SOLU-CORTEF POWDER FOR SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE)

Fáanlegur frá:

PFIZER CANADA ULC

ATC númer:

H02AB09

INN (Alþjóðlegt nafn):

HYDROCORTISONE

Skammtar:

1G

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE) 1G

Stjórnsýsluleið:

INTRAMUSCULAR

Einingar í pakka:

8ML-VIAL

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ADRENALS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2001-04-10

Vara einkenni

_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
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
6
1.2
Geriatrics
...................................................................................................................
6
2
CONTRAINDICATIONS
.................................................................................................
6
4
DOSAGE AND ADMINISTRATION
.................................................................................
7
4.1
Dosing Considerations
..............................................................................................
7
4.2
Recom