Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
bluetongue virus vaccine, serotype 8 (inactivated)
Intervet International BV
QI04AA02
bluetongue virus serotype 8
Sheep; Cattle
Inactivated viral vaccines, bluetongue virus, SHEEP
Cattle To stimulate active immunity in sheep from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia Sheep To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia,
Revision: 4
Withdrawn
2010-09-06
16 B. PACKAGE LEAFLET Medicinal product no longer authorised 17 PACKAGE LEAFLET FOR: BOVILIS BTV8 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 BTV8 suspension for injection for cattle and sheep 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose (1 ml) contains: Active ingredient: bluetongue virus serotype 8: 500 antigenic units* (* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log 2 ) Adjuvants: aluminium hydroxide, saponin. Opalescent pink with resuspendable sediment. 4. INDICATION(S) Sheep To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia * . *(cycling value (Ct) > 30 by a validated rRT-PCR method, indicating absence of infectious virus) Cattle To stimulate active immunity in cattle from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia*. * (for details see section 12) Onset of immunity: 3 weeks after vaccination. Duration of immunity: 6 months. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS In very rare cases vaccination may result in a slight rise in temperature (usually not more than 0.5 °C, in individual cases up to about 2 °C) for up to three days after vaccination, and temporary swellings at the injection site. In sheep, these swellings typically last for up to three weeks, while in cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of Medicinal product no longer authorised 18 vaccinates. After administration of a double dose in cattle and sheep no other reactions were observed. However, the temperature rise may be 0.5 °C higher and the swellings may be more pronounced and palpable for a longer period. In sheep, swellings may still b Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis BTV8 suspension for injection for cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1 ml) contains: ACTIVE SUBSTANCE: Bluetongue virus serotype 8 (prior to inactivation): 500 antigenic units*. (* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log 2 ) ADJUVANTS Aluminium hydroxide (as 100%) 16.7 mg Saponin 0.31 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Opalescent pink with resuspendable sediment. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Sheep To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia * . *(cycling value (Ct) > 30 by a validated rRT-PCR method, indicating absence of infectious virus) Cattle To stimulate active immunity in cattle from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia*. * (for details see section 4.4) Onset of immunity: 3 weeks after vaccination. Duration of immunity: 6 months. 4.3 CONTRAINDICATIONS None. Medicinal product no longer authorised 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES This vaccine has been shown to reduce but not prevent viraemia in cattle. The extent of this reduction has been shown by epidemiological modelling studies to be likely to reduce virus transmission to an extent that can limit the spread of an outbreak in a vaccinated population. This vaccine has been tested for safety in sheep and cattle. 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. No information is available on the use of th Pročitajte cijeli dokument