Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
West Nile recombinant canarypox virus (vCP2017 virus)
Boehringer Ingelheim Vetmedica GmbH
QI05AX
West Nile fever vaccine (live recombinant)
Horses
Immunologicals for equidae, Horse, Immunologicals
Active immunisation of horses from five 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.
Revision: 15
Authorised
2011-08-05
13 B. PACKAGE LEAFLET 14 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 CCID* 50 * 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. 15 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 Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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: West Nile recombinant canarypox virus (vCP2017) ....................................... 6.0 to 7.8 log10 CCID* 50 * 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 PARTICULARS 4.1 TARGET SPECIES Horses 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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. 3 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 precaut Pročitajte cijeli dokument