Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
FLUBENDAZOLE
Janssen Cilag Ltd.
QP52AC12
100 mg/g
Oral Emulsion
Endoparasiticide
Fowl - Chicken
2007-08-31
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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/11/2011_ _CRN 7010612_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Chickens: In chickens, optimal results can only be achieved if strict rules of hygiene are respected in the maintenance of the cages. Pigs: None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Development disorders of the feathers can not be fully excluded after the administration of flubendazole. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Direct contact with product Prečítajte si celý dokument