Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Oxyclozanide
Boehringer Ingelheim Animal Health UK Ltd
QP52AG06
Oxyclozanide
Oral suspension
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Cattle
Anthelmintic flukicide
Authorized
2016-11-16
Revised: July 2019 AN: 00598/2018 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Distocur 34 mg/ml Oral Suspension for Cattle and Sheep Distocur.vet 34 mg/ml Oral Suspension for Cattle (DK, NO, SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Oxyclozanide ………………………………………… 34.0 mg EXCIPIENTS: Methyl parahydroxybenzoate (E218)…………………. 1.35 mg Propyl parahydroxybenzoate …………………………. 0.15 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension. Whitish to beige suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and Sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections caused by the adult stage of_ Fasciola hepatica,_ sensitive to oxyclozanide. Elimination of gravid tapeworm segments (_Moniezia spp_.). 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. Page 1 of 6 Revised: July 2019 AN: 00598/2018 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES To date no resistance to oxyclozanide has been reported. Use of the product should be based on local (regional, farm) epidemiological information about susceptibility of trematodes and recommendations on how to limit further selection for resistance to anthelmintics. 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. - Underdosing, which may be due to underestimation 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 Read the complete document