VR MYOTON PHENYLBUTAZONE GRANULES
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
19-06-2017
Active ingredient:
PHENYLBUTAZONE
Available from:
JUROX PTY LIMITED
INN (International Name):
phenylbutazone(1g/Sach)
Pharmaceutical form:
ORAL GRANULES, PELLETS
Composition:
PHENYLBUTAZONE ANALGESIC Active 1.0 g/sa
Units in package:
100 Sachet; carton of
Class:
VM - Veterinary Medicine
Manufactured by:
JUROX
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
Product summary:
Poison schedule: 4; Withholding period: WHP: (Horses): NOT TO BE USED in horse s intended for human consumption.; Host/pest details: HORSE: [MUSCULOSKELETAL CONDITIONS]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [MUSCULOSKELETAL CONDITIONS]; For the relief of pain and inflammation in arthritic and musculo-skeletal conditions in horses.DO not administer to horses with cardiac, renal or liver disease. Discontinue therapy if signs of gastric or oral ulceration, inappetence or vascular disorders occur. Phenylbutazone should not be used in conjunction with other drug therapy especially NSAI
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
VR Myoton Phenylbutazone Granules
25 March 04
page 1/2
CARTON LABEL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
Info
PEST
9
Verified
FOR ANIMAL TREATMENT ONLY
VR
MYOTON PHENYLBUTAZONE GRANULES
ACTIVE CONSTITUENT:
Each 2.5g (one sachet) contains 1 g PHENYLBUTAZONE
For the relief of pain and inflammation in arthritic and
musculo-skeletal conditions in horses
100 Sachets
JUROX
DIRECTIONS FOR USE:
DO NOT ADMINISTER TO HORSES WITH CARDIAC, RENAL OR LIVER DISEASE.
DISCONTINUE THERAPY IF SIGNS OF
GASTRIC OR ORAL ULCERATION, INAPPETANCE OR VASCULAR DISORDERS OCCUR.
PHENYLBUTAZONE SHOULD NOT
BE USED IN CONJUNCTION WITH OTHER DRUG THERAPY ESPECIALLY NSAIDS OR
COUMARIN ANTICOAGULANTS.
Horses (450 kg bodyweight): Give 1 – 4 sachets daily for 2 days,
then reduce dose to lowest level
which produces the desired clinical response, or as directed by the
veterinary surgeon. (Give 2.2 – 8.8
mg/kg bodyweight daily for 2 days then reduce).
Ponies (225 kg bodyweight): Give 1 sachet daily for 2 days, then
reduce dose to lowest level which
produces the desired clinical response, or as directed by the
veterinary surgeon. (Give 2.2 mg/kg
bodyweight daily for 2 days then reduce).
MEAT WITHHOLDING PERIOD (HORSES):
NOT TO BE USED IN HORSES INTENDED FOR HUMAN CONSUMPTION
NEW ZEALAND INFORMATION:
IN NEW ZEALAND IT IS A LEGAL REQUIREMENT THAT THIS PRODUCT IS NOT USED
IN ANY ANIMAL
PRODUCING OR INTENDED TO PRODUCE FOOD FOR HUMAN CONSUMPTION.
Registered to Jurox New Zealand Limited, 38A Firth St, Drury,
Auckland. Ph 0800 587 696
Registered pursuant to the ACVM Act 1997 No. A3130
Prescription Animal Remedy (P.A.R.) Class 1,
for use only under the authority or prescription of a veterinarian.
See www.nzfsa.govt.nz/acvm for registration conditions.
FIRST AID
If poisoning occurs, contact a doctor or Poisons Information Centre.
_Phone _
_Australia131126, New Zealand 0800 764 766. _
Made in Australia by
Jurox Pty Ltd, 85 Gardiners Rd, Rutherford NSW 2320 Australia.
Infoline 1800 023 312
APVMA Approval No. 36279/1g/0104
DISPOSE of contai
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Summary of Product characteristics
MYOTON GRANULES
Page 1 of 5
continued
ISSUED:
24 AUGUST 2012
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
MYOTON GRANULES
PRODUCT CODE:
61140
RECOMMENDED USE:
For the relief of pain and inflammation in arthritic and
musculo-skeletal
conditions in horses.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9a.m. – 5p.m.)
SECTION 2: HAZARDS IDENTIFICATION
1
GHS HAZARD CLASSIFICATIONS:
ACUTE TOXICITY CATEGORY 4
Exclamation mark
SIGNAL WORD:
WARNING
HAZARD STATEMENTS:
H302
Harmful if swallowed.
PRECAUTIONARY STATEMENTS:
PREVENTION
P264
Wash hands thoroughly after handling.
P270
Do not eat, drink or smoke when using this product.
RESPONSE
P301+P312
IF SWALLOWED: Call the POISONS INFORMATION CENTRE on
131126 or doctor/physician if you feel unwell. Rinse mouth.
DISPOSAL
P501
Dispose of contents/container in accordance with local/national
regulations.
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Sucrose
57-50-1
60%
Phenylbutazone
50-33-9
40%
1
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.
MYOTON GRANULES
Page 2 of 5
continued
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:
If fumes, aerosols or combustion products are inhaled remove from
contaminated area. Other
measures are usually not necessary.
INGESTION:
IF SWALLOWED, REFER FOR MEDICAL ATTENTI
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