Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Toltrazuril
Krka, d.d., Novo mesto
QP51AJ01
Toltrazuril
50 milligram(s)/millilitre
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs, Sheep
toltrazuril
Coccidiostats
Authorised
2011-05-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tratol 50 mg/ml oral suspension for pigs, cattle and sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral suspension. Thick white suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (Piglet 3 – 5 days old). Cattle (calves on dairy farms). Sheep (lambs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: For the prevention of clinical signs of coccidiosis in neonatal piglets (3 - 5 days) on farms with a confirmed history of coccidiosis caused by_ Isospora suis_. 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 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 body weight. Do not use in veal or beef calves. For more details see sections 4.5, other precautions and section 5, environmental properties. 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Read the complete document