METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

Available from:

TEVA CANADA LIMITED

ATC code:

H02AB04

INN (International Name):

METHYLPREDNISOLONE

Dosage:

500MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 500MG

Administration route:

INTRAMUSCULAR

Units in package:

8ML

Prescription type:

Prescription

Therapeutic area:

ADRENALS

Product summary:

Active ingredient group (AIG) number: 0106290005; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-04-02

Summary of Product characteristics

_Methylprednisolone Sodium Succinate for Injection Page 1 of 42 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
METHYLPREDNISOLONE SODIUM SUCCINATE
FOR INJECTION
Methylprednisolone Sodium Succinate for Injection
Sterile Powder for Solution, 40mg, 125mg, 500 mg, 1 g Vials,
intravenous or intramuscular
USP
Glucocorticoid
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
MAY 06, 2014
Toronto, ON
M1B 2K9
Date of Revision:
Canada
September 23, 2022
www.tevacanada.com
Submission Control Number: 263266
_Methylprednisolone Sodium Succinate for Injection Page 2 of 42 _
RECENT MAJOR LABEL CHANGES
WARNINGS AND PRECAUTIONS, SPECIAL POPULATIONS, PEDIATRICS
09/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................................
4
1 INDICATIONS
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4
1.1 Pediatrics
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5
1.2 Geriatrics
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5
2
CONTRAINDICATIONS............................................................................................................
5
4 DOSAGE AND ADMINISTRATION
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6
4.1 Dosing Considerations
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6
4.2 Recommended Dose and Dosage Adjustment
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