Land: Tyskland
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
Infectious Bronchitis Virus 0
Fort Dodge Animal Health
Suspension for injection
Chicken
2011-09-15
Revised: July 2013 AN: 00938/2012 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT POULVAC IBMM + ARK – Powder for nebuliser solution for Broiler chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION QUANTITATIVE COMPOSITION Active Substances: Global Amount per Dose Avian Infectious Bronchitis Virus (Strain Massachusetts1263 and Strain Arkansas 3168) 10 3.3 EID 50 * *EID 50 : Embryo infective dose 50% Excipients: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for nebuliser solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Broiler chickens 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of chickens to reduce the severity of upper respiratory tract infections caused by Massachusetts and 793/B/91-type strains of Avian Infectious Bronchitis virus. The onset of immunity is from three weeks post vaccination and lasts for six weeks post vaccination. Revised: July 2013 AN: 00938/2012 Page 2 of 5 Protection has also been demonstrated in the presence of maternally derived antibody. 4.3 CONTRAINDICATIONS Do not use in unhealthy birds. Do not re-vaccinate birds. Do not use during the laying period or in birds intended for laying or breeding. Spray vaccination should not be used if an intercurrent infection is suspected. 4.4 SPECIAL WARNINGS Infectious Bronchitis virus strains Massachusetts and Arkansas may spread to in contact birds. The duration of spreading of the vaccine virus is for up to 30 days following vaccination. It is recommended that all Læs hele dokumentet