Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
bluetongue-virus serotype-2 antigen, bluetongue-virus serotype-4 antigen
Mérial
QI04AA02
inactivated adjuvanted vaccine against bluetongue virus serotype 2 and 4 infections
Sheep
bluetongue virus, Inactivated viral vaccines, Immunologicals for ovidae
Active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 2 and 4.
Revision: 4
Withdrawn
2010-11-04
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 1 BOTTLE OF 10 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 2-4 suspension for injection for sheep 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1ml of vaccine contains: BTV2 antigen ................................................................................................................ 6.8–9.5 CCID 50 *, BTV4 antigen ................................................................................................................ 7.1–8.5 CCID 50 *, Aluminium hydroxide, Saponin, qs 1 dose *. *see package leaflet. 3. PHARMACEUTICAL FORM Suspension for injection 4. PACKAGE SIZE 10 doses (10 ml) 5. TARGET SPECIES Sheep 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. 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. Medicinal product no longer authorised 12 10. EXPIRY DATE EXP {month/year} Once broached, use immediately. 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/2/10/108/005 17. MANUFACTURER’S BATCH NUMBER Lot {number} Medicinal product no longer authorised 13 PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 1 BOTTLE OF 50 ML, OR OF 10 BOTTLES OF 50 ML, OR OF 1 BOTTLE OF 100 ML, OR OF 10 BOTTLES OF 100 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT B Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 2-4 suspension for injection for sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1ml of vaccine contains: ACTIVE SUBSTANCES: Bluetongue virus serotype 2 antigen ............................................................................... 6.8–9.5 CCID 50 * Bluetongue virus serotype 4 antigen ............................................................................... 7.1–8.5 CCID 50 * * Cell culture infectious dose 50% equivalent to titre prior to inactivation (log 10 ) ADJUVANTS: Aluminium hydroxide 2.7 mg, Saponin 30 HU** **Haemolytic units For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep 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 2 and 4. *(below the level of detection by the validated RT-PCR method at 3.68 log 10 RNA copies/ml, indicating no infectious virus transmission) Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for serotype 4 and serotype 2, respectively. The duration of immunity is 1 year after 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. Medicinal product no longer authorised 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate healthy animals only. Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable. Прочетете целия документ