البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
FLUBENDAZOLE
Elanco Animal Health, Eli Lilly and Company Limited
QP52AC12
FLUBENDAZOLE
100 mg/g
Oral Emulsion
POM: Prescription Only Medicine as defined in relevant national legislation
Fowl - Chicken, Porcine
flubendazole
Endoparasiticide
Authorised
2012-09-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Solubenol 100 mg/g oral emulsion for pigs and chickens. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral emulsion. White homogeneous viscous fluid. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (piglets, pigs for fattening and pregnant sows) and chickens (layer hens, chickens for reproduction and pullets). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In chickens: Treatment of helminthiasis caused by: -_ Ascaridia galli_ (mature stages) -_ Heterakis gallinarum_ (mature stages) -_ Capillaria spp.(mature_ stages) In pigs: Treatment of infection by mature stages and intestinal larval stages of_ Ascaris suum_ in piglets, pigs for fattening and pregnant sows. 4.3 CONTRAINDICATIONS Do not use in the case of hypersensitivity to the active substance or to any of the excipients. Each gram contains: ACTIVE SUBSTANCE Flubendazole 100.0 mg EXCIPIENTS Propyl parahydroxybenzoate (E216) 4.0 mg Methyl parahydroxybenzoate (E218) 4.0 mg Butylhydroxytoluene (E321) 0.2 mg Propylene glycol (E1520) 50.0 mg For a 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _9_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _0_ _6_ _6_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In chickens, optimal results can only be achieved if strict rules of hygiene are respected in the maintenance of the اقرأ الوثيقة كاملة