Summary of medicine characteristics - Proteq West Nile
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Proteq West Nile suspension for injection for horses
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
Active substance:
6.0 to 7.8 log10 CCID*50
West Nile recombinant canarypox virus (vCP2017) * Cell culture infectious dose 50 %
Adjuvant:
Carbomer......................................................................................................................................... 4 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
Homogeneous opalescent suspension.
4. CLINICAL PARTICULARS4.1 Target species
Horses
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4.2 Indications for use, specifying the target species
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.
4.3 Contraindications
None.
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4.4 Special warnings for each target species
None.
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4.5 Special precautions for use
Special precautions for use in animals
Vaccinate only healthy animals.
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.
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 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.
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4.6 Adverse reactions (frequency and seriousness)
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:
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– very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment)
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
4.8 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.
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4.9 Amounts to be administered and administration route
For intramuscular use.
Shake the vaccine gently before use.
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions other than those already mentioned in section 4.6 have been observed after the administration of more than 10 doses.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for equidae, other immunologicals.
ATC vet code: QI05AX.
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.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Sodium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 27 months.
Use immediately after opening.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C-8 °C)
Do not freeze
Protect from light
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6.5 Nature and composition of immediate packaging
Type I glass vial, with a butyl elastomer closure, sealed with an aluminium cap.
Box of 1, 2, 5 or 10 vial(s) of 1 dose.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/11/129/001–004
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 05/08/2011
Date of last renewal: 17/05/2016