COVID-19 Vaccine (inactivated, adjuvanted) Valneva

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

COVID-19 vaccine (inactivated, adjuvanted, adsorbed)

זמין מ:

Valneva Austria GmbH

קוד ATC:

J07BX03

INN (שם בינלאומי):

COVID-19 vaccine (inactivated, adjuvanted, adsorbed)

קבוצה תרפויטית:

Vaccines

איזור תרפויטי:

COVID-19 virus infection

סממני תרפויטית:

COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age. The use of this vaccine should be in accordance with official recommendations.

leaflet_short:

Revision: 6

מצב אישור:

Withdrawn

תאריך אישור:

2022-06-24

עלון מידע

23
B. PACKAGE LEAFLET
Medicinal product no longer authorised
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
COVID-19 VACCINE (INACTIVATED, ADJUVANTED) VALNEVA
SUSPENSION FOR INJECTION
COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
•
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 VACCINE
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 COVID-19 Vaccine (inactivated, adjuvanted) Valneva is and what it
is used for
2.
What you need to know before you are given COVID-19 Vaccine
(inactivated, adjuvanted)
Valneva
3.
How COVID-19 Vaccine (inactivated, adjuvanted) Valneva is given
4.
Possible side effects
5.
How to store COVID-19 Vaccine (inactivated, adjuvanted) Valneva
6.
Contents of the pack and other information
1.
WHAT COVID-19 VACCINE (INACTIVATED, ADJUVANTED) VALNEVA IS AND WHAT IT
IS USED FOR
COVID-19 Vaccine (inactivated, adjuvanted) Valneva is a vaccine used
to prevent COVID-19 caused
by SARS-CoV-2.
COVID-19 Vaccine (inactivated, adjuvanted) Valneva is given to adults
18 to 50 years of age.
The vaccine causes the immune system (the body’s natural defences)
to produce antibodies and blood
cells that works 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 COVID-19 VACCINE
(INACTIVATED, ADJUVANTED)
VALNEVA
_ _
COVID-19 VACCINE (INACTIVATED, ADJUVANTED) VALNEVA MUST NOT BE GIVEN
-
if you are allergic to the active substance, to yeast or yeast-derive

מאפייני מוצר

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
COVID-19 Vaccine (inactivated, adjuvanted) Valneva suspension for
injection
COVID-19 vaccine (inactivated, adjuvanted, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This is a multi-dose vial which contains 10 doses of 0.5 mL
One dose (0.5 mL) contains 33 Antigen Units (AgU) of inactivated
SARS-CoV-2 virus
1,2,3.
1
Wuhan strain hCoV-19/Italy/INMI1-isl/2020
2
Produced on Vero cells (African green monkey cells)
3
Adsorbed on aluminium hydroxide (0.5 mg Al
3
+ in total) and adjuvanted by 1 mg CpG 1018
(cytosine phospho-guanine) in total.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection (injection)
White to off-white suspension (pH 7.5 ± 0.5)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for
active immunisation to prevent
COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age.
The use of this vaccine should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Primary series _
_Individuals 18 to 50 years of age_
_ _
COVID-19 Vaccine (inactivated, adjuvanted) Valneva is administered
intramuscularly as a course of
2 doses of 0.5 mL each. The second dose should be administered 28 days
after the first dose (see
sections 4.4 and 5.1).
There are no data available on the interchangeability of COVID-19
Vaccine (inactivated, adjuvanted)
Valneva with other COVID-19 vaccines to complete the vaccination
course. Individuals who have
received the first dose of COVID-19 Vaccine (inactivated, adjuvanted)
Valneva should receive the
Medicinal product no longer authorised
3
second dose o