SOLU-CORTEF POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE)

Available from:

PFIZER CANADA ULC

ATC code:

H02AB09

INN (International Name):

HYDROCORTISONE

Dosage:

1G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE) 1G

Administration route:

INTRAMUSCULAR

Units in package:

8ML-VIAL

Prescription type:

Prescription

Therapeutic area:

ADRENALS

Product summary:

Active ingredient group (AIG) number: 0106344010; AHFS:

Authorization status:

APPROVED

Authorization date:

2001-04-10

Summary of Product characteristics

_Solu-Cortef (Hydrocortisone sodium succinate) _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SOLU-CORTEF*
Hydrocortisone sodium succinate for injection USP
Sterile Powder and Diluent
100 mg, 250 mg, 500 mg and 1 g Act-O-Vials†
Glucocorticoid
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Québec H9J 2M5
Date of Initial Authorization:
September 24, 2003
Date of Revision:
September 18, 2023
Submission Control Number: 274957
*
®
Pfizer Enterprises SARL
Pfizer Canada ULC, Licensee
†
®
Pharmacia & Upjohn Company LLC
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC 2023
_ _
_Solu-Cortef (Hydrocortisone sodium succinate) _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, OTHER
09/2023
8 ADVERSE REACTIONS, 8.1 ADVERSE REACTIONS
OVERVIEW
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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6
1.2
Geriatrics
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6
2
CONTRAINDICATIONS
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6
4
DOSAGE AND ADMINISTRATION
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7
4.1
Dosing Considerations
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7
4.2
Recom