Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
bluetongue virus vaccine, serotype 8 (inactivated)
Intervet International B.V.
QI04AA02
bluetongue virus vaccine (inactivated) serotype 8
Cattle; Sheep
Immunologicals for ovidae
SheepFor the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.CattleFor the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Revision: 4
Authorised
2017-11-21
16 B. PACKAGE LEAFLET page 16 of 20 17 PACKAGE LEAFLET: BOVILIS BLUE-8 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 Intervet International BV Wim de Körverstraat 35, 5831 AN Boxmeer The NETHERLANDS 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis Blue-8 suspension for injection for cattle and sheep 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml of vaccine contains: Bluetongue virus inactivated, serotype 8 10 6.5 CCID 50 * Aluminium hydroxide 6 mg Purified saponin (Quil A) 0.05 mg Thiomersal 0.1 mg (* equivalent to titre prior to inactivation) 4. INDICATION(S) Sheep For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8. *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity: 20 days after the second dose. Duration of immunity: 1 year after the second dose. Cattle For the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8. *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity: 31 days after the second dose. Duration of immunity: 1 year after the second dose. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle. It lasted not longer than 24 to 48 hours. Transient fever was observed in rare cases. Temporary local reactions can occur very rarely at the injection site in the form of a nodule page 17 of 20 18 of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest and which may be painful. Loss of appetite can occur in very rare cases. Hypersensitivity reactions are very rarely observed. The frequency of adverse re Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS page 1 of 20 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis Blue-8 suspension for injection for cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of vaccine contains: ACTIVE SUBSTANCE: Bluetongue virus inactivated, serotype 8: 10 6.5 CCID 50 * (* equivalent to titre prior to inactivation) ADJUVANTS: Aluminium hydroxide 6 mg Purified saponin (Quil A) 0.05 mg EXCIPIENT: Thiomersal 0.1 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White or pinkish-white. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep and cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Sheep For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8. *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity: 20 days after the second dose. Duration of immunity: 1 year after the second dose. Cattle For the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8. *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity: 31 days after the second dose. Duration of immunity: 1 year after the second dose. 4.3 CONTRAINDICATIONS None. page 2 of 20 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine. No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies. 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 Прочетете целия документ