ANTIHISTALONE TABLETS ANTI-INFLAMMATORY AND ANTIHISTAMINE
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:
CHLORPHENIRAMINE MALEATE; PREDNISOLONE
Available from:
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
INN (International Name):
prednisolone(5mg/Tb)+chlorpheniramine maleate(2mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
CHLORPHENIRAMINE MALEATE ANTIHISTAMINE Active 2.0 mg/Tb; PREDNISOLONE STEROID-GLUCOCORTICOID Active 5.0 mg/Tb
Units in package:
1000 Tabs
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:
ANTIHISTAMINE + ENDOCRINE
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: WHP: MEAT: Horses: 60 days.; Host/pest details: DOG: [ANTI-INFLAMMATORY AGENT]; HORSE: [ANTI-INFLAMMATORY AGENT]; Treatment of inflammation, in dermatoses or orthopaedic conditions in dogs and cats.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
Apex Laboratories Pty Ltd
Antihistalone Tablets Anti-inflammatory and Antihistamine
Specification No:LB-ANTIHISTM/A
Supersedes:
N/A
Page
1
of
1
24
October
2001
Label:Self Adhesive
---------------------------
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT
Of
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
ANTIHISTALONE
TABLETS
ANTI-INFLAMMATORY
AND
ANTIHISTAMINE
Each tablet contains:
PREDNISOLONE
5mg
CHLORPHENIRAMINE
MALEATE
2mg
INDICATIONS:
in the
treatment
of
inflammation. in dermatoses or
orthopaedic
conditions in dogs
and
horses.
1000Toblets
F:\word\REGO\LABELS\A
1
05LAB.DOC
DIRECTIONS
FOR
USE:
1 Tablet/10Kg
body
weight
daily in
divided
doses.
MEAT
WITHHOLDING
PERIOD
(HORSES):
60
DAYS.
APEX
LABORATORIES
PTY
LTD
61
Chivers Rd Somersby
NSW
2250
Australia.
Dispose of
empty
container
by
wrapping
with
paper
and
putting
in
garbage.
Store Below 25°C(Air Conditioning)
NRA:
35619/
~'o,
Batch:
Expiry:
MADE IN
AUSTRALIA
FROM
LOCAL AND
IMPORTED
INGREDIENTS
N
..
R.A!I
~:~~~:E~~~~~)
Date:
.lb
..
J.QL.~OO.
Signature:
d.
..
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Summary of Product characteristics
MATERIAL SAFETY DATA SHEET
ANTIHISTALONE TABLETS ANTI-INFLAMMATORY AND ANTIHISTAMINE
CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC
Product Name
Antihistalone Tablets Anti-inflammatory and Antihistamine
Recommended Use
Treatment or prevention of histamine mediated adverse effects.
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
R61(2) May cause harm to the unborn child
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
Prednisolone
50-24-8
<10%
not set
not set
Chlorpheniramine maleate
113-92-8
<10%
not set
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
Generally not required. If concerned rinse mouth with water, give
water to
drink and seek medical advice.
Eye
Generally not required. If irritation does occur irrigate with copies
quantities of luke warm water for 10 minutes and seek medical advice.
Skin
Generally not required. If concerned wash with lukewarm water and soap
and seek medical advice.
Inhalation
Generally not required. If concerned move to fresh air and seek
me
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