Nobilis Influenza H7N1

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99)

Saatavilla:

Intervet International BV

ATC-koodi:

QI01AA23

INN (Kansainvälinen yleisnimi):

adjuvanted inactivated vaccine against avian influenza virus type A, subtype H7

Terapeuttinen ryhmä:

Chicken; Ducks

Terapeuttinen alue:

Immunologicals for aves

Käyttöaiheet:

For active immunisation of chickens and ducks against avian influenza type A, subtype H7N1.Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals.In chickens, reduction of clinical signs, mortality, excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.In ducks, reduction of excretion and transmission of virus after challenge were shown by two weeks after a single dose vaccination.Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. The duration of immunity in ducks is unknown.

Tuoteyhteenveto:

Revision: 2

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2007-05-14

Pakkausseloste

Medicinal product no longer authorised
15
B. PACKAGE LEAFLET
Medicinal product no longer authorised
16
PACKAGE LEAFLET FOR:
NOBILIS INFLUENZA H7N1
EMULSION FOR INJECTION
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer for the batch release:
Intervet International BV
Wim de Körverstraat 35
NL-5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Influenza H7N1
Emulsion of injection
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
On dose of 0.5 ml contains:
Inactivated
whole
avian
influenza
virus
antigen
of
H7N1
subtype
(strain,
A/CK/Italy/473/99),
inducing an HI titre of ≥6.0 log
2
as tested according to the potency test.
Adjuvant: Liquid paraffin
4.
INDICATION
For active immunisation of chickens and ducks against avian influenza
type A, subtype H7N1.
Efficacy has been evaluated on the basis of preliminary results in
chickens and ringed teals.
-In chickens, reduction of clinical signs, mortality, excretion and
transmission of virus after challenge
were shown by two weeks after a single dose vaccination.
-In ducks, reduction of excretion and transmission of virus after
challenge were shown by two weeks
after a single dose vaccination.
Although it has not been investigated with this particular AI vaccine
strain, studies performed with
other strains show that protective levels of serum antibody titres
would be expected to persist in
chickens for at least 12 months after administration of two doses of
vaccine. The duration of
immunity in ducks is unknown.
Medicinal product no longer authorised
17
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Safety has been assessed on the basis of results in chickens. A
transient diffuse swelling may occur at
the vaccination site in 50% of the animals, which persists for about
14 days.
Supportive data in duck

Valmisteyhteenveto

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Influenza H7N1 emulsion for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.5ml contains:
ACTIVE SUBSTANCE:
Inactivated
whole
avian
influenza
virus
antigen
of
H7N1
subtype
(strain,
A/CK/Italy/473/99),
inducing an HI titre of ≥6.0 log
2
as tested according to the potency test.
ADJUVANT:
Liquid light paraffin 234.8 mg/0,5 ml
For a list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Emulsion for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens and ducks
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens and ducks against avian influenza
type A, subtype H7N1.
Efficacy has been evaluated on the basis of preliminary results in
chickens and ringed teals.
-In chickens, reduction of clinical signs, mortality, excretion and
transmission of virus after challenge
were shown by two weeks after a single dose vaccination.
-In ducks, reduction of excretion and transmission of virus after
challenge were shown by two weeks
after a single dose vaccination.
Although it has not been investigated with this particular AI vaccine
strain, studies performed with
other strains show that protective levels of serum antibody titres
would be expected to persist in
chickens for at least 12 months after administration of two doses of
vaccine. The duration of
immunity in ducks is unknown.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
This vaccine has been tested for safety in chickens and only
supportive data for safety in ducks are
available. If used in other avian species that are considered at risk
of infection, its use in these species
should be undertaken with care and it is advisable to test the vaccine
on a small number of birds prior
to mass vaccination. The level of efficacy for other species may
differ from that observed in chickens.
The level of efficacy a