Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Oxfendazole
Ancare Ireland Ltd.
QP52AC02
Oxfendazole
22.65 milligram(s)/millilitre
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Sheep
oxfendazole
Endoparasiticide
Authorised
1992-06-09
Health Products Regulatory Authority 31 January 2022 CRN00CRDM Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Oxfencare Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Oxfendazole 22.65 mg Excipients Formaldehyde Solution 2.0 mg Potassium sorbate 1.0 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. Aqueous off white free flowing suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the control of sensitive mature and immature gastrointestinal roundworms, lungworms and tapeworms in cattle and sheep, including: Gastro‑intestinal roundworms: _Ostertagia_ spp. _Haemonchus_ spp. _Trichostrongylus _spp. _Nematodirus _spp_., _including _N. battus_ _Cooperia _spp. _Capillaria_ spp. _Oesophagostomum _spp. _Chabertia_ spp. _Trichuris_ spp. Lungworms: _Dictyocaulus _spp. Tapeworms:_Monezia _spp. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active ingredient.Do not use in sheep producing milk for human consumption. Health Products Regulatory Authority 31 January 2022 CRN00CRDM Page 2 of 4 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. - Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device. 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. 4.5 Læs hele dokumentet