ประเทศ: ไอร์แลนด์
ภาษา: อังกฤษ
แหล่งที่มา: HPRA (Health Products Regulatory Authority)
Ivermectin; Closantel sodium
Norbrook Laboratories (Ireland) Limited
QP54AA51
Ivermectin; Closantel sodium
5, 200 milligram(s)/millilitre
Pour-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
ivermectin, combinations
Authorised
2009-08-07
Health Products Regulatory Authority 07 October 2021 CRN00CHZN Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT(S) Ivermectin 5 mg/ml Closantel (as closantel sodium) 200 mg/ml EXCIPIENTS Brilliant Blue FCF (E133) 0.1 mg/ml For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Pour-On solution. A clear blue/green solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eyeworms, warbles, mites and lice of cattle. Gastrointestinal roundworms (adults and fourth stage larvae) _Ostertagia ostertagi _(including inhibited _O. ostertagi_), _Haemonchus placei_, _Trichostrongylus axei_, _Trichostrongylus colubriformis_, _Cooperia_spp_, Oesophagostomum radiatum, Nematodirus helvetianus_(adult), _Strongyloides papillosus _(adult). Lungworms (adult and fourth stage larvae) _Dictyocaulus viviparus_ Trematodes (adult and late immatures) _Fasciola gigantica_ _Fasciola hepatica_ Treatment of fluke at 12 weeks (mature) >95% efficacy. Treatment of fluke at 7 weeks (late immature) >95% efficacy. Eyeworms (adult) _Thelazia_ spp Cattle grubs (parasitic stages) _Hypoderma bovis, Hypoderma lineatum_ Lice _Linognathus vituli, Haematopinus eurysternus, Damalinia bovis_ Health Products Regulatory Authority 07 October 2021 CRN00CHZN Page 2 of 6 Mange Mites _Chorioptes bovis, Sarcoptes scabiei _var _bovis_ 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substances or to any of the excipients. Do not apply to areas of skin which have mange, scabs or other lesions or to areas contaminated with mud or manure. Avermectins may not be well tolerated in non-target อ่านเอกสารฉบับเต็ม