البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Levamisole hydrochloride ; Rafoxanide
Pharvet (Ireland) Limited
QP52AE51
Levamisole hydrochloride ; Rafoxanide
15.0, 22.5 milligram(s)/millilitre
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Sheep
levamisole, combinations
Endoparasiticide
Authorised
1989-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Triazole Fluke and Worm Drench 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCES Levamisole Hydrochloride 15 mg Rafoxanide 22.5 mg EXCIPIENTS Sodium Metabisulphite (E223) 0.5 mg Propyl Parahydroxybenzoate(E216) 0.1 mg Methyl Parahydroxybenzoate(E218) 1.0 mg Quinoline Yellow (E104) 0.09 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension A yellow aqueous oral suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _Triazole _ is a combination product for the treatment of the common nematode parasites (including lung worm - _Dictyocaulus _ spp.) and liver fluke ( _Fasciola hepatica) _ of cattle and sheep. Triazole is active against: _Fasciola hepatica _ (mature and immature over 8 weeks of age) _Nematodirus _ spp. _Dictyocaulus _ spp. _Ostertagia _ spp. (except inhibited ostertagia larvae) 4.3 CONTRAINDICATIONS Do not use in concurrent treatment with organophosphates and / or diethylcarbamazine. Do not use in animals with known hypersensitivity to the active ingredients. 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 bodyweight, 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 tests 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 SPECIA اقرأ الوثيقة كاملة