Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02
Zoetis Belgium SA
QI04AA02
inactivated bluetongue virus, serotype 8
Sheep
Immunologicals
Active immunisation of sheep from 1.5 months of age for the prevention of viraemia caused by bluetongue virus, serotype 8.
Revision: 9
Authorised
2010-01-15
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: ZULVAC 8 OVIS SUSPENSION FOR INJECTION FOR 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: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L. Ctra. de Camprodón, s/n° Finca La Riba Vall de Bianya Gerona, 17813 SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 8 Ovis suspension for injection for sheep 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose of 2 ml of 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 sheep. ADJUVANT(S): Aluminium hydroxide (Al 3+ ) 4 mg Quil-A ( _Quillaja saponaria_ saponin extract) 0.4 mg EXCIPIENT: Thiomersal 0.2 mg Off-white or pink suspension for injection. 4. INDICATION(S) Active immunisation of sheep from 1.5 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). 18 Onset of immunity: 25 days after administration of the second dose. Duration of immunity: at least 1 year after the primary vaccination course. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS A transient increase in rectal temperature during the 24 hours following vaccination not exceeding 1.2°C and local reaction at the injection site, in most cases in the form of a general swelling (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days) were observed very commonly in one laboratory safety study. These clinical signs have been reported very rarely from the field. The frequency of adverse reactions is defined using the following convention: - very Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 8 Ovis suspension for injection for sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 2 ml of 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 sheep. ADJUVANT(S): Aluminium hydroxide (Al 3+ ) 4 mg Quil-A ( _Quillaja saponaria_ saponin extract) 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 Sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of sheep from 1.5 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. Duration of immunity: at least 1 year after the primary vaccination course. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 3 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 sheep. No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Lesen Sie das vollständige Dokument