Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
avian infectious bursal disease virus 3 EID50
Lohmann Animal Health & Co.
QI01AD09
Powder for oral solution
Avian infectious bursal disease virus vaccine (Gumboro disease)
Chicken Young
2011-05-06
PACKAGE LEAFLET DIRECTIONS FOR USE AviPro ® PRECISE 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-Straße 4, D-27472 Cuxhaven, Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT AviPro ® PRECISE 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) ACTIVE SUBSTANCE: 1 dose contains min. 10³ EID 50 and max 10 4,5 EID 50 * live IBD (Infectious Bursal Disease)-Virus, strain LC 75. Host system: embryonated SPF-hen’s eggs. * EID 50 = 50% egg- infectious dose: the virus titre that is required in order to cause an infection in 50% of the embryos EXCIPIENTS: Di-sodium hydrogen phosphate, Potassium di-hydrogen phosphate, Lactose monohydrate, Skimmed milk powder 4. INDICATION(S) For active immunisation of susceptible chickens against Infectious Bursal Disease (IBD/Gumboro). The vaccine reduces clinical signs of IBD and severe bursal lesions. 5. CONTRAINDICATIONS Do not vaccinate unhealthy birds. 6. ADVERSE REACTIONS On day 7 post vaccination moderate to severe generalised lymphocyte depletion is seen in the majority of birds. Lymphocyte repopulation occurs after day 7 post vaccination and by day 28 post vaccination only mild necrosis remains in some birds. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon or pharmacist. 7. TARGET SPECIES Chickens (from 7 days old) 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION One dose (min. 10³ EID 50 ) should be administered per animal by drinking Read the complete document
1 _[Version 7, 08/2005] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AviPro ® PRECISE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 1 dose contains min. 10³ and max 10 4,5 EID 50 * live IBD (Infectious Bursal Disease)-Virus, strain LC 75. Host system: embryonated SPF-eggs * EID 50 = 50% egg-infectious dose: the virus titre required to cause infection in 50% of the inoculated embryos EXCIPIENT(S): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for suspension Appearance : rose to red brown pellet 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 susceptible chickens against Infectious Bursal Disease (IBD/Gumboro). The vaccine reduces clinical signs of IBD and severe bursal lesions. Onset of immunity: 14 days Duration of immunity demonstrated by challenge 28 days, antibodies may last up to 15 weeks. 4.3 CONTRAINDICATIONS Do not vaccinate unhealthy birds 4.4 SPECIAL WARNINGSNONE. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The vaccine may spread to unvaccinated chickens, since it is excreted via the faeces for at least 9 days. Avoid spreading to laying hens. To reduce infection pressure before the onset of immunity, litter should be removed and chicken housing cleaned between rearing cycles. Ensure that the drinking water is cold, clean, and free from detergents and disinfectants to ensure the viability Read the complete document