Ország: Egyesült Királyság
Nyelv: angol
Forrás: VMD (Veterinary Medicines Directorate)
Infectious bronchitis virus
Boehringer Ingelheim Animal Health UK Ltd
QI01AD07
Infectious bronchitis virus
Effervescent tablet
POM-V - Prescription Only Medicine – Veterinarian
Chickens
Live Viral Vaccine
Authorized
2017-01-30
Revised: March 2023 AN: 00871/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HATCHPAK IB H120 NEO effervescent tablet for oculonasal suspension for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH DOSE CONTAINS: ACTIVE SUBSTANCE: Live Infectious Bronchitis virus, H120 strain .............................3.7 to 4.7 log 10 EID 50 (*) (*) EID 50 : 50 per cent egg infective dose EXCIPIENT(S): For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Effervescent tablet for nebuliser suspension. Orange mottled, round tablet. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES One-day-old chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In one-day-old chickens: active immunisation against Infectious Bronchitis in order to reduce infection with Massachusetts serotype of Infectious Bronchitis virus. Onset of immunity: 21 days. Duration of immunity: 6 weeks after a single administration. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Revised: March 2023 AN: 00871/2022 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccine viruses can spread to unvaccinated birds. Infection of unvaccinated chickens with the vaccine virus from vaccinated birds does not cause any signs of disease. Reversion to virulence trials carried out in the laboratory have shown that the vaccine viruses do not acquire any pathogenic characteristics after at least 5 passages in chickens. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wear respiratory and eye protection during spraying. Wash and disinfect hands and equipment after vaccinating. Special precautions for the protection of the environment: Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) One-day-old chickens: Very common (> 1 animal / 10 animals treated): Bronchial rales* *not associated with respiratory distress or any general sign, are very common b Olvassa el a teljes dokumentumot