Summary of medicine characteristics - Equip WNV (previously Duvaxyn WNV)
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Equip WNV emulsion for injection for horses
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
Active substance :
Inactivated West Nile virus, strain VM-2 RP* 1.0–2.2
*Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
Adjuvant :
SP oil 4.0% – 5.5% (v/v)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for injection.
4. CLINICAL PARTICULARS4.1 Target species
Horses.
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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.
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4.4 Special warnings for each target species
None.
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4.5 Special precautions for use
Special precautions for use in animals
Vaccinate healthy animals only.
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, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
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4.6 Adverse reactions (frequency and seriousness)
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 and that are sometimes associated with pain and mild depression were reported in very rare cases. In very rare cases transient hyperthermia may occur for up to 2 days.
As with any vaccine rare, occasional hypersensitivity reactions may occur. If such a reaction occurs, appropriate treatment should be administered without delay.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
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– common (more than 1 but less than 10 animals in 100 animals)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals)
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– rare (more than 1 but less than 10 animals in 10,000 animals)
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– very rare (less than 1 animal in 10,000 animals, including isolated reports).
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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.
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4.9 Amounts to be administered and administration route
For intramuscular use.
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.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines for horses. ATCvet code: QI05AA10.
The vaccine stimulates active immunity against West Nile virus.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Minimum essential medium (MEM)
Phosphate buffered saline
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary product as packaged for sale:
pre-filled glass syringe: 2 years.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
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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.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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 Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM