DISTOCUR 34/MG/ML ORAL SUSP 5 LITRE

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. 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:Revised: August 2019 AN: 00702/2019 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 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 pharmaceutical class and having a different mode of action should be used. At normal dose levels, oxyclozanide is not active against immature flukes present in liver tissue. Milking cattle, particularly high yielders, may show a reduction in yield, occasionally of 5 % or more, for about 48 hours after handling. The effect of this small loss may be minimised by spreading herd dosing over a period of about one week. 4.5 Special precautions for use Special precautions for use in animals To avoid damage to the pharyngeal region, care should be taken when administering by dosing gun. Adverse effects (see section 4.6) are occasionally enhanced in animals suffering from severe liver damage and/or dehydration at the time of dosing. Due regard must always be given to the physical condition of animals undergoing treatment, particularly those in advanced pregnancy and/or under stress from adverse weather conditions, poor nutrition, penning, handling, etc. Special precautions to be taken by the person administering the veterinary medicinal product to animals This veterinary medicinal product may cause irritation to skin, eyes and mucous membranes. People with known hypersensitivity to oxyclozanide or any of the excipients should avoid contact with the veterinary medicinal product. Wash hands after use. Operators should wear rubber gloves when applying the product. Do not smoke, eat or drink while handling the product. In case of contact with the product, rinse the affected area immediately with plenty of water. Contaminated clothing should be removed immediately. In the event of accidental ingestion, seek medical advice. Other precautions Oxyclozanide is toxic to dung fauna and aquatic organisms. The risk can be reduced by avoiding too frequent and repeated use of oxyclozanide in cattle. Treated cattle must not graze near watercourses and must not have access to water bodies for 5 days after treatment. 4.6 Adverse reactions (frequency and seriousness) Slight softening of the faeces with animal showing increased frequency of defecation and transient inappetence may appear very rarely. The frequency of adverse reactions is defined using the following convention: Revised: August 2019 AN: 00702/2019 Page 3 of 6 - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated ) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 4.7 Use during pregnancy, lactation Laboratory studies during different phases of reproduction have not produced any evidence of teratogenic or foetotoxic effects, or negative effects on fertility. Can be used during pregnancy and lactation. However care should be taken when treating heavily pregnant animals and animals under stress from adverse weather conditions, poor nutrition, penning, handling etc. 4.8 Interaction with other medicinal products and other forms of interaction No information is available on the safety and efficacy of this veterinary medicinal product when used with any other veterinary medicinal product. A decision to use this veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Vat Rate: 20%