Proteq West Nile
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
20-08-2020
Karatteristiċi tal-prodott
(SPC)
20-08-2020
Rapport ta 'Valutazzjoni Pubblika
(PAR)
15-02-2021
Ingredjent attiv:
West Nile recombinant canarypox virus (vCP2017 virus)
Disponibbli minn:
Boehringer Ingelheim Vetmedica GmbH
Kodiċi ATC:
QI05AX
INN (Isem Internazzjonali):
West Nile fever vaccine (live recombinant)
Grupp terapewtiku:
Horses
Żona terapewtika:
Immunologicals for equidae, Horse, Immunologicals
Indikazzjonijiet terapewtiċi:
Active immunisation of horses from five months of age against West Nile disease by reducing the number of viraemic horses. If clinical signs are present, their duration and severity are reduced.
Sommarju tal-prodott:
Revision: 15
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2011-08-05
Fuljett ta 'informazzjoni
13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET
Proteq West Nile suspension for injection for horses
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’Aviation
69800 Saint Priest
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Proteq West Nile suspension for injection for horses
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Homogeneous opalescent suspension for injection
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
West Nile recombinant canarypox virus (vCP2017)
....................................... 6.0 to 7.8 log10 CCID*
50
* Cell culture infectious dose 50%
ADJUVANT:
Carbomer
.........................................................................................................................................
4 mg
4.
INDICATIONS
Active immunisation of horses from 5 months of age against West Nile
disease by reducing the
number of viraemic horses. If clinical signs are present, their
duration and severity are reduced.
Onset of immunity: 4 weeks after the first dose of the primary
vaccination course. In order to achieve
full protection, the full vaccination course of two doses must be
given.
Duration of immunity: 1 year after a full primary vaccination course
of two injections.
5.
CONTRAINDICATION
None.
15
6.
ADVERSE REACTIONS
A transient swelling (max. diameter 5 cm) which resolves within 4 days
may appear commonly at the
injection site.
Pain and local hyperthermia can occur in rare cases.A slight increase
in temperature (max. 1.5 °C)
may occur in rare cases for 1 day, exceptionally 2 days. Apathy,
usually resolving within two days,
and reduced appetite may be observed in rare cases the day after
vaccination. A hypersensitivity
reaction may occur in rare cases, which may require
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Proteq West Nile suspension for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
West Nile recombinant canarypox virus (vCP2017)
....................................... 6.0 to 7.8 log10 CCID*
50
* Cell culture infectious dose 50 %
ADJUVANT:
Carbomer
.........................................................................................................................................
4 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Homogeneous opalescent suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of horses from 5 months of age against West Nile
disease by reducing the
number of viraemic horses. If clinical signs are present, their
duration and severity are reduced.
Onset of immunity: 4 weeks after the first dose of the primary
vaccination course. In order to achieve
full protection, the full vaccination course of two doses must be
given.
Duration of immunity: 1 year after a full primary vaccination course
of two injections.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only healthy animals.
The safety of the vaccine has been demonstrated in foals from 5 months
of age. However, the vaccine
has also been shown to be safe in a field study including animals of 2
months of age.
3
Vaccination may interfere with existing sero-epidemiological surveys.
However, since the IgM
response following vaccination is infrequent, a positive IgM-ELISA
test result is a strong indicator of
natural infection with West Nile Virus. If infection is suspected as a
result of a positive IgM response,
additional testing would need to be conducted to conclusively
determine whether the animal was
infected or vaccinated.
Special precaut
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