Equip WNV
Active substance
ATC code
Species
Horses.
Indications
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.
Dose to be administered and administration route
Administer the entire content of the syringe (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:
• Primary vaccination course: first injection from 6 months of age, second injection 3–5 weeks later.
• Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single 1 ml dose although this schedule has not been fully validated.
Adverse reactions
Horses:
|
Rare (1 to 10 animals / 10,0000 animals treated): |
Hypersensitivity reaction (including vomiting, incoordination, lethargy and laboured breathing)1 |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports) |
Hyperthermia2 Injection site swelling (sometimes associated with injection site pain and mild depression)3 |
1As with any vaccine rare, occasional hypersensitivity reactions may occur. If such a reaction occurs, appropriate treatment should be administered without delay.
2Resolves within 2 days
3Transient local reactions in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to 2 days. Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
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
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment Not applicable.
Other precautions Not applicable.
4.6 Adverse reactions (frequency and seriousness) Horses:
|
Rare (1 to 10 animals / 10,0000 animals treated): |
Hypersensitivity reaction (including vomiting, incoordination, lethargy and laboured breathing)[1] |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports) |
Hyperthermia[2] Injection site swelling (sometimes associated with injection site pain and mild depression)[3] |
competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
No specific efficacy studies were conducted in pregnant mares. As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
4.9 Amount(s) to be administered and administration route
Administer the entire content of the syringe (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:
• Primary vaccination course: first injection from 6 months of age, second injection 3–5 weeks later.
• Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single 1 ml dose although this schedule has not been fully validated.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of a double dose of vaccine, no adverse reactions other than those described under section 4.6 have been observed.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
ATCvet code: QI05AA10.
Immunologicals for Equidae, inactivated viral vaccines for horses.
The vaccine stimulates active immunity against West Nile virus.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Minimum essential medium (MEM)
Phosphate buffered saline SP oil
6.2 Major Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary product as packaged for sale: 2 years.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
6.5 Nature and composition of immediate packaging
Single-dose (1 ml) pre-filled type I glass syringe closed with bromobutyl rubber tip. Packaging: box of 2, 4 or 10 single-dose syringes with needles.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
1st Floor, Birchwood Building
Springfield Drive
Leatherhead
Surrey
KT22 7LP
8. MARKETING AUTHORISATION NUMBER
Vm 42058/5023
9. DATE OF FIRST AUTHORISATION
21 November 2008
10. DATE OF REVISION OF THE TEXT
October 2023
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT
Veterinary medicinal product subject to prescription.
Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.
Approved 01 March 2024
[1] As with any vaccine rare, occasional hypersensitivity reactions may occur. If such a reaction occurs, appropriate treatment should be administered without delay.
[2] Resolves within 2 days
[3] Transient local reactions in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to 2 days.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national
