Fluenz Tetra vaccine nasal suspension 0.2ml unit dose

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Influenza virus live attenuated

Beszerezhető a:

AstraZeneca UK Ltd

ATC-kód:

J07BB03

INN (nemzetközi neve):

Influenza virus live attenuated

Gyógyszerészeti forma:

Spray

Az alkalmazás módja:

Nasal

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 14040000; GTIN: 5000456005562

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUENZ TETRA NASAL SPRAY SUSPENSION
Influenza vaccine (live attenuated, nasal)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of
section 4 for how to report side effects.
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
Fluenz Tetra is identical to Fluenz (a nasal influenza vaccine
containing three strains), except Fluenz
Tetra provides protection against an additional influenza strain.
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

Termékjellemzők

OBJECT 1
FLUENZ TETRA NASAL SPRAY SUSPENSION INFLUENZA
VACCINE (LIVE ATTENUATED, NASAL)
Summary of Product Characteristics Updated 27-Mar-2018 | AstraZeneca
UK Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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/Michigan/45/2015 (H1N1)pdm09 - like strain
(A/Slovenia/2903/2015, MEDI 279432)
10
7.0±0.5
FFU***
A/Hong Kong/4801/2014 (H3N2) - like strain
(A/New Caledonia/71/2014, MEDI 263122)
10
7.0±0.5
FFU***
B/Brisbane/60/2008 - like strain
(B/Brisbane/60/2008, MEDI 228030)
10
7.0±0.5
FFU***
B/Phuket/3073/2013 - like strain
(B/Phuket/3073/2013, MEDI 254977)
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
2017/2018 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.
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.
4.2 Posology and method of ad