EQUIBUTAZONE ORAL PHENYLBUTAZONE
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
01-07-2013
Summary of Product characteristics
(SPC)
01-07-2013
Active ingredient:
PHENYLBUTAZONE
Available from:
VIRBAC (AUSTRALIA) PTY LTD
Class:
Veterinary Medicine
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:
MUSCULOSKELETAL CONDITIONS | ARTHRITIS | ARTHROSIS | BURSITIS | EXTERNAL MYOPATHY | INFLAMATION OF SOFT TISSUES AN | OSTEITIS | OSTEOARTHRITIS | TENDON AND LIGAMENT SPRAINS | TENDONITIS | TENOSYNOVITIS | TRAUMATIC JOINT AND CONNECTIVE
Authorization status:
Registered
Authorization date:
0000-00-00
Patient Information leaflet
8 June, 2005
Page 1 of 2
Draft Label – Equibutazone
_______________________________________________________________________________________________
PRESCRIPTION ANIMAL REMEDY (RED)
Info
PEST
9
Verified
KEEP OUT OF REACH OF CHILDREN (RED)
FOR ANIMAL TREATMENT ONLY
EQUIBUTAZONE
ORAL PHENYLBUTAZONE
ACTIVE CONSTITUENT: Each 1.5 g sachet contains:
1 g PHENYLBUTAZONE
FOR THE TREATMENT OF MUSCULO-SKELETAL DISORDERS IN HORSES
100 SACHETS
VIRBAC (AUSTRALIA) PTY. LIMITED
15 Pritchard Place, Peakhurst NSW 2210
DIRECTIONS FOR USE:
DOSAGE AND ADMINISTRATION:
HORSES: 450 kg body weight:
2 sachets twice on day 1
1 sachet twice daily for 4 days
1 sachet daily or on alternate days.
PONIES: 225 kg body weight:
1 sachet daily for 4 days followed by one sachet on alternate
days.
WITHHOLDING PERIOD: MEAT: NOT TO BE USED IN HORSES INTENDED FOR
HUMAN
CONSUMPTION.
DISPOSAL:
Dispose of empty container by wrapping with paper and placing in the
garbage.
_ _
_ _
STORAGE:
Store below 30
°C (Room Temperature).
[B]:
CODE:
EXP:
NRA:
46054/1101
-------------------------
DOCUMENT OUTLINE * FOR ANIMAL TREATMENT ONLY [/46054.html#1] * EQUIBUTAZONE [/46054.html#1]
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Summary of Product characteristics
VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
EQUIBUTAZONE
REVISION C
MATERIAL SAFETY DATA SHEET
Product Name:
Equibutazone Oral Phenylbutazone
PAGE: 1 OF 4
DATE OF ISSUE
17 SEPTEMBER,
2008
EMERGENCY: VIRBAC: 02 9772 9772 OR 1800 242 100 (BUSINESS HOURS
ONLY)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
COMPANY:
VIRBAC (AUSTRALIA) PTY. LTD
ABN 77 003 268 871
ADDRESS
361 Horsley Rd, Milperra, NSW 2214, Australia
Locked Bag 6000, Milperra Business Centre, NSW 1891, Australia
TELEPHONE:
(02) 9772 9772 or 1800 242 100
FAX:
(02) 9772 9773
EMERGENCY PHONE
As above during business hours; answering machine after hours
SUBSTANCE:
Phenylbutazone is a nonsteroidal anti-inflammatory drug.
TRADE NAME:
Equibutazone Oral Phenylbutazone
PRODUCT CODE: EQUIB100
PRODUCT USE:
For the treatment of musculo-skeletal disorders in horses.
CREATION DATE:
NOVEMBER, 2002
REVISION DATE:
JANUARY, 2008
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as: Not classified as hazardous
according to the criteria of ASCC Australia.
Not a Dangerous Good according to the Australian Dangerous Goods
(ADG) Code.
RISK PHRASES: Not Hazardous - No criteria found.
SAFETY PHRASES: Not Hazardous - No criteria found.
SUSDP CLASSIFICATION: S4
ADG CLASSIFICATION: None allocated. Not a Dangerous Good.
UN NUMBER: None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR: White powdered solid.
ODOUR: Mild odour.
MAJOR HEALTH HAZARDS: No major health hazards are known.
POTENTIAL HEALTH EFFECTS
Nausea, water-retention and rashes occur commonly as a side effect
of this drug, while black or blood stained bowel
movements, sore throat or fever should be reported to a doctor
without delay.
Blood disorders may occur during long-term use so regular blood
tes
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