Fluenz Tetra
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
07-08-2023
Valmisteyhteenveto
(SPC)
07-08-2023
Julkisesta arviointikertomuksesta
(PAR)
05-09-2016
Aktiivinen ainesosa:
A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) / A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) / B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) / B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444)
Saatavilla:
AstraZeneca AB
ATC-koodi:
J07BB03
INN (Kansainvälinen yleisnimi):
influenza vaccine (live attenuated, nasal)
Terapeuttinen ryhmä:
Influenza vaccines, Influenza, live attenuated
Terapeuttinen alue:
Influenza, Human
Käyttöaiheet:
Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. The use of Fluenz Tetra should be based on official recommendations.
Tuoteyhteenveto:
Revision: 24
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2013-12-04
Pakkausseloste
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUENZ TETRA NASAL SPRAY SUSPENSION
Influenza vaccine (live attenuated, nasal)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THE VACCINE IS GIVEN BECAUSE
IT CONTAINS IMPORTANT
INFORMATION FOR YOU OR YOUR CHILD.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This vaccine has been prescribed for you or your child only. Do not
pass it on to others.
-
If any of the side effects gets serious, talk to your doctor, nurse or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Fluenz Tetra is and what it is used for
2.
What you need to know before you are given Fluenz Tetra
3.
How Fluenz Tetra is given
4.
Possible side effects
5.
How to store Fluenz Tetra
6.
Contents of the pack and other information
1.
WHAT FLUENZ TETRA IS AND WHAT IT IS USED FOR
Fluenz Tetra is a vaccine to prevent influenza (flu). It is used in
children and adolescents 24 months to
less than 18 years of age. Fluenz Tetra will help to protect against
the four virus strains contained in
the vaccine, and other strains closely related to them.
HOW FLUENZ TETRA WORKS
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 the flu.
Fluenz Tetra vaccine viruses are grown in chicken eggs. Each year the
vaccine targets four strains of
influenza, following the annual recommendations by the World Health
Organisation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FLUENZ TETRA
YOU WILL NOT BE GIVEN FLUENZ TETRA:
IF YOU ARE ALLERGIC to gentamicin, gelatin or any of the other
ingredients of this vaccine (listed in
section 6 “Contents of the pack and other information”).
if you have ever had a severe allergic reaction to eggs or egg
proteins. For signs of allergic
reactions, see section 4 “Poss
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fluenz Tetra nasal spray suspension
Influenza vaccine (live attenuated, nasal)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Reassortant influenza virus* (live attenuated) of the following four
strains**:
A/Victoria/4897/2022 (H1N1)pdm09 - like strain
(A/Norway/31694/2022, MEDI 369815)
10
7.0±0.5
FFU***
A/Darwin/9/2021 (H3N2) - like strain
(A/Norway/16606/2021, MEDI 355293)
10
7.0±0.5
FFU***
B/Austria/1359417/2021 - like strain
(B/Austria/1359417/2021, MEDI 355292)
10
7.0±0.5
FFU***
B/Phuket/3073/2013 - like strain
(B/Phuket/3073/2013, MEDI 306444)
10
7.0±0.5
FFU***
.................................................................................................................per
0.2 ml dose
*
propagated in fertilised hens’ eggs from healthy chicken flocks.
**
produced in VERO cells by reverse genetic technology. This product
contains genetically
modified organisms (GMOs).
***
fluorescent focus units.
This vaccine complies with the WHO recommendation (Northern
Hemisphere) and EU decision for
the 2023/2024 season.
The vaccine may contain residues of the following substances: egg
proteins (e.g. ovalbumin) and
gentamicin. The maximum amount of ovalbumin is less than 0.024
micrograms per 0.2 ml dose (0.12
micrograms per ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, suspension
The suspension is colourless to pale yellow, clear to opalescent with
a pH of approximately 7.2. Small
white particles may be present.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza in children and adolescents from 24 months to
less than 18 years of age.
The use of Fluenz Tetra should be based on official recommendations.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Children and adolescents from 24 months:_
0.2 ml (administered as 0.1 ml per nostril).
For children who have not previously been vaccinated against seasonal
influenza, a second dose
should be given after an interval o
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