Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
TOLTRAZURIL
Bayer Limited
QP51AJ01
TOLTRAZURIL
50 Mg/Ml
Oral Suspension
POM
Bovine, Porcine, Sheep
Toltrazuril
Coccidiostats
Authorised
2016-11-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox Multi 50 mg/ml oral suspension for Cattle, Pigs and Sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral suspension White or yellowish suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (calves on dairy farms), Pigs (Piglets, 3 -5 days old), Sheep (lambs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: For the prevention of clinical signs of coccidiosis and reduction of coccidia shedding in housed calves replacing cows producing milk for human consumption (dairy cows) on farms with a confirmed history of coccidiosis caused by _Eimeria bovis _or _Eimeria zuernii_. Pigs: For the prevention of clinical signs of coccidiosis in neonatal piglets (3 -5 days old) on farms with a confirmed history of coccidiosis caused by _Isospora suis_. Sheep: For the prevention of clinical signs of coccidiosis and reduction of coccidia shedding in lambs on farms with a confirmed history of coccidiosis caused by _Eimeria crandallis _and _Eimeria ovinoidalis_. 1 ml contains: ACTIVE SUBSTANCE: Toltrazuril 50 mg EXCIPIENTS: Sodium benzoate (E211) 2.1 mg Sodium propionate (E281) 2.1 mg For the full list of excipients, see section 6.1. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 25/11/2016_ _CRN 7022575_ _page number: 1_ 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substance or any of the excipients. Cattle For environmental reasons: Do not use in calves weighing more than 80 kg bodyweight. Do not use in fattening units such as veal or beef calves. For more details see sections 4.5, other precautions and section 5.3, environmental propertie Lugege kogu dokumenti