TRIBACTRAL S ANTIBACTERIAL SOLUTION FOR INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TRIMETHOPRIM; SULFADOXINE

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

trimethoprim(40mg/mL)+sulfadoxine(200mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TRIMETHOPRIM PYRIMIDINE Active 40.0 mg/ml; SULFADOXINE SULFANYL Active 200.0 mg/ml

Units in package:

100mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

CAT | CATTLE | DOG | HORSE | PIGS | SHEEP | BEEF | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK |

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

ORGANISMS SENSITIVE TO SULFADOXINE | ORGANISMS SENSITIVE TO TRIMETHOPRIM

Product summary:

Poison schedule: 4; Withholding period: MEAT: (CATTLE, SHEEP, PIGS): DO NOT USE less than 14 days before slaughter for h uman consumption. (HORSES): DO NOT USE l ess than 28 days before slaughter for hu man consumption. MILK: Milk collected f rom cows and ewes within 36 hours (3 mil kings) following a single treatment or 7 2 hours (6 milkings) following the last of multiple treatments, MUST NOT BE USED or processed for human consumption, or fed to bobby calves. Any variation by t he prescribing veterinarian to the appro ved dose, frequency, duration, route, di sease or target species may result in th e need to extend the approved withholdin g period. EXPORT SLAUGHTER INTERVAL (ES I): An ESI has not established for this product. Note–observing the meat withho lding period may not be sufficient to mi tigate potential risks to export trade. Trade advice should be sought from Jurox Pty Limited on 1800 023 312 before usin g this product.; Host/pest details: CAT: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; CATTLE: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; DOG: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; HORSE: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; PIGS: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; SHEEP: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; Poison schedule: 4; Withholding period: WHP: Meat: (Cattle Sheep Pigs): Do n ot use less than 14 days before slaught er for human consumption. (Horses): Do not use less than 28 days before slaugh ter for human consumption. Milk: Milk collected from cows and ewes within 36 hours (3 milkings) following a single t reatment or 72 hours (6 milkings) follo wing the last of multiple treatments m ust not be used for human consumption o r processing. This milk should not be f ed to bobby calves. TRADE ADVICE: Expo rt Slaughter Interval (ESI): ESI not es tablished. For advice on the ESI contac t Jurox Pty Limited on 1800 023 312 bef ore using this product.; Host/pest details: CAT: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; CATTLE: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; DOG: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; HORSE: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; PIGS: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; SHEEP: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; CATTLE: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; DOG: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; HORSE: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; PIGS: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; SHEEP: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; For the treatment of infections caused by organisms sensitive to trimethoprim and sulfadoxine in cattle, sheep, pigs, horses, cats and dogs.See warnings on label/leaflet re use in horses & cats.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Info
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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIBACTRAL-S INJECTION
Issue Date: 01FEB08
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 Gardiner Road, Rutherford NSW 2320
Telephone:
[phone] or 1800 023 312
Emergency Telephone No.:
[phone] or 1800 023 312
IDENTIFICATION
Product Name:
Tribactral-S Injection
Other Names:
Manufacturer’s Product Code:
60230
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 and horses.
PHYSICAL PROPERTIES / DESCRIPTION
Appearance:
Pale yellow, clear solution, free from particulate matter.
Boiling Point/Melting Point:
Vapour Pressure:
Specific Gravity:
1.14 - 1.16
Flashpoint:
Flammability Limits:
Solubility in Water:
Miscible
pH:
10 – 11
OTHER PROPERTIES
INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Sulphadoxine
2447-57-6
20.0%
Trimethoprim
738-70-5
4.0%
Water
7732-18-5
to 100%
MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIBACTRAL-S INJECTION
Issue Date: 01FEB08
QAF140
Page 2 of 3
HEALTH & HAZARD INFORMATION
HEALTH EFFECTS
ACUTE
Swallowed:
Harmful if swallowed. Rapidly absorbed through the gastrointestinal
tract. May lead nausea, vomiting and possible convulsions.
Eye:
Severe irritant.
Skin:
Irritating to the skin. Has a degreasing effect on the skin which may
cause allergic reaction and sensitisation.
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
Due to the presence of Sulphadoxine, prolonged or repeated exposure
may lead to sensitisation
reactions, anorexia, goitre, insomnia, fatigue, depression, and renal
complications.
FIRST AID
If poisoning occurs, contact a doctor or Poisons Informatio

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Trimethoprim 40 mg/mL, sulfadoxine 200 mg/mL
ACTIONS
Effective against most Gram-positive and Gram-negative bacteria. The
two components produce a sequential double blockade of
bacterial metabolism providing a broader spectrum of activity than
either component acting alone.
INDICATIONS
Bacterial infections due to susceptible organisms.
NOTE: These pathogens are NOT sensitive to Tribactral S:
_Erysipelothrix, Leptospira, Pseudomonas _and _Mycobacterium
tuberculosis_.
CONTRAINDICATIONS
Known sulfonamide sensitivity. Parenchymal hepatic damage. Blood
dyscrasias. Prior to and after treatment with sedatives /
anaesthetics when horse is recumbent.
WITHHOLDING PERIODS
MEAT: DO NOT USE less than 14 days (cattle, sheep, pigs) or 28 days
(horses) before slaughter for human consumption.
MILK: 36 hours (3 milkings) for single dose, 72 hours (6 milkings) for
multiple doses.
TRIBACTRAL
® S
Antibacterial Solution for Injection
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
DOSAGE AND ADMINISTRATION
Shake well before use.
INTRAMUSCULAR INJECTION
Cattle, sheep, pigs: 1 mL/15 kg bodyweight daily. 1 mL/10 kg
bodyweight in cases of severe infection.
Cats: 1 mL/15 kg.
SUBCUTANEOUS INJECTION
Dogs, cats: 1 mL/15 kg.
Note: In dogs and cats, if treatment is to be continued with a course
of either Tribrissen 20 or Tribrissen 80 within 12 hours,
administer at a dose of 1 mL/15 kg. If the administration of the first
tablet is to be delayed until the day following injection,
then the dose is 1 mL/8 kg bodyweight.
SLOW INTRAVENOUS INJECTION
Horses: 1 mL/15 kg daily. THE SUBCUTANEOUS AND INTRAMUSCULAR ROUTES
ARE NOT RECOMMENDED IN HORSES.
Where necessary, for instance in cases of acute infection, Tribactral
S may also be administered intravenously to cattle, sheep, pigs and
dogs. DO NOT USE intravenously in cats.
PRESENTATION
Injection: 100 mL
GHS INFORMATI