SOLU-CORTEF POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE)

Pieejams no:

PFIZER CANADA ULC

ATĶ kods:

H02AB09

SNN (starptautisko nepatentēto nosaukumu):

HYDROCORTISONE

Deva:

1G

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE) 1G

Ievadīšanas:

INTRAMUSCULAR

Vienības iepakojumā:

8ML-VIAL

Receptes veids:

Prescription

Ārstniecības joma:

ADRENALS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2001-04-10

Produkta apraksts

_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