País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Triclabendazole
Elanco GmbH
QP52AC01
Triclabendazole
240 milligram(s)/millilitre
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
triclabendazole
Endoparasiticide
Authorised
2008-09-05
Health Products Regulatory Authority 01 June 2018 CRN000YK1 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Fasinex 240 mg/ml oral suspension for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Triclabendazole 240 mg EXCIPIENTS: Methyl parahydroxybenzoate (E218) 1.1 mg Propyl parahydroxybenzoate (E216) 0.4 mg Benzyl alcohol (E1519) 5.0 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral Suspension. White to cream-coloured aqueous suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of acute, subacute and chronic infection due to early immature, immature, and mature stages of _Fasciola hepatica_. If infected animals are treated before disease has developed, fasciolosis can be prevented. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the ingredients. 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. Health Products Regulatory Authority 01 June 2018 CRN000YK1 Page 2 of 6 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 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 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 h Leia o documento completo