Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Triclabendazole
Cross Vetpharm Group Ltd
QP52ACO1
Triclabendazole
Oral suspension
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Cattle, Sheep
Anthelmintic flukicide
Authorized
2003-02-20
Revised: August 2017 AN: 00085/2017 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Endofluke 100 mg/ml Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: per ml Triclabendazole 100mg EXCIPIENTS: Methyl Parahydroxybenzoate (E218) 2mg (preservative) Propyl Parahydroxybenzoate (E216) 0.2mg (preservative) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Suspension. A white to off-white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle & Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of adult, immature and early immature stages of liver fluke (_Fasciola _ _hepatica_) susceptible to triclabendazole. 4.3 CONTRAINDICATIONS Do not use in animals known to be hypersensitive to the active substance . 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. - Under dosing, which may be due to underestimation of bodyweight, 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 Page 1 of 6 Revised: August 2017 AN: 00085/2017 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. Resistance to triclabendazole has been reported in _Fasciola hepatica_ in cattle and sheep. Therefore, the use of this product should be based on local (regional/farm) epidemiological information about susceptibility of the _Fasciola hepatica_ and recommendations on how to limit further selection for resistance to anthelmintics. 4.5 SPECIAL PRE Read the complete document