ILIUM TRISOPRIM-480 ANTI-BACTERIAL INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

31-01-2001

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

TRIMETHOPRIM; SULFADIAZINE

Available from:

TROY LABORATORIES PTY LTD

INN (International Name):

sulfadiazine(400mg/mL)+trimethoprim(80mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TRIMETHOPRIM PYRIMIDINE Active 80.0 mg/ml; SULFADIAZINE SULFANYL Active 400.0 mg/ml

Units in package:

100 mL PET vial; 100 mL vial; 250 mL glass vial; 250 mL HDPE vial; 250 mL PET vial

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: DO NOT USE in sheep which are prod ucing or may in the future produce milk or milk products for human consumption. Meat - cattle sheep pigs: DO NOT USE l ess than 28 days before slaughter for hu man consumption. Meat - horses: 28 days . Milk: Milk collected from cows within 3 days following treatment MUST NOT BE USED for human consumption. This milk s hould not be fed to bobby calves. An ES I has not been established for this prod uct. Note—observing the meat withholding period may not be sufficient to mitigat e potential risks to export trade. Trade advice should be sought from Troy Labor atories Pty Ltd on 02 8808 3600 before u sing this product.; Host/pest details: CATTLE: [BACTERIAL INFECTION]; HORSE: [BACTERIAL INFECTION]; PIGS: [BACTERIAL INFECTION]; SHEEP EWE - DRY: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: WHP: DO NOT USE in sheep which are pro ducing or may in the future produce mil k or milk products for human consump- t ion. Meat - cattle sheep pigs: DO NOT USE less than 28 days before slaughter for human consumption. Meat - horses: 28 days. Milk: Milk collected from cow s within 3 days following treatment MUS T NOT BE USED for human consumption. T his milk should not be fed to bobby cal ves.; Host/pest details: CATTLE: [BACTERIAL INFECTION]; HORSE: [BACTERIAL INFECTION]; PIGS: [BACTERIAL INFECTION]; SHEEP EWE - DRY: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [BACTERIAL INFECTION]; HORSE: [BACTERIAL INFECTION]; PIGS: [BACTERIAL INFECTION]; SHEEP EWE - DRY: [BACTERIAL INFECTION]; For the systemic treatment of bacterial infections caused by organisms sensitive to trimethoprim and sulphadiazine for cattle, horses, sheep and pigs.DO NOT use in sheep which are producing or may in the future produce milk or milk products for human consumption.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

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MILK:
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EXPORT SLAUGHTER INTERVAL ( ESI)
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If poisoning occurs, contact a doctor or Poisons lnfonnation
Centre.
PHONE
Australia
131 126
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and
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in garbage.
5.,.
BELOW 2S•C
(Air-conditioning). Protect from light.
APVMA Approval
NO.:
51143/250MLP/0609
Batch:
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PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
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TRISOPRIM-�
ANTI-BACTERIAL INJECTION
ACTIVE CONSTITUENT:
4OOmg/ml SULPHADIAZINE
8Omg/ml TRIMETHOPRIM
FOR THE SYSTEMIC TREATMENT OF BACTERIAL
INFECTIONS CAUSED BY ORGANISMS SENSITIVE
TO TRLMETHOPRLM AND SULPHADLAZLNE FOR
CATTLE, HORSES, SHEEP AND PIGS.
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If poisoning occurs, contact a doctor or
Poisons Information Centre. Phone Australia
131 126
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AUSTRALIA
W: www.troylab.com.au
E: info@troylab.com.au
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Dispose of empty container by wrapping
with paper and putting in the garbage.
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Store below 25
°
C (Air Conditioning).
Protect from light.
APVMA Approval No.:
51143/250MLP/0609
9313754376408
BARCODE
Batch:
Expiry:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REA

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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET

PRODUCT NAME: TRISOPRIM-480 ANTI-BACTERIAL INJECTION
PAGE: 1 OF 5
THIS REVISION ISSUED: AUGUST, 2005

SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
TROY LABORATORIES PTY. LIMITED
ABN: 21 000 283 769
TEL:
(02)9604
6266
98 LONG STREET

FAX: (02) 9725 1772
SMITHFIELD NSW 2164
SUBSTANCE:
Water solution/suspension. Major ingredients are antibiotics.

TRADE NAME:
TRISOPRIM-480 ANTI-BACTERIAL INJECTION
PRODUCT CODE: 3760
PRODUCT USE:
Systemic treatment of bacterial infections due to susceptible
organisms in cattle,
horses, sheep and pigs.

CREATION DATE:
AUGUST, 2005
REVISION DATE:
AUGUST, 2005
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as: Not classified as hazardous
according to the criteria of NOHSC Australia.
Not a Dangerous Good according to the Australian Dangerous Goods
(ADG) Code.

RISK PHRASES: Not Hazardous - No criteria found.
SAFETY PHRASES: S25. Avoid contact with eyes.
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: Odour typical of antibiotic preparations.
MAJOR HEALTH HAZARDS: no significant risk factors have been found
for this product. A significant ingredient is an
antibiotic. Any person with a history of allergies to this class of
substances should avoid all contact with this product
as it may cause sensitisation.
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

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