Pumarix
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
17-03-2015
Produktets egenskaber
(SPC)
17-03-2015
Offentlige vurderingsrapport
(PAR)
17-03-2015
Aktiv bestanddel:
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Tilgængelig fra:
GlaxoSmithKline Biologicals S.A.
ATC-kode:
J07BB02
INN (International Name):
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Terapeutisk gruppe:
Vaccines
Terapeutisk område:
Influenza, Human; Immunization; Disease Outbreaks
Terapeutiske indikationer:
Prophylaxis of influenza in an officially declared pandemic situation.Pandemic-influenza vaccine should be used in accordance with official guidance.
Produkt oversigt:
Revision: 4
Autorisation status:
Withdrawn
Autorisation dato:
2011-03-04
Indlægsseddel
31
B. PACKAGE LEAFLET
Medicinal product no longer authorised
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
PUMARIX SUSPENSION AND EMULSION FOR EMULSION FOR INJECTION
Pandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted)
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 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. This includes any
possible side effects not listed
in this leaflet.
WHAT IS IN THIS LEAFLET
:
1.
What Pumarix is and what it is used for
2.
What you need to know before you are given Pumarix
3.
How Pumarix is given
4.
Possible side effects
5.
How to store Pumarix
6.
Contents of the pack and other information
1.
WHAT PUMARIX IS AND WHAT IT IS USED FOR
WHAT PUMARIX IS AND WHAT IT IS USED FOR
Pumarix is a vaccine for use in adults from 18 years old to prevent
pandemic flu (influenza).
Pandemic flu is a type of influenza that happens at intervals that
vary from less than 10 years to many
decades. It spreads rapidly around the world. The signs of pandemic
flu are similar to those of
ordinary flu but may be more serious.
HOW PUMARIX WORKS
When a person is given the vaccine, the body’s natural defence
system (immune system) produces its
own protection (antibodies) against the disease. None of the
ingredients in the vaccine can cause flu.
As with all vaccines, Pumarix may not fully protect all persons who
are vaccinated.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PUMARIX
PUMARIX SHOULD NOT BE GIVEN:
•
if you have previously had a sudden life-threatening allergic reaction
to any ingredient of this
vaccine (listed in section 6) or to anything else that may be present
in very small amounts, such
as: egg and chicken protein, ovalbumin, formaldehyde or sodium
deoxycholate.
-
Signs of an allergic reaction may include itchy skin r
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Pumarix suspension and emulsion for emulsion for injection
Pandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After mixing, 1 dose (0.5 ml) contains:
Split influenza virus, inactivated, containing antigen
*
equivalent to:
_ _
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
3.75 micrograms
**
*
propagated in eggs
**
haemagglutinin
This vaccine complies with the WHO recommendation and EU decision for
the pandemic.
AS03 adjuvant composed of squalene (10.69 milligrams), DL-
α
-tocopherol (11.86 milligrams) and
polysorbate 80 (4.86 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.
Excipient with known effect: the vaccine contains 5 micrograms
thiomersal
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension and emulsion for emulsion for injection.
The suspension is a translucent to off white opalescent suspension,
which may sediment slightly.
The emulsion is a whitish homogeneous liquid.
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
_Adults from the age of 18 years onwards: _
One dose of 0.5 ml at an elected date.
A second dose of 0.5 ml should be given after an interval of at least
three weeks.
Medicinal product no longer authorised
3
_Persons previously vaccinated with one or two doses of
AS03-containing vaccine containing HA _
_derived from a different clade of the same subtype _
Adults from the age of 18 years onwards: one dose of 0.5 ml at an
elected date.
_Paediatric population_
There are very limited safety and immunogenicity data available on the
administration of an AS
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