AUSTRAZOLE TOPICAL FUNGICIDE FOR DOGS AND HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

ENILCONAZOLE

Available from:

AUSRICHTER 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; 50mL

Class:

VM - Veterinary Medicine

Therapeutic area:

DERMATOLOGICAL PREPS.

Product summary:

Poison schedule: 5; Withholding period: WITHHOLDING PERIOD: MEAT WITHHOLDING P ERIOD (HORSES): DO NOT USE less than 28 days before slaughter for human consum ption.; Host/pest details: DOG: [DERMATOMYCOSIS, RINGWORM - MICROSPORUM SPP., RINGWORM - TRICHOPHYTON SPP.]; HORSE: [DERMATOMYCOSIS, RINGWORM - MICROSPORUM SPP., RINGWORM - TRICHOPHYTON SPP.]; Poison schedule: 5; Withholding period: ; Host/pest details: DOG: [DERMATOMYCOSIS, RINGWORM - MICROSPORUM SPP., RINGWORM - TRICHOPHYTON SPP.]; HORSE: [DERMATOMYCOSIS, RINGWORM - MICROSPORUM SPP., RINGWORM - TRICHOPHYTON SPP.]; For the control of ringworm (Microsporum spp. and Trichophyton spp.) and other forms of dermatomycosis in dogs and horses.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

RELEVANT LABEL PARTICULARS
~~'
Product! app. Number
70030/62332
Issue
2
·.·
. .
.
.
_P~a~c~k~s~----------~5~0~m~L~·~1~0~0~m~L~,~1L~~Is~s~u~e~d~a~te~------~2~7~·~11~·=20~1~4~----~'
'
APPENDIX2
RLP
Approved
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPS)
(VETERINARY
PRODUCTS)
Select appropriate:
X
New
Product (include
all
applicable
RLPs)
OR
D
Variation (highlight instructions that
are
being
varied). Approval
no.
of
label
being
varied:
Signal
heading:
CAUTION
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
PRODUCT
NAME:
Austrazole Topical fungicide for dogs and horses
ACTIVE
CONSTITUENTLS:
Enilconazole 100 mg/mL
STATEMENT
OF
CLAIMS:
For the control
of
ringworm
(Microsporum
spp. and
Trichophyton
spp.)
and other forms
of
dermatomycosis
in
dogs and horses.
Net
contents:
50mL, 1
OOmL,
1
L
DIRECTIONS
FOR
USE
DIRECTIONS FOR USE
Heading:
Enilconazole is a synthetic antimycotic with potent antifungal actions
against dermatop hytes.
RESTRAINTS:
CONTRAINDICATIONS:
PRECAUTIONS:
Side
effects:
Page
1
of
3
RELEVANT LABEL PARTICULARS
Product! app. Number
Packs
70030/62332
Issue
50ml,
1
OOmL,
1
L
Issue date
2
27.11.2014
DOSAGE
&
DOSAGE AND ADMINISTRATION:
ADMINISTRATION:
Dilute 1 part Austrazole topical fungicide
in
50 parts of lukewarm water
(to
20ml
of
Austrazole topical fungicide add lukewarm water and make
up to 1 Litre).
Make up the quantity
of
wash needed to treat the animal immediately.
Discard any remaining unused diluted wash after application.
Remove crusts from skin and hair with a hard brush which has been
soaked
in
the diluted Austrazole topical fungicide.
At the first treatment the animal should be sprayed or washed
completely.
Horses:
The skin lesions/infected and surrounding area should
be washed using Austrazole topical fungicide
4
times, at
3 to 4 day intervals.
Dogs:
Wash using Austrazole topical fungicide
at
3 to
4
day
intervals.
It
is important that the skin
is
thoroughly wet
with the emulsion. When applying the diluted emulsion
brush the hair
in
the o

Summary of Product characteristics

PRODUCT NAME: AUSTRAZOLE TOPICAL FUNGICIDE FOR DOGS AND HORSES
PAGE: 1 OF 4
THIS VERSION ISSUED: AUGUST, 2015
SAFETY DATA SHEET
ISSUED BY: AUSRICHTER PTY LTD
PHONE: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
AUSRICHTER PTY LTD
PHONE: [phone]
2/21 CHESTER ST
FAX: [phone]
CAMPERDOWN NSW 2050
[e-mail]
CHEMICAL NATURE:
Enilconazole in a suitable water based medium.
TRADE NAME:
AUSTRAZOLE TOPICAL FUNGICIDE FOR DOGS AND HORSES
APVMA CODE:
70030
PRODUCT USE:
Topical fungicide for dogs and horses for use as described on the
product label.
CREATION DATE:
AUGUST, 2015
THIS VERSION ISSUED:
AUGUST, 2015
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S36, S24/25. Wear suitable protective clothing. Avoid contact with
skin and eyes.
SUSMP CLASSIFICATION:
S5
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: In case of fire, use carbon dioxide, dry chemical, foam,
water fog.
STORAGE
P410: Protect from sunlight.
P402+P404: Store in a dry place. Store in a closed container.
P411+P235: Store at temperatures not exceeding 30°C. Keep cool.
DISPOSAL
P501: Dispose of small quantities and empt