País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
inactivated West Nile virus, strain VM-2
Zoetis Belgium SA
QI05AA10
vaccine to aid in prevention of West Nile virus
Horses
Immunologicals for equidae
For the active immunisation of horses of six months of age or older against West-Nile-virus disease by reducing the number of viraemic horses.
Revision: 13
Authorised
2008-11-21
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET FOR: EQUIP WNV EMULSION 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 and manufacturer responsible for batch release: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Equip WNV emulsion for injection for horses 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains: Active substance: Inactivated West Nile virus, strain VM-2 RP* 1.0–2.2 * Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses. Adjuvant: SP oil 4.0% – 5.5% (v/v). 4. INDICATION(S) 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. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS 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. 15 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 reaction(s) during the course of one tre Leia o documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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: ACTIVE SUBSTANCE : Inactivated West Nile virus, strain VM-2 RP* 1.0–2.2 *Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses. ADJUVANT : SP oil 4.0% – 5.5% (v/v) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS 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. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate healthy animals only. 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. 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 medicina Leia o documento completo