País: Reino Unido
Língua: inglês
Origem: VMD (Veterinary Medicines Directorate)
Infectious bronchitis virus
MSD Animal Health UK Limited
QI01AD07
Infectious bronchitis virus
Lyophilisate for suspension
POM-V - Prescription Only Medicine – Veterinarian
Chickens
Live Viral Vaccine
Authorized
2014-09-04
Revised: February 2021 AN: 01346/2020 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension for chickens Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: ACTIVE SUBSTANCE: Live attenuated avian infectious bronchitis virus, strain D388: 10 4.0 – 10 5.5 EID 50 1 1 50% egg infective dose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for oculonasal suspension Lyophilisate for oculonasal suspension. Lyophilisate: Off white, predominantly sphere shaped. Solvent (Solvent Oculo/Nasal): blue-coloured solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus (IBV). Onset of immunity: 3 weeks. Duration of immunity: 8 weeks. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Revised: February 2021 AN: 01346/2020 Page 2 of 6 The vaccine virus is capable of spreading to in contact birds for a minimum of 20 days after vaccination and appropriate care should be taken to separate vaccinated from non-vaccinated chickens. Precautionary measures should be taken to prevent spreading to wildlife. The premises must be cleaned and disinfected after each production round. This vaccine should only be used after it has been established that the QX-like IBV variant strain is epidemiologically relevant. It is important to avoid introduction of the IB D388 vaccine virus into premises in which the wild type strain is not present. The IB D388 vaccine should only be applied in hatcheries to chickens from 1 day of age or older if adequate controls are in place to avoid the spread of the vaccine virus to bir Leia o documento completo