Intanza
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
04-09-2018
Karatteristiċi tal-prodott
(SPC)
04-09-2018
Rapport ta 'Valutazzjoni Pubblika
(PAR)
04-09-2018
Ingredjent attiv:
influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)
Disponibbli minn:
Sanofi Pasteur Europe
Kodiċi ATC:
J07BB02
INN (Isem Internazzjonali):
influenza vaccine (split virion, inactivated)
Grupp terapewtiku:
Vaccines
Żona terapewtika:
Influenza, Human; Immunization
Indikazzjonijiet terapewtiċi:
Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.The use of Intanza should be based on official recommendations.
Sommarju tal-prodott:
Revision: 18
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2009-02-24
Fuljett ta 'informazzjoni
20
B. PACKAGE LEAFLET
Medicinal product no longer authorised
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
INTANZA 15 MICROGRAM/STRAIN SUSPENSION FOR INJECTION
Influenza vaccine (split virion, inactivated)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE
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 only. Do not pass it on to
others.
-
If you 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 INTANZA is and what it is used for
2.
What you need to know before you use INTANZA
3.
How to use INTANZA
4.
Possible side effects
5.
How to store INTANZA
6.
Contents of the pack and other information
1.
WHAT INTANZA IS AND WHAT IT IS USED FOR
INTANZA is a vaccine. This vaccine is recommended to help to protect
you against flu.
The vaccine may be administered to individuals of 60 years of age and
over, especially in those who
run an increased risk of associated complications.
When an injection of INTANZA is given, the immune system (body's
natural defences) will develop
protection against flu infection.
INTANZA will help to protect you against the three strains of virus
contained in the vaccine, or other
strains closely related to them. Full effect of the vaccine is
generally achieved 2-3 weeks after the
vaccination.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE INTANZA
DO NOT USE INTANZA:
-
If you are allergic to:
The active substances,
Any of the other ingredients of this vaccine (listed in section 6),
Any component that may be present in very small amounts such as eggs
(ovalbumin,
chicken proteins), neomycin, formaldehyde and octoxinol 9.
-
If you have an illness with fever or acute infection, the vaccination
shall be postponed until
after you have recovered.
WARNINGS AND PRECAUTIONS
Talk to your docto
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
INTANZA 15 microgram/strain suspension for injection
Influenza vaccine (split virion, inactivated)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*:
A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC
X-275)
.............................................................................................................................
15 micrograms HA**
A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014,
NYMC X-263B)
.............................................................................................................................
15 micrograms HA**
B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)
.................... 15 micrograms HA**
Per 0.1 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 2017/2018 season.
For the full list of excipients, see section 6.1.
INTANZA may contain residues of eggs such as ovalbumin and residues of
neomycin, formaldehyde
and octoxinol 9, which are used during the manufacturing process (see
section 4.3).
3.
PHARMACEUTICAL FORM
Suspension for injection.
Colourless and opalescent suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza in individuals 60 years of age and over,
especially in those who run an
increased risk of associated complications.
The use of INTANZA should be based on official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Individuals 60 years of age and over: 0.1 ml.
_Paediatric population_
INTANZA is not recommended for use in children and adolescents below
18 years due to insufficient
data on safety and efficacy.
Medicinal product no longer authorised
3
Method of administration
Immunisation should be carried out by intradermal route.
The recom
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