TRIBRISSEN INJECTION-480

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

TRIMETHOPRIM; SULFADIAZINE

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

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

50mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat: DO NOT USE less than 28 days before slaughter for human consumption . Milk (cattle): Milk collected from co ws within 72 hours following treatment MUST NOT BE USED for human consumption or processing. This milk should not be fed to bobby calves. Milk (sheep): DO NOT USE in female sheep which are prod ucing or may in the future produce milk or milk products for human consumption .; Host/pest details: CATTLE: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; HORSE: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; PIGS: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; SHEEP EWE - DRY: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; HORSE: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; PIGS: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; SHEEP EWE - DRY: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; For the treatment of infections caused by organisms sensitive to trimethoprim and sulfadiazine.DO NOT USE in female 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

TRIBRISSEN INJECTION 480
PRIMARY PACK
PRESCRIPTION
ANIMAL
REMEDY
KEEP OUT OF
REACH
OF CHILDREN
FOR ANIMAL
TREATMENT
ONLY
TRIBRISSEN®
INJECTION - 480
TRIMETHOPRIM 80 mg/mL
SULFADIAZINE 400 mg/mL
FOR THE TREATMENT
OF
INFECTIONS
CAUSED BY ORGANISMS SENSITIVE
TO TRIMETHOPRIM AND SULFADIAZINE
50ML
JUROXLOGO
CARTON - FRONT
&
REAR
PANELS
File Name;
Tribrissen Injection 480 Cat
Preparation Date:
9.2.2001
Version:
2
Page 1
of?
38 Milk WHP.DOC
Last Revised:
12.12.2000
(8/3/2001)
Prepared By:
L. Wirth
TRIBRISSEN
INJECTION
480
PRIMARY
PACK
CARTON
(RIGHT PANEL)
READ THE ACCOMPANYING LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:SHAKE WELL BEFORE USE
DO NOT USE IN FEMALE SHEEP WHICH ARE PRODUCING OR MAY IN THE FUTURE
PRODUCE MILK
OR MILK PRODUCTS FOR HUMAN CONSUMPTION.
DOSE RATE:
1-1.5mL
per
30kg
bodyweight daily.
Cattle,
horses:
Inject intravenously
(slowly) or intramuscularly.
Sheep, pigs:
Inject intramuscularly.
WITHHOLDING PERIODS
MEAT:
DO NOT USE LESS THAN 28 DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION.
MILK (CATTLE):
MILK COLLECTED FROM COWS
WITHIN 72 HOURS
FOLLOWING TREATMENT
MUST NOT BE USED FOR HUMAN CONSUMPTION OR PROCESSING.
THIS MILK SHOULD NOT BE
FED TO BOBBY CALVES.
MILK (SHEEP):
DO NOT USE IN FEMALE SHEEP WHICH ARE PRODUCING OR MAY IN THE
FUTURE PRODUCE
milk
OR MILK PRODUCTS FOR HUMAN CONSUMPTION.
TRIBRISSEN
INJECTION
480
PRIMARY
PACK
CARTON
(LEFT PANEL)
DISPOSE
of
container
by
wrapping with paper
and
putting in garbage.
® Schering-Plough
Pty
Ltd Registered Trademark
Made in Australia by:
Jurox
Pty
Ltd
85 Gardiners Road,
Rutherford,
NSW
2320
Australia.
Under
Licence from:
Schering-Plough
Pty
Ltd
STORE
below
_2SoC_
(Air Conditioning)
PROTECT
from light.
NRA
36120/
_O'&J/_
EXP.
File Name:
Tribrissen Injection 480 Cat
Preparation Date:
9.2.2001
Version:
2
Page 2
of7
38 Milk WHP.DOC
Last
Revised:
12.12.2000
(8/3/2001 )
Prepared By:
L. Wirth
TRIBRISSEN INJECTION 480
PRIMARY PACK
TRIBRISSEN®
INJECTION - 480
TRllMETHOPRIM80mymL
SULFADIAZINE 400
mg/ml,
SOML
CARTON (TOP PANEL)
FILENAME:
TRIBRISSEN
INJECTION
48

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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIBRISSEN 48% INJECTION
Issue Date: March 2001
QAF140
Page 1 of 3
STATEMENT OF HAZARDOUS NATURE
HAZARDOUS ACCORDING TO CRITERIA OF NOHSC AUSTRALIA
COMPANY DETAILS
Company:
Jurox Pty Limited,
Address:
85 Gardiners Road, Rutherford NSW 2320
Telephone:
(02) 4931 8200 or 1800 023 312
Emergency Telephone No.:
(02) 4931 8200 or 1800 023 312
IDENTIFICATION
Product Name:
Tribrissen 48% Injection
Other Names:
Manufacturer’s Product Code:
60240
UN Number:
None Allocated
Dangerous Goods Class:
None Allocated
Subsidiary Risk:
None Allocated
Hazchem Code:
None Allocated
Poisons Schedule Number:
4
Use:
Antibiotic injection for the treatment of susceptible bacterial
infections in cattle, pigs, sheep and horses.
PHYSICAL PROPERTIES / DESCRIPTION
Appearance:
A suspension of almost white solid in pale straw coloured
liquid
Boiling Point/Melting Point:
Vapour Pressure:
Specific Gravity:
1.18 – 1.20
Flashpoint:
Flammability Limits:
Solubility in Water:
Miscible
pH:
10.0 – 11.0
OTHER PROPERTIES
INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Sulphadiazine
68-35-9
40%
Trimethoprim
738-70-5
8%
Water
7732-18-5
to 100%
MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIBRISSEN 48% INJECTION
Issue Date: March 2001
QAF140
Page 2 of 3
HEALTH & HAZARD INFORMATION
HEALTH EFFECTS
ACUTE
Swallowed:
May lead to epigastric distress, nausea and vomiting.
Eye:
Severe eye irritant.
Skin:
Moderate irritant.
Inhaled:
Does not present an inhalation problem.
Injected:
Effects will vary in severity according to the quantity involved, from
localised site reaction (pain, redness, swelling), to acute systemic
reaction.
CHRONIC
Sensitisation reactions from repeated skin contact. (rashes,
dermatitis) may occur.
FIRST AID
If poisoning occurs, contact a doctor or Poisons Information Centre
Phone: 13 11 26
Swallowed:
Rinse mouth with water. Give plenty of water or bland fluids to drink.
Induce vomiting. Seek medical attention. Show this MSDS to a
medical practitioner.
Eye:
Rinse immediately with plenty of water. Seek med

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