Proteq West Nile Suspension for Injection for Horses

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: VMD (Veterinary Medicines Directorate)

সক্রিয় উপাদান:

West Nile virus

থেকে পাওয়া:

Boehringer Ingelheim Vetmedica Gmbh

এটিসি কোড:

QI05AX

INN (আন্তর্জাতিক নাম):

West Nile virus

ফার্মাসিউটিকাল ফর্ম:

Suspension for injection

প্রেসক্রিপশন টাইপ:

POM-V - Prescription Only Medicine – Veterinarian

থেরাপিউটিক গ্রুপ:

Horses

থেরাপিউটিক এলাকা:

Vector Vaccine

অনুমোদন অবস্থা:

Authorized

অনুমোদন তারিখ:

2011-08-05

পণ্য বৈশিষ্ট্য

Revised: November 2023
AN: 02843/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
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 log
10
CCID*
50
* Cell culture infectious dose 50 %
ADJUVANT:
Carbomer
..............................................................................................
4 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Homogeneous opalescent suspension.
Suspension for injection.
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.
Revised: November 2023
AN: 02843/2022
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in 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.
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.