Kraj: Holandia
Język: angielski
Źródło: HMA (Heads of Medicines Agencies)
Live Infectious Bursal Disease Virus, strain CH/80 3.5 log10 CCID50, Live Infectious Bursal Disease Virus, strain CH/80 5.5 log10 CCID50
Laboratorios Hipra S. A.
QI01AD09
Oral lyophilisate
avian infectious bursal disease virus (gumboro disease)
Chicken Broilers
2011-06-14
_ [Version 7.3, 04/2010] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRAGUMBORO CW Lyophilisate for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION COMPOSITION PER DOSE: ACTIVE SUBSTANCE: Live Infectious Bursal Disease Virus, strain CH/80…………….. 10 3.5 – 10 5.5 CCID 50 (cell culture infective dose 50%). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for oral suspension. Appearance: brown freeze-dried tablet. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens: broilers. 4.2 INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES For active immunisation of 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. The onset of immunity is 14 days and the duration of 30 days post vaccination. 4.3 CONTRAINDICATIONS Do not use in sick birds. 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. 4.4 SPECIAL WARNINGSThe optimal day of vaccination is calculated according to the Deventer’s formula, using 115 as the ELISA breakthrough titre value. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS - The vaccine strain is excreted up to a maximum of 10 days; thus, during this time, it may spread to unvaccinated chickens. - Appropriate veterinary and Przeczytaj cały dokument
_ [Version 7.3, 04/2010] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRAGUMBORO CW Lyophilisate for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION COMPOSITION PER DOSE: ACTIVE SUBSTANCE: Live Infectious Bursal Disease Virus, strain CH/80…………….. 10 3.5 – 10 5.5 CCID 50 (cell culture infective dose 50%). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for oral suspension. Appearance: brown freeze-dried tablet. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens: broilers. 4.2 INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES For active immunisation of 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. The onset of immunity is 14 days and the duration of 30 days post vaccination. 4.3 CONTRAINDICATIONS Do not use in sick birds. 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. 4.4 SPECIAL WARNINGSThe optimal day of vaccination is calculated according to the Deventer’s formula, using 115 as the ELISA breakthrough titre value. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS - The vaccine strain is excreted up to a maximum of 10 days; thus, during this time, it may spread to unvaccinated chickens. - Appropriate veterinary and Przeczytaj cały dokument