VR TRIBACTRAL DUALS ANTIBACTERIAL PESSARY/BOLUS

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(200mg/PB)+sulfadiazine(1000mg/PB)

Pharmaceutical form:

ORAL BOLUS + INTRA VAGINAL/UTERINE

Composition:

TRIMETHOPRIM PYRIMIDINE Active 200.0 mg/PB; SULFADIAZINE SULFANYL Active 1000.0 mg/PB

Units in package:

20 Bol/Pes

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 14 days before slaughter for human consumption. Milk:Do not use in female cattle or s heep which are producing or may in the future produce milk or milk products for human consumption.; Host/pest details: CATTLE: [BACTERIAL INFECTION]; HORSE: [BACTERIAL INFECTION]; PIGS: [BACTERIAL INFECTION]; SHEEP: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [BACTERIAL INFECTION]; HORSE: [BACTERIAL INFECTION]; PIGS: [BACTERIAL INFECTION]; SHEEP: [BACTERIAL INFECTION]; For the treatment of infections in cattle, sheep, horses and pigs caused by organisms sensitive to trimethoprim and sulfadiazine.Do not use in female cattle or 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

File Name:
36206_0102c.doc
Prepared By:
L. Wirth
Preparation Date:
7/1/2002
Last Revised:
9/2/2001
Schering-Plough Label & Printer
Specifications:
Jurox Pty Ltd
Version:
1
(7/1/2002)
Page 1 of 4
TRIBACTRAL DUALS
IMMEDIATE CONTAINER
LABEL - MAIN PANEL
PRESCRIPTION ANIMAL REMEDY_ _
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
VR
®
TRIBACTRAL
® DUALS
_ _
ANTIBACTERIAL PESSARY/BOLUS
Each pessary/bolus contains
200 mg TRIMETHOPRIM
1000 mg SULFADIAZINE
20 PESSARIES/BOLUSES
JUROX LOGO
Info
PEST

Verified
File Name:
36206_0102c.doc
Prepared By:
L. Wirth
Preparation Date:
7/1/2002
Last Revised:
9/2/2001
Schering-Plough Label & Printer
Specifications:
Jurox Pty Ltd
Version:
1
(7/1/2002)
Page 2 of 4
TRIBACTRAL DUALS
IMMEDIATE CONTAINER
LABEL - RIGHT PANEL (SIDE)
For the treatment of infections in cattle, sheep, horses and pigs
caused by organisms sensitive
to trimethoprim and sulfadiazine.
READ THE ACCOMPANYING LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
DO NOT USE IN LACTATING OR PREGNANT COWS/EWES WHERE MILK OR MILK
PRODUCTS MAY BE
USED FOR HUMAN CONSUMPTION.
DOSE RATES: ORAL - Calves and foals - 1 bolus per 40 kg bodyweight
daily. Ideally dose
should be divided and given twice daily as required. Repeat treatment
daily.
INTRA-UTERINE – Non-lactating cows – 2-4 pessaries. Mares 2-4
pessaries. Non-lactating ewes
1-2 pessaries. Sows 1-2 pessaries. Repeat treatment as required.
WITHHOLDING PERIODS: MEAT - 14 DAYS.
MILK -
DO NOT USE IN LACTATING OR PREGNANT COWS/EWES WHERE MILK OR MILK
PRODUCTS
MAY BE USED FOR HUMAN CONSUMPTION.
TRIBACTRAL DUALS
IMMEDIATE CONTAINER
LABEL - LEFT PANEL (SIDE)
®
Registered Trade Mark
JUROX PTY. LIMITED
85 Gardiners Road, Rutherford,NSW 2320 Australia
Under Licence from Schering-Plough Pty Ltd
DISPOSE of container by wrapping with paper and putting in garbage.
STORE below 30
0
C (Room Temperature)
(B)
EXP.
NRA 36206/0102
File Name:
36206_0102c.doc
Prepared By:
L. Wirth
Preparation Date:
7/1/2002
Last Revised:
9/2/2001
Schering-Plough Label & Printer
Specifications:
Ju

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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIBACTRAL DUALS
Issue Date: March 2001
QAF140
Page 1 of 3
STATEMENT OF HAZARDOUS NATURE
NOT CLASSIFIED AS 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:
Tribactral Duals
Other Names:
Manufacturer’s Product Code:
60170
UN Number:
None Allocated
Dangerous Goods Class:
None Allocated
Subsidiary Risk:
None Allocated
Hazchem Code:
None Allocated
Poisons Schedule Number:
4
Use:
Antibiotic bolus for the treatment of bacterial enteritis in foals,
calves and sheep. Pessary for the intrauterine prevention and
treatment of post-parturient bacterial infections and other
genital tract infections.
PHYSICAL PROPERTIES / DESCRIPTION
Appearance:
Long white oblet, half-scored on one side
Boiling Point/Melting Point:
Vapour Pressure:
Specific Gravity:
Flashpoint:
Non-flammable
Flammability Limits:
Solubility in Water:
Partly soluble, disintegrate
Table Weight:
~5.4g
OTHER PROPERTIES
INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Sulphadiazine
68-35-9
19%
Trimethoprim
738-70-5
0.37%
Lactose
63-42-3
to 100%
MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIBACTRAL DUALS
Issue Date: March 2001
QAF140
Page 2 of 3
HEALTH & HAZARD INFORMATION
HEALTH EFFECTS
ACUTE
Swallowed:
Rapidly absorbed from the gastrointestinal tract. May lead to nausea,
vomiting and possible convulsions.
Eye:
Non-irritant due to the nature of the produce.
Skin:
Non-irritant. May cause sensitisation reactions in certain
individuals.
Inhaled:
Does not present an inhalation problem.
CHRONIC
Due to the presence of Trimethoprim, prolonged or repeated exposure
may lead to skin rash,
pruritis and dermatitis. Due to the presence of Sulphadiazine,
prolonged or repeated exposure may
lead to sensitisation and allergic reactions
FIRST AID
If poisoning occurs, contact a doctor or Poisons Information Centre
Phone: 13 11

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