Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
bluetongue-virus serotype-1 antigen, bluetongue virus serotype 8 antigen
Boehringer Ingelheim Vetmedica GmbH
QI04AA02, QI02AA08
inactivated vaccine against bluetongue virus serotypes 1 and 8
Sheep; Cattle
Immunologicals
SheepActive immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/ or 8 (combination of maximum 2 serotypes), active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1,2, 4 and/ or 8 (combination of maximum 2 serotypes), active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).CattleActive immunisation of cattle to prevent viraemia caused by bluetongue virus serotype 1, 2, 4 and/ or 8, and to reduce clinical signs caused by bluetongue virus serotypes when observed in this species: serotype 1, 4 and / or 8 (combination of maximum 2 serotypes).Active immunisation of cattle to prevent viraemia caused by bluetongue virus serotype 1, 2, 4 and/ or 8, and to reduce clinical signs caused by bluetongue virus serotypes when observed in this species: serotype 1, 4 and / or 8 (combination of maximum 2 serotypes).Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).
Revision: 12
Authorised
2010-12-17
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: BTVPUR 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: 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 BTVPUR suspension for injection for sheep and cattle 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains: ACTIVE SUBSTANCE*: Inactivated Bluetongue Virus ......................................... ≥ strain specific pass level (log 10 pixels) ** * maximum of two different inactivated bluetongue virus serotypes (**)Strain-specific pass levels (**) Antigen content (VP2 protein) by immuno-assay BTV1 1.9 log10 pixels/mL BTV2 1.82 log10 pixels/mL BTV4 1.86 log10 pixels/mL BTV8 2.12 log10 pixels/mL A confirmatory final potency test by seroneutralisation in rats is conducted when a batch is released. ADJUVANTS: Al3+ (as hydroxide) .................................................................................................................. 2.7 mg Saponin ................................................................................................................................... 30 HU** ( ** ) Haemolytic units The type of strain(s) (two strains at most) included in the final product will be selected based on the epidemiological situation at the time of manufacturing and will be stated on the label. Appearance: homogeneous milky white. 20 4. INDICATION(S) Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by Bluetongue Virus Serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes). Active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1, 2, 4 and/or 8, and to r Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR suspension for injection for sheep and cattle. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCES *: Inactivated bluetongue virus ........................................ ≥ strain specific pass level (log10 pixels) ** (*) maximum of two different inactivated bluetongue virus serotypes (**)Strain-specific pass levels (**) Antigen content (VP2 protein) by immuno-assay BTV1 1.9 log10 pixels/mL BTV2 1.82 log10 pixels/mL BTV4 1.86 log10 pixels/mL BTV8 2.12 log10 pixels/mL A confirmatory final potency test by seroneutralisation in rats is conducted when a batch is released. ADJUVANTS: Al 3+ (as hydroxide) 2.7 mg Saponin 30 HU** ( ** ) Haemolytic units For the full list of excipients, see section 6.1. The type of strain(s) (two strains at most) included in the final product will be selected based on the epidemiological situation at the time of manufacturing and will be stated on the label. 3. PHARMACEUTICAL FORM Suspension for injection Appearance: homogeneous milky white . 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep and cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes). Active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1, 2, 4 and/or 8, and to reduce clinical signs caused by bluetongue virus serotypes 1, 4 and/or 8 (combination of maximum 2 serotypes). *below the level of detection by the validated RT-PCR method at 3.68 log 10 RNA copies/ml, indicating no infectious virus transmission. 3 Onset of immunity has been demonstrated 3 weeks (or 5 weeks in sheep for BTV2) after the primary vaccination course for BTV-1, BTV-2 (cattle), BTV-4 and BTV-8 serotypes. The duration of immunity for cattle and sheep is 1 year after primary vaccination course. 4.3 CONTRAINDICATIO Прочетете целия документ