Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
TRICLABENDAZOLE
Chanelle Pharmaceuticals Manufacturing Limited
QP52AC
TRICLABENDAZOLE
10 Per Cent
Oral Suspension
LM-Licensed Merchant
Bovine
Benzimidazoles and related substances
Endoparasiticide
Authorised
2002-12-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Triclaben 10% Oral Suspension for Cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral suspension. Description: An aqueous pink-coloured suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Triclaben 10% is indicated for the treatment of 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. Each ml contains ACTIVE SUBSTANCE: Triclabendazole 100mg EXCIPIENT(S): Methyl Parahydroxybenzoate (E218) 2.0 mg Propyl Parahydroxybenzoate (E216) 0.2 mg Carmoisine supra (E122). 22.5 micrograms For a full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 24/06/2015_ _CRN 7021048_ _page number: 1_ 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 pha Прочетете целия документ