Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

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

Beschikbaar vanaf:

GlaxoSmithKline Biologicals S.A.

ATC-code:

J07BB02

INN (Algemene Internationale Benaming):

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

Therapeutische categorie:

Vaccines

Therapeutisch gebied:

Influenza, Human; Immunization; Disease Outbreaks

therapeutische indicaties:

Active immunisation against H5N1 subtype of Influenza A virus.This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1).Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.

Product samenvatting:

Revision: 3

Autorisatie-status:

Withdrawn

Autorisatie datum:

2008-09-26

Bijsluiter

25
B. PACKAGE LEAFLET
Medicinal product no longer authorised
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED,
ADJUVANTED) GLAXOSMITHKLINE
BIOLOGICALS 3.75 ΜG SUSPENSION AND EMULSION FOR EMULSION FOR
INJECTION
Prepandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
VACCINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This vaccine has been prescribed for you. Do not pass it on to others.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted)
GlaxoSmithKline Biologicals 3.75 µg is and what it is used for
2.
Before you receive Prepandemic influenza vaccine (H5N1) (split virion,
inactivated, adjuvanted)
GlaxoSmithKline Biologicals 3.75 µg
3.
How Prepandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted)
GlaxoSmithKline Biologicals 3.75 µg is given
4.
Possible side effects
5.
How to store Prepandemic influenza vaccine (H5N1) (split virion,
inactivated, adjuvanted)
GlaxoSmithKline Biologicals 3.75 µg
6.
Further information
1.
WHAT PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED,
ADJUVANTED)
GLAXOSMITHKLINE BIOLOGICALS 3.75 ΜG IS AND WHAT IT IS USED FOR
Prepandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted) GlaxoSmithKline
Biologicals 3.75 µg is a vaccine for use in adults from 18 years old.
It is intended to be given before or
during the next influenza (flu) pandemic to prevent flu caused by the
H5N1 type of the virus.
Pandemic flu is a type of influenza that occurs at intervals that vary
from less than 10 years to many
decades. It spreads rapidly around the world. The symptoms of pandemic
flu are similar to those of
ordinary flu but are usually m

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Prepandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted) GlaxoSmithKline
Biologicals 3.75 µg suspension and emulsion for emulsion for
injection.
Prepandemic 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
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.
Excipients: It 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 colourless light opalescent liquid.
The emulsion is a whitish homogeneous liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation against H5N1 subtype of Influenza A virus.
This indication is based on immunogenicity data from healthy subjects
from the age of 18 years
onwards following administration of two doses of vaccine prepared from
A/VietNam/1194/2004
NIBRG-14 (H5N1) (see section 5.1).
Prepandemic influenza vaccine (H5N1) (split virion, inactivated,
adjuvanted) GlaxoSmithKline
Biologicals 3.75 µg should be used in accordance with official
guidance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
Medicinal product no longer authorised
3
Based on very limited data, adults aged >80 years may require a double
dose of Prepandemic
influenza vaccine (H5N1) (split virion, inactiva