البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: VMD (Veterinary Medicines Directorate)
Infectious bursal disease virus
Lohmann Animal Health GmbH
QI01AD09
Infectious bursal disease virus
Oral lyophilisate
POM-V - Prescription Only Medicine – Veterinarian
Chickens
Live Viral Vaccine
Authorized
2008-05-29
Revised: March 2015 AN: 00880/2014 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.) Lyophilisate for suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 1 dose contains 10 1.5 - 10 3.0 EID 50 * live intermediate plus IBD (Infectious Bursal Disease) virus, strain V217. *EID 50 = 50 % embryo infective dose: the virus titre required to infect 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: rose to red brown lyophilisate 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (from 7 days old) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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 As described under 4.6. Page 1 of 5 Revised: March 2015 AN: 00880/2014 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The vaccine strain may spread to unvaccinated chickens, since it is excreted via the faeces for at least 9 days. Avoid spreading to laying hens, birds approaching lay and young birds below 7 days of age. The vaccine should not be used in birds without maternally derived antibodies. Spread of the vaccine strain to such birds should be prevented. This vaccine induces serious and prolonged lesions in the bursa of Fabricius. It should therefore only be used to compete with very virulent (vv) IBD virus infection or to induce immunity in the face of still high maternally derived antibody (MDA) levels (b اقرأ الوثيقة كاملة