COVID-19 Vaccine Janssen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ad26.COV2.S 100 GVP/mL (GVP = Giga Viral Particles; equivalent to not less than to 8.92 log10 infectious units per dose)

Available from:

Janssen-Cilag (New Zealand) Ltd

Pharmaceutical form:

Suspension for injection

Composition:

Active: Ad26.COV2.S 100 GVP/mL (GVP = Giga Viral Particles; equivalent to not less than to 8.92 log10 infectious units per dose) Excipient: Citric acid monohydrate Ethanol Hydrochloric acid Hydroxypropyl-beta-cyclodextrin Polysorbate 80 Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water for injection

Prescription type:

Prescription

Therapeutic indications:

COVID-19 Vaccine Janssen has provisional consent for the indication below: 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:

Package - Contents - Shelf Life: Vial, glass, multi-dose, 10 x 2.5mL 2R Type 1 glass vial closed with latex-free chlorobutyl rubber stopper - 50 dose units - 24 months from date of manufacture stored below -20°C (Deep freeze) protect from light 11 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 3 hours opened stored at or below 25°C protect from light

Authorization date:

2020-12-08

Patient Information leaflet

COVID-19 V
ACCINE JANSSEN (230309) NZCMIv8
1
COVID-19 VACCINE JANSSEN
NEW ZEALAND 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.
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.
- 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.
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.
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, pharmacist or nurse will give the vaccine as an injection
into the muscle (usually in the upper arm).
You may receive COVID-19 Vaccine Janssen as a single dose as a primary
vaccination.
You may also receive COVID-19 Vaccine Janssen as a booster dose after
primary vaccination with COVID-19 Vaccine Janssen or
after a primary v

Summary of Product characteristics

12.220614
Page 1 of 26
COVID-19 VACCINE JANSSEN (230309) DSv10
COVID-19 VACCINE JANSSEN
®
AD26.COV2.S
DATA SHEET
1. PRODUCT NAME
COVID-19 Vaccine Janssen 5×10
10
virus particles (VP) in 0.5 mL 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 (S) glycoprotein*
(Ad26.COV2-S), 5×10
10
virus
particles (VP) (equivalent to 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) under GMO
regulations in other
jurisdictions. Please note that under the New Zealand Hazardous
Substances and New Organisms
(HSNO) Act, this product is not considered a GMO.
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 consent (see section 5.1) for
the indication below:
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.
12.220614
Page 2 of 26
COVID-19 VACCINE JANSSEN (230309) DSv10
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
INDIVIDUALS 18 YEARS OF AGE AND OLDER
_PRIMARY VACCINATION _
COVID-19 Vaccine Janssen is administered as a single dose of 0.5 mL by
intramuscular injection
only.
_BOOSTER DOSE _
A booster dose (second dose) of 0.5 mL of COVID-19 Vaccine Janssen may
be administered
intramuscularly at least 2 months after the primary vaccination in
individuals 18 years of age and
older. Higher immune responses are observed with an interval up to 6
months between