FLUARIX TETRA

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

A/DARWIN/9/2021 (H3N2)-LIKE VIRUS; A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE VIRUS; B/AUSTRIA/1359417/2021 (B/VICTORIA LINEAGE)-LIKE VIRUS; B/PHUKET/3073/2013 (B/YAMAGATA LINEAGE)-LIKE VIRUS

Disponible desde:

GLAXO SMITH KLINE (ISRAEL) LTD

Código ATC:

J07BB02

formulario farmacéutico:

SUSPENSION FOR INJECTION

Composición:

B/PHUKET/3073/2013 (B/YAMAGATA LINEAGE)-LIKE VIRUS 30 MCG HA / 1 ML; B/AUSTRIA/1359417/2021 (B/VICTORIA LINEAGE)-LIKE VIRUS 30 MCG HA / 1 ML; A/DARWIN/9/2021 (H3N2)-LIKE VIRUS 30 MCG HA / 1 ML; A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE VIRUS 30 MCG HA / 1 ML

Vía de administración:

I.M

tipo de receta:

Required

Fabricado por:

GLAXO SMITHKLINE BIOLOGICALS, GERMANY

Área terapéutica:

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

indicaciones terapéuticas:

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 types contained in the vaccine.

Fecha de autorización:

2019-07-31

Información para el usuario

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
The medicine is dispensed with a physician’s prescription only
Fluarix Tetra
Suspension for injection in pre-filled syringe
Inactivated influenza vaccine
Each dose (0.5 ml) contains:
Four influenza strains:
A/VICTORIA/4897/2022 )H1N1(PDM09-LIKE STRAIN )A/VICTORIA/4897/2022,
IVR-238(
15 micrograms
A/DARWIN/9/2021 )H3N2(-LIKE STRAIN )A/DARWIN/6/2021, IVR-227(
15 micrograms
B/AUSTRIA/1359417/2021-LIKE STRAIN )B/AUSTRIA/1359417/2021, BVR-26(
15 micrograms
B/PHUKET/3073/2013-LIKE STRAIN )B/PHUKET/3073/2013, WILD TYPE(
15 micrograms
The list of additional ingredients is detailed in section 6.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information about the medicine. If you
have
further questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Fluarix Tetra is a vaccine. This vaccine will help to protect you
against
influenza (flu), particularly in people who run a high risk of
associated
complications.
The use of Fluarix Tetra is based on official recommendations.
When a person is given the Fluarix Tetra vaccine, the immune system
(the
body’s natural defense system) will produce its own protection
(antibodies)
against the disease. None of the ingredients of 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 there is risk of catching flu until then. The
physician will
be able to recommend to you the best time to be vaccinated. Fluarix
Tetra wil

Ficha técnica

Page 1 of 14
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Fluarix Tetra
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
Page 2 of 14
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.
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 ha