Equip WNV (previously Duvaxyn WNV)
vaccine to aid in prevention of West Nile virus
Marketing authorisation holder and manufac turer res ponsible for batc h releas e: Zoetis Belgium SA
Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM
Equip WNV emulsion for injection for horses
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 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.
None.
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.
Horses.
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.
Not applicable.
Zero days.
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.
Spec ial prec autions 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.
Spec ial prec autions to be taken by the person administering the veterinary medic inal produc t 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.
Pregnanc y and lac tation:
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.
Interac tion w ith other medic inal produc ts and other forms of interac tion:
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.
Inc ompatib ilit ies:
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.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Detailed information on this product is available on the website of the European Medicines Agency (https://w w w.ema. europa. eu/).
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.
Oriola Vilnius UAB Tel: +370 610 05088
Zoetis Belgium SA
Teл: +359 2 4775791
Zoetis Česká republika, s.r.o. Tel: +420 257 101 111
Zoetis Finland Oy
Tlf: +358 (0)9 4300 40
Agrimed Limited
Tel: +356 21 465 797
Zoetis Deutschland GmbH Tel: +49 30 330063 0
Zoetis B.V.
Tel: +31 (0)10 714 0900
Oriola Vilnius UAB Tel: +370 610 05088
Zoetis Finland Oy
Tlf: +358 (0)9 4300 40
Zoetis Hellas S.A. Τηλ.: +30 210 6791900
Zoetis Österreich GmbH Tel: +43 1 2701100 110
Zoetis Spain, S.L. Tel: +34 91 4191900
Zoetis Polska Sp. z o.o. Tel: +48 22 2234800
Zoetis France
Tél: +33 (0)810 734 937
Zoetis Portugal, Lda. Tel: +351 21 042 72 00
Zoetis B.V., Podružnica Zagreb za promidžbu Tel: +385 1 644 1460
Zoetis România S.R.L. Tel: +40 21 202 3083
Zoetis Belgium SA
Tel: +353 (0) 1 256 9800
Zoetis B.V., Podružnica Zagreb za promidžbu Tel: +385 1 644 1460
Zoetis Finland Oy
Sími: +358 (0)9 4300 40
Zoetis Česká republika, s.r.o. Tel: +420 257 101 111
Zoetis Italia S.r.l.
Tel: +39 06 3366 8133
Zoetis Finland Oy
Puh/Tel: +358 (0)9 4300 40
Zoetis Hellas S.A. Τηλ.: +30 210 6791900
Zoetis Finland Oy
Tel: +358 (0)9 4300 40
Oriola Vilnius UAB Tel: +370 610 05088
Zoetis UK Limited
Tel: +44 (0) 845 300 8034