Fluarix Tetra Susp for Inj in pre-filled syringe / Influenza vaccine (split viron, inactivated)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

A, BRISBANE, H, IVR, KANSAS, NYMC X, PHUKET, WILD TYPE, NYMC BX

Available from:

GlaxoSmithKline Biologicals S.A. Rue de L'Institut 89 B-1330 Rixensart, Belgium

ATC code:

J07BB02

INN (International Name):

A/DARWIN/9/2021 (H3N2) - like strain (A/DARWIN/6/2021, IVR-227 15 µg B/PHUKET/3073/2013 - like strain (B/PHUKET/3073/2013, WILD TYPE) 15 µg B/AUSTRIA/1359417/2021 - like strain (B/AUSTRIA/1359417/2021 BVR-26 15 µg A/VICTORIA/4897/2022 (H1N1) PDM09 - like strain (A/VICTORIA/4897/2022 IVR-238 15 µg

Pharmaceutical form:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Composition:

A/DARWIN/9/2021 (H3N2) - like strain (A/DARWIN/6/2021, IVR-227 15 µg B/PHUKET/3073/2013 - like strain (B/PHUKET/3073/2013, WILD TYPE) 15 µg B/AUSTRIA/1359417/2021 - like strain (B/AUSTRIA/1359417/2021 BVR-26 15 µg A/VICTORIA/4897/2022 (H1N1) PDM09 - like strain (A/VICTORIA/4897/2022 IVR-238 15 µg

Prescription type:

POM

Therapeutic area:

VACCINES

Authorization status:

Authorised

Authorization date:

2018-05-14

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUARIX TETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Influenza vaccine (split virion, inactivated)
This leaflet has been written assuming the person receiving the
vaccine is reading it, but it can be
given to adolescents and children so you may be reading it for your
child.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
RECEIVING 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 or pharmacist.
-
This vaccine has been prescribed for you or your child only. Do not
pass it on to others.
-
If you or your child get any side effects, talk to your doctor. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fluarix Tetra is and what it is used for
2.
What you need to know before you use Fluarix Tetra
3.
How Fluarix Tetra is given
4.
Possible side effects
5.
How to store Fluarix Tetra
6.
Contents of the pack and other information
1.
WHAT FLUARIX TETRA IS AND WHAT IT IS USED FOR
Fluarix Tetra is a vaccine. This vaccine helps to protect you against
influenza (flu), particularly in
subjects who run a high risk of associated complications. The use of
Fluarix Tetra should be
based on official recommendations.
When a person is given the vaccine Fluarix Tetra, the immune system
(the body’s natural defence
system) will produce its own protection (antibodies) against the
disease. None of the ingredients
in the vaccine can cause flu.
Flu is a disease that can spread rapidly and is caused by different
types of strains that can change
every year. Therefore, this is why you might need to be vaccinated
every year. The greatest risk
of catching flu is during the cold months between October and March.
If you were not vaccinated
in the autumn, it is still sensible to be vaccinated up until the
spring since you run the risk of
catching flu until then. Your doctor will be

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fluarix Tetra suspension for injection in pre-filled syringe
Influenza vaccine (split virion, inactivated)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*:
A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE STRAIN (A/VICTORIA/4897/2022,
IVR-238)
15 micrograms HA**
A/DARWIN/9/2021 (H3N2)-LIKE STRAIN (A/DARWIN/6/2021, IVR-227)
15 micrograms HA**
B/AUSTRIA/1359417/2021-LIKE STRAIN (B/AUSTRIA/1359417/2021, BVR-26)
15 micrograms HA**
B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE)
15 micrograms HA**
per 0.5 ml dose
*
propagated in fertilized hens’ eggs from healthy chicken flocks
**
haemagglutinin
This vaccine complies with the World Health Organisation (WHO)
recommendation (northern
hemisphere) and EU recommendation for the
2023/2024
season.
Fluarix Tetra may contain traces of eggs (such as ovalbumin, chicken
proteins), formaldehyde,
gentamicin sulphate and sodium deoxycholate which are used during the
manufacturing process
(see section 4.3).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The suspension is colourless and slightly opalescent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluarix Tetra is indicated for active immunisation of adults and
children from 6 months of age for
the prevention of influenza disease caused by the two influenza A
virus subtypes and the two
influenza B virus lineages contained in the vaccine (see section 5.1).
The use of Fluarix Tetra should be based on official recommendations.
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Annual revaccination with the current vaccine is recommended because
immunity declines during
the year after vaccination, and because circulating strains of
influenza virus might change from
year to year.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 0.5 ml
_ _
_Paediatric population _
Children from 6 months onwards: 0.5 ml.
For children aged < 9 years, who have not previously been