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

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

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

Available from:

Novartis Vaccines and Diagnostics S.r.l.

ATC code:

J07BB02

INN (International Name):

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

Therapeutic group:

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 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.,

Product summary:

Revision: 2

Authorization status:

Withdrawn

Authorization date:

2010-11-29

Patient Information leaflet

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

Summary of Product characteristics

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