Prepandrix

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)

Saadav alates:

GlaxoSmithKline Biologicals S.A.

ATC kood:

J07BB02

INN (Rahvusvaheline Nimetus):

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

Terapeutiline rühm:

Vaccines

Terapeutiline ala:

Influenza, Human; Immunization; Disease Outbreaks

Näidustused:

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 with H5N1 subtype strains.Prepandrix should be used in accordance with official guidance.

Toote kokkuvõte:

Revision: 13

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2008-05-14

Infovoldik

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREPANDRIX SUSPENSION AND EMULSION FOR EMULSION FOR INJECTION
Prepandemic 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Prepandrix is and what it is used for
2.
What you need to know before you receive Prepandrix
3.
How Prepandrix is given
4.
Possible side effects
5.
How to store Prepandrix
6.
Contents of the pack and other information
1.
WHAT PREPANDRIX IS AND WHAT IT IS USED FOR
WHAT PREPANDRIX IS AND WHAT IT IS USED FOR
Prepandrix 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 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 PREPANDRIX 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, Prepandrix may not fully protect all persons who
are vaccinated.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE PREPANDRIX
PREPANDRIX 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, o

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Prepandrix 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/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
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.
Excipient with known effect
The vaccines 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
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 with
H5N1 subtype strains (see
section 5.1).
Prepandrix 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 and up to twelve
months after the first dose for maximum efficacy.
3
_Special population: _
Based on very limited data, adults aged >80 years may require a double
dose of Prepandrix 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).
A complete vaccination course with Prepandrix consists of t