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)|
|Substance:||inactivated West Nile virus, strain VM-2|
|Manufacturer:||Zoetis Belgium SA|
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period(s)
- 5. IMMUNOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBERS
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
- 10. DATE OF THE REVISION OF THE TEXT
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:
Inactivated West Nile virus, strain
*Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
4.0% – 5.5% (v/v)
For the full list of excipients, see section 6.1.
Emulsion for injection.
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.
4.4Special warnings for each target species
4.5Special precautions for use
Special precautions for use in animals
Vaccinate healthy animals only.
Vaccination may interfere with existing
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
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
•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)
Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines for horses. ATCvet code: QI05AA10.
The vaccine stimulates active immunity against West Nile virus.
6.1List of excipients
Minimum essential medium (MEM)
- Equilis west nile - QI05AA10
Prescription drugs listed. ATC Code: "QI05AA10"
Phosphate buffered saline
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary product as packaged for sale:
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
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
8.MARKETING AUTHORISATION NUMBERS
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.