Humenza
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
30-06-2011
Karatteristiċi tal-prodott
(SPC)
30-06-2011
Rapport ta 'Valutazzjoni Pubblika
(PAR)
30-06-2011
Ingredjent attiv:
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs.
Disponibbli minn:
Sanofi Pasteur S.A.
Kodiċi ATC:
J07BB02
INN (Isem Internazzjonali):
pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Grupp terapewtiku:
Vaccines
Żona terapewtika:
Influenza, Human; Immunization; Disease Outbreaks
Indikazzjonijiet terapewtiċi:
Prophylaxis of influenza in an officially declared pandemic situation.Pandemic influenza vaccine should be used in accordance with Official Guidance.
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2010-06-08
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
31
B. PACKAGE LEAFLET
Medicinal product no longer authorised
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMENZA
SUSPENSION AND EMULSION FOR EMULSION FOR INJECTION
Pandemic influenza vaccine (H1N1) (split virion, inactivated,
adjuvanted)
FOR THE MOST UP-TO-DATE INFORMATION PLEASE CONSULT THE WEBSITE OF THE
EUROPEAN MEDICINES
AGENCY : HTTP://WWW.EMA.EUROPA.EU/.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS VACCINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET
:
1.
What HUMENZA is and what it is used for
2.
Before you receive HUMENZA
3.
How HUMENZA is given
4.
Possible side effects
5.
How to store HUMENZA
6.
Further information
1.
WHAT HUMENZA IS AND WHAT IT IS USED FOR
HUMENZA is a vaccine to prevent pandemic influenza (flu).
Pandemic flu is a type of influenza that occurs every few decades and
which spreads rapidly around
the world. The symptoms (signs) of pandemic flu are similar to those
of an ordinary flu but may be
more severe.
When a person is given the vaccine, the immune system (the body’s
natural defence system) will
produce its own protection (antibodies) against the disease. None of
the ingredients in the vaccine can
cause flu.
2.
BEFORE YOU RECEIVE HUMENZA
YOU SHOULD NOT RECEIVE HUMENZA:
-
if you have previously had a sudden life-threatening allergic reaction
to any ingredient of
HUMENZA (these are listed at the end of the leaflet) or to any of the
substances that may be
present in trace amounts as follows: ovalbumin, egg and chicken
proteins, neomycin,
octoxinol-9, formaldehyde. Signs of an allergic reaction may include
itchy skin rash, shortness
of breath and swelling of the face or tongue. However, in a pandemic
situation, it may be
appropriate for you to have the vaccine provided that appropriate
medical treatment is
immediately ava
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Karatteristiċi tal-prodott
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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2
1.
NAME OF THE MEDICINAL PRODUCT
HUMENZA suspension and emulsion for emulsion for injection
Pandemic influenza vaccine (H1N1) (split virion, inactivated,
adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
HUMENZA consists of two vials: one vial containing the antigen
(suspension) and one vial containing
the adjuvant (emulsion), which are mixed prior to administration.
After mixing, 1 dose (0.5ml) contains:
Split influenza virus*, inactivated containing antigen equivalent to:
A/California/7/2009 (H1N1)-like strain (NYMC
X-179A).......................................3.8 micrograms**
*
propagated in eggs
**
expressed in microgram haemagglutinin
This vaccine complies with the WHO recommendation and EU decision for
the pandemic.
AF03 adjuvant composed of squalene (12.4 milligrams), sorbitan oleate
(1.9 milligrams),
polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3
milligrams)
The suspension and emulsion, once mixed, form a multidose vaccine in a
vial. See section 6.5 for the
number of doses per vial.
Excipients:
The vaccine contains 11.3 micrograms thiomersal.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension and emulsion for emulsion for injection.
The antigen is a colourless limpid to opalescent suspension.
The adjuvant is a white opaque emulsion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza in an officially declared pandemic situation
(see sections 4.2 and 5.1).
Pandemic influenza vaccine should be used in accordance with Official
Guidance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In the different age groups, there are limited data (adults aged 18 to
60 years), very limited data (adults
aged 61 years and over, children aged 6 months to 17 years) or no data
(children aged less than 6
months) with HUMENZA as detailed in sections 4.4, 4.8 and 5.1.
Medicinal product no longer authorised
3
Children fr
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