METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-08-2018
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Active ingredient:
METHYLPREDNISOLONE; WATER
Available from:
HOSPIRA HEALTHCARE ULC
ATC code:
H02AB04
INN (International Name):
METHYLPREDNISOLONE
Dosage:
1G; 20ML
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
METHYLPREDNISOLONE 1G; WATER 20ML
Administration route:
INTRAMUSCULAR
Units in package:
16ML
Prescription type:
Prescription
Therapeutic area:
ADRENALS
Product summary:
Active ingredient group (AIG) number: 0232014003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2019-04-05
Summary of Product characteristics
_Pr_
_Methylprednisolone Sodium Succinate for Injection, USP- Product
Monograph _
_Page 1 of 35_
PRODUCT MONOGRAPH
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Methylprednisolone Sodium Succinate for Injection, USP
Sterile Powder for Solution
500 mg, 1 g Vials
Glucocorticoid
Hospira Healthcare Corporation
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Revision: August 03, 2018
Submission Control No: 218009
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_Methylprednisolone Sodium Succinate for Injection, USP- Product
Monograph _
_Page 2 of 35_
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
.................................................................................................
15
DRUG INTERACTIONS
..................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 31
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
...
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