Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Triclabendazole
Chanelle Pharmaceuticals Manufacturing Limited
QP52AC
Triclabendazole
5 percent weight/volume
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Sheep
Benzimidazoles and related substances
Endoparasiticide
Authorised
2002-12-06
Health Products Regulatory Authority 09 May 2019 CRN0091RX Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Triclaben 5% Oral Suspension for Sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each ml contains 50mg Triclabendazole ADJUVANT(S): N/A EXCIPIENT(S): Each ml contains: 2.0mg Methyl Parahydroxybenzoate (E218) 0.2mg Propyl Parahydroxybenzoate (E216) 17.5 microgram Brilliant Blue (E133). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral suspension. Description: An aqueous blue-coloured suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Triclaben 5% is indicated for the treatment of fasciolosis in sheep caused by early immature, immature and adult stages of liverfluke (_Fasciola hepatica)_ susceptible to triclabendazole. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active ingredient. 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 under estimation 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. Resistance to triclabendazole has been reported in _Fasciola hepatica_ in sheep. Therefore, the use of this product should be based on local (regional / farm) epidemiological information about susceptibility of the _Fasciola hepatica_ and reco Les hele dokumentet