Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
bluetongue virus serotype 8 antigen
Merial
QI02AA08
adjuvanted bluetongue virus vaccine
Sheep; Cattle
Immunologicals for ovidae, Immunologicals for bovidae
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.*(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml, indicating no infectious virus transmission).Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.
Revision: 5
Withdrawn
2009-03-17
Medicinal product no longer authorised 10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 1 BOTTLE OF 10 ML BOX OF 1 BOTTLE OF 50 ML, BOX OF 10 BOTTLES OF 50 ML, BOX OF 1 BOTTLE OF 100 ML, BOX OF 10 BOTTLES OF 100 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 8 suspension for injection 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains: BTV8 antigen............................................... ≥ 2.1 log10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet 3. PHARMACEUTICAL FORM Suspension for injection 4. PACKAGE SIZE 1 bottle of 10 doses (1 x 10 ml) 1 bottle of 50 doses (1 x 50 ml) 10 bottles of 50 doses (10 x 50 ml) 1 bottle of 100 doses (1 x 100 ml) 10 bottles of 100 doses (10 x 100 ml) 5. TARGET SPECIES Sheep and cattle 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use Read the package leaflet before use. 8. WITHDRAWAL PERIOD Withdrawal period: zero days. Medicinal product no longer authorised 11 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP {month/year} Shelf life after first opening the immediate packaging: immediately after broaching. 11. SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 ° C-8 ° C). Do not freeze. Protect from light. 12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Read the package leaflet before use. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only – to be supplied only on veterinary prescription. 14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER MERIAL 29, avenue Tony Garnier 69007 Lyon FRANCE 16. MARKETING AUTHORISATION NUMBER(S) EU/2/09/094/001 EU/2/09/094/002 EU/2/09/094/003 EU/2/09/094/004 EU/2/09/094/005 Medicinal product no longer authorised 12 17. MANUFACTURER’S BATCH NU Прочетете целия документ
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 8, suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml of vaccine contains: ACTIVE SUBSTANCES: Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay ADJUVANTS: Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (**) Haemolytic units EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep and cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8. * (below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission) Onset of immunity has been demonstrated 3 weeks after the primary vaccination course. The duration of immunity for cattle and sheep is 1 year after the primary vaccination course. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination. The level of efficacy for other species may differ from that observed in sheep and cattle. Medicinal product no longer authorised 3 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinate healthy animals only Прочетете целия документ