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, 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: 9

Authorization status:

Authorised

Authorization date:

2009-10-09

Patient Information leaflet

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 pandem

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 pandem