Země: Irsko
Jazyk: angličtina
Zdroj: 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
2007-01-05
Health Products Regulatory Authority 21 March 2019 CRN008Y4L Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Dugmectin 18.7 mg/g Oral Paste for Horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Ivermectin 18.7 mg/g EXCIPIENT(S): For a 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 infections 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 L5 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) Health Products Regulatory Authority 21 March 2019 CRN008Y4L Page 2 of 5 4.3 CONTRAINDICATIONS Do not use in horses with known hypersensitivity to the active substance or to any of the excipients. 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 development of resistance and Přečtěte si celý dokument