IDflu

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

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)

Διαθέσιμο από:

Sanofi Pasteur S.A.

Φαρμακολογική κατηγορία (ATC):

J07BB02

INN (Διεθνής Όνομα):

influenza vaccine (split virion, inactivated)

Θεραπευτική ομάδα:

Vaccines

Θεραπευτική περιοχή:

Influenza, Human; Immunization

Θεραπευτικές ενδείξεις:

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 IDflu should be based on official recommendations.

Περίληψη προϊόντος:

Revision: 13

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2009-02-24

Φύλλο οδηγιών χρήσης

20
B. PACKAGE LEAFLET
Medicinal product no longer authorised
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
IDFLU 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 IDflu is and what it is used for
2.
What you need to know before you use IDflu
3.
How to use IDflu
4.
Possible side effects
5.
How to store IDflu
6.
Contents of the pack and other information
1.
WHAT IDFLU IS AND WHAT IT IS USED FOR
IDflu
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 IDflu
is given, the immune system (body's natural defences) will develop
protection against flu infection.
IDflu 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 IDFLU
DO NOT USE IDFLU:
-
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 doctor, pharmacist or nurse

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
IDflu 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/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009,
NYMC X-179A)
..............................................................................................................................
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 2016/2017 season.
For the full list of excipients, see section 6.1.
IDflu 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 IDflu 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_
IDflu 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 recomme