METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION USP
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-07-2018
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Active ingredient:
METHYLPREDNISOLONE ACETATE
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
H02AB04
INN (International Name):
METHYLPREDNISOLONE
Dosage:
40MG
Pharmaceutical form:
SUSPENSION
Composition:
METHYLPREDNISOLONE ACETATE 40MG
Administration route:
INTRA-ARTICULAR
Units in package:
1 ML
Prescription type:
Prescription
Therapeutic area:
ADRENALS
Product summary:
Active ingredient group (AIG) number: 0106292002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-04-22
Summary of Product characteristics
_Methylprednisolone Acetate Injectable Suspension USP _
_Page 1 of 32 _
PRODUCT MONOGRAPH
PR
METHYLPREDNISOLONE ACETATE INJECTABLE
SUSPENSION USP
40 mg/mL and 80 mg/mL
GLUCOCORTICOID
Sandoz Canada Inc.
Date of Revision: July 20, 2018
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Control No.: 217576
_Methylprednisolone Acetate Injectable Suspension USP _
_Page 2 of 32 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................3
INDICATIONS AND CLINICAL
USE.................................................................................3
CONTRAINDICATIONS
.....................................................................................................5
WARNINGS AND PRECAUTIONS
....................................................................................5
ADVERSE REACTIONS
...................................................................................................13
DRUG
INTERACTIONS....................................................................................................15
DOSAGE AND ADMINISTRATION
................................................................................18
OVERDOSAGE
.................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
...............................................................23
STORAGE AND STABILITY
...........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................23
PART II: SCIENTIFIC INFORMATION
...................................................................................25
PHARMACEUTICAL INFORMATION
............................................................................25
TOXICOLOGY
.......................................................................................
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