Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Live newcastle disease virus (VG/GA) component
Boehringer Ingelheim Vetmedica GmbH
QI01AD06
Live newcastle disease virus (VG/GA) component
.
Effervescent tablet
POM: Prescription Only Medicine as defined in relevant national legislation
newcastle disease virus / paramyxovirus
Authorised
2015-11-13
Health Products Regulatory Authority 09 February 2022 CRN00CHGZ Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT AVINEW NEO effervescent tablet for chickens and turkeys 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose contains: ACTIVE SUBSTANCE: Live Newcastle disease virus, VG/GA-AVINEW strain 5.5 – 7.0 log 10 EID 50 (*) (*) EID 50 : Egg Infective Dose 50 per cent. EXCIPIENTS: Brilliant blue FCF (E 133) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet. Blue mottled, round tablet. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (broiler, future layer and future breeder pullets). Turkeys 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 section 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 the leaflet of the inactivated booster vaccine. In turkeys from the age of one day: - Active immunisation against Newcastle disease to reduce mortality and clinical signs associated with the disease. Onset of immunity: 21 days after primary vaccination. Duration of immunity: 7 weeks after a single administration. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy birds only. Health Products Regulatory Authority 09 February 2022 CRN00CHGZ Page 2 of 4 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccine virus can spread to unvaccinated birds. In turkeys, this spread has been shown to be less than 21 days aft Pročitajte cijeli dokument