NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Friday, April 19, 2024 21:12

Description: Logo Audevard
Release 2.79
Imaverol 100 mg/ml Concentrate for Cutaneous Emulsion
 
Species: Cattle, Dogs, Horses and other equidae
Therapeutic indication: Pharmaceuticals: Antimicrobials: Topical preparations: Skin, Pharmaceuticals: Antimicrobials: Antifungal products
Active ingredient: Enilconazole
Product:Imaverol 100 mg/ml Concentrate for Cutaneous Emulsion
Product index: Imaverol 100 mg/ml Concentrate for Cutaneous Emulsion
Cattle - milk: Zero hours
Cattle - meat: Zero hours
Withdrawal notes: Horses: meat - Zero days
Incorporating:
Qualitative and quantitative composition
Active Substance:
per ml
Enilconazole
100mg
Pharmaceutical form
Cutaneous emulsion.
Brown-yellow, clear, viscous solution.
Clinical particulars
Target Species
Cattle, horse, dog
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 metagrophytes
Trichophyton equinum
Microsporum canis
Microsporum gypseum
Contraindications
None.
Special warnings for each target species
None.
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.
Adverse reactions (frequency and seriousness)
None known.
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.
Interaction with other medicinal products and other forms of interaction
None known.
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 mgl/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 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
None known. Enilconazole as a 2 mg/ml emulsion is well tolerated. Supportive treatment as required.
Withdrawal Period(s)
Cattle: Meat - zero days
Cattle: Milk - zero hours
Horse: Meat - zero days
Pharmacological particulars
Pharmacotherapeutic group
Antifungals for topical use - imidazole and triazole derivatives.
ATCvet code: QD01AC90
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 or ergosterol biosynthesis, an essential component of the cell membrane of fungi and yeasts. This results in irreversible changes which are the origin of the fungi and yeasts. This results in irreversible changes which are the origin of the fungicide effect.
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 resides are almost non-existent and, relatively, are highest in the liver. Depletion from tissues and plasm 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.
Pharmaceutical particulars
List of Excipients
Sorbitan Monolaureate
Polysorbate 20
Incompatibilities
None know.
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
Special precautions for storage
Do not store above 25°C
Keep the bottle in the outer carton
Keep in adequately ventilated area
Nature and composition of immediate packaging
100ml pack size:
Container:
amber Type III glass bottle containing 100 ml of concentrate
Closure:
tamper evident and child resistant polypropylene screw cap lined with LDPE
Dosing device:
polypropylene measuring cup
1 litre pack size
Container:
white, high density polyethylene bottle with transparent window containing 1 litre of concentrate
Closure:
white high desnity polyethylene screw cap and seal insert lined with polyethylene
Dosing device:
low density polyethylene measuring cup
Not all pack sizes may be marketed.
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 regulatory authority.
Marketing Authorisation Holder (if different from distributor)
--
Marketing Authorisation Number
UK: 44684/4003
Significant changes
Date of the first authorisation or date of renewal
13 August 1985
Date of revision of the text
January 2020
Any other information
Nil
Legal category
Legal category: POM-VPS
GTIN
GTIN description:IMAVEROL 100ml bottle
GTIN:03515652020001