Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
inactivated chimaeric flavivirus strain YF-WN
Intervet International BV
QI05AA10
inactivated chimaeric flavivirus strain YF-WN
Horses
Immunologicals
Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia. Onset of immunity: 2 weeks after primary vaccination course of two injections. Duration of immunity: 12 months.,
Revision: 2
Authorised
2013-06-06
B. PACKAGE LEAFLET 13 PACKAGE LEAFLET: EQUILIS 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 and manufacturer responsible for batch release: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile suspension for injection for horses 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains: Inactivated chimeric flavivirus strain YF-WN ≥ 492 AU 1 Iscom-Matrix containing: Purified saponin 250 micrograms Cholesterol 83 micrograms Phosphatidylcholine 42 micrograms 1 Antigenic units Opalescent suspension. 4. INDICATION(S) Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia. Onset of immunity : 2 weeks after primary vaccination course of two injections. Duration of immunity: 12 months . _ _ 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS In laboratory studies and field trials: After vaccination a mild transient swelling may very commonly develop at the injection site (max. 3 cm in diameter). This swelling normally resolves within 1 to 5 days. A mild body temperature increase (max. 1.5 ° C) may very commonly occur for 1 to 2 days. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) 14 - 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 side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please in Прочитать полный документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile suspension for injection for horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCE: Inactivated chimeric flavivirus strain YF-WN ≥ 492 AU 1 ADJUVANT: Iscom-Matrix containing: Purified saponin 250 micrograms Cholesterol 83 micrograms Phosphatidylcholine 42 micrograms 1 Antigenic units determined by ELISA. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Opalescent suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia. Onset of immunity : 2 weeks after primary vaccination course of two injections. Duration of immunity: 12 months . _ _ 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. 2 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. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In laboratory studies and field trials: After vaccination a mild transient swelling may very commonly develop at the injection site (max. 3 cm in diameter). This swelling normally resolves within 1 to 5 days. A mild body temperature increase (max. 1.5 ° C) may very commonly occur for 1 to 2 days. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - 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 Прочитать полный документ