Negara: Hungaria
Bahasa: Inggris
Sumber: HMA (Heads of Medicines Agencies)
flubendazole 100 mg/ml
Krka d.d.
QP52C
Oral suspension
AGENTS AGAINST NEMATODOSIS
Chicken, Pigs
2012-12-21
1.3.1 Flubendazole SPC, Labeling and Package Leaflet FR SmPCPIL034186/6 12.11.2012 – Updated: 02.01.2013 Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1.3.1 Flubendazole SPC, Labeling and Package Leaflet FR SmPCPIL034186/6 12.11.2012 – Updated: 02.01.2013 Page 2 of 21 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FLIMABEND 100 mg/g suspension for use in drinking water for chickens and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g of suspension for use in drinking water contains: ACTIVE SUBSTANCE: Flubendazole 100 mg EXCIPIENTS: Methyl parahydroxybenzoate (E218) 2.0 mg Sodium benzoate (E211) 5.0 mg Disodium edetate 0.1 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for use in drinking water. White to brownish white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (piglets, pigs for fattening, pregnant sows) and chickens (layer hens, chickens for reproduction , pullets, broilers). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In hens/chickens: - Treatment of helminthiasis caused by _Ascaridia galli_ (adult stages), _Heterakis gallinarum _ (adult stages), _Capillaria _spp. (adult stages). In pigs: - Treatment of helminthiasis caused by _Ascaris suum_ (adult and intestinal larval stages) in piglets, fattening pigs and pregnant sows. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL W Baca dokumen lengkapnya