Proteq West Nile
West Nile fever vaccine (live recombinant)
Proteq West Nile suspension for injection for horses
Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release: Boehringer Ingelheim Animal Health France SCS Laboratoire Porte des Alpes
Rue de l’Aviation 69800 Saint Priest
France
Proteq West Nile suspension for injection for horses
Homogeneous opalescent suspension for injection Each dose of 1 ml contains:
West Nile recombinant canarypox virus (vCP2017) ....................................... 6.0 to 7.8 log10 CCID*50
* Cell culture infectious dose 50%
Carbomer ......................................................................................................................................... 4 mg
Active immunisation of horses from 5 months of age against West Nile disease by reducing the number of viraemic horses. If clinical signs are present, their duration and severity are reduced. Onset of immunity: 4 weeks after the first dose of the primary vaccination course. In order to achieve full protection, the full vaccination course of two doses must be given.
Duration of immunity: 1 year after a full primary vaccination course of two injections.
None.
A transient swelling (max. diameter 5 cm) which resolves within 4 days may appear commonly at the injection site.
Pain and local hyperthermia can occur in rare cases.A slight increase in temperature (max. 1.5 °C)
may occur in rare cases for 1 day, exceptionally 2 days. Apathy, usually resolving within two days, and reduced appetite may be observed in rare cases the day after vaccination. A hypersensitivity reaction may occur in rare cases, which may require appropriate symptomatic treatment.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment)
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Horses.
Administer one dose of 1 ml, by intramuscular injection, preferably in the neck region, according to the following schedule:
Primary vaccination course: first injection from 5 months of age, second injection 4-6 weeks later,
Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single dose although this schedule has not been fully validated.
Shake the vaccine gently before use.
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.
Use immediately after opening.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Special precautions for use in animals: Vaccinate only healthy animals.
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.
Special warnings for each target species:
The safety of the vaccine has been demonstrated in foals from 5 months of age. However the vaccine has also been shown to be safe in a field study including animals of 2 months of age.
Pregnancy and lactation:
This vaccine can be used during pregnancy and lactation.
Overdose (symptoms, emergency procedures, antidotes):
No adverse reactions other than those already mentioned in the section “Adverse Reactions” have been observed after the administration of more than 10 doses.
Incompatibilities:
Do not mix with any other veterinary medicinal product.
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
The manufacture, import, possession, sale, supply and/or use of Proteq West Nile 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 Proteq West Nile 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.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
To stimulate active immunity against West Nile virus.
The vaccine strain vCP2017 is a recombinant canarypox virus expressing the preM/E genes of West Nile virus. After inoculation, the virus does not multiply in the horse but expresses the protective proteins. As a consequence, these proteins induce protective immunity against equine West Nile disease.
Box of 1, 2, 5 or 10 vial(s) of 1 dose. Not all pack sizes may be marketed.