Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Oxyclozanide
Dopharma Research B.V.
QP52AG06
Oxyclozanide
Oral suspension
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Cattle, Sheep
Anthelmintic flukicide
Authorized
2016-11-16
Revised: November 2022 AN: 02755/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Distocur 34 mg/ml oral suspension for cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Oxyclozanide 34.0 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUCT Methyl parahydroxybenzoate (E218) 1.35 mg Propyl parahydroxybenzoate 0.15 mg Aluminium magnesium silicate Carmellose sodium (E466) Sodium laurilsulfate Monohydrate citric acid (E330) Sodium citrate (E331) Purified water Whitish to beige oral suspension. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle and sheep. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES For treatment of infections caused by the adult stage of_ Fasciola hepatica,_ sensitive to oxyclozanide. For elimination of gravid tapeworm segments (_Moniezia _spp.). Revised: November 2022 AN: 02755/2022 Page 2 of 6 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS 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 _Fasciola hepatica_ 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). Wh Read the complete document