Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Flubendazole
Elanco GmbH
QP52AC12
Flubendazole
50 milligram(s)/gram
Oral powder
POM: Prescription Only Medicine as defined in relevant national legislation
flubendazole
Authorised
2013-02-22
Health Products Regulatory Authority 27 July 2018 CRN008DD9 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flubendazole Elanco 50 mg/g oral powder for pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: ACTIVE SUBSTANCE: Flubendazole 50mg EXCIPIENT(S): Titanium dioxide (E171) 20mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral Powder. White to slightly yellow powder. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of helminthiasis due to mature and immature stages of the following nematodes of the gastro-intestinal tract: _Ascaris suum_, (large roundworm), _Hyostrongylus rubidus_, (red stomach worm), _Oesophagostomum dentatum_ (nodular worm), _Trichuris suis_ (whipworm), _Strongyloidesransomi_ (threadworm) (adult). Flubendazole is ovicidal. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Health Products Regulatory Authority 27 July 2018 CRN008DD9 Page 2 of 5 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 (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 pharmacological class and having a different mode of action should be used. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals None. Special precautions to be taken by the person administ Read the complete document