Vaxigrip Tetra Suspension for injection / Quadrivalent influenza vaccine (split virion, inactivated)

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

INFLUENZA VACCINE, SPLIT VIRION, INACTIVATED

Pieejams no:

Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France

ATĶ kods:

J07BB02

SNN (starptautisko nepatentēto nosaukumu):

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

Zāļu forma:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Kompozīcija:

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

Receptes veids:

POM

Ārstniecības joma:

VACCINES

Autorizācija statuss:

Authorised

Autorizācija datums:

2016-09-12

Lietošanas instrukcija

Page
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PACKAGE LEAFLET: INFORMATION FOR THE USER
VAXIGRIP TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Quadrivalent influenza vaccine (split virion, inactivated)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED 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.
-
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,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Vaxigrip Tetra is and what it is used for
2.
What you need to know before you or your child use Vaxigrip Tetra
3.
How to use Vaxigrip Tetra
4.
Possible side effects
5.
How to store Vaxigrip Tetra
6.
Contents of the pack and other information
1.
WHAT VAXIGRIP TETRA IS AND WHAT IT IS USED FOR
Vaxigrip Tetra is a vaccine. This vaccine administered to you or your
child from 6 months of age helps to
protect you or your child against influenza (flu).
When a person is given Vaxigrip Tetra, the immune system (the body’s
natural defence system) will produce
its own protection (antibodies) against the disease. When given during
pregnancy the vaccine helps to protect
the pregnant women but also helps to protect her baby from birth to
less than 6 months of age through the
transmission of protection from mother to baby during pregnancy (see
also Sections 2 and 3).
None of the ingredients in the vaccine can cause flu.
The use of Vaxigrip Tetra should be based on official recommendations.
Flu is a disease that can spread rapidly and is caused by different
types of strains that can change every year.
Due to this potential change in circulating strains on a yearly basis,
as well as the duration of protection
intended by the vaccine, vaccination is recommended every year. The
greatest risk of catching flu is during
the

Produkta apraksts

PAGE 1 OF 17
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 17
1.
NAME OF THE MEDICINAL PRODUCT
Vaxigrip Tetra, suspension for injection in pre-filled syringe
Quadrivalent 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/9/2021, IVR-228)
15 micrograms HA**
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type)
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 fertilised hens’ eggs from healthy chicken flocks
**
haemagglutinin
This vaccine complies with the WHO recommendations (Northern
Hemisphere) and EU decision for the
2023/2024 season.
For the full list of excipients, see Section 6.1.
Vaxigrip Tetra may contain traces of eggs, such as ovalbumin, and of
neomycin, formaldehyde and
octoxinol-9, which are used during the manufacturing process (see
Section 4.3).
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine, after shaking gently, is a colourless opalescent liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vaxigrip Tetra is indicated 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
for:
-
active immunisation of adults, including pregnant women, and children
from 6 months of age and
older,
-
passive protection of infant(s) from birth to less than 6 months of
age following vaccination of
pregnant women (see Sections 4.4, 4.6 and 5.1).
PAGE 3 OF 17
The use of Vaxigrip Tetra should be based on official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Based on clinical experience with the trivalent vaccine, annual
revaccination with influenza vaccine is
recommended given the duration of immunity provided by the vaccine and
bec