Država: Velika Britanija
Jezik: angleščina
Source: VMD (Veterinary Medicines Directorate)
Infectious bronchitis virus, Newcastle disease virus
MSD Animal Health UK Limited
QI01AD
Infectious bronchitis virus, Newcastle disease virus
Lyophilisate for oculonasal suspension/use in drinking water
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Chickens
Live Viral Vaccine
Authorized
1997-02-20
Revised: September 2023 AN: 02901/2022 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Ma5 + Clone 30 lyophilisate for oculonasal suspension/use in drinking water for chickens. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE PER DOSE Live Infectious Bronchitis virus strain Ma5 ≥ 10 3.0 EID 50* Live Newcastle Disease virus Clone 30 ≥ 10 6.0 ELD 50** * egg infective dose 50% ** embryo lethal dose 50% EXCIPIENTS For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for oculonasal suspension / use in drinking water. Vials: white/off-white coloured pellet. Cups: white/off white, predominantly spherical shaped. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens. 4.2 INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES For the active immunisation of fowls against Massachusetts type or serologically related types of Infectious Bronchitis and against Newcastle Disease. Duration of immunity: 6 weeks. 4.3 CONTRAINDICATIONS Only healthy birds should be vaccinated. Sick or weak birds will not develop adequate immunity following vaccination. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The vaccine viruses spread rapidly to susceptible chicks. Revised: September 2023 AN: 02901/2022 Page 2 of 7 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immuno-competence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress. Under certain conditions, for example extreme disease pressure and variant challenge, fully immune birds may succumb to disease. Therefore, successful vaccination may not be synonymous with full protection in the face of a disease challenge. Special precautions to be taken by the person administer Preberite celoten dokument