국가: 영국
언어: 영어
출처: VMD (Veterinary Medicines Directorate)
Newcastle disease virus
Zoetis UK Limited
QI01AD06
Newcastle disease virus
Eye drops, solution
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Chickens
Live Viral Vaccine
Authorized
1995-05-28
Revised: August 2020 AN: 00620/2020 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac NDW 2. QUALITATIVE AND QUANTITATIVE COMPOSITION QUALITATIVE COMPOSITION Live Newcastle Disease Virus, strain Ulster 2C QUANTITATIVE COMPOSITION Active Substances: Per dose Live Newcastle Disease Virus; strain Ulster 2C 10 5.7 - 10 6.6 EID 50 Excipients: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for reconstitution for eye drops solution, nasal drops solution, oral solution or nebulisation solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens from one day of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of chickens to reduce mortality and clinical signs due to infection with Newcastle Disease. The onset of immunity is from three weeks post vaccination. 4.3 CONTRAINDICATIONS Do not vaccinate unhealthy birds. 4.4 SPECIAL WARNINGS Maternally derived antibody (MDA) can interfere with the development of active immunity. Where it is likely that recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high Revised: August 2020 AN: 00620/2020 Page 2 of 6 level of MDA, the timing of the vaccination programme should be planned accordingly. 4.5 SPECIAL PRECAUTIONS FOR USE i Special precautions for use in animals None. ii Special precautions to be taken by the person administering the veterinary medicinal product to animals Live Newcastle disease virus may cause conjunctivitis in man. When using the vaccine, operators must protect eyes and nose by wearing goggles and a full-face mask, especially with spray method. An appropriate helmet with filtered air circulation may be used instead of goggles and a mask. On completion, operators should wash and disinfect hands in an approved disinfectant. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None 4.7 USE DURING PREGNANCY, LACTATION OR LAY Do not use in birds in lay (breeding birds and/or within 4 weeks 전체 문서 읽기