País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Triclabendazole
Chanelle Pharmaceuticals Manufacturing Limited
QP52AC01
Triclabendazole
10 percent weight/volume
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
triclabendazole
Authorised
2000-10-02
Health Products Regulatory Authority 22 November 2018 CRN008PVZ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tribex 10 % Oral Suspension for Cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains ACTIVE SUBSTANCE: Triclabendazole 100 mg EXCIPIENTS(S): Methyl Parahydroxybenzoate (E218) 2.0 mg Propyl Parahydroxybenzoate (E216) 0.2 mg Carmoisine supra (EB122). 22.5 microgram For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension An aqueous pink-coloured suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the treatment of acute, sub-acute and chronic fasciolosis in cattle 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: Health Products Regulatory Authority 22 November 2018 CRN008PVZ Page 2 of 6 • 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 cattle. Therefore, the use of this product should be based on local epidemiological information abou Leer el documento completo