البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Ivermectin
ECO Animal Health Europe Limited
QP54AA01
Ivermectin
18.7 milligram(s)/gram
Oral paste
POM: Prescription Only Medicine as defined in relevant national legislation
ivermectin
Authorised
2019-06-21
Health Products Regulatory Authority 04 July 2019 CRN000YL4 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Nexmectin 18.7 mg/g Oral Paste for Horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: ACTIVE SUBSTANCE: Ivermectin 18.7 mg EXCIPIENT(S): Titanium dioxide (E171) 20 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Paste A white homogeneous paste 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of nematode or arthropod infection due to: Large strongyles: _Strongylus vulgaris_ (adults and L 4 stage larvae [arterial]) _Strongylus edentatus_ (adults and L 4 stage larvae [tissue]) _Strongylus equinus_ (adults) Small strongyles (including benzimidazole resistant strains): _Cyathostomum _spp.(adults and luminal L 4 stage larvae) _Cylicocyclus _spp. (adults and luminal L 4 stage larvae) _Cylicodontophorus _spp. (adults and luminal L 4 stage larvae) _Cylicostephanus _spp. (adults and luminal L 4 stage larvae) _Gyalocephalus _spp. (adults and luminal L 4 stage larvae) Ascarids: _Parascaris equorum_ (luminal L 5 larvae and adults) Pinworms: _Oxyuris equi_ (L 4 stage larvae and adults) Neck threadworms: _Onchocerca_ spp. (microfilariae) Stomach bots: _Gasterophilus _spp_._ (oral and gastric stages) 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Health Products Regulatory Authority 04 July 2019 CRN000YL4 Page 2 of 5 Do not use in dogs or cats as severe adverse reactions may occur. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Some horses with heavy infections of _Onchocerca_ spp. microfilariae have experienced oedema and pruritus following treatment, such reactions are assumed to be the result of death of large numbers of microfilariae. These signs resolve within a few days but symptomatic treatment may be advisable. Care should be taken to avoid the following practices because they increase the risk of اقرأ الوثيقة كاملة