מדינה: יוון
שפה: אנגלית
מקור: HMA (Heads of Medicines Agencies)
Infectious Bursal Disease (Gumboro) Virus 10 EID50/dose
Laboratorios Hipra S. A.
QI01AD09
Oral suspension
Avian infectious bursal disease virus vaccine (Gumboro disease)
Chicken Broilers
2011-05-20
Revised: May 2011 AN: 00040/2011 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. HIPRAGUMBORO-G97. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION. Composition per dose: ACTIVE SUBSTANCE: - Live Infectious Bursal Disease Virus, strain GM97:10 2 - 10 3 EID 50 (embryo infective dose 50%). EXCIPIENTS AND ADJUVANTS WHERE KNOWLEDGE OF THIS IS ESSENTIAL FOR THE SAFE ADMINISTRATION OF THE MEDICINAL PRODUCT: None. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM. Lyophilisate for oral suspension. Appearance: reddish tablet. 4. CLINICAL PARTICULARS. 4.1. TARGET SPECIES. Species: Chickens. Category: Broilers. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES. For active immunisation of broilers with insignificant levels of maternally derived antibodies (ELISA of 500 or below) to reduce mortality, clinical signs and bursal lesions of Gumboro disease. Such birds can be vaccinated from one day of age. The onset of immunity is 14 days post vaccination and the duration 43 days post vaccination. 4.3. CONTRAINDICATIONS. Do not vaccinate sick birds. Do not use in infected flocks showing clinical signs. Revised: May 2011 AN: 00040/2011 Page 2 of 7 Since no studies to demonstrate the safety of this vaccine when it is administered to layers and breeders have been carried out, its use is not recommended for these categories of the target species (see section 4.7). 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES. Use only in flocks with low levels of maternal antibod קרא את המסמך השלם