BUTE PASTE ORAL ANTI-INFLAMMATORY AND ANALGESIC FOR HORSES

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

Buy It Now

Active ingredient:
PHENYLBUTAZONE
Available from:
RANVET PTY. LIMITED
INN (International Name):
phenylbutazone(200mg/mL)
Pharmaceutical form:
ORAL PASTE
Composition:
PHENYLBUTAZONE ANALGESIC Active 200.0 mg/ml
Units in package:
100mL; 150mL; 1L; 20mL; 30mL; 500mL; 80mL
Class:
VM - Veterinary Medicine
Therapeutic group:
HORSE | PONY | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACE
Therapeutic area:
MUSCULOSKELETAL SYSTEM
Therapeutic indications:
ANALGESIC | ANTI-INFLAMMATORY AGENT | MUSCULOSKELETAL CONDITIONS | SOFT TISSUE INJURY | ANTIPYRETIC | ARTHRITIS | ARTHROSIS | BONE SORENESS | BRUISING | BURSITIS | COLIC | EXTERNAL MYOPATHY | INFLAMATION OF SOFT TISSUES AN | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MUSCLE RELAXANT | MUSCLE SORENESS | OSTEITIS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SEDATIVE | SPASMOLYTIC | SPRAINS | STRAINS | TENDON AND LIGAMENT SPRAINS | TENDON SPRAINS | TENDONITIS | TENOSYNOVITIS | TRAUMATIC JOINT AND CONNECTIVE | TRAUMATIC SWELLING
Product summary:
Poison schedule: 4; Withholding period: WHP: Meat: NOT TO BE USED in horses in tended for human consumption.; Host/pest details: HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT, MUSCULOSKELETAL CONDITIONS, SOFT TISSUE INJURY]; PONY: [ANALGESIC, ANTI-INFLAMMATORY AGENT, MUSCULOSKELETAL CONDITIONS, SOFT TISSUE INJURY]; An aid in the treatment of musculo-skeletal conditions and soft tissue injuries in horses where anti-inflammatory, antipyretic and analgesic activity would be beneficial.Do not administer to horses with a history of cardiac, renal or hepatic disorders, or when gastro-intestinal tract ulceration or blood dyscrasias are present or suspected. See Precautions and Contra-Indications on label.
Authorization status:
Registered
Authorization number:
52595
Authorization date:
2020-07-01

anvet

BUTE PASTE

Oral

Anti-Inflammatory

Analgesic for

Date:

November 19,

Horses

2002

Version:

Page

C/N : 000

Immediate

Container

Label

Anything above this line is

not

draft / text label.

PRESCRIPTION

ANIMAL

REMEDY

KEEP

REACH

CHILDREN

ANIMAL

TREATMENT

ONLY

BUTEPASTE

Oral

Anti-Inflammatory

Analgesic for Horses

Active

constituent:

Phenylbutazone

200mg/ml

aid in the treatment

musculo-skeletal

conditions and soft tissue injuries in horses where anti-inflammatory,

antipyretic and analgesic activity would be beneficial.

20rrtL,

30rrtL,

80rrtL,

500rrtL,

DIRECTIONS FOR USE

Precautions

Contra-indications

Do not

administer to horses

with a history

cardiac,

renal

or hepatic disorders,

or when gastro-intestinal

tract

ulceration or

blood

dyscrasias

present

suspected.

Discontinue

therapy If

signs

lethargy,

colic,

diarrhoea,

inappetance, oral

ulceration or vascular disorders resulting in ventral

oedema occur during treatment.

Foals or pony breeds

have a greater risk

toxicity than horses and care should be taken to adhere to the

recommended dose rates in these animals.

Therapy in ponies should be discontinued

ifno

response is seen after

4-5 days of treatment.

Dosage

administration:

Administer paste orally 30 minutes prior to feeding.

Horses

(450 kg):

10 mL (2 g PBZ) twice on first day,

then 5 mL (1 g PBZ) twice daily for 4 days,

then 5

g PBZ) daily or every second day as required or as directed by a vet.

Ponies (225kg):

g PBZ) daily for 4 days,

then 2.5 mL

(\'2

g PBZ) daily or

every

second

as required

or as directed by a vet.

MEAT

WITH~OLDING

PE~I~D:

USEI?_~n

horses

intended

human

consumption.

used in performance animals,

the regulations

the relevant

authorities regarding medication should be

observed.

Dispose

empty container by wrapping with paper and putting in garbage.

Store below 30° C (room temperature).

Ranvet Pty Ltd,

10-12 Green St, BotanyNSW 2019 Australia.

TOLL FREE 1800 727 217 Tel,

02 9666-1 744Fax.

9666-1755

NRA:

52595/1102

Batch No',

Ranvet Pty

BUTE PASTE Oral

Anti-Inflammatory

Analgesic for

Date:

November 19,

Horses

2002

Version:

Page

CIN:

Outer

Container

Label

Anything

above this line is not draft / text label.

PRESCRIPTION

ANIMAL

REMEDY

KEEP

REACH

CHILDREN

ANIMAL

TREATMENT

ONLY

BUTEPASTE

Oral

Anti-Inflammatory and Analgesic for Horses

Active constituent: Phenylbutazone 200mglml

An aid in the treatment

musculo-skeletal

conditions and soft tissue injuries in horse where anti-inflammatory,

antipyretic and analgesic activity would be beneficial.

20rriL,

JOrriL,

80rriL,

500rriL,

DIRECTIONS FOR USE

Precautions and Contra-indications:

Do not administer to horses with a history

cardiac,

renal or hepatic

disorders,

or when gastro-intestinal

tract

ulceration or blood dyscrasias are present

or suspected.

Discontinue

therapy

signs

lethargy,

colic,

diarrhoea,

inappetance,

oral

ulceration or

vascular

disorders

resulting

ventral

oedema occur during treatment.

Foals or pony breeds may have a greater risk

toxicity than horses and care should be taken to adhere to the

recommended dose rates in these animals.

Therapy in ponies should be discontinued

ifno

response is seen after

4-5 days

treatment.

Dosage

administration:

Administer paste orally 30 minutes prior to feeding.

Horses (450 kg):

(2 g PBZ) twice on first day,

then 5 mL

g PBZ) twice daily for 4 days,

then 5

g PBZ) daily or every second day as required or as directed by a vet.

Ponies (225 kg):

(1 g PBZ)

daily for

4 days,

then 2.5

(112

g PBZ)

daily or

every second day as

required or as directed by a vet.

MFA.T

WITHHOLDING

PFFJOD:

TO BE USED in horses

Intended

human

consumption

If used on performance animals,

regulations

relevant authorities regarding medication should be observed.

Dispose

empty container by wrapping with paper and putting in garbage.

Store below 30° C (room temperature).

Ranvet

Pty Ltd,

I0-12 Green St, NSW 2019 Australia.

TOLL FREE 1S00 727 217 Tel:

02 9666-1744 Fax:

02 9666-1755.

NRA:

5259511102

Batch No:

Exp:

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)

ChemWatch Material Safety Data Sheet

CHEMWATCH 4966-74

For Workplace - Small Volume Use Only.

Issue Date: 5-Mar-2008

CD 2004/3 Page 1 of 9

Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)

SYNONYMS

PRODUCT USE

For animal treatment only. Anti-inflammatory, analgesic and antipyretic oral paste for

relief of painful musculoskeletal conditions in horses.

SUPPLIER

Company: Ranvet Pty Ltd ACN 001 606 033

Address:

10-12 Green Street

East Botany

NSW 2019

Telephone: +61 2 9666 1744

Emergency Telephone: +61 418 493 533 A/H

Fax: +61 2 9666 1755

Section 2 - HAZARDS IDENTIFICATION

STATEMENT OF HAZARDOUS NATURE

NON-HAZARDOUS SUBSTANCE. NON-DANGEROUS GOODS.

According to the Criteria of NOHSC, and the ADG Code.

POISONS SCHEDULE

RISK

Ingestion may produce health damage*.

Cumulative effects may result following exposure*.

May produce discomfort of the eyes*.

Limited evidence of a carcinogenic effect*.

* (limited evidence)

SAFETY

Wear eye/face protection.

Take off immediately all contaminated clothing.

In case of contact with eyes, rinse with plenty of water and contact Doctor or

Poisons Information Centre.

continued...

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)

ChemWatch Material Safety Data Sheet

CHEMWATCH 4966-74

For Workplace - Small Volume Use Only.

Issue Date: 5 - Mar - 2008

CD 2004/3 Page 2 of 9

Section 2 - HAZARDS IDENTIFICATION ...

If you feel unwell contact Doctor or Poisons Information Centre. (Show the label

if possible).

Section 3 - COMPOSITION / INFORMATION ON INGREDIENTS

NAME

CAS RN

phenylbutazone

50-33-9

additives nonhazardous

>60

Section 4 - FIRST AID MEASURES

SWALLOWED

- If swallowed do NOT induce vomiting.

- 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.

- Never give liquid to a person showing signs of being sleepy or with reduced

awareness; i.e. becoming unconscious.

- Give water to rinse out mouth, then provide liquid slowly and as much as

casualty can comfortably drink.

- Seek medical advice.

If this product comes in contact with the eyes:

- Wash out immediately with fresh 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.

- If pain persists or recurs seek medical attention.

- Removal of contact lenses after an eye injury should only be undertaken by

skilled personnel.

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.

INHALED

- If fumes or combustion products are inhaled remove from contaminated area.

- Other measures are usually unnecessary.

NOTES TO PHYSICIAN

Treat symptomatically.

continued...

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)

ChemWatch Material Safety Data Sheet

CHEMWATCH 4966-74

For Workplace - Small Volume Use Only.

Issue Date: 5 - Mar - 2008

CD 2004/3 Page 3 of 9

Section 5 - FIRE FIGHTING MEASURES

EXTINGUISHING MEDIA

- There is no restriction on the type of extinguisher which may be used.

Use extinguishing media suitable for surrounding area

FIRE FIGHTING

- Alert Fire Brigade and tell them location and nature of hazard.

- Wear breathing apparatus plus protective gloves for fire only.

- Prevent, by any means available, spillage from entering drains or water

courses.

- Use fire fighting procedures suitable for surrounding area.

- DO NOT approach containers suspected to be hot.

- Cool fire exposed containers with water spray from a protected location.

- If safe to do so, remove containers from path of fire.

- Equipment should be thoroughly decontaminated after use.

FIRE/EXPLOSION HAZARD

- The material is not readily combustible under normal conditions.

- However, it will break down under fire conditions and the organic component

may burn.

- Not considered to be a significant fire risk.

- Heat may cause expansion or decomposition with violent rupture of containers.

- Decomposes on heating and may produce toxic fumes of carbon monoxide (CO).

- May emit acrid smoke.

Decomposition may produce toxic fumes of

carbon dioxide (CO2)

nitrogen oxides (NOx)

other pyrolysis products typical of burning organic material

May emit poisonous fumes.

FIRE INCOMPATIBILITY

Avoid contamination with oxidising agents i.e. nitrates, oxidising acids,

chlorine bleaches, pool chlorine etc. as ignition may result

HAZCHEM

None

Personal Protective Equipment

PERSONAL PROTECTION EQUIPMENT

Breathing apparatus.

Chemical splash suit.

continued...

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)

ChemWatch Material Safety Data Sheet

CHEMWATCH 4966-74

For Workplace - Small Volume Use Only.

Issue Date: 5 - Mar - 2008

CD 2004/3 Page 4 of 9

Section 6 - ACCIDENTAL RELEASE MEASURES

EMERGENCY PROCEDURES

MINOR SPILLS

- Clean up all spills immediately.

- Avoid contact with skin and eyes.

- Wear impervious gloves and safety goggles.

- Trowel up/scrape up.

- Place spilled material in clean, dry, sealed container.

- Flush spill area with water and detergent.

Personal Protective Equipment advice is contained in Section 8 of the MSDS.

Section 7 - HANDLING AND STORAGE

PROCEDURE FOR HANDLING

- Limit all unnecessary personal contact.

- Wear protective clothing when risk of exposure occurs.

- Use in a well-ventilated area.

- Avoid contact with incompatible materials.

- When handling, DO NOT eat, drink or smoke.

- Keep containers securely sealed when not in use.

- Avoid physical damage to containers.

- Always wash hands with soap and water after handling.

- Work clothes should be laundered separately.

- Use good occupational work practice.

- Observe manufacturer's storing and handling recommendations.

- Atmosphere should be regularly checked against established exposure standards

to ensure safe working conditions are maintained.

SUITABLE CONTAINER

Plastic container

STORAGE INCOMPATIBILITY

Avoid strong acids, bases.

Avoid reaction with oxidising agents

STORAGE REQUIREMENTS

- Store in original containers.

- Keep containers securely sealed.

- Store in a cool, dry, well-ventilated area.

- Store away from incompatible materials and foodstuff containers.

- Protect containers against physical damage and check regularly for leaks.

- Observe manufacturer's storing and handling recommendations.

Store below 30 deg. C.

continued...

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)

ChemWatch Material Safety Data Sheet

CHEMWATCH 4966-74

For Workplace - Small Volume Use Only.

Issue Date: 5 - Mar - 2008

CD 2004/3 Page 5 of 9

Section 7 - HANDLING AND STORAGE ...

Protect from light.

Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION

EXPOSURE CONTROLS

None assigned.

INGREDIENT DATA

PHENYLBUTAZONE:

Particulate (insoluble or poorly soluble *) Not Otherwise Specified (P.N.O.C)

TLV TWA: 10 mg/m³ Inhalable particulate

TLV TWA: 3 mg/m³ Respirable particulate

OEL-Sweden, United Kingdom: 10 mg/m³ total

dust, 5 mg/m³ respirable dust

These "dusts" have little adverse effect on the lungs and do not produce toxic

effects or organic disease. Although there is no dust which does not evoke some

cellular response at sufficiently high concentrations,

the cellular response

caused by P.N.O.C.s has the following characteristics:

- the architecture of the air spaces remain intact,

- scar tissue (collagen) is not synthesised to any degree,

- tissue reaction is potentially reversible.

Extensive concentrations of P.N.O.C.s may:

- seriously reduce visibility,

- cause unpleasant deposits in the eyes, ears and nasal

passages,

- contribute to skin or mucous membrane injury by chemical

or mechanical

action,

per se, or by the rigorous skin cleansing procedures necessary for their

removal. [ACGIH]

This limit does not apply:

- to brief exposures to higher concentrations

- nor does it apply to those substances that may cause physiological

impairment

at lower concentrations but for which a TLV has as yet to be determined.

This exposure standard applies to particles which

- are insoluble or poorly soluble* in water or, preferably, in aqueous lung

fluid (if data is available) and

- have a low toxicity (i.e.. are not cytotoxic, genotoxic, or otherwise

chemically reactive with lung tissue, and do not emit ionizing radiation, cause

immune sensitization,

or cause toxic effects other than by inflammation or by a

mechanism of lung overload)

* Notice of intended change

Dusts not otherwise classified, as inspirable dust;

ES TWA: 10 mg/m³

PERSONAL PROTECTION

continued...

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)

ChemWatch Material Safety Data Sheet

CHEMWATCH 4966-74

For Workplace - Small Volume Use Only.

Issue Date: 5 - Mar - 2008

CD 2004/3 Page 6 of 9

Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION ...

- Safety glasses with side shields; or as required,

- Chemical

goggles.

- Contact lenses pose a special

hazard; soft lenses may absorb irritants and all

lenses concentrate them.

HANDS/FEET

Wear chemical

protective gloves, eg. PVC.

Wear safety footwear or safety gumboots, eg. Rubber

OTHER

- Overalls.

- P.V.C. apron.

- Barrier cream.

- Skin cleansing cream.

- Eye wash unit.

The local

concentration of material, quantity and conditions of use determine

the type of personal

protective equipment required. For further information

consult site specific CHEMWATCH data (if available), or your Occupational

Health and Safety Advisor.

ENGINEERING CONTROLS

General

exhaust is adequate under normal

operating conditions. If risk of

overexposure exists, wear SAA approved respirator. Correct fit is essential

obtain adequate protection. Provide adequate ventilation in warehouse or closed

storage areas.

Section 9 - PHYSICAL AND CHEMICAL PROPERTIES

APPEARANCE

Aqua thick paste with suspended particles and odour of apple; does not mix with

water.

PHYSICAL PROPERTIES

Liquid.

Does not mix with water.

Sinks in water.

Molecular Weight: Not Applicable

Boiling Range (°C): Not Available

Melting Range (°C): Not Available

Specific Gravity (water=1): 1.08-1.18

Solubility in water (g/L): Immiscible

pH (as supplied): 6.0-7.0

pH (1% solution): Not Available

Vapour Pressure (kPa): Negligible

Volatile Component (%vol): Not Available

Evaporation Rate: Not Applicable

Relative Vapour Density (air=1): Not Applicable

Flash Point (°C): Not Applicable

continued...

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)

ChemWatch Material Safety Data Sheet

CHEMWATCH 4966-74

For Workplace - Small Volume Use Only.

Issue Date: 5 - Mar - 2008

CD 2004/3 Page 7 of 9

Section 9 - PHYSICAL AND CHEMICAL PROPERTIES ...

Lower Explosive Limit (%): Not Applicable

Upper Explosive Limit (%): Not Applicable

Autoignition Temp (°C): Not Available

Decomposition Temp (°C): Not Available

State: Non Slump Paste

Section 10 - CHEMICAL STABILITY AND REACTIVITY INFORMATION

CONDITIONS CONTRIBUTING TO INSTABILITY

Product is considered stable and hazardous polymerisation will not occur.

Section 11 - TOXICOLOGICAL INFORMATION

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

Ingestion may result in nausea, abdominal irritation, pain and vomiting

Other effects are oedema, skin rash, vertigo, headache, blurred vision,

ulcerative stomatitis, hepatitis, jaundice, haematuria, nephritis, renal failure,

goitre, bone marrow depression, sweating, tinnitus, acidosis, convulsions and

coma.

The material may produce moderate eye irritation leading to inflammation.

Repeated or prolonged exposure to irritants may produce conjunctivitis.

SKIN

The material is not thought to produce adverse health effects or skin irritation

following contact (as classified by EC Directives using animal models).

Nevertheless, good hygiene practice requires that exposure be kept to a minimum

and that suitable gloves be used in an occupational setting.

Entry into the blood-stream, through, for example, cuts, abrasions or lesions,

may produce systemic injury with harmful effects. Examine the skin prior to the

use of the material and ensure that any external damage is suitably protected.

INHALED

The material is not thought to produce adverse health effects or irritation of

the respiratory tract (as classified by EC Directives using animal models).

Nevertheless, good hygiene practice requires that exposure be kept to a minimum

and that suitable control measures be used in an occupational setting.

CHRONIC HEALTH EFFECTS

Substance accumulation, in the human body, may occur and may cause some concern following

repeated or long-term occupational exposure. There has been some concern that this

continued...

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)

ChemWatch Material Safety Data Sheet

CHEMWATCH 4966-74

For Workplace - Small Volume Use Only.

Issue Date: 5 - Mar - 2008

CD 2004/3 Page 8 of 9

Section 11 - TOXICOLOGICAL INFORMATION ...

material can cause cancer or mutations but there is not enough data to make an assessment.

Exposure to small quantities may induce hypersensitivity reactions characterised by acute

bronchospasm, hives (urticaria), deep dermal wheals (angioneurotic oedema), running nose

(rhinitis) and blurred vision. Anaphylactic shock and skin rash (non-thrombocytopenic

purpura) may occur. An individual may be predisposed to such anti-body mediated reaction

if other chemical agents have caused prior sensitisation (cross-sensitivity).

Ranvet Bute Paste (Oral Anti-Inflammatory & Analgesic)

Not available. Refer to individual

constituents.

unless otherwise specified data extracted from RTECS - Register of Toxic Effects

of Chemical

Substances

PHENYLBUTAZONE:

IRRITATION TOXICITY

Eye (rabbit): 100 mg - moderate

Oral

(rat) LD50: 245 mg/kg

Intraperitoneal

(rat) LD50: 142 mg/kg

Subcutaneous (rat) LD50: 230 mg/kg

Intravenous (rat) LD50: 100 mg/kg

Intramuscular (rat) LD50: 220 mg/kg

Oral

(mouse) LD50: 270 mg/kg

Intraperitoneal

(mouse) LD50: 128 mg/kg

Subcutaneous (mouse) LD50: 230 mg/kg

Intravenous (mouse) LD50: 90 mg/kg

Intramuscular (mouse) LD50: 430 mg/kg

Oral (dog) LD50: 332 mg/kg

Altered sleep time, somnolence,

tremor, convulsions, change in motor

activity, ataxia, analgesia, elevated blood pressure, dyspnea, glomeruli

and tubule changes, anuria, haematuria, leukopenia, agranulocytosis,

changes in blood cell

count, leukaemia, maternal

effects, effects on

fertility, foetoxicity, foetolethality,

specific developmental

abnormalities (musculoskeletal

system, cardiovascular system), effects

on newborn recorded.

Carcinogenic by RTECS criteria.

The substance is classified by IARC as Group 3:

NOT classifiable as to its carcinogenicity to humans.

Evidence of carcinogenicity may be inadequate or limited in animal

testing.

Section 12 - ECOLOGICAL INFORMATION

DO NOT discharge into sewer or waterways.

Section 13 - DISPOSAL CONSIDERATIONS

Puncture containers to prevent re-use and bury at an authorised landfill.

continued...

RANVET BUTE PASTE (ORAL ANTI-INFLAMMATORY & ANALGESIC)

ChemWatch Material Safety Data Sheet

CHEMWATCH 4966-74

For Workplace - Small Volume Use Only.

Issue Date: 5 - Mar - 2008

CD 2004/3 Page 9 of 9

Section 14 - TRANSPORTATION INFORMATION

Shipping Name:

None

Dangerous Goods Class: None

UN/NA Number: None

ADR Number: None

Packing Group: None

Labels Required:

Additional Shipping Information:

International Transport Regulations:

IMO: None

HAZCHEM

None

Section 15 - REGULATORY INFORMATION

POISONS SCHEDULE

REGULATIONS

No data available for phenylbutazone as (CAS: 50-33-9).

Section 16 - OTHER INFORMATION

This document is copyright. Apart from any fair dealing for the purposes of

private study, research, review or criticism, as permitted under the Copyright

Act, no part may be reproduced by any process without written permission from

CHEMWATCH. TEL (+61 3) 9572 4700.

Issue Date: 5 - Mar - 2008

Print Date:

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