Fluenz
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
03-12-2014
Karatteristiċi tal-prodott
(SPC)
03-12-2014
Rapport ta 'Valutazzjoni Pubblika
(PAR)
03-12-2014
Ingredjent attiv:
Reassortant influenza virus (live attenuated) of the following strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain
Disponibbli minn:
MedImmune LLC
Kodiċi ATC:
J07BB03
INN (Isem Internazzjonali):
influenza vaccine (live attenuated, nasal)
Grupp terapewtiku:
Vaccines
Żona terapewtika:
Influenza, Human; Immunization
Indikazzjonijiet terapewtiċi:
Prophylaxis of influenza in individuals 24 months to less than 18 years of age.The use of Fluenz should be based on official recommendations.
Sommarju tal-prodott:
Revision: 4
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2011-01-27
Fuljett ta 'informazzjoni
21
B. PACKAGE LEAFLET
Medicinal product no longer authorised
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUENZ 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 is and what it is used for
2.
What you need to know before you are given Fluenz
3.
How Fluenz is given
4.
Possible side effects
5.
How to store Fluenz
6.
Contents of the pack and other information
1.
WHAT FLUENZ IS AND WHAT IT IS USED FOR
Fluenz is a vaccine to prevent influenza (flu). It is used in children
and adolescents 24 months
to less than 18 years of age.
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 vaccine viruses are grown in chicken eggs. The vaccine targets
three strains of influenza
virus each year, following the annual recommendations by the World
Health Organisation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FLUENZ
YOU WILL NOT BE GIVEN FLUENZ
IF YOU ARE ALLERGIC
to eggs, egg proteins, gentamicin, or gelatin or any of the other
ingredients
of Fluenz (listed in section 6 “Contents of the pack and other
information”). For signs of allergic
reactions, see section 4 “Possible
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
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 nasal spray suspension
Influenza vaccine (live attenuated, nasal)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Reassortant influenza virus* (live attenuated) of the following
strains**:
A/California/7/2009 (H1N1)pdm09-like strain
(A/California/7/2009, MEDI 228029)
10
7.0±0.5
FFU***
A/Victoria/361/2011 (H3N2)-like strain
(A/Texas/50/2012, MEDI 237514)
10
7.0±0.5
FFU***
B/Massachusetts/2/2012-like strain
(B/Massachusetts/2/2012, MEDI 237751)
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 2013/2014 season.
The vaccine may contain residues of the following substances: egg
proteins (e.g. ovalbumin)
and gentamicin.
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 individuals 24 months to less than 18
years of age.
The use of FLUENZ should be based on official recommendations.
Medicinal product no longer authorised
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
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