Equip WNV (previously Duvaxyn WNV) – patient leaflet, side effects, dosage

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release:

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Equip WNV emulsion for injection for horses

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

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).

4. INDICATION(S)

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.

5. CONTRAINDICATIONS

None.

6. ADVERSE REACTIONS

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:

• very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
• common (more than 1 but less than 10 animals in 100 animals)
• uncommon (more than 1 but less than 10 animals in 1,000 animals)
• rare (more than 1 but less than 10 animals in 10,000 animals)
• very rare (less than 1 animal in 10,000 animals, including isolated reports).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7. TARGET SPECIES

Horses.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

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.

9. ADVICE ON CORRECT ADMINISTRATION

Not applicable.

10. WITHDRAWAL PERIOD

Zero days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C - 8 °C).

Do not freeze.

Protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

12. SPECIAL WARNING(S)

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.

Pregnancy and lactation:

The vaccine can be used during pregnancy and lactation. However, 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.

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.

Incompatibilities:

Do not mix with any other veterinary medicinal product.

The use of Equip WNV reduces the number of animals with viraemia after natural infection, but may not systematically prevent it.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency (http://www. ema. europa. eu/).

15. OTHER INFORMATION

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.

The manufacture, import, possession, sale, supply and/or use of Equip WNV may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation. Any person intending to manufacture, import, possess, sell, supply and use Equip WNV must consult the relevant Member State’s competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

Kvnpog

Zoetis Hellas S.A.

Tip..: +30 210 6791900

Latvija

Oriola Vilnius UAB

Tel: +370 610 05088

Sverige

Zoetis Finland Oy

Tel: +358 (0)9 4300 40

United Kingdom

Zoetis UK Limited

Tel: +44 (0) 845 300 8034

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