Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1)

Saatavilla:

Novartis Vaccines and Diagnostics S.r.l.

ATC-koodi:

J07BB02

INN (Kansainvälinen yleisnimi):

prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

Terapeuttinen ryhmä:

Vaccines

Terapeuttinen alue:

Influenza, Human

Käyttöaiheet:

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 the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain.; Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic should be used in accordance with official recommendations.

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2010-11-29

Pakkausseloste

24
B. PACKAGE LEAFLET
Medicinal product no longer authorised
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED,
ADJUVANTED) NOVARTIS
VACCINES AND DIAGNOSTICS
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated,
adjuvanted)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVE THIS
VACCINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET:
1.
What
Prepandemic
Influenza
vaccine
(H5N1)
(surface
antigen,
inactivated,
adjuvanted)
Novartis Vaccines and Diagnostics is and what it is used for
2.
Before
you
receive
Prepandemic
Influenza
vaccine
(H5N1)
(surface
antigen,
inactivated,
adjuvanted) Novartis Vaccines and Diagnostics
3.
How Prepandemic Influenza vaccine (H5N1) (surface antigen,
inactivated, adjuvanted) Novartis
Vaccines and Diagnostics is given
4.
Possible side effects
5.
How to store Prepandemic Influenza vaccine (H5N1) (surface antigen,
inactivated, adjuvanted)
Novartis Vaccines and Diagnostics
6.
Further information
1.
WHAT PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN,
INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS IS
AND WHAT IT IS USED FOR
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated,
adjuvanted) Novartis Vaccines
and Diagnostics is a vaccine for use in adults (from 18 to 60 years
old). and elderly (over 60 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 every few decades and
which spreads rapidly around
the world. The symptoms of pandemic flu are similar to those of an
ordinary flu but may be more
severe.
When a person is given the vaccine, the immune system (the body’s
natural defense

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
_ _
_ _
_ _
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated,
adjuvanted) Novartis Vaccines
and Diagnostics suspension for injection in pre-filled syringe.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated,
adjuvanted).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase)*
of strain:
A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
7.5 micrograms** per 0.5 ml dose
* propagated in eggs
** expressed in microgram haemagglutinin.
Adjuvant MF59C.1 containing:
squalene
9.75 milligrams per 0.5 ml
polysorbate 80
1.175 milligrams per 0.5 ml
sorbitan trioleate
1.175 milligrams per 0.5 ml
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
Milky-white 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 the vaccine
containing A/Vietnam/1194/2004
(H5N1)-like strain (see section 5.1).
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated,
adjuvanted) Novartis Vaccines
and Diagnostics should be used in accordance with official
recommendations.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology:_
Adults and elderly (18 years of age and above):
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
3 weeks.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated,
adjuvanted) Novartis Vaccines
and Diagnostics has been evaluated in healthy adults (18-60 years of
age) and healthy elderly (over 60
years of age) following a 1, 22 day primary vaccination schedule, and
booster vaccination (see
sections 4.8 and 5.1).
There is limited experience in elderly over 70 yea