VidPrevtyn Beta

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain)

Saatavilla:

Sanofi Pasteur

ATC-koodi:

J07BX03

INN (Kansainvälinen yleisnimi):

COVID-19 Vaccine (recombinant, adjuvanted)

Terapeuttinen ryhmä:

Vaccines

Terapeuttinen alue:

COVID-19 virus infection

Käyttöaiheet:

VidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received an mRNA or adenoviral vector COVID-19 vaccine (see sections 4.2 and 5.1 in product information document).The use of this vaccine should be in accordance with official recommendations.

Tuoteyhteenveto:

Revision: 1

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2022-11-10

Pakkausseloste

29
B. PACKAGE LEAFLET
Medicinal product no longer authorised
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIDPREVTYN BETA SOLUTION AND EMULSION FOR EMULSION FOR INJECTION
COVID-19 vaccine (recombinant, adjuvanted)
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 RECEIVE THIS MEDICINE
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 VidPrevtyn Beta is and what it is used for
2.
What you need to know before you receive VidPrevtyn Beta
3.
How VidPrevtyn Beta is given
4.
Possible side effects
5.
How to store VidPrevtyn Beta
6.
Contents of the pack and other information
1.
WHAT VIDPREVTYN BETA IS AND WHAT IT IS USED FOR
VidPrevtyn Beta is a vaccine used for preventing COVID-19.
VidPrevtyn Beta is given to adults who previously received either mRNA
or adenoviral vector
COVID-19 vaccine.
The vaccine stimulates the immune system (the body’s natural
defences) to produce specific
antibodies that work against the virus, giving protection against
COVID-19. None of the ingredients
in this vaccine can cause COVID-19.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE VIDPREVTYN BETA
_ _
DO NOT USE VIDPREVTYN BETA:
If you are allergic to the active substance or any of the other
ingredients of this medicine (listed in
section 6);
If you are allergic to octylphenol ethoxylate, a substance that is
used in the manufacturing process.
Small amounts of this substance may remain after manufacturing.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given the
vaccine if:
•
you

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
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
VidPrevtyn Beta solution and emulsion for emulsion for injection
COVID-19 vaccine (recombinant, adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
These are two multidose vials (antigen vial and adjuvant vial) that
must be mixed before use. After
mixing, the vaccine vial contains 10 doses of 0.5 mL.
One dose (0.5 mL) contains 5 micrograms of SARS-CoV-2 spike protein
(B.1.351 strain) produced
by recombinant DNA technology using a baculovirus expression system in
an insect cell line that is
derived from Sf9 cells of the fall armyworm,
_Spodoptera frugiperda._
AS03 adjuvant is composed of squalene (10.69 milligrams),
DL-α-tocopherol (11.86 milligrams) and
polysorbate 80 (4.86 milligrams).
VidPrevtyn Beta may contain traces of octylphenol ethoxylate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution and emulsion for emulsion for injection
The antigen solution is a colourless, clear liquid.
The adjuvant emulsion is a whitish to yellowish homogeneous milky
liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VidPrevtyn Beta is indicated as a booster for active immunisation to
prevent COVID-19 in adults
who have previously received an mRNA or adenoviral vector COVID-19
vaccine (see sections 4.2
and 5.1).
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 _
VidPrevtyn Beta is administered intramuscularly as a single dose of
0.5 mL at least 4 months after a
previous COVID-19 vaccine. VidPrevtyn Beta may be given once as a
booster to adults that have
received prior vaccination series with either