מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Avian infectious bursal disease virus, live
Laboratorios Hipra S.A.
QI01AD09
Avian infectious bursal disease virus, live
.
Lyophilisate for use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
avian infectious bursal disease virus (gumboro disease)
Authorised
2018-12-07
1. NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRAGUMBORO CW Lyophilisate for use in drinking water. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH DOSE CONTAINS: ACTIVE SUBSTANCE: Live attenuated infectious bursal disease virus, strain CH/80…………….. 10 3.5 – 10 5.5 CCID 50 * *cell culture infective dose 50 %. EXCIPIENT: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Povidone Potassium chloride Sodium chloride Sucrose Monosodium glutamate Water for injections Lyophilisate: Brown freeze-dried lyophilisate. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Chickens. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For active immunisation of chicken (broilers) with maternally derived antibodies (MDA ELISA breakthrough titre of 115) to prevent clinical signs and to reduce loss of weight and bursal damage caused by Gumboro Disease. Onset of immunity: 14 days post vaccination. Duration of immunity: 30 days post vaccination. 3.3 CONTRAINDICATIONS None. 3.4 SPECIAL WARNINGS Vaccinate healthy animals only. The optimal day of vaccination is calculated according to the Deventer’s formula, applying an ELISA titre of 115 as the MDA breakthrough titre. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: Vaccinated chickens may excrete the vaccine strain up to 10 days following vaccination. During this time, the vaccine strain can spread to unvaccinated chicken. Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible species. The vaccine should not be used in birds without maternally derived antibodies (MDA). Special precautions to be taken by the person administering the veterinary medicinal product to animals: Personal protective equipment consisting of impervious gloves should be worn when handling the veterinary medicinal product. Wash and disinfect hands and equipment after use. In case of accidental ingestion, contact with the eyes, or spillage o קרא את המסמך השלם