Patient leaflet - Proteq West Nile
B. PACKAGE LEAFLET
PACKAGE LEAFLET
Proteq West Nile suspension for injection for horses
-
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
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
-
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Proteq West Nile suspension for injection for horses
-
3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Homogeneous opalescent suspension for injection
Each dose of 1 ml contains:
Active substance:
West Nile recombinant canarypox virus (vCP2017)....................................... 6.0 to 7.8 log10 CCID50
Cell culture infectious dose 50%
Adjuvant:
Carbomer......................................................................................................................................... 4 mg
4.
INDICATIONS
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.
-
5. CONTRAINDICATION
None.
-
6. ADVERSE REACTIONS
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.
-
7. TARGET SPECIES
Horses.
-
8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
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.
-
9. ADVICE ON CORRECT ADMINISTRATION
Shake the vaccine gently before use.
-
10. WITHDRAWAL PERIOD(S)
Zero days.
-
11. SPECIAL STORAGE PRECAUTIONS
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.
-
12. SPECIAL WARNINGS
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.
-
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
-
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.
-
15. OTHER INFORMATION