Land: Grækenland
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
flubendazole 100 mg/g
JANSSEN Animal Health BVBA
QP52AC12
Oral emulsion
flubendazole
Chicken, Pigs
2011-11-15
1 Dokument1 APPENDIX I SUMMARY OF PRODUCT CHARACTERISTICS 2 Dokument1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Solubenol 100 mg/g oral emulsion for pigs and chickens. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBS TANCE : 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. 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. 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. 3 Dokument1 Pigs: None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Development disorders of the feathers can not Læs hele dokumentet