País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
FLUBENDAZOLE
Janssen Cilag Ltd.
QP52AC12
5 %w/w
Premix for Med.Feedstuffs
Endoparasiticide
Fowl - Chicken
1989-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flubenol 5 % w/w Premix for Medicated Feeding Stuff 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Premix for medicated feeding stuff. White powder. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pig and Poultry. 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 and respiratory tract: In pigs: _Ascaris suum, _(large roundworm) including migrating larvae, _Hyostrongylus rubidus, _(red stomach worm), _Oesophagostomum dentatum _(nodular worm). _Trichuris suis _(whipworm), _Strongyloides ransomi _(adult) and _Metastrongylus apri _(lungworm). In poultry: _Syngamus trachea, Ascaridia galli, Heterakis gallinarum, Capillaria gallinarum, Amidostomum anseris,_ _Trichostrongylus tenuis._ Flubendazole is ovicidal. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. Each g contains: Active substance Flubendazole 50 mg Excipients Titanium Dioxide (E171) 20 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/02/2011_ _CRN 7010260_ _page number: 1_ 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. Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Llegiu el document complet