IMAVEROL FUNGICIDAL WASH FOR HORSES AND DOGS
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
19-06-2017
Active ingredient:
ENILCONAZOLE
Available from:
ELANCO AUSTRALASIA PTY LTD
INN (International Name):
enilconazole(100mg/mL)
Pharmaceutical form:
TOPICAL SOLUTION/SUSPENSION
Composition:
ENILCONAZOLE TRIAZOLE Active 100.0 mg/ml
Units in package:
100mL; 1L
Class:
VM - Veterinary Medicine
Manufactured by:
ELANCO ANIMAL HEALTH
Therapeutic group:
DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT
Therapeutic area:
DERMATOLOGICAL PREPS.
Therapeutic indications:
DERMATOMYCOSIS | RINGWORM - MICROSPORUM SPP. | RINGWORM - TRICHOPHYTON SPP. | FUNGAL INFECTIONS OF THE SKIN
Product summary:
Poison schedule: 5; Withholding period: WHP: HORSES: MEAT - DO NOT APPLY LATER THAN 28 DAYS BEFORE SLAUGHTER FOR HUMA N CONSUMPTION; Host/pest details: DOG: [DERMATOMYCOSIS, RINGWORM - MICROSPORUM SPP., RINGWORM - TRICHOPHYTON SPP.]; HORSE: [DERMATOMYCOSIS, RINGWORM - MICROSPORUM SPP., RINGWORM - TRICHOPHYTON SPP.]; For control of ringworm and other forms of dermatomycosis in horses and dogs.
Authorization status:
Stopped
Authorization date:
2023-07-01
Patient Information leaflet
For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD
PRODUCT NAME:
IMAVEROL FUNGICIDAL WASH FOR HORSES AND DOGS
ELABEL APPLICATION NO:
DC12-96759922E42
APVMA APPROVAL NO:
35970/103528
PRODUCT NO:
35970
VERSION NO:
4.0
APPLICATION STARTED:
2015-Jul-21 14:42:09
VERSION CREATED:
2015-Dec-01 15:23:10
STARTED BY:
Hayley Holland
PRINTED:
2015-Dec-01 15:32:48
LABEL NAME:
IMAVEROL FUNGICIDAL WASH FOR HORSES AND DOGS
SIGNAL HEADINGS:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
CONSTITUENT
STATEMENTS:
100 mg/mL ENILCONAZOLE
CLAIMS:
For the control of ringworm (Microsporum spp. and Trichophyton spp.)
and other forms of
dermatomycosis in horses and dogs.
NET CONTENTS:
100mL
1L
DIRECTIONS FOR USE:
DOSAGE AND
ADMINISTRATION:
Use undiluted solution within 3 months of opening.
Dilute 1 part Imaverol Fungicidal wash in 50 parts of lukewarm water.
Only dilute quantity required to treat animal immediately. Undiluted
Imaverol solution can
be used up to 3 months after first opening the container.
Remove crusts from skin and hair with a hard brush which has been
soaked in the diluted
Imaverol emulsion.
At the first treatment the animal should be sprayed or washed
completely.
Horses: The skin lesions/infected and surrounding area should be
washed with Imaverol 4
times, at 3 to 4 day intervals.
Dogs: Wash with Imaverol 4 times, at 3 to 4 day intervals. It is
important that the skin is
thoroughly wet with emulsion. When applying the diluted emulsion brush
the hair in the
opposite direction to hair growth. Long haired dogs should be clipped.
Alternatively dogs may be dipped thoroughly in a bath containing the
emulsion.
New hair growth may be temporarily discoloured.
Specifically: Treat twice weekly for two weeks (4 treatments). RLP APPROVED
For Official Use Only
First Treatment: Wash the entire animal with the emulsion.
Brush hair to ensure skin and hair is thoroughly soaked with Imaverol.
Second Treatment: Ap
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Summary of Product characteristics
Issue date: 25-September-2015
Version number: 01
SAFETY DATA SHEET
1. Identification
Imaverol Fungicidal Wash for Horses and Dogs
Product identifier
Other means of identification
CA0794, AH0794, MN0812
Item Code
Recommended use of the chemical and restrictions on use
Veterinary Pharmaceutical
Recommended use
Not available.
Restrictions on use
Details of manufacturer or importer
Manufacturer
Company name
Elanco Animal Health
A Division of Eli Lilly Australia Pty Ltd
Address
A.B.N. 39 000 233 992
112 Wharf Road, West Ryde, N.S.W. 2114, Australia
Telephone
(02) 9878 7777
Fax
(02) 9878 7720
e-mail
lilly_msds@lilly.com
Emergency phone
number
Elanco Animal Health: 1800 226 324 (Toll free)
OR Poisons Information Centre: 131126 (Australia-wide)
24 hr emergency contact
number
CHEMWATCH 1800 039 008 (spills and accidents)
24 hr emergency contact
number (Local)
CHEMWATCH +61 2 9186 1132 (spills and accidents)
2. Hazard(s) identification
Classification of the hazardous chemical
Not classified.
Physical hazards
Category 4
Acute toxicity, oral
Health hazards
Category 1
Serious eye damage/eye irritation
Category 2
Hazardous to the aquatic environment, acute
hazard
Environmental hazards
Category 2
Hazardous to the aquatic environment,
long-term hazard
Label elements, including precautionary statements
Hazard symbol(s)
Corrosion
Exclamation
mark
Environment
Signal word
Danger
Hazard Statement(s)
Harmful if swallowed. Causes serious eye damage. Toxic to aquatic life
with long lasting effects.
Precautionary Statement(s)
Prevention
Wash hands thoroughly after handling. Do not eat, drink or smoke when
using this product. Wear
protective gloves/eye protection/face protection.
Response
IF SWALLOWED: Call a POISON CENTRE or doctor/physician if you feel
unwell. Rinse mouth. IF IN
EYES: Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy
to do. Continue rinsing. Immediately call a POISON CENTRE or
doctor/physician.
Storage
Not available.
1 / 9
Material name: Imaverol Fungicidal Wash for Horses and D
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