Imaverol 100ml. Imaverol is a synthetic antimycotic. It is indicated for the treatment of dermatomycoses or ringworm in cattle, horses and dogs induced by the following pathogenic fungi: Trichophyton verrucosum, Trichophyton mentagrophytes, Trichophyton equinum, Microsporum canis.
Treat 3-4 times at three day intervals
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.
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 evidence of embryotoxic or teratogenic effects. This product may be given to pregnant and lactating animals.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
For topical use only.
To be prepared and administered in adequately ventilated surroundings.
The concentrated Imaverol solution should be diluted by adding 1 part to 50 parts warm water to provide a 2 mg/ml emulsion.
Dermatophytes will extend into the hair follicles. Possible crusts must therefore be removed with a hard brush which has been soaked in the diluted Imaverol emulsion.
It is highly recommended that the animal is sprayed entirely at the first treatment so as to reach the subclinical lesions as well.
Cattle: depending on the nature of the lesions, cattle should be treated 3 to 4 times at 3-day intervals. The animals should either be washed with the diluted emulsion or the emulsion should be applied to them with a sprayer or high-pressure cleaning unit.
Horses: the lesions and surrounding skin should be washed with the diluted emulsion 4 times at 3-day intervals.
Dogs: the animals should be washed with the diluted emulsion 4 times at 3-day intervals. While doing this, one should rub thoroughly in the direction opposite to the hair growth to make sure that the skin is thoroughly wet. For the same reason, it is recommended that long haired dogs be clipped before treatment.
Alternatively dogs may be dipped thoroughly in a bath containing the prepared emulsion. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
None known.
Enilconazole as a 2 mg/ml emulsion is well tolerated. Supportive treatment as required.
4.11 Withdrawal Period(s)
Cattle: Meat - zero days Cattle: Milk - zero hours Horse: Meat - zero days
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antifungals for topical use - imidazole and triazole derivatives. ATCvet code: QD01AC90
5.1 Pharmacodynamic properties
Enilconazole is a synthetic broad-spectrum antimycotic with a high activity against most of the common dermatophytes and various other fungi and yeasts.
It is a selective inhibitor of ergosterol biosynthesis, an essential component of the cell membrance of fungi and yeasts. This results in irreversible changes which are the origin of the fungicidal effect.
5.2 Pharmacokinetic properties
The systemic availability after topical administration of enilconazole in animals is very low. An extensive first-pass metabolism has been demonstrated after oral administration. Tissue residues are almost non-existent and, relatively, are highest in the liver. Depletion from tissues and plasma occurs with a half-life of about 12 to 16 hours in cattle.
Enilconazole is extensively metabolised and the main excretion routes are urine and faeces. Excretion in the milk from cattle is very limited.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sorbitan Monolaurate
Polysorbate 20
6.2 Incompatibilities
None known.
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging : 3 months. Shelf life after dilution according to directions: 6 weeks.
6.4 Special precautions for storage
Do not store above 25oC.
Keep the bottle in the outer carton.
Keep in an adequately ventilated area.
6.5 Nature and composition of immediate packaging
i) 100 ml pack size:
Container: amber Type III glass bottle containing 100ml of concentrate.
Closure: tamper evident and child resistant polypropylene screw cap lines with LDPE Dosing device: polypropylene measuring cup. ii) 1 litre pack size:
Container: white, high density polyethylene bottle with transparent window containing 1 litre of concentrate.
Closure: white high density polyethylene screw cap and seal insert lined with polyethylene Dosing device: low density polyethylene measuring cup
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Do not allow the product to contaminate streams or water supplies.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.
7 MARKETING AUTHORISATION HOLDER
Eli Lilly & Company Limited
Elanco Animal Health
Lilly House
Priestly Road
Basingstoke
RG24 9NL
MARKETING AUTHORISATION NUMBER(S)
VPA 10047/038/001
DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30th September 2009
10 DATE OF REVISION OF THE TEXT
August 2012
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