Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063.
Boehringer Ingelheim Vetmedica GmbH
QI02AA04
inactivated vaccine against foot-and-mouth disease
Pigs; Cattle; Sheep
Immunologicals
Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.
Revision: 8
Withdrawn
2013-07-15
17 B. PACKAGE LEAFLET Medicinal product no longer authorised 18 PACKAGE LEAFLET: AFTOVAXPUR DOE EMULSION FOR INJECTION FOR CATTLE, SHEEP AND PIGS 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 AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT Each dose of 2 ml of emulsion contains: ACTIVE SUBSTANCES: Purified, inactivated foot-and-mouth disease virus strain antigens, at least 6 PD 50 * per strain. * PD 50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063. The number and type of strains 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. ADJUVANT: Liquid paraffin 537 mg. White emulsion after shaking. 4. INDICATIONS Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs. Onset of immunity: Cattle and sheep: 7 days after vaccination. Pigs: 4 weeks after vaccination. Medicinal product no longer authorised 19 Duration of immunity: vaccination of cattle, sheep and pigs induced the production of neutralising antibodies that persisted for at least 6 months. In cattle, the antibody levels measured were above those shown to be protective. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS Swellings (diameter of up to 12 cm in ruminants and 4 cm in pigs) occurred very commonly in most animals after administration of a dose of vaccine. These local reactions normally resolve over a period of four weeks post vaccination, but may persist for longer in a s Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml of emulsion contains: ACTIVE SUBSTANCES: Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ................................................................................................................................. ≥ 6 PD 50 * O1 BFS ....................................................................................................................................... ≥ 6 PD 50 * O Taiwan 3/97 ........................................................................................................................... ≥ 6 PD 50 * A22 Iraq ..................................................................................................................................... ≥ 6 PD 50 * A24 Cruzeiro ............................................................................................................................. ≥ 6 PD 50 * A Turkey 14/98 ......................................................................................................................... ≥ 6 PD 50 * Asia 1 Shamir ............................................................................................................................. ≥ 6 PD 50 * SAT2 Saudi Arabia ................................................................................................................... ≥ 6 PD 50 * * PD 50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063. The number and type of strains 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. ADJUVANT: Liquid paraffin ............................................................................................................................. Прочетете целия документ