국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Closantel sodium
Elanco GmbH
QP52AG09
Closantel sodium
5 percent weight/volume
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Sheep
closantel
Endoparasiticide
Authorised
2013-01-18
Health Products Regulatory Authority 06 June 2018 CRN000YJZ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flukiver 5% w/v Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Closantel (as Clostanel sodium) 50 mg/ml Excipients: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral suspension. A white suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep and lambs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and control of adult and immature liver fluke, haematophagous nematodes and larval stages of some arthropods in sheep. Liver fluke: _Fasciola hepatica _(average efficacy against 6 week immature stages is 86%) _Fasciola gigantica_ Haematophagous nematodes _Haemonchus contortus_ (including benzimidazole resistant strains) _Chabertia ovina_ _Gaigeria pachyscelis_ Arthropods Health Products Regulatory Authority 06 June 2018 CRN000YJZ Page 2 of 6 _Oestrus ovis_ (Sheep Nasal Bot Fly) Ticks (_lxodes ricinus_) feeding on sheep at the time of treatment are likely to produce fewer viable eggs. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. 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 PR 전체 문서 읽기