PRED-X 20 ANTI-INFLAMMATORY-ANTI-ALLERGY

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PREDNISOLONE

Available from:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

INN (International Name):

prednisolone(20mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

PREDNISOLONE STEROID-GLUCOCORTICOID Active 20.0 mg/Tb

Units in package:

300 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:

ENDOCRINE SYSTEM

Therapeutic indications:

ALLERGIC DERMATITIS | ANTI-INFLAMMATORY AGENT | ANTIPYRETIC | ATOPY | 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 WITHHOLDING PERIOD (HORSES): NOT TO BE USED IN HORSES THAT MAY BE S LAUGHTERED FOR HUMAN CONSUMPTION.; Host/pest details: DOG: [ALLERGIC DERMATITIS, ANTI-INFLAMMATORY AGENT]; HORSE: [ALLERGIC DERMATITIS, ANTI-INFLAMMATORY AGENT]; An aid in the treatment of inflammatory rheumatic arthritic conditions, for the treatment of allergic dermatitis.DO NOT USE in horses that may be slaughtered for human consumption.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

COMPANY NAME:
APEX LAB ORA
TORIES PTY LTD
PRODUCT NAME:
PRED-X
20
ANTI-INFLAMMATORY-ANTI-ALLERGY
APVMA APPROVAL
NO:
35701/100557
PRODUCT
NO:
35701
LABEL NAME:
PRED-X 20 ANTI-INFLAMMATORY-ANTI-ALLERGY
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT
OF
REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each tablet contains: 20mg PREDNISOLONE
+
RLP
APPROVED
CLAIMS:
An aid
in
the treatment of inflammatory rheumatic arthritic conditions,
lor
the treatment of
allergic dermatitis.
I
NET CONTENTS:
DIRECTIONS FOR USE:
RESTRAINTS:
PRECAUTIONS:
WITHHOLDING
PERIODS:
FIRST AID
INSTRUCTIONS:
I
FIRST AID WARNINGS:
DISPOSAL:
I
300 Tablets
Dogs
and
Horses: 0.5-2.5mg/kg bodyweight daily.
DO NOT USE
in
horses that may
be
slaughtered
lor
human consumption.
Prolonged glucocorticoid therapy may suppress adrenocortical activity.
Gradual lowering
of
dosage and reduction
of
frequency of administration is recommended.
MEAT WITHHOLDING PERIOD (HORSES):
DO
NOT USE
in
horses that may be
slaughtered lor human consumption.
II poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia
131
126.
Dispose
of
empty containers by wrapping with paper and putting
in
garbage.
STORAGE:
Store below
30'C
(room temperature)

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
[phone] (Business hours – 8.30am – 5.00pm)
Fax
[phone] (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
appropriate fo