PRED-X 5 ANTI-INFLAMMATORY - ANTI-ALLERGY
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
30-12-1996
Summary of Product characteristics
(SPC)
01-07-2013
Active ingredient:
PREDNISOLONE
Available from:
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
INN (International Name):
prednisolone(5mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
PREDNISOLONE STEROID-GLUCOCORTICOID Active 5.0 mg/Tb
Units in package:
1000 Tabs
Class:
VM - Veterinary Medicine
Manufactured by:
APEX LABORATORIES
Therapeutic group:
CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
Therapeutic area:
DERMATOLOGICAL PREPS.
Therapeutic indications:
ARTHRITIS | DERMATOSES | RHEUMATIC JOINT DISEASE
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ARTHRITIS, DERMATOSES, RHEUMATIC JOINT DISEASE]; DOG: [ARTHRITIS, DERMATOSES, RHEUMATIC JOINT DISEASE]; For the treatment of dermatoses and as an aid in the treatment of arthritic and rheumatic joint disease in dogs and cats.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
APEX LABORATORIES PTY LTD
PRED-X 5 ANTI-INFLAMMATORY - ANTI-ALLERGY
DC13-15680495E52
35702/100559
COMPANY NAME:
PRODUCT NAME:
ELABEL APPLICATION NO:
APVMA APPROVAL NO:
LABEL NAME:
PRED-X 5 ANTI-INFLAMMATORY - ANTI-ALLERGY
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each tablet contains: 5mg PREDNISOLONE
CLAIMS:
For the treatment of dermatoses and as an aid in the treatment of
arthritic and rheumatic
joint disease in dogs and cats.
NET CONTENTS:
1000 Tablets
DIRECTIONS FOR USE:
Dogs and Cats: 0.5-2.5mg/kg bodyweight daily.
PRECAUTIONS:
Prolonged glucocorticoid therapy may suppress adrenocortical activity.
Gradual lowering of
dosage and reduction of frequency of administration is recommended.
FIRST AID
INSTRUCTIONS:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 131
126.
FIRST AID WARNINGS:
DISPOSAL:
Dispose of empty container by wrapping with paper and putting in
garbage.
STORAGE:
Store below 30°C (room temperature)
NAME AND ADDRESS:
Apex Laboratories Pty Ltd
61 Chivers Road Somersby NSW 2250 RLP APPROVED
For Official Use Only
AUSTRALIA
(02) 4372 1661
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Summary of Product characteristics
MATERIAL SAFETY DATA SHEET
PRED-X ANTI-INFLAMMATORY ANTI-ALLERGY 5MG & 20MG TABLETS
CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC
Product Name
Pred-X Anti-Inflammatory Anti-Allergy 5mg & 20mg Tablets
Recommended Use
To treat allergic dermatoses and inflammatory arthritic conditions in
horses, dogs and cats.
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
R40 Possible risks of irreversible effects.
R61 May impair fertility
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
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
Rinse mouth with water, give water to drink and seek medical advice.
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 chemical powder, water fog, mist or spray, carbon dioxide. As
ap
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