Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
inactivated bluetongue virus, serotype 1
Zoetis Belgium SA
QI02AA08
inactivated bluetongue virus, serotype 1
Cattle
Immunologicals
Active immunisation of cattle from 2½ months of age for the prevention of viraemia caused by bluetongue virus, serotype 1.Onset of immunity: 15 days after completion of the primary vaccination course.Duration of immunity: 12 months.
Revision: 7
Withdrawn
2011-08-05
Medicinal product no longer authorised 15 B. PACKAGE LEAFLET Medicinal product no longer authorised 16 PACKAGE LEAFLET: ZULVAC1 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. Camprodón s/n "la Riba" 17813 Vall de Bianya Girona SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1 Bovis suspension for injection for cattle 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each 2 ml dose contains: ACTIVE SUBSTANCE: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 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 Off-white or pink liquid. 4. INDICATIONS(S) For active immunisation of cattle from 2 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotypes 1. *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity: 15 days after completion of the primary vaccination scheme. Duration of immunity: 12 months after completion of the primary vaccination scheme. Medicinal product no longer authorised 17 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS After first vaccination a rectal temperature increase of up to 1.6°C may occur very commonly the 3 rd day after the injection. Rectal temperatures should then return to normal values. After second and third vaccination a rectal temperature increase of up to 1.3°C and 2.8°C respectively may occur very commonly one day after the injection and then rectal temperatures return to normal values. The frequency of adverse reactions is defined using the follow Izlasiet visu dokumentu
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1 Bovis suspension for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains: ACTIVE SUBSTANCE: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in calves. 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 Suspension for injection. Off-white or pink liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of cattle from 2 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotype 1. *(Cycling value (Ct) ≥ 36 by a validated RT- PCR method, indicating no presence of viral genome) Onset of immunity: 15 days after completion of the primary vaccination course. Duration of immunity: 12 months after completion of the primary vaccination course. 4.3 CONTRAINDICATIONS None. Medicinal product no longer authorised 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 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 cattle. No information is available on the use of the vaccine in animals with maternally derived antibodies. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate only healthy animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals None 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) After first vaccinati Izlasiet visu dokumentu