Equip WNV Emulsion for Injection for Horses

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

West Nile virus

Available from:

Zoetis UK Limited

ATC code:

QI05AA10

INN (International Name):

West Nile virus

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Horses

Therapeutic area:

Inactivated Viral Vaccine

Authorization status:

Authorized

Authorization date:

2008-11-21

Summary of Product characteristics

Issued March 2024
AN: 00634/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equip WNV emulsion for injection for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated West Nile virus, strain VM-2
1.0–2.2 RP*
ADJUVANT:
SP oil
4.0% - 5.5% (v/v)
*Relative potency by in vitro method, compared to a reference vaccine
that was
shown efficacious in horses.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Slight pink opaque emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of horses of 6 months of age or older
against West Nile
virus (WNV) disease by reducing the number of viraemic horses after
infection with
WNV lineage 1 or 2 strains and to reduce duration and severity of
clinical signs
against WNV of lineage 2 strains.
Onset of immunity: 3 weeks after primary vaccination course.
Duration of immunity: 12 months after primary vaccination course for
WNV lineage 1
strains. For WNV lineage 2 strains the duration of immunity has not
been
established.
4.3
CONTRAINDICATIONS
None
Issued March 2024
AN: 00634/2022
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
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.
No specific studies have been conducted to demonstrate absence of
interferences
from maternally derived antibodies on vaccine take. It is therefore
recommended not
to vaccinate foals of less than 6 months of age.
Specia