国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
RAFOXANIDE, LEVAMISOLE HYDROCHLORIDE
Chanelle Pharmaceuticals Manufacturing Limited
QP52AE51
RAFOXANIDE, LEVAMISOLE HYDROCHLORIDE
Unknown
Oral Suspension
LM-Licensed Merchant
Bovine, Ovine
Levamisole, combinations
Endoparasiticide
Authorised
1989-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Rafazole Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, Sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Rafazole is effective in the treatment and control of roundworm, lungworm and fluke infections in cattle and sheep. It is highly effective against mature and developing immature stages of levamisole-susceptible major stomach and bowel worm species including _Trichostrongylus _spp, _Cooperia _spp, _Ostertagia _spp (except _Ostertagia _larvae in cattle), _Haemonchus_ spp, _Nematodirus _spp, _Bunostomum _spp, _Oesophagostomum _spp, _Chabertia _spp and lungworms (_Dictyocaulus _spp.). Rafazole is effective against mature liverfluke in cattle and sheep. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredients. Do not use in animals less than 6 months of age. Each ml contains: Active Substances Rafoxanide 30 mg Levamisole Hydrochloride 30 mg Excipients Sodium Metabisulphite (E223) 1 mg Tartrazine (E102) 0.075 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/01/2014_ _CRN 7016824_ _page number: 1_ 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 阅读完整的文件