Vepacel

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

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

Available from:

Ology Bioservices Ireland LTD

ATC code:

J07BB01

INN (International Name):

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

Therapeutic group:

Influenza vaccines

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

Active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. Vepacel should be used in accordance with Official guidance.,

Product summary:

Revision: 9

Authorization status:

Withdrawn

Authorization date:

2012-02-17

Patient Information leaflet

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
VEPACEL SUSPENSION FOR INJECTION
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,
prepared in cell culture)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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.
-
If you get any of the side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What VEPACEL is and what it is used for
2.
What you need to know before you receive VEPACEL
3.
How VEPACEL is given
4.
Possible side effects
5.
How to store VEPACEL
6.
Contents of the pack and other information
1.
WHAT VEPACEL IS AND WHAT IT IS USED FOR
VEPACEL is a vaccine for use in individuals aged 6 months and older.
It is intended to be given
before 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 every few decades and
which spreads rapidly around
the world. The symptoms of pandemic flu are similar to those of an
ordinary flu but are usually more
severe.
When a person is given the vaccine, the immune system (the body’s
natural defence system) will
produce its own protection (antibodies) against the disease. None of
the ingredients in the vaccine can
cause flu.
As with all vaccines, VEPACEL may not fully protect all persons who
are vaccinated.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE VEPACEL
YOU SHOULD NOT RECEIVE VEPACEL
-
if you have previously had a severe allergic reaction to any
ingredient of VEPACEL (these are
listed at the end of the leaflet – section 6) or to any substances
that may be present i

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
VEPACEL suspension for injection in multidose container
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,
prepared in cell culture)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Influenza virus (whole virion, inactivated), containing antigen* of
strain:
A/Vietnam/1203/2004 (H5N1)
7.5 micrograms**
*
produced in Vero cells
**
haemagglutinin
This is 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.
Clear to opalescent suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation against H5N1 subtype of influenza A virus.
This indication is based on immunogenicity data from subjects from the
age of 6 months onwards
following administration of two doses of vaccine prepared with H5N1
subtype strains (see section 5.1).
The use of this vaccine should be in accordance with official
recommendations.
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 0.5 ml should be given after an interval of at least
three weeks.
_other paediatric Population _
No data is available on the safety and efficacy of VEPACEL in children
younger than 6 months of
age.
3
Method of administration
Immunisation should be carried out by intramuscular injection into the
deltoid muscle or anterolateral
thigh, depending on the muscle mass.
See section 6.6 for administration instructions.
4.3
CONTRAINDICATIONS
History of anaphylactic reactions to the active substance, or to any
of the excipients listed in
section 6.1, or trace residues (formaldehy