Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ChAdOx1-SARS-COV-2

Available from:

AstraZeneca AB

ATC code:

J07BN02

INN (International Name):

COVID-19 Vaccine (ChAdOx1-S [recombinant])

Therapeutic group:

Vaccines

Therapeutic area:

COVID-19 virus infection

Therapeutic indications:

Vaxzevria 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:

2021-01-29

Patient Information leaflet

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
VAXZEVRIA SUSPENSION FOR INJECTION
COVID-19 Vaccine (ChAdOx1-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 THE VACCINE IS GIVEN 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 Vaxzevria is and what it is used for
2.
What you need to know before you are given Vaxzevria
3.
How Vaxzevria is given
4.
Possible side effects
5.
How to store Vaxzevria
6.
Contents of the pack and other information
1.
WHAT VAXZEVRIA IS AND WHAT IT IS USED FOR
Vaxzevria is used for preventing COVID-19 caused by the SARS-CoV-2
virus.
Vaxzevria 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 VAXZEVRIA
THE VACCINE MUST NOT BE GIVEN:
-
If you are allergic to the active substance or any of the other
ingredients of this vaccine (listed in
section 6).
-
If 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
Vaxzevria.
-
If 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
Vaxzevria:
-
If

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
Vaxzevria suspension for injection
COVID-19 Vaccine (ChAdOx1-S [recombinant])
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a multidose vial which contains 10 doses of 0.5 ml (see
section 6.5).
One dose (0.5 ml) contains:
Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein
(ChAdOx1-S)
*
, not less than
2.5 × 10
8
infectious units (Inf.U)
*
Produced in genetically modified human embryonic kidney (HEK) 293
cells and by recombinant
DNA technology.
This product contains genetically modified organisms (GMOs).
Excipient 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).
The suspension is colourless to slightly brown, clear to slightly
opaque with a pH of 6.6.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vaxzevria 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.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Individuals 18 years of age and older_
The Vaxzevria primary vaccination course consists of two separate
doses of 0.5 ml each. The second
dose should be administered between 4 and 12 weeks (28 to 84 days)
after the first dose (see
section 5.1).
A booster dose (third dose) of 0.5 ml may be given to individuals who
completed the primary
vaccination course with Vaxzevria or an mRNA COVID-19 vaccine (see
sections 4.8 and 5.1). The
third dose should be administered at least 3 months after completing
the primary vaccination course.
_Elderly population_
No dose adjustment is req