देश: यूरोपीय संघ
भाषा: अंग्रेज़ी
स्रोत: EMA (European Medicines Agency)
inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01, inactivated bluetongue virus, serotype 8, strain btv-8/bel2006/02
Zoetis Belgium SA
QI04AA02
inactivated bluetongue serotype 1+8 vaccine
Sheep
bluetongue virus, SHEEP, Inactivated viral vaccines
Active immunisation of sheep from 1.5 months of age to prevent viraemia caused by bluetongue virus, serotypes 1 and 8.Onset of immunity: 21 days after completion of the primary vaccination scheme.Duration of immunity: 12 months.
Revision: 6
Authorised
2011-03-14
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: ZULVAC 1+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. Camprodón s/n "la Riba" 17813 Vall de Bianya Girona SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1+8 Ovis suspension for injection for sheep 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 2 ml of vaccine contains: ACTIVE SUBSTANCE: Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 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: Aluminium hydroxide 4 mg (Al 3+ ) Saponin 0.4 mg EXCIPIENT: Thiomersal 0.2 mg Off-white or pink liquid. 4. INDICATION(S) Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by Bluetongue virus, serotypes 1 and 8. *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity: 21 days after completion of the primary vaccination scheme. Duration of immunity: 12 months after completion of the primary vaccination scheme. 18 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS A transient increase in rectal temperature, not exceeding 1.2 °C, may occur commonly during the 24 hours following vaccination. Vaccination may be followed in most animals by a local reaction at the injection site. These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma possibly persisting for more than 48 days). The frequency of adverse reactions is defined using the following c पूरा दस्तावेज़ पढ़ें
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1+8 Ovis suspension for injection for sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml of vaccine contains: ACTIVE SUBSTANCES: Inactivated Bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 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. ADJUVANTS: Aluminium hydroxide 4 mg (Al 3+ ) Saponin 0.4 mg EXCIPIENTS: 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 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, serotypes 1 and 8. *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome). Onset of immunity: 21 days after completion of the primary vaccination scheme. Duration of immunity: 12 months after completion of the primary vaccination scheme. 4.3 CONTRAINDICATIONS None. 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 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 Vaccinate only 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) A transient increase in पूरा दस्तावेज़ पढ़ें