Pandemic Influenza Vaccine H5N1 Baxter AG

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1)

Beschikbaar vanaf:

Resilience Biomanufacturing Ireland Limited

ATC-code:

J07BB01

INN (Algemene Internationale Benaming):

pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)

Therapeutische categorie:

Vaccines

Therapeutisch gebied:

Influenza, Human; Immunization; Disease Outbreaks

therapeutische indicaties:

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

Product samenvatting:

Revision: 8

Autorisatie-status:

Withdrawn

Autorisatie datum:

2009-10-16

Bijsluiter

39
B. PACKAGE LEAFLET
Medicinal product no longer authorised
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
SUSPENSION FOR INJECTION
PANDEMIC INFLUENZA VACCINE (H5N1) (WHOLE VIRION, INACTIVATED, PREPARED
IN CELL CULTURE)
READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU ARE VACCINATED 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 pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for
2.
What you need to know before you are vaccinated with PANDEMIC
INFLUENZA VACCINE
H5N1 BAXTER
3.
How PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given
4.
Possible side effects
5.
How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
6.
Contents of the pack and other information
1.
WHAT PANDEMIC INFLUENZA VACCINE H5N1 BAXTER IS AND WHAT IT IS USED FOR
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in
individuals
aged 6 months adults and older. It is used to prevent influenza (flu)
in an officially declared pandemic.
Pandemic flu is a type of influenza that occurs every few decades and
which spreads rapidly to affect
most countries and regions around the world. The symptoms (signs) of
pandemic flu are similar to
those of an ‘ordinary’ flu but are usually more severe.
The vaccine works by helping the body to produce its own protection
(antibodies) against the disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOUR ARE VACCINATED WITH PANDEMIC
INFLUENZA
VACCINE H5N1 BAXTER
DO NOT USE PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
•
if you previously had a serious allergic reaction (i.e.
life-threatening) to PANDEMIC
INFLUENZA VACCINE H5N1 BAXTER.
•
if you are allergic to any of the ingredients or trace residues
(formaldehyde, benzonase, sucrose)
contained in the vaccine. The active substance and

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Suspension for injection
Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared
in cell culture)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza vaccine (whole virion, inactivated) containing antigen * of:
A/Vietnam/1203/2004 (H5N1)
7.5 micrograms**per
0.5 ml dose
*
produced in Vero cells
**
haemagglutinin
This vaccine complies with the WHO recommendation and EU decision for
the pandemic.
The vaccine is available in a multidose container (see section 6.5 for
the number of doses per vial).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
The vaccine is an off-white, opalescent, translucent suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza in an officially declared pandemic situation.
Pandemic influenza vaccine
should be used in accordance with official guidance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children from 6 months onwards: _
One dose of 0.5 ml at an elected date.
_ _
A second dose of vaccine should be given after an interval of at least
3 weeks.
Method of administration
Immunization should be carried out by intramuscular injection into the
deltoid muscle or anterolateral
thigh, depending on the muscle mass.
For further information, see section 5.1.
4.3
CONTRAINDICATIONS
History of an anaphylactic (i.e. life-threatening) reaction to the
active substance, to any of the
excipients listed in section 6.1 or to trace residues (e.g.
formaldehyde, benzonase, sucrose) of this
vaccine. However, in a pandemic situation, it may be appropriate to
give the vaccine, provided that
facilities for resuscitation are immediately available in case of
need.
Medicinal product no longer authorised
3
See section 4.4.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
•
Hypersensitivity reactions, including anaphylaxis, have been reported
followin