Flucelvax Tetra

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

A/Darwin/6/2021(H3N2)-like strain (A/Darwin/11/2021, wild type) / A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022 CVR-167) / B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021) / B/Phuket/3073/2013-like virus (B/Singapore/INFTT-16-0610/2016, wild type)

Available from:

Seqirus Netherlands B.V.

ATC code:

J07BB02

INN (International Name):

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Therapeutic group:

influenza, inactivated, split virus or surface antigen

Therapeutic area:

Influenza, Human

Therapeutic indications:

Prophylaxis of influenza in adults and children from 2 years of age.Flucelvax Tetra should be used in accordance with official recommendations.

Product summary:

Revision: 14

Authorization status:

Authorised

Authorization date:

2018-12-12

Patient Information leaflet

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCELVAX TETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Influenza vaccine (surface antigen, inactivated, prepared in cell
cultures)
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 Flucelvax Tetra is and what it is used for
2.
What you need to know before you receive Flucelvax Tetra
3.
How Flucelvax Tetra is given
4.
Possible side effects
5.
How to store Flucelvax Tetra
6.
Contents of the pack and other information
1.
WHAT FLUCELVAX TETRA
IS AND WHAT IT IS USED FOR
Flucelvax Tetra is a vaccine against flu (influenza). Flucelvax Tetra
is prepared in cell cultures, and,
therefore, is egg-free.
When a person is given the vaccine, the immune system (the body’s
natural defence system) will
produce its own protection against the influenza virus. None of the
ingredients in the vaccine can
cause flu.
Flucelvax Tetra is used to prevent flu in adults and children from 2
years of age.
The vaccine targets four strains of influenza virus following the
recommendations by the World
Health Organisation for the 2023/2024 SEASON.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE
FLUCELVAX TETRA
YOU SHOULD NOT RECEIVE
FLUCELVAX TETRA:
If you are allergic to:
•
the active ingredients or any of the other ingredients of this
medicine (listed in section 6)
•
beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80,
which are trace
residues from the manufacturing process.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before receiving Flucelvax
Tetra.
BEFORE receiving the vaccine
•
Your doctor or nurse will make sure that appropriate medical treatment
a

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Flucelvax Tetra suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell
cultures)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase),
inactivated, of the following
strains*:
A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022
CVR-167) 15 micrograms HA**
A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) 15
micrograms HA**
B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild
type) 15 micrograms HA**
B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild
type) 15 micrograms HA**
per 0.5 ml dose
……………………………………….
*
propagated in Madin Darby Canine Kidney (MDCK) cells
**
haemagglutinin
The vaccine complies with the World Health Organisation (WHO)
recommendation (northern
hemisphere) and EU recommendation for the 2023/2024 SEASON.
Flucelvax Tetra may contain traces of beta-propiolactone,
cetyltrimethylammonium bromide, and
polysorbate 80 (see section 4.3).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection (injection)
Clear to slightly opalescent liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza in adults and children from 2 years of age.
Flucelvax Tetra should be used in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children from 2 years of age _
AGE GROUP
DOSE
SCHEDULE
2 to < 9 years
One or two
a
0.5 mL doses
If 2 doses, administer at least
3
4 weeks apart
9 years of age and older
One 0.5 mL dose
Not applicable
a
Children less than 9 years of age who have not been previously
vaccinated against influenza, should
receive a second dose.
_Children below 2 years of age _
The safety and efficacy of Flucelvax Tetra in children from birth to
less than 2 years of age has not
been established. No data are availab