SOLU-CORTEF POWDER FOR SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE)

Disponível em:

PFIZER CANADA ULC

Código ATC:

H02AB09

DCI (Denominação Comum Internacional):

HYDROCORTISONE

Dosagem:

500MG

Forma farmacêutica:

POWDER FOR SOLUTION

Composição:

HYDROCORTISONE (HYDROCORTISONE SODIUM SUCCINATE) 500MG

Via de administração:

INTRAMUSCULAR

Unidades em pacote:

4ML-VIAL

Tipo de prescrição:

Prescription

Área terapêutica:

ADRENALS

Resumo do produto:

Active ingredient group (AIG) number: 0106344011; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2001-04-10

Características técnicas

_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