Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
bluetongue-virus serotype-1 antigen
Merial
QI04AA02
bluetongue-virus serotype-1 antigen
Sheep; Cattle
Immunologicals
Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotype 1.Onset of immunity has been demonstrated three weeks after the primary vaccination course. The duration of immunity for cattle and sheep is one year after the primary vaccination course.
Revision: 4
Withdrawn
2010-12-17
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 1 suspension for injection for sheep and cattle 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml contains: Inactivated BTV1 ..................................................................................................... ≥ 1.9 log 10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) ( * ) see package leaflet 3. PHARMACEUTICAL FORM Suspension for injection 4. PACKAGE SIZE 1 bottle of 10 doses (1x 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. Medicinal product no longer authorised 11 8. WITHDRAWAL PERIOD Withdrawal period: zero days 9. SPECIAL WARNING(S), IF NECESSARY 10. EXPIRY DATE EXP {month/year} Once broached, use immediately. 11. SPECIAL STORAGE CONDITIONS Store and transport refrigerated. Do not freeze. Protect from light. 12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY 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/2/10/112/005 EU/2/10/112/003 EU/2/10/112/004 EU/2/10/112/001 EU/2/10/112/002 Medicinal product no longer authorised 12 17. MANUFACTURER’S BATCH NUMBER Lot {number} Medicinal product no longer authorised 13 MINIMUM PARTICUL 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 1 suspension for injection for sheep and cattle. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCES: Inactivated Bluetongue Virus Serotype 1 ................................................................. ≥ 1.9 log 10 pixels* ( * ) Antigen content (VP2 protein) by immuno-assay ADJUVANTS: . Al 3+ (as hydroxide) 2.7 mg . Saponin 30 HU** ( ** ) Haemolytic units For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Homogeneous milky white 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 1. *(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 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. Special precautions to be taken by the person administering the veterinary medicinal product to animals None 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In very rare cases it has been observed a small local swelling at Прочетете целия документ