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
Pigs
toltrazuril
Coccidiostats
Authorised
2010-09-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Toltarox 50 mg/ml oral suspension for pigs 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 Pigs (Piglet 3 – 5 days old). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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_. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 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. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals None known. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash any splashes from skin or eyes immediately with water. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _7_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _5_ _4_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None known. 4. Read the complete document