Ország: Németország
Nyelv: angol
Forrás: HMA (Heads of Medicines Agencies)
Infectiuos Bursitis Virus 0
Lohmann Animal Health & Co.
QI01AD
Oral lyophilisate
Chicken
2011-05-06
1 _________________________________________________________________________________________________ A m e n d e d P a c k a g e I n f o r m a t i o n L e a f l e t f o r M R ( J u l y 2 0 0 9 ) C L E A R E D B. PACKAGE LEAFLET 2 _________________________________________________________________________________________________ A m e n d e d P a c k a g e I n f o r m a t i o n L e a f l e t f o r M R ( J u l y 2 0 0 9 ) C L E A R E D PACKAGE LEAFLET AVIPRO GUMBORO VAC Lyophilisate for suspension for chicken 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 2. NAME OF THE VETERINARY MEDICINAL PRODUCT AviPro GUMBORO VAC Lyophilisate for suspension for chicken 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) ACTIVE SUBSTANCE: 1 dose contains min. 10 2.0 EID 50 and max. 10 3.7 EID 50 * live IBD (Infectious Bursal Disease)-Virus, strain Cu-1M. * EID 50 = 50% egg-infectious dose: the virus titre required to cause an infection in 50% of the inoculated embryos. Host system: embryonated SPF-hen´s eggs Appearance: Off-white pellet 4. INDICATION(S) For active immunisation of healthy susceptible chicken against Infectious Bursal Disease (IBD/Gumboro) Onset of immunity: 3 weeks Duration of immunity after 2nd vaccination: 14 weeks 5. CONTRAINDICATIONS Do not vaccinate unhealthy birds 6. ADVERSE REACTIONS The vaccine may cause transient l Olvassa el a teljes dokumentumot
1 _________________________________________________________________________________________________ A m e n d e d S P C f o r M R ( J u l y 2 0 0 9 ) C L E A R E D ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 _________________________________________________________________________________________________ A m e n d e d S P C f o r M R ( J u l y 2 0 0 9 ) C L E A R E D 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AviPro GUMBORO VAC Lyophilisate for suspension for chicken 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 1 dose contains min 10 2.0 EID 50 and max 10 3.7 EID 50 * live IBD (Infectious Bursal Disease)-Virus, strain Cu-1M. * EID 50 = 50% egg-infectious dose: the virus titre required to cause an infection in 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: Off-white pellet 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens 4.2 INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES For active immunisation of healthy susceptible chicken against Infectious Bursal Disease (IBD/Gumboro). Onset of immunity: 3 weeks Duration of immunity after 2nd vaccination: 14 weeks 4.3 CONTRAINDICATIONS Do not vaccinate unhealthy birds 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinated birds may excrete the vaccine strain via the faeces for at least 9 days following vaccination. During this time, the contact Olvassa el a teljes dokumentumot