Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated]
CZ Veterinaria S.A.
QI04AA02
bluetongue virus inactivated, serotype 8
Sheep, Cattle
Immunologicals
SheepActive immunisation against bluetongue virus serotype 8 to prevent viraemia and to reduce clinical signs.Onset of immunity: 20 days after second dose.Duration of immunity: 1 year after second dose.CattleActive immunisation against bluetongue virus serotype 8 to prevent viraemia.Onset of immunity: 31 days after second dose.Duration of immunity: 1 year after second dose.
Revision: 7
Authorised
2011-04-14
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: BLUEVAC BTV SUSPENSION FOR INJECTION FOR CATTLE AND SHEEP 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: CZ Veterinaria, S.A. La Relva s/n - Torneiros 36410 Porriño (Spain) 2. NAME OF THE VETERINARY MEDICINAL PRODUCT BLUEVAC BTV Suspension for injection for cattle and sheep 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml of vaccine contains: ACTIVE SUBSTANCES: Inactivated bluetongue virus (BTV) One of the following inactivated bluetongue virus serotypes: Inactivated bluetongue virus, serotype 1 (BTV-1), strain BTV-1/ALG/2006/01 ≥ 22.60 µg/ml Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 ≥ 2.55 µg/ml Inactivated bluetongue virus, serotype 8 (BTV-8), strain BTV8/BEL/2006/01 ≥ 55.80 µg/ml ADJUVANTS: Aluminium hydroxide 6 mg Purified saponin (Quil A) 0.05 mg EXCIPIENT: Thiomersal 0.1 mg The type of strain 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. White or pinkish-white suspension. 4. INDICATION(S) Sheep For active immunisation of sheep to prevent the viraemia* caused by bluetongue virus serotype 1 or 4 or 8) and to reduce clinical signs caused by bluetongue virus serotype 8. * Below the level of detection by the validated RT-PCR method at 1 log10 TCID 50 /ml for serotypes 8 and 4, and 1.3 log10 TCID 50 /ml for serotype 1 18 Onset of immunity: 21 days after completion of the primary vaccination scheme. Duration of immunity: 1 year after completion of the primary vaccination scheme. Cattle For active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotype 1 or 4or 8 * Below the level of detection by the validated RT-PCR method at 1 log10 TCID 50 /ml for serotypes 8 and 4, and 1.3 log10 TCID 50 /ml for serotype 1. Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BLUEVAC BTV Suspension for injection for cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of vaccine contains: ACTIVE SUBSTANCES: Inactivated bluetongue virus (BTV) One of the following inactivated bluetongue virus serotypes: Inactivated bluetongue virus, serotype 1 (BTV-1), strain BTV-1/ALG/2006/01 ≥ 22.60 µg/ml Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 ≥ 2.55 µg/ml Inactivated bluetongue virus, serotype 8 (BTV-8), strain BTV8/BEL/2006/01 ≥ 55.80 µg/ml ADJUVANTS: Aluminium hydroxide 6 mg Purified saponin (Quil A) 0.05 mg EXCIPIENTS: Thiomersal 0.1 mg For the full list of excipients, see section 6.1. The type of strain 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. White or pinkish-white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep and cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Sheep For active immunisation of sheep to prevent the viraemia* caused by bluetongue virus serotype 1 or 4 or 8) and to reduce clinical signs caused by bluetongue virus serotype 8 * Below the level of detection by the validated RT-PCR method at 1 log10 TCID 50 /ml for serotypes 8 and 4, and 1.3 log10 TCID 50 /ml for serotype 1. Onset of immunity: 21 days after completion of the primary vaccination scheme. 3 Duration of immunity: 1 year after completion of the primary vaccination scheme. Cattle For active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotype 1 or 4 or 8. * Below the level of detection by the validated RT-PCR method at 1 log10 TCID 50 /ml for serotypes 8 and 4, and 1.3 log10 TCID 50 /ml for serotype 1. Onset of immunity: BTV, serotype 1: 28 days after completion of the primary vaccination scheme BTV, serotype 4: 21 days after completion of the primary vaccination sche Pročitajte cijeli dokument