Equip WNV (Duvaxyn WNV) (inactivated West Nile virus, strain...) – Summary of product characteristics - QI05AA10

Updated on site: 09-Feb-2018

Medication name: Equip WNV (Duvaxyn WNV)
ATC: QI05AA10
Substance: inactivated West Nile virus, strain VM-2
Manufacturer: Zoetis Belgium SA

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 PARTICULARS

4.1Target species

Horses.

4.2Indications 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.

4.4Special warnings for each target species

None.

4.5Special 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.

4.6Adverse 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:

-very common (more than 1 in 10 animals displaying adverse reactions 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).

4.7Use 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.

4.8Interaction 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.

4.9Amounts 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.

4.11 Withdrawal period(s)

Zero days.

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 PARTICULARS

6.1List of excipients

Minimum essential medium (MEM)

Phosphate buffered saline

6.2Incompatibilities

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.

6.4Special precautions for storage

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

Do not freeze.

Protect from light.

6.5Nature 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

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

8.MARKETING AUTHORISATION NUMBERS

EU/2/08/086/004–006

9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 21/11/2008

Date of last renewal: 12/09/2013

10.DATE OF THE REVISION OF THE TEXT

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

PROHIBITION OF SALE, SUPPLY AND/OR USE

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.

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