Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OXYCLOZANIDE
Merial Animal Health Limited
QP52AG06
OXYCLOZANIDE
34 Mg/Ml
Oral Suspension
LM-Licensed Merchant
Bovine
Oxyclozanide
Anthelmintic
Authorised
2017-01-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Distocur 34 mg/ml Oral suspension for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Oxyclozanide ………………………………………… 34.0 mg EXCIPIENTS: Methyl parahydroxybenzoate (E218)…………………. 1.35 mg Propyl parahydroxybenzoate …………………………. 0.15 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension A whitish to beige suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections caused by the adult stage of_ Fasciola hepatica,_ sensitive to oxyclozanide. Elimination of gravid tapeworm segments (_Moniezia spp_.). 4.3 CONTRAINDICATIONS Do not use in grazing animals. The product is restricted to use on stabled animals (see section 4.5iii). Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 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_ _ _ _2_ _4_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _9_ _6_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES To date no resistance to oxyclozanide has been reported. Use of the product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance t Read the complete document