TRIBACTRAL ANTIBACTERIAL SUSPENSION FOR INJECTION

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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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:
100mL; 50mL
Class:
VM - Veterinary Medicine
Manufactured by:
INTERVET AUSTRALIA
Therapeutic group:
CATTLE | HORSE | PIGS | SHEEP EWE - DRY | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | CO
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
BACTERIAL INFECTION | INFECTIONS OF THE ALIMENTARY TRACT | INFECTIONS OF THE RESPIRATORY TRACT | INFECTIONS OF THE UROGENITAL TRACT | ACUTE RESPIRATORY INFECTIONS | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | BRONCHISEPTICA | BRONCHITIS | CYSTITIS | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | METRITIS | NEPHRITIS | PHARYNGITIS | PNEUMONIA | POST PARTURIENT BACTERIAL INFE | PRIMARY BACTERIAL INFECTION | SULFADIAZINE SENSITIVE BACTERI | TONSILLITIS | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA
Product summary:
Poison schedule: 4; Withholding period: WITHHOLDING PERIODS: MEAT: 28 Days. MI LK: (CATTLE): Milk collected from cows within 72 hours following treatment MUS T NOT BE USED for human consumption or processing. This milk should not be fed to bobby calves. TRADE ADVICE: Export Slaughter Interval (ESI): ESI not estab lished. For advice on the ESI contact J urox Pty Limited on 1800 023 312 before using this product.; 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 in cattle, sheep, pigs and horses.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 number:
48032
Authorization date:
2020-07-01

Info

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TRIBACTRAL ANTIBACTERIAL SUSPENSION FOR INJECTION

Page 1 of 7

Issued by: Jurox Pty Limited

Phone: 1800 023 312

Poisons Information Centre: 13 1126 from anywhere in Australia

ISSUED:

11 April 2016

SAFETY DATA SHEET

Section 1: IDENTIFICATION of CHEMICAL PRODUCT and COMPANY

Product Name:

TRIBACTRAL ANTIBACTERIAL SUSPENSION FOR

INJECTION

Product Code:

60210 (100 mL)

Recommended Use:

A sterile antibiotic injection for the treatment of infections caused

by organisms sensitive to trimethoprim and sulfadiazine in cattle,

sheep, pigs and horses.

Restrictions on Use:

For animal treatment only.

Company Identification:

Jurox Pty Limited

Address:

85 Gardiner Street,

Rutherford, NSW 2320,

Australia

Email:

jenq@jurox.com.au

Customer Centre:

1800 023 312

National Poisons Information Centre:

13 1126 (Australia-wide)

Emergency Telephone Number:

1800 023 312 (9am – 5pm, Monday to Friday)

Section 2: HAZARDS IDENTIFICATION

Hazard Classifications: This product has been assessed according to GHS and is classified as follows:

GHS Category

Hazard code

Hazard Statement

Acute Toxicity (Oral) Category 4

H302

Harmful if swallowed

Skin Corrosion/Irritation Category 2

H315

Causes skin irritation

Eye Irritation Category 2A

H319

Causes serious eye irritation

Respiratory Sensitizer Category 1

H334

May cause allergy or asthma symptoms or

breathing difficulties if inhaled.

Skin Sensitizer Category 1

H317

May cause an allergic skin reaction

Germ cell mutagenicity Category 2

H341

Suspected of causing genetic defects

Reproductive Toxicity Category 1B

H360

May damage fertility or the unborn child

Signal word: DANGER

GHS Pictograms:

Health Exclamation

hazard mark

TRIBACTRAL ANTIBACTERIAL SUSPENSION FOR INJECTION

Page 2 of 7

Issued by: Jurox Pty Limited

Phone: 1800 023 312

Poisons Information Centre: 13 1126 from anywhere in Australia

Precautionary statements:

Prevention

P201 Obtain special instructions before use.

P202 Do not handle until all safety precautions have been read and understood.

P261 Avoid breathing vapours.

P264 Wash hands areas thoroughly after handling.

P270 Do not eat, drink or smoke when using this product.

P272 Contaminated work clothing should not be allowed out of the workplace.

P280 Wear protective gloves, eye protection and face protection.

P281 Use personal protective equipment as required.

P285 In case of inadequate ventilation wear respiratory protection.

Response

P301+P312 IF SWALLOWED: Call a POISON CENTRE or doctor if you feel unwell.

P330 Rinse mouth.

P302+P352 IF ON SKIN: Wash with plenty of soap and water.

P333+P313 If skin irritation or rash occurs: Get medical advice/attention.

P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if

present and easy to do. Continue rinsing.

P337+P313 If eye irritation persists: Get medical advice/attention.

P304+P340 IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position

comfortable for breathing.

P342+P311 If experiencing respiratory symptoms: Call a POISON CENTRE or doctor.

P363 Wash contaminated clothing before reuse.

P308+P313: If exposed or concerned: Get medical advice.

Storage

P405 Store locked up.

Disposal

P501 Dispose of unused product in accordance with local regulations. Dispose of empty container by

wrapping with paper and placing in garbage.

Section 3: COMPOSITION / INFORMATION on INGREDIENTS

INGREDIENT

CAS No.

CONTENT

Sulfadiazine

68-35-9

Trimethoprim

738-70-5

Sodium hydroxide

1310-73-2

< 10%

Ingredients not contributing to the hazards

30 – 60%

Section 4: FIRST AID MEASURES

General Information: Never give fluids or induce vomiting if a patient is unconscious or convulsing

regardless of cause of injury. If medical advice/attention is needed, have this SDS, product container or label

at hand.

Symptoms and Effects of Exposure: Overdose of sulfadiazine may cause an accumulation of acid in the

blood or a diminished blood sugar level with confusion and coma resulting. Symptoms of exposure to

trimethoprim include nausea, vomiting, headache, pruritis (itchiness) and skin rash. Disturbance of liver and

kidney function may also occur.

Inhalation: If fumes, aerosols or combustion products are inhaled remove from contaminated area. Other

measures are usually not necessary. If respiratory symptoms occur, remove patient to fresh air. Lay patient

down and keep warm and rested. If breathing is shallow or has stopped, ensure airway is clear and apply

resuscitation. If breathing is difficult, give oxygen and seek medical assistance immediately.

TRIBACTRAL ANTIBACTERIAL SUSPENSION FOR INJECTION

Page 3 of 7

Issued by: Jurox Pty Limited

Phone: 1800 023 312

Poisons Information Centre: 13 1126 from anywhere in Australia

Ingestion: IF SWALLOWED, REFER FOR MEDICAL ATTENTION, WHERE POSSIBLE, WITHOUT DELAY.

For advice, contact a Poisons Information Centre or a doctor. Urgent hospital treatment is likely to be needed.

In the meantime, give water to rinse out mouth, then provide liquid slowly and as much as casualty can

comfortably drink. Never give liquid to a person showing signs of being sleepy or with reduced awareness; i.e.

becoming unconscious. If vomiting occurs, lean patient forward or place on left side (head-down position, if

possible) to maintain open airway and prevent aspiration. Observe the patient carefully.

Injection: Treat as for needlestick injury. Wash area well and disinfect. If other symptoms become evident,

seek medical advice.

Skin: If skin contact occurs: Immediately remove all contaminated clothing, including footwear. Flush skin and

hair with running water (and soap if available). Seek medical attention in event of irritation.

Eye: If eye contact occurs:

Immediately flush the eye continuously with running water. Ensure complete

irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally lifting

the upper and lower lids. Continue flushing for at least 20 minutes. Seek medical advice/attention.

Recommended First Aid Facilities: Ready access to running water and soap is required. Accessible

eyewash is required.

Advice to Doctor: Treat symptomatically.

Flash Point: No data.

Hazardous Combustion Products: If involved in a fire, may emit noxious and irritant fumes.

Extinguishing Media: There is no restriction on the type of extinguisher which may be used. Use

extinguishing media suitable for surrounding area.

Protective Equipment: Protective gloves and breathing apparatus.

HAZCHEM Code: None specified.

Spills and Disposal: Wear gloves and appropriate protective clothing. Avoid breathing and contact with skin

and eyes. For small spills, sweep up spilled product then wipe area and put empty container in garbage. For

large spills, exclude non-essential people from the area. Prevent spillage from entering drains or water

courses and call emergency services.

Protective Clothing: For appropriate personal protective equipment see section 8.

Environmental Precautions: Prevent from entering drains, waterways or sewers. If spill does enter

waterways contact local authority.

Handling: Use in a well-ventilated area. Avoid accidental self-injection. Avoid contact with skin, eyes and

inhalation of vapours. Use personal protective equipment as required. DO NOT allow clothing wet with

material to stay in contact with skin. Do not eat, drink or smoke while handling product. Wash hands after use.

Storage: Keep out of reach of children. Store below 25ºC (air conditioning). Protect from light.

Other Information: Avoid contact with incompatible substances as listed in Section 10. Always read the label

before use.

Section 5: FIRE FIGHTING MEASURES

Section 6: ACCIDENTAL RELEASE MEASURES

Section 7: HANDLING AND STORAGE

TRIBACTRAL ANTIBACTERIAL SUSPENSION FOR INJECTION

Page 4 of 7

Issued by: Jurox Pty Limited

Phone: 1800 023 312

Poisons Information Centre: 13 1126 from anywhere in Australia

This SDS describes personal protective measures relating to long term industrial and manufacturing

exposure and emergency situations, such as accidents and spills. See product label for personal

protective measures during normal use of the marketed product.

Exposure Limits: No exposure limits have been assigned for this product nor for any ingredients. The ADI

for trimethoprim is 0.02 mg/kg/day. The NOEL for trimethoprim is 33 mg/kg/day.

Engineering Controls: Use in a well-ventilated area and make sure that the work environment remains

clean.

Personal Protective Equipment (PPE):

Eye protection: Protective glasses or goggles are recommended when handling this product.

Skin protection: Prevent skin contact by wearing chemical protective gloves e.g. PVC.

Respiratory protection: Not required for the normal use of this product.

Appearance:

Pale yellow solution with

white precipitate which is

readily dispersible to form a

suspension.

Odour:

Not available

Odour threshold:

Not available

pH:

10.0 – 10.5

Melting Point:

Not available

Boiling Point:

Not available

Flash Point:

Not available

Evaporation Rate:

Not available

Flammability:

Not flammable

Upper flammability

Not available

limits:

Lower flammability

Not available

limits:

Vapour Pressure:

Not available

Vapour density:

Not available

Relative density:

Not available

Specific Gravity:

Approx. 1.19

Solubility in Water:

Miscible

Partition coefficient:

Not available

Auto-ignition

temperature:

Not available

Decomposition

temperature:

Not available

Viscosity:

Not available

Reactivity: This product is unlikely to react or polymerise under normal storage conditions.

Stability: When stored appropriately this product should show no significant degradation within the expiry

period shown on the label.

Conditions to Avoid: Extreme temperatures.

Incompatible Materials: Oxidising agents.

Hazardous Decomposition Products: No data available.

Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

Section 9: PHYSICAL AND CHEMICAL PROPERTIES

Section 10: STABILITY AND REACTIVITY

TRIBACTRAL ANTIBACTERIAL SUSPENSION FOR INJECTION

Page 5 of 7

Issued by: Jurox Pty Limited

Phone: 1800 023 312

Poisons Information Centre: 13 1126 from anywhere in Australia

Acute Toxicity:

Ingestion: The product is classified as harmful if swallowed. Sulfadiazine is readily absorbed from the gastro-

intestinal tract. Animal experiments indicate that ingestion of less than 150 g of sulfadiazine or trimethoprim

may be fatal or may produce serious damage to the health of the individual.

Sulfadiazine: Oral (mouse) LD

: 1500 mg/kg.

Trimethoprim: Oral (mouse) LD

: 2764 mg/kg.

Sodium hydroxide: Oral (rabbit) LD

: 500 mg/kg.

Inhalation: No data available.

Dermal: No data available.

Injection: If injected perivascularly irritation or tissue death may occur due to the alkaline nature of the

product.

Sulfadiazine: Subcutaneous (mouse) LD

: 1600 mg/kg; Intraperitoneal (mouse) LD

: 750 mg/kg;

Intravenous (mouse) LD

: 180 mg/kg.

Trimethoprim: Subcutaneous (mouse, rat) LD

: > 5000 mg/kg; Intraperitoneal (mouse) LD

400 mg/kg; Intravenous (mouse) LD

: 132 mg/kg.

Sodium hydroxide: Intraperitoneal (mouse) LD

: 40 mg/kg.

Skin Corrosion / Irritation: The product is classified as a skin irritant. Sulfadiazine is considered to be a skin

irritant and the alkaline nature of the solution can also cause skin irritation / corrosion.

Serious Eye Damage / Irritation: The product is classified as a serious eye irritant. Sulfadiazine is

considered to be an eye irritant and the alkaline nature of the solution can also cause serious eye irritation.

Respiratory or Skin Sensitisation: Due to the presence of sulfadiazine the product is classified as a

respiratory sensitiser and a skin sensitiser.

Germ Cell Mutagenicity: The product is classified as a germ cell mutagen. Strong evidence exists that

trimethoprim may cause irreversible mutations (though not lethal) even following a single exposure.

Carcinogenicity: No data for the mixture is available. Based on available data for the ingredients, the mixture

is not considered to be carcinogenic.

Reproductive Toxicity: The product is classified as a reproductive toxicant. Ample evidence exists that

developmental disorders are directly caused by human exposure to trimethoprim. Trimethoprim is teratogenic

and embryotoxic at high doses through folic acid antagonism. In addition, there is a suspicion that

trimethoprim directly reduces fertility.

STOT: Single exposure: No data for the mixture is available. Based on available data for the ingredients, the

mixture is not considered to be a specific target organ toxicant after single exposure.

STOT: Repeat exposure: No data for the mixture is available. Based on available data for the ingredients,

the mixture is not considered to be a specific target organ toxicant after repeat exposure. However,

sulfonamides and their derivatives have been known to cause extensive kidney damage, and destroy red

blood cells.

Aspiration hazard: No data available.

Section 11: TOXICOLOGICAL INFORMATION

TRIBACTRAL ANTIBACTERIAL SUSPENSION FOR INJECTION

Page 6 of 7

Issued by: Jurox Pty Limited

Phone: 1800 023 312

Poisons Information Centre: 13 1126 from anywhere in Australia

Ecotoxicity:

Trimethoprim is harmful in the aquatic environment.

Fish

Sulfadiazine: LC

(96h): 4033 mg/L.

Trimethoprim: LC

(96h): 796 mg/L.

Sodium hydroxide: LC

(96h): 4.2 mg/L; NOEC (96h): 56 mg/L.

Crustacea

Sulfadiazine: LC

(48h): 88 mg/L.

Sodium hydroxide:

(48h): 40.4 mg/L; EC

(384h) 27902 mg/L.

Algae and other aquatic plants

Sulfadiazine: EC

(168h): 0.14 mg/L.

Trimethoprim: EC

(96h): 2.6 mg/L, NOEC (72h): 16 mg/L.

Sodium hydroxide: EC

(96h): 1034 mg/L.

Ingredient

Persistence:

Water/Soil

Persistence:

Air

Bioaccumulation

Mobility

Sulfadiazine

HIGH

HIGH

(LogKOW = -0.09)

(KOC = 188.9)

Trimethoprim

HIGH

HIGH

(LogKOW = 0.91)

(KOC = 905)

Sodium hydroxide

(LogKOW = -3.8796)

(KOC = 14.3)

Product Disposal: Dispose of product only by using according to label or at an approved landfill.

Container Disposal: Dispose of container by wrapping with paper and placing in garbage.

Dangerous Goods Classification: Not considered a Dangerous Good for land, sea and air transport.

Poison Schedule (SUSMP): S4

APVMA No.: 48032

AICS: All of the significant ingredients in this formulation are compliant with NICNAS regulations.

Section 12: ECOLOGICAL INFORMATION

Section 13: DISPOSAL INFORMATION

Section 14: TRANSPORT INFORMATION

Section 15: REGULATORY INFORMATION

TRIBACTRAL ANTIBACTERIAL SUSPENSION FOR INJECTION

Page 7 of 7

Issued by: Jurox Pty Limited

Phone: 1800 023 312

Poisons Information Centre: 13 1126 from anywhere in Australia

This information is based on data believed by Jurox Pty Limited to be accurate at the time of writing but is subject to change without notice. It is given

in good faith, but no warranty expressed or implied is made as to its accuracy, completeness otherwise and no assumption of liability from howsoever

arising is made by Jurox Pty Limited by reason of the provision of this information. Every person dealing with the materials referred to herein does so

at his/her own risk absolutely and must make independent determinations of suitability and completeness of information from all sources to ensure

their proper use.

Legend:

ADG Code

Australian Dangerous Goods Code.

ADI

AICS

Australian Inventory of Chemical Substances.

CAS No.

Chemical Abstracts Service Registry Number.

EC

50

The median effect concentration, being a statistically derived concentration of a substance

that can be expected to cause an adverse reaction in 50% of organisms or a 50%

reduction in growth or in the growth rate of organisms.

GHS

Globally Harmonized System of Classification and Labelling of Chemicals.

Hazchem Code

Emergency action code of numbers and letters that provide information to emergency

services especially firefighters.

IATA

International Air Transport Association.

IMDG Code

International Maritime Dangerous Goods Code.

KOC

Soil-Water Partition Coefficient. The ratio of a chemical’s concentration that is adsorbed in

the soil to the concentration of chemical in solution.

KOW

Octanol Water Partition Coefficient. The ratio of a compound's concentration in a known

volume of n-octanol to its concentration in a known volume of water after the octanol and

water have reached equilibrium.

LC

50

The median lethal concentration, being a statistically derived concentration of a substance

that can be expected to cause death in 50% of animals.

LD

50

The median lethal dose, being a statistically derived single dose of a substance that can

be expected to cause death in 50% of animals.

NICNAS

National Industrial Chemicals Notification and Assessment Scheme.

NOEC

No-observable-effect-concentration.

NOEL

No-observable-effect-level

PPE

Personal Protective Equipment.

PVC

Polyvinyl chloride.

SDS

Safety Data Sheet.

STOT

Specific Target Organ Toxicity.

SUSMP

Standard for the Uniform Scheduling of Medicines and Poisons.

SWA

Safe Work Australia.

References:

ChemID Plus

EPA New Zealand Chemical Classification and Information Database (CCID)

HSDB (Hazardous Substances Data Bank)

This version issued: 11 April 2016 and is valid for 5 years from this date.

Supercedes: This SDS supercedes the version issued on 30 June 2011.

Revision History:

Date of Revision

Reason

11 April 2016

GHS classification and update of SDS to comply with SWA Code of Practice.

END OF SDS

Section 16: OTHER INFORMATION

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