Arepanrix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs.

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07BB02

INN (International Name):

pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

Therapeutic group:

Influenza vaccines

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance

Product summary:

Revision: 1

Authorization status:

Withdrawn

Authorization date:

2010-03-23

Patient Information leaflet

Medicinal product no longer authorised
33
B. PACKAGE LEAFLET
Medicinal product no longer authorised
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PACKAGE LEAFLET: INFORMATION FOR THE USER
AREPANRIX 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 (EMEA): HTTP://WWW.EMEA.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 Arepanrix is and what it is used for
2.
Before you receive Arepanrix
3.
How Arepanrix is given
4.
Possible side effects
5.
How to store Arepanrix
6.
Further information
1.
WHAT AREPANRIX IS AND WHAT IT IS USED FOR
Arepanrix is a vaccine against a pandemic influenza (flu).
Pandemic flu is a type of influenza that occurs every few decades and
which spreads rapidly around
the world. The symptoms of pandemic flu are similar to those of
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.
As with all vaccines, Arepanrix may not fully protect all persons who
are vaccinated.
2.
BEFORE YOU ARE GIVEN AREPANRIX
YOU SHOULD NOT RECEIVE AREPANRIX:
•
if you have previously had a sudden life-threatening allergic reaction
to any ingredient of
Arepanrix (these are listed at the end of the leaflet) or to any of
the substances that may be
present in trace amounts as follows: egg and chicken protein,
ovalbumin, formaldehyde or
sodium deoxycholate. 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 b

Summary of Product characteristics

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Arepanrix suspension and emulsion for emulsion for injection
Pandemic influenza vaccine (H1N1)v (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/California/7/2009 (H1N1)v-like strain (X-179A)
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.
Excipients: the vaccine contains 5 micrograms thiomersal
For a 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
The dose recommendations take into account available data from:
•
Ongoing clinical studies in healthy subjects who received a single
dose of Arepanrix (H1N1)
•
Clinical studies in healthy subjects (including elderly subjects) who
received two doses of a
version of Arepanrix containing 3.75 µg HA derived from
A/Indonesia/05/2005 (H5N1)
Medicinal product no longer authorised
3
And also from:
•
On-going clinical studies in healthy subjects who received a single
dose or two doses of an
AS03-containing vaccine containing HA from H1N1v m