Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Toltrazuril
J. & M. Veterinary Services Ltd.
QP51AJ01
Toltrazuril
50 milligram(s)/millilitre
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Sheep
toltrazuril
Coccidiostats
Authorised
2013-09-20
Health Products Regulatory Authority 07 October 2019 CRN000Y93 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bovicox 50 mg/ml oral suspension for cattle and sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of oral suspension 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 3 PHARMACEUTICAL FORM Oral suspension. Thick white suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (calves on dairy farms). Sheep (lambs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: For the prevention of clinical signs of coccidiosis and reduction of oocyst 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_. Sheep: For the prevention of clinical signs of coccidiosis and reduction of oocyst shedding in lambs on farms with a confirmed history of coccidiosis caused by _Eimeria crandallis_ and _Eimeria ovinoidalis_. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Cattle: For environmental reasons: Do not use in calves weighing more than 80 kg body weight. Do not use in fattening units such as veal or beef calves. For more details see sections 4.5, other precautions and section 5, environmental properties. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES As with any antiparasiticide frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance. It is recommended to treat all calves or lambs in a pen. Health Products Regulatory Authority 07 October 2019 CRN000Y93 Page 2 of 4 Hygienic measures may reduce the risk of coccidiosis. It is therefore, recommended to improve concomitantly the hygienic conditions in the concerned facility, particularly dryness and cleanliness. To obtain maximum benefit, animals should b Read the complete document