IMAVEROL 100 MG/ML CONCENTRATE FOR CUTANEOUS EMULSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-05-2024
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Active ingredient:
ENILCONAZOLE
Available from:
Janssen Cilag Ltd.
ATC code:
QD01AC90
Dosage:
100 Mg/Ml
Pharmaceutical form:
Cutaneous Emulsion
Therapeutic group:
Antifungal
Therapeutic area:
Bovine
Authorization date:
1989-10-01
Summary of Product characteristics
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/06/2011_
_CRN 7010628_
_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 not produced
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