País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Flubendazole
Dechra Regulatory B.V.
QP52AC12
Flubendazole
Suspension for use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
flubendazole
2023-05-05
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fluboral 200 mg/ml, suspension for use in drinking water for pigs and chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Flubendazole 200.0 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t _ _ Methyl parahydroxybenzoate (E218) 2.7 mg Propyl parahydroxybenzoate 0.75 mg Propylene glycol Poloxamer 407 Sodium chloride Simethicone (as an emulsion) Purified water White to off-white suspension 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Pigs and chickens. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Chickens: Treatment of helminthiasis caused by: - _Ascaridia galli_ (adult stages) - _Heterakis gallinarum_ (adult stages) - _Capillaria_ spp. (adult stages) Pigs: Treatment of helminthiasis caused by _Ascaris suum_ (adult and L4 intestinal stages) 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infection based on its epidemiological features, for each herd/flock. The use of this product should take into account local information about susceptibility of the target parasites, where available. 2 It is recommended to further investigate cases of suspected resistance, using an appropriate diagnostic method (e.g. Faecal Egg Count Reduction Test (FECRT)). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used. Optimal results can only be achieved if strict rules of hygiene are applied. Con Leer el documento completo