Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Eimeria acervulina, strain 003; Eimeria maxima, strain 013; Eimeria mitis, strain 006; Eimeria praecox, strain 007; Eimeria tenella, strain 004
Laboratorios Hipra S.A.
QI01AN01
Eimeria acervulina, strain 003; Eimeria maxima, strain 013; Eimeria mitis, strain 006; Eimeria praecox, strain 007; Eimeria tenella, strain 004
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Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens
coccidia
Immunological - Live Vaccine
Authorised
2007-10-31
Health Products Regulatory Authority 15 January 2022 CRN00CRJG Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Hipracox Broilers Oral suspension for chicken 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per dose (0.007 ml) of HIPRACOX BROILERS: 1. ACTIVE SUBSTANCES - Each 0.007 ml dose of vaccine contains the following numbers of sporulated oocysts derived from five precocious attenuated lines of coccidia: _Eimeria acervulina, _strain 003................... 300 – 390 * _Eimeria maxima, _strain 013....................... 200 – 260 * _Eimeria mitis, _strain 006.............................300 – 390 * _Eimeria praecox, _strain 007....................... 300 – 390 * _Eimeria tenella, _strain 004..........................250 – 325 * * According to in vitro procedures of the manufacturer at the time of blending and at release. 2. EXCIPIENTS AND ADJUVANTS Diluent for coarse spray only: UNIFLOCK (0.02ml /dose) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Slightly brownish to white turbid oral suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chicken (broilers). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of broiler chicks to reduce intestinal colonisation, intestinal lesions and clinical signs of Coccidiosis caused by _Eimeria acervulina_, _Eimeria maxima,Eimeria mitis, Eimeria praecox_ and _Eimeria tenella_. The onset of immunity is 14 days post-vaccination and the duration of protection is maintained at least for 42 days post-vaccination. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The vaccine will not protect species other than chickens against Coccidiosis and is only effective against the _Eimeria_ species indicated. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Health Products Regulatory Authority 15 January 2022 CRN00CRJG Page 2 of 5 Chickens must be strictly floor-reared on litter. Do not vaccinate unhealthy or stressed birds. For the drin Прочитать полный документ