DEPO-MEDROL 40 MG/ML INJECTABLE CORTICOSTEROID
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:
METHYLPREDNISOLONE ACETATE
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
methylprednisolone acetate(40mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
METHYLPREDNISOLONE ACETATE STEROID-GLUCOCORTICOID Active 40.0 mg/ml
Units in package:
5mL Vial
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH
Therapeutic area:
ENDOCRINE SYSTEM
Therapeutic indications:
CORTICOSTEROID | ADVANCING PARTURITION | ALLERGIC REACTIONS | ANTIADRENAL SUPPRESSION | ANTI-INFLAMMATORY | ANTISHOCK | ARTHRITIS | BRONCHITIS | CATABOLIC COMPLICATIONS | CHRONIC BRONCHITIS | CORTICOSTEROIDS | CORTICOSTEROIDS AND RELATE | COUGHS | DERMATITIS | DERMATOLOGICAL DISORDERS | DERMATOSES | ECZEMA | GLUCOGENIC STEROID | JOINT DISEASE | KETOSIS | LOCOMOTIVE DISEASES | MUSCULO SKELETAL INFLAMMAT | ORTHOPAEDIC | PARTURIENT UDDER OEDEMA | PARTURITION | PRURITIS | RESPIRATORY TRACT DISEASES | RHEUMATIC DISEASES | STRESS | TOXAEMIA | WATER RETENTION
Product summary:
Poison schedule: 4; Withholding period: WHP: MEAT WITHHOLDNING PERIOD (HORSES): NOT TO BE USED in horses intended for human consumption.; Host/pest details: CAT: [CORTICOSTEROID]; DOG: [CORTICOSTEROID]; HORSE: [CORTICOSTEROID]; For corticosteroid therapy in dogs, cats and horses.See DIRECTIONS FOR USE, PRECAUTIONS on label.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
VIAL LABEL
MAIN PANEL
PRESCRIPTION
ANIMAL
REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
Depo-Medrol®
40mg/mL
Injectable
Corticosteroid
METHYLPREDNISOLONE ACETATE 40
mg/mL
5
ml
READ ENCLOSED
LEAFLET
BEFORE USE
Store below 25°C (Air-conditioning)
APVMA 38689/5 7332
RVM; ACVM No. A0473
CODE
LEFT EDGE
Batch/Expiry:
•
RLP
Approved
Pfizer [logo]
COMMON LEAFLET
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
DEPO-MEDROL® INJECTABLE CORTICOSTEROID 20MG/ML
METHYLPREDNISOLONE ACETATE 20MGLML
DEPO-MEDROL® 40MG/ML INJECTABLE CORTICOSTEROID
METHYLPREDNISOLONE ACETATE 40MGLML
DESCRIPTION
These preparations are recommended for intramuscular and intrasynovial
injection in
horses and dogs, and intramuscular injection
in
cats.
DEPO-MEDROL Injectable
Corticosteroid
is
available in two concentrations, 20 mg per
ml
and 40 mg per
ml.
Each
ml
of
these preparations contains:
Methylprednisolone acetate
Macrogol
3350
Sodium chloride
Myristyl-gamma-picolinium chloride
added as preservative
20 MG
20 mg
29.6
mg
8.9
mg
0.198
mg
40 MG
40
mg
29
mg
8.7
mg
0.195
mg
When necessary,
pH
was adjusted with sodium hydroxide and/or hydrochloric acid.
METABOLIC AND HORMONAL EFFECTS
Methylprednisolone, an anti-inflammatory steroid synthesised and
developed
in
the
Research Laboratories
of
The Upjohn Company, is the 6-methyl derivative
of
prednisolone.
Exceeding prednisolone
in
anti-inflammatory potency and having
even less tendency than prednisolone to induce sodium and water
retention,
methylprednisolone offers the same advantage over older
corticosteroids
of
offering
equally satisfactory anti-inflammatory effect with the use
of
lower doses and an
enhanced split between anti-inflammatory and miner-
EAN
Depo-Medrol® I
njectable Corticosteroid
Methylprednisolone Acetate
Depo-Medrol®
Injectable Corticosteroid
Methylprednisolone Acetate
EAN
alocorticoid activities.
Estimates
of
the relative potencies
of
methylprednisolone and
prednisolone range from 1.13 to 2.1, with an average
of
1.5.
In
anti-inflam
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Summary of Product characteristics
PRODUCT NAME: DEPO MEDROL® INJECTABLE CORTICOSTEROID
PAGE: 1 OF 6
THIS VERSION ISSUED: 30 APRIL 2015
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: 1800 814 883
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 1 - IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: 1800 814 883
Fax: (02) 8876 0444
Email: australia.animalhealth@zoetis.com
PRODUCT IDENTIFIER:
DEPO MEDROL® INJECTABLE CORTICOSTEROID
APVMA APPROVAL NO:
38678 (20mg/mL), 38689 (40mg/mL)
OTHER NAMES:
None.
CHEMICAL FAMILY:
Injectable corticosteroid in a saline solution.
RECOMMENDED USE:
Animal injectable for use as described on the product label.
RESTRICTIONS ON USE
For veterinary use only.
EMERGENCY PHONE:
1800 814 883 (ALL HOURS)
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25, S36. Avoid contact with eyes. Wear suitable protective clothing.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
GHS LABEL ELEMENTS: NONE
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P402+P404: Store in a dry place. Store in a closed container.
P411+P235: Store at temperatures not exceeding 25°C. Keep cool.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities,
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