ILIUM TRIMEDEXIL ANTI-INFLAMMATORY STEROID INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

DEXAMETHASONE TRIMETHYLACETATE

Available from:

TROY LABORATORIES PTY LTD

INN (International Name):

dexamethasone trimethylacetate(5mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

DEXAMETHASONE TRIMETHYLACETATE STEROID-GLUCOCORTICOID Active 5.0 mg/ml

Units in package:

50mL

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: MILK (Cattle) - Nil. MEAT: Do no t use less than the following days befo re slaughter for human consumption. Ca ttle - 7 days. Pigs - 28 days. Horses - 28 days. TRADE ADVICE: EXPORT SLAUGHT ER INTERVAL (ESI): ESI Not established.; Host/pest details: CALF: [CORTICOSTEROID]; CATTLE: [CORTICOSTEROID]; DOG: [CORTICOSTEROID]; HORSE: [CORTICOSTEROID]; HORSE FOAL: [CORTICOSTEROID]; PIGS: [CORTICOSTEROID]; Poison schedule: 4; Withholding period: ; Host/pest details: CALF: [CORTICOSTEROID]; CATTLE: [CORTICOSTEROID]; DOG: [CORTICOSTEROID]; HORSE: [CORTICOSTEROID]; HORSE FOAL: [CORTICOSTEROID]; PIGS: [CORTICOSTEROID]; Anti-inflammatory steroid injection for use in horses, cattle, pigs, foals, calves and dogs.DO NOT inject cattle other than high on the side of the neck. Failure to do so may result in residue violations

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

01 Nov 2010
Ilium Trimedexil Anti-Inflammatory Steroid Injection
Primary Label
________________________________________________________________________
_ _
_ _
_ _
_Main panel –Carton LABEL_
_ _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
ILIUM TRIMEDEXIL
ANTI-INFLAMMATORY STEROID INJECTION
ACTIVE CONSTITUENT:
5 MG/ML DEXAMETHASONE TRIMETHYLACETATE
ILIUM 50mL
_ _
_Ancillary panel: _
For use in horses, cattle, pigs, foals, calves and dogs.
DIRECTIONS FOR USE:
RESTRAINTS: DO NOT INJECT CATTLE OTHER THAN HIGH ON SIDE OF THE NECK.
FAILURE TO DO SO MAY RESULT IN RESIDUE VIOLATIONS.
DOSAGE AND ADMINISTRATION
Use contents within 24 hours of first broaching of the vial. Discard
the unused portion.
SHAKE WELL BEFORE USE.
HORSES, CATTLE & PIGS:
2.5 – 5mg per 100 kg bodyweight (maximum 25mg) i.m. or s.c.
5-10 mg INTRASYNOVIAL or INTRA-ARTICULAR ROUTE.
FOALS, CALVES & DOGS:
2.5-5mg per 50kg bodyweight, i.m. or s.c.
2.5 mg INTRASYNOVIAL or INTRA-ARTICULAR ROUTE.
WITHHOLDING PERIODS:
MEAT – DO NOT USE LESS THAN THE FOLLOWING DAYS BEFORE SLAUGHTER FOR
HUMAN CONSUMPTION. CATTLE: 7 DAYS; PIGS: 28 DAYS; HORSES: 28DAYS.
MILK (CATTLE): 0 DAYS.
TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI
established. For advice on the ESI, contact the manufacturer on (02)
9604 6266
before using this product.
FIRST AID:
If poisoning occurs, contact a doctor or Poisons Information Centre.
_Phone Australia 131126 _
Version: V02
Page 1 of 2 RLP APPROVED
Info
PEST

Verified
01 Nov 2010
Ilium Trimedexil Anti-Inflammatory Steroid Injection
Primary Label
________________________________________________________________________
Version: V02
Page 2 of 2
TROY LABORATORIES PTY. LIMITED
31-35 Glendenning Road, Glendenning NSW 2761
website: www.troylab.com.au email: info@troylab.com.au
DISPOSE of empty container by wrapping with paper and putting in the
garbage.
STORE below 25

C (air conditioning). Protect from light
APVMA Approval No. 51447/50419
Batch.:
Expiry:
_ _
01 Nov 2010
I

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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: ILIUM TRIMEDEXIL ANTI-INFLAMMATORY STEROID INJECTION
PAGE: 1 OF 4
THIS REVISION ISSUED: JULY, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Troy Laboratories Australia Pty Ltd
Phone: 02 9677 9000
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
TROY LABORATORIES AUSTRALIA PTY. LTD ABN: 21 000 283 769
TEL:
(02)9677 9000
31-35 GLENDENNING ROAD
FAX:
(02) 9677 9300
GLENDENNING NSW 2761
CHEMICAL NATURE:
Water solution/suspension of ingredients. Dexamethasone is a
corticosteroid.
TRADE NAME:
ILIUM TRIMEDEXIL ANTI-INFLAMMATORY STEROID INJECTION
PRODUCT CODE:
3750
PRODUCT USE:
Treatment of conditions requiring an anti-inflammatory steroid in
horses, cattle, pigs,
foals, calves and dogs.
CREATION DATE:
AUGUST, 2005
THIS VERSION ISSUED:
JULY, 2010
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: White micronised suspension which settles on standing but disperses
on
shaking.
ODOUR:
Mild odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
POTENTIAL HEALTH EFFECTS
This is a pharmacologically active preparation, and contact should be
avoided except for its intended veterinary use. If
you have come into contact with this product, seek medical attention
if you experience any unusual symptoms.
INHALATION
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely.
Available data indicates that
this product is not harmful. Howev

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