Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02
Zoetis Belgium
QI02AA08
inactivated bluetongue virus, serotype 8
Cattle
Immunologicals
Active immunisation of cattle from three months of age for the prevention of viraemia caused by bluetongue virus, serotype 8.
Revision: 7
Withdrawn
2010-01-15
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET FOR: ZULVAC 8 BOVIS SUSPENSION FOR INJECTION FOR CATTLE 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L. Ctra. Camprodon s/n "la Riba" 17813 Vall de Bianya Girona SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC 8 Bovis suspension for injection for cattle 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose of 2 ml of vaccine contains: Inactivated blue T ongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle. ADJUVANTS: Aluminium hydroxide (Al 3+ ) 4 mg Saponin 0.4 mg EXCIPIENT: Thiomersal 0.2 mg 4. INDICATION(S) Active immunisation of cattle from 3 months of age for the prevention* of 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: 25 days after administration of the second dose. The duration of immunity is at least 1 year after the primary vaccination course. 18 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS In one laboratory safety study, no adverse reactions were observed after the first injection of a single dose of vaccine to calves. After the second injection of a single dose, a slight and transient but significant increase in the mean rectal temperature of 0.4ºC was very commonly recorded in the vaccinated calves during the first 24 hours. On day 2 after vaccination, rectal temperatures had returned to normal values. This clinical sign has been reported very rarely from the field. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC 8 Bovis suspension for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml of the vaccine contains: ACTIVE SUBSTANCE: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle. ADJUVANTS: Aluminium hydroxide (Al 3+ ) 4 mg Saponin 0.4 mg EXCIPIENT: Thiomersal 0.2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Off-white or pink suspension for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of cattle from 3 months of age for the prevention* of 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: 25 days after administration of the second dose. The duration of immunity is at least 1 year after the primary vaccination course. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Use in other domestic and wild ruminant species that are considered at risk of infection 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 cattle. 3 No information is available on the use of the vaccine in animals with maternally derived antibodies however the vaccine has been shown safe and efficacious in seropositive cattle. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Only use in healthy animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In one laboratory safety study, no adverse reactions were observed after the first injection of a single dose Pročitajte cijeli dokument