Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
FLUBENDAZOLE
Janssen Cilag Ltd.
QP52AC12
5 %w/w
Oral Powder
Endoparasiticide
Porcine
2008-01-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flubenol 5% w/w Oral Powder for Pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral Powder White powder 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Flubendazole is a broad spectrum anthelmintic, effective against mature and immature stages of the following nematodes of the gastro-intestinal tract: _Ascaris suum_, (large roundworm) including migrating larvae, _Hyostrongylus rubidus, _(red stomach worm), _Oesophagostomum dentatum _(nodular worm), _Trichuris suis _(whipworm), _Strongyloides ransomi _(threadworm) (adult). Flubendazole is ovicidal. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: • Too frequent and repeated use of anthelmintics from the same class, over an extended period of time. • Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any). Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). 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. ACTIVE INGREDIENT(S) MG/G Flubendazole 50 EXCIPIENTS Titanium dioxide (E171) 20 For a full list of excipients, see section 6.1 IRISH MEDICINES BOARD _______________________________ Прочитајте комплетан документ