Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Newcastle disease virus VG/GA AVINEW strain live
Boehringer Ingelheim Vetmedica GmbH
QI01AD
Newcastle disease virus VG/GA AVINEW strain live
5.5-7.0 log 10 50% embryo infective dose/dose
Lyophilisate for suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Live viral vaccines
Authorised
2002-11-28
Health Products Regulatory Authority 07 December 2018 CRN008MP1 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Avinew. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: ACTIVE SUBSTANCE: Live Newcastle disease virus, VG/GA-AVINEW strain, at least 5.5 log 10 EID 50 EID50: Egg Infective Dose 50 per cent. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for suspension for oral and ocular administration and for spraying. Pale, homogeneous lyophilisate. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (broiler, future layer and future breeder pullets). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In broiler chickens from the age of one day: Active immunisation against Newcastle disease to reduce mortality and clinical signs associated with the disease. Onset of immunity: 14 days after primary vaccination. Duration of immunity induced by the vaccination scheme described under 4.9: protection until the age of 6 weeks. In future layer and future breeder pullets from the age of 4 weeks: Priming for active immunisation against egg drop caused by Newcastle disease before vaccination with an inactivated vaccine (strain Ulster 2C) prior to the beginning of lay.For duration of immunity of full schedule, see SPC of the inactivated booster vaccine. 4.3 CONTRAINDICATIONS None. Health Products Regulatory Authority 07 December 2018 CRN008MP1 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccine virus can spread to unvaccinated birds. Infection of unvaccinated birds with the vaccine virus from vaccinated birds does not induce any sign of disease. Moreover, a reversion to virulence trial carried out in the laboratory has shown that the vaccine virus does not acquire any pathogenic characteristic after 10 passages in chickens. Therefore, spread to unvaccinated birds, in the present state of knowledge, can be considered as safe. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS V Baca dokumen lengkapnya