BUTALONE TABLETS ANALGESIC AND ANTI-INFLAMMATORY
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:
Dechra Veterinary Products (Australia) Pty. Ltd.
INN (International Name):
phenylbutazone(100mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
PHENYLBUTAZONE ANALGESIC Active 100.0 mg/Tb
Units in package:
100 Tabs; 1000 Tabs; Unit=1 Tab
Class:
VM - Veterinary Medicine
Manufactured by:
APEX LABORATORIES
Therapeutic group:
DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT
Therapeutic area:
MUSCULOSKELETAL SYSTEM
Therapeutic indications:
ANTI-INFLAMMATORY AGENT | ANTIPYRETIC | BONE SORENESS | BRUISING | BURSITIS | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SPRAINS | STRAINS | TENDON SPRAINS | TRAUMATIC SWELLING
Product summary:
Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ANTI-INFLAMMATORY AGENT]; HORSE: [ANTI-INFLAMMATORY AGENT]; An analgesic and anti-inflammatory in the treatment of musculoskeletal disorders in horses and dogs.
Authorization status:
Stopped
Authorization date:
2018-06-30
Patient Information leaflet
..
Apex Laboratories
Pty Ltd
Butalone Tablets
Analgesic
and Anti-lnflammatory
Specification
No:
LBMBUTATCM/A
Supersedes:
N/A
Page 1 of
1
18 June 2002
Label-
Self adhesive
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PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT
Of
REACH
Of
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
BUTALONE
TABLETS
ANALGESIC
AND
ANTI~INFLAMMATORY
DIRECTIONS
FOR
USE:
Dogs:
2~20mg/kg
Bodyweight Daily
Horses:
4-8mg/kg
Bodyweight Daily
MEAT
WITHHOLDING
PERIOD:
NOT
TO
BE
USED
in
horses
that
may
be
slaughtered for
human
consumptfon.
Each
tablet
contains:
PHENYLBUTAZONE
An
analgesic
and
ontl-
'll"flammatory
in
the
treatment
of
musculoskeletal
disorders in
horses
and
dogs.
(100
Ioblets/I
000 Tablets)
lOOmg
APEX
lABORATORIES
pry
LTD
61
Chivers
Road
Somersby
NSW
2250
Australia.
Dispose of
empty
container
by
wrapping
with
paper
and
putting
in
garbage,
Store
below
25°C.
(air conditioning).
NRA:
35621/0'702-
Batch:
Expiry:
MADE IN
AUSTRALIA
FROM
LOCAL AND
IMPORTED
INGREDIENTS
; '
N~R.
..
A~
.
APPROVED
LABEL
(iEX1)
Label
No:
...
aRk~l.I9J23.
Date:
..
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..
.I.Q2
....
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F;\word\REGO\lABElS\6
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32LAB.DOC
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Summary of Product characteristics
MATERIAL SAFETY DATA SHEET
BUTALONE TABLETS ANALGESIC AND ANTI-INFLAMMATORY
CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC
Product Name
Butalone Tablets Analgesic and Anti-inflammatory
Recommended Use
To treat musculoskeletal disorders and other conditions where NSAIDs
are indicated.
Supplier Details
Apex Laboratories Pty. Ltd.
ACN Number
000 397 240
Street
61 Chivers Road
Suburb
Somersby
State
NSW
Country
Australia
Post Code
2250
Phone
+61 2 4372 1661 (Business hours – 8.30am – 5.00pm)
Fax
+61 2 4372 1668 (fax)
Website
http://www.apexlabs.com.au
Emergency contact
As above or Poisons Information Centre 131126 (Australia)
Classification
Classified as hazardous according to the criteria of NOHSC
Risk Phrases
R22 Harmful if swallowed
R36/37/38 Irritating to eyes, respiratory
system and skin.
Safety Phrases
None allocated
ADG Class
None allocated
Hazchem Code
None allocated
Poisons Schedule
S4
INGREDIENTS
CAS NO
PROPORTION
TWA MG/M3
STEL MG/M3
Phenylbutazone
50-33-9
30-60%
10
not set
Other non hazardous ingredients
NA
to 100%
NA
NA
The TWA exposure value is the average airborne concentration of a
particular substance when calculated over a normal 8 hour working day
for a 5 day
working week over an entire working lifetime. The TWA exposure
standard set by Worksafe Australia for dusts not otherwise specified
is 10mg/m3. The
STEL (Short Term Exposure Limit) is an exposure value that should not
be exceeded for more than 15 minutes and should not be repeated for
more than 4
times per day. There should be at least 60 minutes between successive
exposures at the STEL.
Ingestion
If swallowed rinse mouth out with water, give water to drink and seek
medical advice. Induce vomiting.
Eye
Irrigate with copious quantities of lukewarm water for 10 minutes and
seek
medical advice.
Skin
Wash well with soap and water and if concerned seek medical advice.
Inhalation
Generally not required. If concerned move to fresh air and seek
medical
advice.
Extinguishing Media
Dry agent, water fog, mist or spray, carbon dioxide. As a
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