Negara: Portugal
Bahasa: Inggris
Sumber: HMA (Heads of Medicines Agencies)
avian infectious bursal disease virus 1.5 ELD50
Lohmann Animal Health & Co.
QI01AD09
Oral lyophilisate
Avian infectious bursal disease virus vaccine (Gumboro disease)
Chicken Young
2011-05-06
1 PACKAGE LEAFLET DIRECTIONS FOR USE AviPro IBD Xtreme (alternative: FR: AviPro IBD X, ES: AviPro IBDX, HU: AviPro IBD X vakcina A.U.V.) Lyophilisate for suspension 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Lohmann Animal Health GmbH, Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT AviPro IBD XTREME (alternative: FR: AviPro IBD X, ES: AviPro IBDX, HU: AviPro IBD X vakcina A.U.V.) 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 dose contains: ACTIVE SUBSTANCE: Live intermediate plus IBD (Infectious bursal disease)-Virus, strain V217, 10 1.5 - 10 3.0 ELD 50 /bird dose* *ELD 50 = 50 % egg-lethal dose: the virus titre required to cause death in 50 % of the inoculated embryos Host system: embryonated SPF-hen´s eggs Appearance: off-white 4. INDICATION(S) For active immunisation of chickens with maternally derived antibodies (breakthrough titre : 636) to reduce clinical disease, weight loss and acute lesions of the bursa of Fabricius associated with infection caused by very virulent Avian Infectious Bursal disease (IBD) viruses. ATC Vet code: QI01AD09. Onset of protection: 2 weeks. Duration of immunity: 12 weeks based on serology 5. CONTRAINDICATIONS Do not use in unhealthy birds. 6. ADVERSE REACTIONS On day 7 post vaccination severe lymphocyte depletion is seen in the bursae of the majority of birds. Lymphocyte repopulation commences after day 7 post vaccination but by day 28 post vaccination notable lesions still remain in the bursae of the birds. The strain causes an a Baca dokumen lengkapnya
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AviPro IBD Xtreme (alternative FR: AviPro IBD X, ES: AviPro IBDX, HU: AviPro IBD X vakcina A.U.V.) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 1 dose contains 10 1.5 - 10 3.0 ELD 50 * live intermediate plus IBD (Infectious Bursal Disease)-Virus, strain V217. *ELD 50 = 50 % egg-lethal dose: the virus titre required to cause death in 50 % of the inoculated embryos Host system: embryonated SPF-hen´s eggs EXCIPIENT(S): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for suspension. Appearance: off-white 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (from 7 days old) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIE S For active immunisation of chickens with maternally derived antibodies (breakthrough titre: 636) to reduce clinical disease, weight loss and acute lesions of the bursa of Fabricius associated with infection caused by very virulent Avian Infectious Bursal disease (IBD) viruses. Onset of protection: 2 weeks. Duration of immunity: 12 weeks based on serology 4.3 CONTRAINDICATIONS Do not use in unhealthy birds. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES On day 7 post vaccination severe lymphocyte depletion is seen in the bursae of the majority of birds. Lymphocyte repopulation commences after day 7 post vaccination but by day 28 post vaccination notable lesions still remain in the bursae of the birds. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS 2 The vaccine may spread to unvaccinated chickens, since it is excreted Baca dokumen lengkapnya