Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
One of the following inactivated bluetongue virus strains:Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02Inactivated bluetongue virus, serotype 4, strain SPA-1/2004
Zoetis Belgium SA
QI02AA
Bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)
Sheep; Cattle
Immunologicals, Immunologicals for bovidae, Inactivated viral vaccines, bluetongue virus, SHEEP
Active immunisation of sheep from 6 weeks of age for the prevention of viraemia caused by bluetongue virus, serotypes 1 and 8, and for the reduction of viraemia caused by bluetongue virus, serotype 4 and active immunisation of cattle from 12 weeks of age for the prevention of viraemia caused by bluetongue virus, serotypes 1 and 8.
Revision: 2
Authorised
2017-04-25
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: ZULVAC BTV SUSPENSION FOR INJECTION FOR SHEEP AND CATTLE 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 Zulvac BTV suspension for injection for sheep and cattle 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) ACTIVE SUBSTANCES: One of the following inactivated bluetongue virus strains AMOUNT PER 2 ML DOSE (BTV-1, BTV-4, BTV-8 in sheep; BTV-1, BTV-8 in cattle) AMOUNT PER 4 ML DOSE (BTV-4 in cattle) Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 n.a. Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1 n.a. Inactivated bluetongue virus, serotype 4, strain SPA-1/2004 RP* ≥ 0.8 RP* ≥ 0.8 ADJUVANTS: Al 3+ (as hydroxide) 4 mg 8 mg Quil-A ( _Quillaja saponaria_ saponin extract) 0.4 mg 0.8 mg EXCIPIENTS: Thiomersal 0.2 mg 0.4 mg n.a.: not applicable *Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep and/or cattle. 29 The type of strain included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label. The target species will also be shown on the label. Off-white or pink liquid. 4. INDICATION(S) Sheep: Active immunisation of sheep from 6 weeks of age for the prevention* of viraemia caused by bluetongue virus, serotype 1 or serotype 8. Active immunisation of sheep from 6 weeks of age for the reduction* of viraemia caused by bluetongue virus, serotype 4. *Below the level of detection of <3.9 log 10 genome copies/ml by the validated RT-qPCR method, indicating no presenc Διαβάστε το πλήρες έγγραφο
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac BTV suspension for injection for sheep and cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: One of the following inactivated bluetongue virus strains AMOUNT PER 2 ML DOSE (BTV-1, BTV-4, BTV-8 in sheep; BTV-1, BTV-8 in cattle) AMOUNT PER 4 ML DOSE (BTV-4 in cattle) Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 n.a. Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1 n.a. Inactivated bluetongue virus, serotype 4, strain SPA-1/2004 RP* ≥ 0.8 RP* ≥ 0.8 ADJUVANTS: Al 3+ (as hydroxide) 4 mg 8 mg Quil-A ( _Quillaja saponaria_ saponin extract) 0.4 mg 0.8 mg EXCIPIENTS: Thiomersal 0.2 mg 0.4 mg For the full list of excipients, see section 6.1. n.a.: not applicable *Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep and/or cattle. The type of strain included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label. The target species will also be shown on the label. 3. PHARMACEUTICAL FORM Suspension for injection. Off-white or pink liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep and cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Sheep: Active immunisation of sheep from 6 weeks of age for the prevention* of viraemia caused by bluetongue virus, serotype 1 or serotype 8. 3 Active immunisation of sheep from 6 weeks of age for the reduction* of viraemia caused by bluetongue virus, serotype 4. *Below the level of detection of < 3.9 log 10 genome copies/ml by the validated RT-qPCR method, indicating no presence of viral genome. Onset of immunity: 21 days after completion of the primary vaccination scheme. Duration of immunity: 12 months after completion of the primary vaccination scheme. Cattle: Active immunisation of cattle from 12 weeks of age for the prevention** of viraemia caused by bl Διαβάστε το πλήρες έγγραφο