Optaflu
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
13-02-2017
Charakterystyka produktu
(SPC)
13-02-2017
Sprawozdanie z oceny publicznego
(PAR)
02-12-2015
Składnik aktywny:
influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2) - like strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013–like strain(B/Utah/9/2014, wild type)
Dostępny od:
Seqirus GmbH
Kod ATC:
J07BB02
INN (International Nazwa):
influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Grupa terapeutyczna:
Vaccines
Dziedzina terapeutyczna:
Influenza, Human; Immunization
Wskazania:
Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications.Optaflu should be used in accordance to official guidance.
Podsumowanie produktu:
Revision: 16
Status autoryzacji:
Withdrawn
Data autoryzacji:
2007-06-01
Ulotka dla pacjenta
24
B. PACKAGE LEAFLET
Medicinal product no longer authorised
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTAFLU SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE
Influenza vaccine (surface antigen, inactivated, prepared in cell
cultures)
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.
-
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 Optaflu is and what it is used for
2.
What you need to know before you receive Optaflu
3.
How Optaflu is given
4.
Possible side effects
5.
How to store Optaflu
6.
Contents of the pack and other information
1.
WHAT OPTAFLU IS AND WHAT IT IS USED FOR
Optaflu is a vaccine against flu (influenza). Due to the kind of
manufacturing Optaflu is free of
chicken/egg protein.
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.
Optaflu is used to prevent flu in adults, especially in those who run
an increased risk of experiencing
associated complications in case they fall ill with flu.
The vaccine targets three strains of influenza virus following the
recommendations by the World
Health Organisation for the 2015/2016 season.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE OPTAFLU
YOU SHOULD NOT RECEIVE OPTAFLU
if you are allergic to influenza vaccine or any of the other
ingredients of this vaccine (listed in
section 6)
if you have an acute infection.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before receiving Optaflu.
BEFORE receiving the vaccine
YOU
should tell your doctor if your immune system is impaired, or if you
are undergoing
treatment which affects the immune system, e.g.
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
OPTAFLU
suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell
cultures)
(2015/2016 season)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase)*,
inactivated, of the following
strains:
A/California/7/2009 (H1N1)pdm09 - like strain
(A/Brisbane/10/2010, wild type)
15 micrograms HA**
A/Switzerland/9715293/2013 (H3N2) - like strain
(A/South Australia/55/2014, wild type)
15 micrograms HA**
B/Phuket/3073/2013 – like strain
(B/Utah/9/2014, wild type)
15 micrograms HA**
per 0.5 ml dose
……………………………………….
*
propagated in Madin Darby Canine Kidney (MDCK) cells
**
haemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere)
and EU decision for
the 2015/2016 season.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
Clear to slightly opalescent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza for adults, especially in those who run an
increased risk of associated
complications.
Optaflu should be used in accordance to Official guidance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults from the age of 18 years:
One dose of 0.5 ml
_ _
Medicinal product no longer authorised
3
_Paediatric population _
The safety and efficacy of Optaflu in children and adolescents less
than 18 years of age have not yet
been established. No data are available. Therefore, Optaflu is not
recommended for use in children and
adolescents less than 18 years of age (see section 5.1).
Method of administration
Immunisation should be carried out by intramuscular injection into the
deltoid muscle.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Immunisation shall be postponed in patients with febrile
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