BUTIN ANTI-INFLAMMATORY ORAL PASTE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PHENYLBUTAZONE

Available from:

INTERNATIONAL ANIMAL HEALTH PRODUCTS PTY LTD

INN (International Name):

phenylbutazone(200mg/mL)

Pharmaceutical form:

ORAL PASTE

Composition:

PHENYLBUTAZONE ANALGESIC Active 200.0 mg/ml

Units in package:

1L; 250mL; 30mL; 400mL; 80mL

Class:

VM - Veterinary Medicine

Manufactured by:

IAHP

Therapeutic group:

HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

ANALGESIC | ANTI-INFLAMMATORY AGENT | ANTIPYRETIC | BONE SORENESS | BRUISING | BURSITIS | COLIC | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MUSCLE RELAXANT | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SEDATIVE | SPASMOLYTIC | SPRAINS | STRAINS | TENDON SPRAINS | TRAUMATIC SWELLING

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat (Horses): Not to be used in horses intended for human consumption.; Host/pest details: HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [ANALGESIC, ANTI-INFLAMMATORY AGENT]; Anti-inflammatory, analgesic and anti-pyretic oral paste for the relief of painful musculoskeletal conditions in horses.Do not use in animals with cardiac, renal or hepatic disorder, blood dyscrasias or pre-existing gastrointestinal ulceration. NOT TO BE USED in horses intended for human consumption.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

READ THE ATTACHED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE: FOR ORAL USE ONLY. THE PRODUCT IS CONTRAINDICATED
IN ANIMALS WITH CARDIAC, RENAL OR HEPATIC DISORDERS, BLOOD
DYSCRASIAS OR PRE-EXISTING GASTROINTESTINAL ULCERATION.
HORSES: Administer prior to feeding. 4.4mg/kg (10mL/450kg) bodyweight
twice daily for the first day; 2.2mg/kg (5mL/450kg) bodyweight twice
daily for the next four days; 2.2mg/kg (5mL/450kg) once daily on
alternate days or as directed by a veterinarian. Maximum daily dose
should
not exceed 4 grams (20mL).
PONIES: Administer prior to feeding. 2.2mg/kg (2.5mL/225kg) bodyweight
twice daily for four days; 2.2mg/kg (2.5mL/225kg) once daily on
alternate days or as directed by a veterinarian. Do not exceed the
recommended dose, as ponies exhibit an increased sensitivity to the
toxic
effects of phenylbutazone.
MEAT WITHHOLDING PERIOD (HORSES): NOT TO BE USED IN HORSES INTENDED
FOR HUMAN CONSUMPTION.
IF USED IN PERFORMANCE ANIMALS, REGULATIONS OF RELEVANT AUTHORITIES
REGARDING MEDICATION SHOULD BE OBSERVED.
FIRST AID: IF POISONING OCCURS, CONTACT A DOCTOR OR POISONS
INFORMATION CENTRE. PHONE AUSTRALIA 131126, NEW ZEALAND 0800 764 766
APVMA Approval No. 46741/30mL/1109 Store below 30°C (Room
Temperature). Protect from light.
NEW ZEALAND INFORMATION
IT IS A LEGAL REQUIREMENT THAT THIS PRODUCT IS NOT USED IN ANY ANIMAL
PRODUCING OR INTENDED TO PRODUCE FOOD FOR HUMAN CONSUMPTION.
PRESCRIPTION ANIMAL REMEDY (P.A.R) CLASS I. For use only under the
authority or prescription of a veterinarian. Registered pursuant to
the
ACVM Act 1997, No. A8131. See www.nzfsa.govt.nz/acvm/ for registration
conditions.
REGISTERED TO INTERNATIONAL ANIMAL HEALTH PRODUCTS LTD L4, Cnr Kent
and Crowhurst Streets, Newmarket,
Auckland 1023.
©
Copyright 2009. All Rights Reserved.
IAH SALES PTY LTD
A.B.N. 57 109 433 883
18 Healey Citcuit, Huntingwood, NSW 2148 Australia
Telephone [phone] Fax [phone]
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
ACTIVE CONSTITUENT: PHE

Summary of Product characteristics

Updated JULY 2009
1 of 5
G:\1ah\MSDS Info:Butin Paste MSDS 18-7-2009
IAH SALES PTY LTD
A.B.N. 57 109 433 883
18 HEALEY CIRCUIT, HUNTINGWOOD NSW 2148
TELEPHONE [phone] FAX. [phone]
MATERIAL SAFETY DATA SHEET: BUTIN PASTE
SECTION 1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
SUPPLIER:
IAH SALES PTY LTD
A.B.N. 57 109 433 883
18 HEALEY CIRCUIT, HUNTINGWOOD NSW 2148
TELEPHONE [phone] FAX. [phone]
WEBSITE: WWW.IAHP.COM.AU EMAIL: [e-mail]
EMERGENCY CONTACT: POISONS INFORMATION CENTRE: PHONE AUSTRALIA
_131126_; NEW ZEALAND _0800 POISON. _
_(0800 764766)_
PRODUCT NAME
:
BUTIN PASTE
UN NUMBER
:
None allocated
DG CLASS
:
Not Classified as Dangerous (Australian Code Transport of Dangerous
Goods)
HAZCHEM
:
None allocated
SUBRISK
:
None allocated
PACKAGING GROUP
:
None Allocated
POISONS SCHEDULE
:
Schedule 4 (PRESCRIPTION ANIMAL REMEDY)
PAR Class I (New Zealand)
OTHER NAMES
:
Bute Paste, PBZ Paste
USES
For the relief of painful musculoskeletal conditions in horses.
SECTION 2. HAZARDS IDENTIFICATION
BUTIN PASTE is considered hazardous according to Worksafe Australia
criteria. Not classified as a
dangerous good according to the Australian Code of Transport of
Dangerous Goods (ACTDG).
RISK PHRASES:
R22
Harmful if swallowed
R38
Irritating to skin
R36
Irritating to eyes
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
CHEMICAL ENTITY:
CAS NO.
PROPORTION
Phenylbutazone
50-33-9
17.2%w/w
Sweetener
<20%w/w
Thickener
1%w/w
Flavour
<1%w/w
Colour
<1%w/w
Vehicle
to 100%w/w
The identity of individual components of this mixture is proprietary
information as is regarded to be a trade secret pursuant to
Section1910.1200 of Title 29 of the Code of Federal Regulations
Updated JULY 2009
2 of 5
MATERIAL SAFETY DATA SHEET: BUTIN PASTE
SECTION 4. FIRST AID MEASURES
IF POISONING OCCURS, CONTACT A DOCTOR OR POISONS INFORMATION CENTRE. _
PHONE AUSTRALIA 131 126; NEW _
_ZEALAND 0800 POISON (0800 764766) _
EYE
: Hold eyes open, flood with water for at least 15 minutes and seek
medical advice.
SKIN
: Wash affected area wi