Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Live aroA gene deleted Escherichia coli, type 078, strain EC34195
Zoetis Belgium SA
QI01AE04
Escherichia coli aroA gene deleted, type O78, strain EC34195 (live)
Chicken; Turkeys
Immunologicals for aves, Live bacterial vaccines
For active immunisation of broiler chickens and future layers / breeders in order to reduce mortality and lesions (pericarditis, perihepatitis, airsacculitis) associated with Escherichia coli serotype O78.
Revision: 10
Authorised
2012-06-15
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET POULVAC E. COLI LYOPHILISATE FOR SUSPENSION FOR SPRAY VACCINATION FOR CHICKENS AND TURKEYS OR FOR USE IN DRINKING WATER FOR CHICKENS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L. Ctra. de Camprodón, s/n° Finca La Riba Vall de Bianya Gerona, 17813 SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose contains: Live aroA gene deleted _Escherichia coli_ , type O78, strain EC34195 5.2 x 10 6 - 9.1 x 10 8 CFU* * Colony forming units when grown on trypticase soy agar plates. Cream coloured lyophilisate. Upon reconstitution, transparent to white-yellowish and opaque suspension (depending on the volume of diluent used). 4. INDICATION(S) For active immunisation of broiler chickens, future layer/breeders and turkeys in order to reduce mortality and lesions (pericarditis, perihepatitis, airsacculitis) associated with _Escherichia coli_ serotype O78. Onset of immunity: Chickens: 2 weeks after vaccination for the reduction of lesions. The onset of immunity has not been established for the mortality claim. Turkeys: 3 weeks after second vaccination for the reduction of lesions and mortality. Duration of immunity: Chickens: 8 weeks for the reduction of lesions and 12 weeks for the reduction of mortality (spray). 12 weeks for the reduction of lesions and mortality (drinking water). 16 Turkeys: duration of immunity has not been established. A cross protection study showed reduction of incidence and severity of airsacculitis caused by _E. coli_ serotypes O1, O2 and O18 for spray application for chickens. For Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac E. coli lyophilisate for suspension for spray vaccination for chickens and turkeys or for use in drinking water for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose contains: ACTIVE SUBSTANCE: Live aroA gene deleted _Escherichia coli_ , type O78, strain EC34195 5.2 x 10 6 - 9.1 x 10 8 CFU* * Colony forming units when grown on trypticase soy agar plates. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for suspension for spray vaccination or for use in drinking water. Cream coloured lyophilisate. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (broilers, future layers/breeders) and turkeys. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of broiler chickens, future layer/breeders and turkeys in order to reduce mortality and lesions (pericarditis, perihepatitis, airsacculitis) associated with _Escherichia coli_ serotype O78. Onset of immunity: Chickens: 2 weeks after vaccination for the reduction of lesions. The onset of immunity has not been established for the mortality claim. Turkeys: 3 weeks after second vaccination for the reduction of lesions and mortality. Duration of immunity: Chickens: 8 weeks for the reduction of lesions and 12 weeks for the reduction of mortality (spray). 12 weeks for the reduction of lesions and mortality (drinking water). Turkeys: duration of immunity has not been established. A cross protection study showed reduction of incidence and severity of airsacculitis caused by _E. coli_ serotypes O1, O2 and O18 for spray application for chickens. For these serotypes no onset of immunity or duration of immunity was established. 4.3 CONTRAINDICATIONS Do not vaccinate animals undergoing antibacterial or immunosuppressive treatment. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Do not use antibiotic treatment within 1 week before and after vaccination because antibiotic treatment mig Прочетете целия документ