSEN (220817) API
▼
COVID-19 VACCINE JANSSEN
®
AD26.COV2.S
AUSTRALIAN PRODUCT INFORMATION
1. NAME OF THE MEDICINE
COVID-19 Vaccine Janssen 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; SARS-CoV-2
spike (S) protein sequence from Wuhan/WIV04/2019; Genbank MN908947),
5×10
10
virus particles
(VP) (equivalent to not less than 8.92 log
_10_
infectious units (Inf.U)).
*The vaccine was manufactured using material sourced from a human
embryo (Human Embryonic
Retinal cells: PER.C6 cells).
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
COVID-19 Vaccine Janssen has PROVISIONAL APPROVAL for the indication:
COVID-19 Vaccine Janssen 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.
11.220211
Page 2 of 17
COVID-19 JANSSEN (220817) API
The decision has been made on the basis of short term efficacy and
safety data. Continued approval
is dependent upon the evidence of longer-term efficacy and safety from
ongoing clinical trials and
post-market assessment.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_INDIVIDUALS 18 YEARS OF AGE AND OLDER _
COVID-19