Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ENILCONAZOLE
Elanco Animal Health, Eli Lilly and Company Limited
QD01AC90
ENILCONAZOLE
100 Mg/Ml
Cutaneous Emulsion
LM-Licensed Merchant
Bovine, Canine, Equine - Food
Enilconazole
Antifungal
Authorised
2009-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Imaverol 100 mg/ml Concentrate for Cutaneous Emulsion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE PER ML Enilconazole 100 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cutaneous emulsion Brown-yellow, clear viscous solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle Horse Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of dermatomycoses in cattle, horses and dogs induced by the following pathogenic fungi: _Trichophyton verrucosum_ _Trichophyton mentagrophytes_ _Trichophyton equinum_ _Microsporum canis_ _Microsporum gypseum_ 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 12/08/2014_ _CRN 7018592_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The solution must be diluted before use. For external use only. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Wear suitable protective clothing including impermeable rubber gloves and safety glasses. If the concentrated solution comes into contact with the skin, remove any contaminated clothing immediately and wash skin generously with soap and water. In the event of accidental eye exposure, flush eye thoroughly with running water. If irritation persists, seek medical attention. In the event of accidental ingestion, flush mouth with plenty of running water and seek medical advice. Wash hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None known. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Laboratory studies in rodents have Read the complete document