Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Triclabendazole
Chanelle Animal Health Ltd.
QP52AC01
Triclabendazole
5 percent weight/volume
Oral suspension
LM: Licensed Merchant as defined in relevant national legislation
Sheep
triclabendazole
Endoparasiticide
Authorised
2000-10-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tribex 5% Oral Suspension for Sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each ml contains 50mg Triclabendazole EXCIPIENT(S): Each ml contains: 2.0mg Methyl Parahydroxybenzoate (E2I8) 0.2mg Propyl Parahydroxybenzoate (E216) 17.5 microgram Brilliant Blue (E133). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral suspension An aqueous blue-coloured suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the treatment of acute, sub-acute and chronic fasciolosis in sheep caused by early immature, immature and adult stages of liverfluke_ (Fasciola hepatica)_ susceptible to triclabendazole. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active ingredient 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 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_ _8_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _4_ _1_ _5_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Only use for liver fluke strains susceptible to triclabendazole. Frequent and repeated use may lead to the development of resistance. Care must be taken not to damage the mouth or pharyngeal region when dosing. Clean drenching equipment before and after use. Use unaltered product from the original c Lestu allt skjalið