Nobilis Influenza H5N6
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
26-07-2010
Karatteristiċi tal-prodott
(SPC)
26-07-2010
Rapport ta 'Valutazzjoni Pubblika
(PAR)
26-07-2010
Ingredjent attiv:
inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84)
Disponibbli minn:
Intervet International BV
Kodiċi ATC:
QI01AA23
INN (Isem Internazzjonali):
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5
Grupp terapewtiku:
Chicken
Żona terapewtika:
Immunologicals for aves
Indikazzjonijiet terapewtiċi:
For active immunisation of chickens against avian influenza type A, subtype H5.Reduction of clinical signs, mortality and excretion of virus after challenge with a virulent H5N1 strain, were shown by two weeks after a single dose vaccination.Serum antibodies have been shown to persist in chickens for at least 7 months and studies performed with other vaccine strains show that serum antibodies would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine.
Sommarju tal-prodott:
Revision: 1
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2008-01-31
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
15
B. PACKAGE LEAFLET
Medicinal product no longer authorised
16
PACKAGE LEAFLET FOR:
NOBILIS INFLUENZA H5N6
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 H5N6
Emulsion for 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
H5
subtype
(strain
H5N6,
A/duck/Potsdam/2243/84), 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 against avian influenza type A,
subtype H5.
Reduction of clinical signs, mortality and excretion of virus after
challenge with a virulent H5N1
strain, were shown by two weeks after a single dose vaccination.
Serum antibodies have been shown to persist in chickens for at least 7
months. Studies performed
with other vaccine strains show that serum antibodies would be
expected to persist in chickens for at
least 12 months after administration of two doses of vaccine.
5.
CONTRAINDICATIONS
None.
Medicinal product no longer authorised
17
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.
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Chickens.
8.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
For subcutaneous or intramuscular use.
_Chickens _
From 8-14 days old: 0.25 ml subcutaneously
From 14
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
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 H5N6 emulsion for injection for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.5ml contains:
ACTIVE SUBSTANCE:
Inactivated
whole
avian
influenza
virus
antigen
of
H5
subtype
(strain
H5N6,
A/duck/Potsdam/2243/84), 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 full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Emulsion for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens against avian influenza type A,
subtype H5.
Reduction of clinical signs, mortality and excretion of virus after
challenge with a virulent H5N1
strain, were shown by two weeks after a single dose vaccination.
Serum antibodies have been shown to persist in chickens for at least 7
months and studies performed
with other vaccine strains show that serum antibodies would be
expected to persist in chickens for at
least 12 months after administration of two doses of vaccine.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The level of efficacy attained may vary depending on the degree of
antigenic homology between the
vaccine strain and circulating field strains.
This vaccine has been tested for safety in chickens. and some
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 vaccine has been shown to induce antibodies in ducks to the
homologous virus by four weeks
after two doses and these persist for at least six months but the
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