Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07BB02

INN (International Name):

pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

Therapeutic group:

Vaccines

Therapeutic area:

Influenza, Human

Therapeutic indications:

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

Authorization status:

Authorised

Authorization date:

2009-10-10

Patient Information leaflet

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADJUPANRIX SUSPENSION AND EMULSION FOR EMULSION FOR INJECTION
Pandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Adjupanrix is and what it is used for
2.
What you need to know before you receive Adjupanrix
3.
How Adjupanrix is given
4.
Possible side effects
5.
How to store Adjupanrix
6.
Contents of the pack and otherinformation
1.
WHAT ADJUPANRIX IS AND WHAT IT IS USED FOR
WHAT ADJUPANRIX IS AND WHAT IT IS USED FOR
Adjupanrix 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 ADJUPANRIX 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, Adjupanrix may not fully protect all persons who
are vaccinated.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ADJUPANRIX
ADJUPANRIX
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, gentamicin
sulphate (antibiotic) or
sodium deoxycholate.
_

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Adjupanrix 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/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
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 vials once mixed form a multidose
container. See section 6.5 for the
number of doses per vial.
Excipient with known effect:
The vaccine contains 5 micrograms thiomersal (see section 4.4).
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension and emulsion for emulsion for injection.
The suspension is a colourless light opalescent liquid.
The emulsion is a whitish to yellowish homogeneous milky liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza in an officially declared pandemic situation.
Adjupanrix should be used in accordance with official guidance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Persons not previously vaccinated with Prepandrix
Adults from the age of 18 years:
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 and up to twelve
months after the first dose for maximum efficacy.
3
Based on very limited data, adults aged >80 years may require a double
dose of Adjupanrix on an
elected date and again after an interval of at least three weeks in
order to achieve an immune response
(see section 5.1).
Persons previously vaccinated with one or two doses of Prepandrix
containing HA derived from a
different clade of the same influenza subtype as the pande