BRONCOPULMIN PLUS TMPS ORAL POWDER

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

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Active ingredient:
CLENBUTEROL HYDROCHLORIDE; TRIMETHOPRIM; SULFADIAZINE
Available from:
Jurox Pty Limited
INN (International Name):
clenbuterol HCl(21.44ug/g)+sulfadiazine(335mg/g)+trimethoprim(67mg/g)
Pharmaceutical form:
ORAL POWDER, PRE-MIX
Composition:
CLENBUTEROL HYDROCHLORIDE ANILIDE/ANILINE Active 21.44 ug/g; TRIMETHOPRIM PYRIMIDINE Active 67.0 mg/g; SULFADIAZINE SULFANYL Active 335.0 mg/g
Units in package:
400g; 500g
Class:
VM - Veterinary Medicine
Therapeutic group:
HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL
Therapeutic area:
RESPIRATORY + ANTIBIOTIC
Therapeutic indications:
ANTIBIOTIC - ANTI-INFECTIVE | BRONCHODILATOR | ABRASIONS | ABSCESSES | AIRSACCULITIS | ANTISEPTIC | AVIAN MYCOPLASMAS | BLACKHEAD | BODY ODOURS | BOWED TENDONS | BROAD SPECTRUM | BURNS | COCCIDIOSIS | COLIFORM COMPLEX | CONJUNCTIVITIS | COWPOX | CRACKS | CRUSTS | DANDRUFF | DERMATOLOGICAL DISORDERS | DERMATOSIS | DRY SKIN | DYSENTERY | ECZEMA | ENDOMETRITIS | ENTERIC DISEASES | ENZOOTIC PNEUMONIA | FEED EFFICIENCY | FUNGAL INFECTIONS | GIRTH GALLS | INFECTIONS | INFLAMMED PADS | ITCHING | KERATOLYTIC | LACERATIONS | MASTITIS | MYCOPLASMAS | ODOURS | OPEN WOUNDS | OTITIS | PRURITIS | QUEENSLAND ITCH | RESPIRATORY DISEASE | SADDLE RASH | SALMONELLOSIS | SCABS | SCALY SKIN | SHEATH ROT | SKIN IRRITATIONS | SORES | SWINE DYSENTERY | TEAT CRACKING | TEAT INFECTIONS | TOPICAL INFECTIONS | UDDER SORES | WEIGHT GAIN | WIRE CUTS | WOUNDS
Product summary:
Poison schedule: 4; Withholding period: WHP: Do not use in horses that may be slaughtered for human consumption.; Host/pest details: HORSE: [ANTIBIOTIC - ANTI-INFECTIVE, BRONCHODILATOR]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [ANTIBIOTIC - ANTI-INFECTIVE, BRONCHODILATOR]; Oral bronchodilator and antibacterial for respiratory disease in horses.DO NOT USE in food producing animals. Should not be used in horses during the last 14 days of digestion as uterine contractions may be prevented
Authorization status:
Registered
Authorization number:
50718
Authorization date:
2019-07-01

BRONCOPULMIN PLUS TMPS ORAL POWDER

Page 1 of 6

continued

ISSUED:

12 February 2013

SAFETY DATA SHEET

Section 1: IDENTIFICATION of CHEMICAL PRODUCT and COMPANY

Product Name:

BRONCOPULMIN PLUS TMPS ORAL POWDER

Product Code:

501805 (500 g)

Recommended Use:

Oral bronchodilator and antibacterial for use in the treatment of respiratory

disease in horses

Company Identification:

Jurox Pty Limited

Address:

85 Gardiner Street

Rutherford NSW 2320

Australia

Customer Centre:

1800 02 3312

National Poisons Information Centre:

13 1126 (Australia-wide)

Emergency Telephone Number:

1800 02 3312 (9 a.m. – 5 p.m.)

Section 2: HAZARDS IDENTIFICATION

GHS Hazard Classifications:

Acute Toxicity (Oral) Category 4

Eye Irritation Category 2A

Reproductive Toxicity Category 2

Respiratory Sensitizer Category 1

Skin Corrosion/Irritation Category 2

Skin Sensitizer Category 1

STOT - SE (Resp. Irr.) Category 3

GHS Pictograms*:

Health hazard

Exclamation

mark

Signal Word*:

Danger

Hazard Statements*:

Harmful if swallowed.

Causes skin irritation.

May cause an allergic skin reaction.

Causes serious eye irritation.

May cause allergy or asthma symptoms or breathing difficulties if inhaled.

May cause respiratory irritation.

Suspected of damaging fertility or the unborn child.

Precautionary Statements*:

Prevention

Obtain special instructions before use.

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

Avoid breathing dust.

Wash hands thoroughly after handling.

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

Use only outdoors or in a well-ventilated area.

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

Wear protective gloves and protective eye protection.

In case of inadequate ventilation wear respiratory protection.

BRONCOPULMIN PLUS TMPS ORAL POWDER

Page 2 of 6

continued

Response

IF exposed or concerned: Get medical advice.

IF SWALLOWED: Call a POISON CENTRE or doctor if you feel unwell. Rinse mouth.

IF ON SKIN: Wash with plenty of soap and water. If skin irritation or rash occurs: Get

medical advice.

Take off contaminated clothing and wash before re-use.

IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for

breathing. If experiencing respiratory symptoms or if you feel unwell: Call a POISON

CENTRE or doctor.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses,

if present and easy to do. Continue rinsing. If eye irritation persists: Get medical

advice.

Storage

Store in a well-ventilated place. Keep container tightly closed.

Store locked up.

Disposal

Dispose of contents / container in accordance with local / national regulations.

* N.B.: These statements are determined by Work Health and Safety regulations and may not reflect Signal Headings and

First Aid and Safety statements on product labelling, which are determined by a competent authority during assessment

for registration.

Section 3: COMPOSITION / INFORMATION on INGREDIENTS

INGREDIENT

CAS No.

CONTENT

Clenbuterol hydrochloride

21898-19-1

<0.01%

Sulfadiazine

68-35-9

33.5%

Trimethoprim

738-70-5

6.7%

Other ingredients determined to be non-

hazardous

~60%

Section 4: FIRST AID MEASURES

First Aid Measures:

Consult the National Poisons Centre on 131126 or a doctor immediately in every case of

suspected chemical poisoning. 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 product

container or label at hand.

Inhalation:

May cause allergy or asthma symptoms or breathing difficulties if inhaled. If suspected,

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. Seek medical assistance immediately.

Ingestion:

If swallowed, DO NOT induce vomiting. Rinse mouth. Keep subject warm and at rest. For

advice, contact a doctor or the National Poisons Centre on 13 1126. Show this SDS to a

medical practitioner.

Clenbuterol is a tocolytic agent and may arrest uterine contractions in labour.

Skin:

May cause sensitive rash in certain individuals. If skin contact occurs, wash affected area

thoroughly with plenty of soap and water. If skin irritation or rash occurs, get medical

advice/attention.

Eye:

If eye contact occurs, rinse cautiously with water for at least 20 minutes. Continue rinsing. If

eye irritation persists, get medical advice.

Advice to Doctor:

Contains clenbuterol which is a bronchodilator and tocolytic agent, and the antimicrobials

sulfadiazine and trimethoprim. Treat symptomatically.

BRONCOPULMIN PLUS TMPS ORAL POWDER

Page 3 of 6

continued

Flash Point:

Not flammable. Combustion is difficult.

Hazardous Combustion

If involved in a fire may emit toxic and corrosive fumes.

Products:

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 boots and breathing apparatus.

HAZCHEM Code:

None specified.

Spills and Disposal:

Due to the nature of the packaging, large spills are unlikely to occur. In the event of a large

spill, wear appropriate protective clothing. Exclude non-essential people from the area. Use dry

clean up procedures and avoid generating dust. Ventilate area and wash spill site after pick-up

complete. Dispose of waste safely.

Protective Clothing:

For appropriate personal protective equipment see section 8.

Environmental

Prevent from entering drains, waterways or sewers. If contamination of drains and waterways

Precautions:

occurs, advise Emergency Services.

Handling:

This is a Schedule 4 (Prescription Animal Remedy) product, available only to or through a

veterinarian. Handle this product with care to avoid exposure, taking all recommended

precautions. Avoid contact with skin and eyes. Wash hands after use. Use other personal

protective equipment as required.

Storage:

Keep out of reach of children. Store below 30ºC (room temperature) in a dry place. Protect

from light. Store away from foodstuffs.

Other Information:

Always read the label before use. See label for further information on handling and storage.

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. Do not handle until all safety

precautions have been read and understood.

Protective Equipment:

Safety glasses with eye side shields or chemical goggles. Chemical protective gloves,

e.g. PVC. Safety footwear or safety gumboots, e.g. rubber. Respirator (particulate) may be

necessary when engineering and administrative controls do not adequately prevent exposure.

Engineering Controls:

Handle in a well-ventilated area.

Hygiene Precautions:

Do not drink, eat or smoke when handling this product. Wash hands after use.

Section 5: FIRE FIGHTING MEASURES

Section 6: ACCIDENTAL RELEASE MEASURES

Section 7: HANDLING AND STORAGE

Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

BRONCOPULMIN PLUS TMPS ORAL POWDER

Page 4 of 6

continued

Appearance:

Fine, white powder.

Odour:

Not available.

Odour threshold:

Not available.

pH:

Not applicable.

Melting Point:

Not available.

Boiling Point:

Not applicable.

Flash Point:

Not flammable.

Evaporation Rate:

Not available.

Flammability:

Not applicable.

Upper flammability

Not applicable.

limits:

Lower flammability

Not applicable.

limits:

Vapour Pressure:

Not applicable.

Vapour density:

Not applicable.

Relative density:

0.7.

Specific Gravity:

Not applicable.

Solubility in Water:

Partly miscible.

Partition coefficient:

Not applicable.

Auto-ignition

temperature:

Not available.

Decomposition

temperature:

Not available.

Viscosity:

Not applicable.

Stability:

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

expiry period shown on the label.

Hazardous

Not known to occur.

Polymerisation:

Materials to Avoid:

Avoid oxidising agents.

Inhalation:

May cause allergy or asthma symptoms or breathing difficulties if inhaled.

Ingestion:

May result in nausea or vomiting, tremors, palpitations, muscle cramps, tachycardia,

headaches and peripheral vasodilation. Clenbuterol is a tocolytic agent and may arrest uterine

contractions in labour.

Clenbuterol: TD

(women) = 0.0046 mg/kg

Trimethoprim: LD

(oral): 1500 – 1850 (rat); 2764 mg/kg (mouse)

Skin:

May cause a sensitivity rash in certain individuals.

Eye:

May cause eye irritation.

Chronic Effects:

Due to the presence of sulfadiazine prolonged or repeated exposure may lead to sensitization

reactions. Keratitis sicca, possibly due to prolonged use of sulfonamides, has been reported in

some animal species. Trimethoprim / sulfonamide combinations may cause folic acid

deficiency, leading to macrocytic anaemia. Due to the presence of trimethoprim, prolonged or

repeated contact may lead to nausea, vomiting, skin rash and pruritus. In addition, lung

function may be altered by long term exposure to dust particles.

Mutagenicity:

Not known to be mutagenic.

Carcinogenicity:

Not known to be carcinogenic.

Reproductive Toxicity:

Possible teratogenic effects may occur after long term exposure to trimethoprim. Sulfadiazine

is a suspected developmental toxicant.

Section 9: PHYSICAL AND CHEMICAL PROPERTIES

Section 10: STABILITY AND REACTIVITY

Section 11: TOXICOLOGICAL INFORMATION

BRONCOPULMIN PLUS TMPS ORAL POWDER

Page 5 of 6

continued

Ecotoxicity:

Not known to be ecotoxic.

Ingredient

Persistence:

Water/Soil

Persistence:

Air

Bioaccumulation

Mobility

sulfadiazine

HIGH

No data

available

trimethoprim

HIGH

No data

available

clenbuterol

hydrochloride

No data

available

No data

available

No data

available

No data

available

Product Disposal:

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

Container Disposal:

Wrap with paper and place in garbage.

Dangerous Goods

Not classified as a Dangerous Good according to the criteria of the Australian Dangerous

Classification:

Goods (ADG) Code.

HAZCHEM Code:

None specified.

Section 12: ECOLOGICAL INFORMATION

Section 13: DISPOSAL INFORMATION

Section 14: TRANSPORT INFORMATION

BRONCOPULMIN PLUS TMPS ORAL POWDER

Page 6 of 6

Poisons Schedule:

APVMA Registration Nos:

50718

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 do 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.

This SDS supersedes the version created on 2 July 2009 and updates the format as per the Code of Practice on

Preparation of Safety Data Sheets for Hazardous Chemicals, December 2011, published by Safe Work Australia.

Legend

Carcinogen means a substance or a mixture which induce cancer or increase its incidence.

CAS No. means a unique number assigned to a chemical by the Chemical Abstracts Service.

Flashpoint means the lowest temperature (corrected to a standard pressure of 101.3 kPa) at which the application of an

ignition source causes the vapours of a liquid to ignite under specified test conditions.

GHS means the ‘Globally Harmonized System of Classification and Labelling of Chemicals, 3

rd

Revised Edition’,

published by the United Nations.

LD

50

means the median lethal dose, being a statistically derived single dose of a substance that can be expected to cause

death in 50% of animals.

Mutagen means an agent giving rise to an increased occurrence of mutations in populations of cells and / or organisms.

PVC means Polyvinyl chloride.

TD

LO

means the lowest toxic dose, that is, the minimum amount of a substance that is toxic to a specified type of animal.

References

ChemIDPLus, entries for Clenbuterol hydrochloride (RN: 21898-19-1), Sulfadiazine (RN: 68-35-9) and Trimethoprim (RN:

738-70-5).

New Zealand Environmental Protection Authority, HSNO Chemical Classification and Information Database (CCID),

entries for Sulphadiazine (CAS Number: 68-35-9) and Trimethoprim (CAS Number: 738-70-5).

VSDB (Veterinary Substances Database, http://sitem.herts.ac.uk/aeru/vsdb/, entries for clenbuterol, sulfadiazine and

trimethoprim.

END OF SDS

Section 15: REGULATORY INFORMATION

Section 16: OTHER INFORMATION

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