Click here to Download Data Sheet Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Curafluke 10% w/v Oral Drench 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substances Fenbendazole 100 mg Rafoxanide 100 mg Excipients Propyl Parahydroxybenzoate 0.1 mg Methyl Parahydroxybenzoate 1 mg Quinoline yellow E104 0.09 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension 4 CLINICAL PARTICULARS 4.1 Target Species Cattle 4.2 Indications for use, specifying the target species Curafluke 10% w/v Oral Drench permits a three way activity against Fluke, Lungworms and Stomach Worms in Cattle. It is a broad spectrum anthelmintic for the treatment of benzimidazole susceptible mature and immature stages of nematodes and cestodes of the gastrointestinal and respiratory tracts of cattle. Rafoxanide is active against immature and mature Fasciola sp. CATTLE: Haemonshus sp. Ostertagia sp. Trichostrongylus sp. Cooperia sp. Nematodirus sp. Bunostomum sp. Trichuris sp. Strongyloides sp. Oesophagostomum sp. Dictyocaulus sp. Moniezia sp. Fasciola sp.(mature and immature over 8 weeks of age) The product has a good therapeutic effect against type II Ostertagiasis 4.3 Contraindications Not for use against Benzimidazole resistant nematodes. 4.4 Special warnings for each target species Where a dosing gun is used to administer the product, care should be taken to avoid causing injury to the mouth and pharynx of animals. 4.5 Special precautions for use Estimate bodyweight carefully. Use only properly calibrated dosing equipment. 4.6 Adverse reactions (frequency and seriousness) None known. 4.7 Use during pregnancy, lactation or lay Fenbendazole and rafoxanide are safe for use during pregnancy. However, the product is not permitted for use in animals producing milk for human consumption, including pregnant animals intended to produce milk for human consumption. 4.8 Interaction with other medicinal products and other forms of interaction None known. 4.9 Amounts to be administered and administration route The recommended therapeutic dose of fenbendazole and rafoxanide is 11.25 mg/kg bodyweight of each active for cattle. For oral administration in cattle. Shake well before use. Practical dosage recommendations are as follows: Cattle: 11.25 ml per 100 kg bodyweight Bodyweight (kg) Dose (ml) CATTLE 50 5.60 100 11.25 300 33.75 500 56.25 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Curafluke 10%Oral Drench is well tolerated in cattle at three times the recommended dosage. 4.11 Withdrawal Period(s) Animals must not be slaughtered for human consumption during treatment or for 60 days thereafter. Milk: Not permitted for use in animals producing milk for human consumption, including pregnant animals intended to produce milk for human consumption. 5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES Summary presentation of the active ingredients Fenbendazole (QP52AC13) is an anthelmintic belonging to the benzimidazole group which acts by blocking fumarate reductase which results in the inhibition of the formation of adenosine triphosphate (involved in mitochondrial energy). Rafoxanide (QP52AG05) is a salicylanilide anthelmintic and these are known to be potent uncouplers of oxidative phosphorylation in animal tissues. 5.1 Pharmacodynamic properties Fenbendazole, like many benzimidazoles, blocks fumarate reductase which results in the inhibition of the formation of adenosine triphosphate (involved in mitochondrial energy). There is also evidence that it inhibits glucose uptake and therefore increases glycogen utilization and depletes the worm’s glycogen reserves. The overall effect of this action is to effectively starve the parasite to death. Furthermore this action results in the detachment of the parasites but in the case of intestinal helminths this detachment does not result in loss of contact with the drug whereas in the case of the liver fluke such detachment would reduce such contact. This probably explains its limited effect on the liver fluke and the good effect on intestinal helminths. In vitro experiments indicate that salicylanilides, including the commercially used flukicides, oxyclozanide and rafoxanide, uncouple oxidative phosphorylation in Fasciola hepatica and other parasites. 5.2 Pharmacokinetic properties Fenbendazole Fenbendazole is absorbed poorly from the gastro-intestinal tract leading to with low plasma levels of fenbendazole, oxfendazole and sulphone. It is mainly excreted in the faeces though some of the metabolites that have been identified are excreted in the urine and bile. The active and its metabolites are mainly found in the plasma. Rafoxanide Kinetic studies of rafoxanide in cattle have shown that it is absorbed into the blood with a mean peak concentration of circa 23 μg.ml-1 achieved in 2 to 3 days. Plasma are considerably higher than those in tissues. Only one metabolite has been identified (3, 5-di-iodosalicylic acid) and this was found in blood tissues and milk. There is little known or reported on the excretion of rafoxanide though apparently it is excreted in the bile. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Xanthan Gum Quinoline Yellow (E104) Simethicone Emulsion Propyl Parahydroxybenzoate (E216) Methyl Parahydroxybenzoate (E218) Polysorbate 80 Sodium Citrate Sodium Metabisulphite Citric Acid Monohydrate Purified Water 6.2 Incompatibilities None known 6.3 Shelf-life Shelf life of the veterinary medicinal product packaged in white HDPE containers: 3 years Shelf life of the veterinary medicinal product packaged in clear HDPE containers: 2 years 6.4 Special precautions for storage Do not store above 25°C. Protect from light and frost. Irish Medicines Board 6.5 Nature and composition of immediate packaging A. 1 L, 2.5 L, 5 L HDPE clear/white rigid containers closed with a 38 mm HDPP screw cap with a wood pulp PVDC liner. B. 1 L, 2.5 L, 5 L white LDPE vaccine packs closed with a 31 mm HDPE screw cap with a wood pulp PVDC liner. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations 7 MARKETING AUTHORISATION HOLDER Univet Ltd. Tullyvin Cootehill County Cavan 8 MARKETING AUTHORISATION NUMBER(S) VPA: 10990/032/002 9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 14th September 2005 10 DATE OF REVISION OF THE TEXT 12th February 2010
