CORTEF TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

HYDROCORTISONE

Tersedia dari:

PFIZER CANADA ULC

Kode ATC:

H02AB09

INN (Nama Internasional):

HYDROCORTISONE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

HYDROCORTISONE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

ADRENALS

Ringkasan produk:

Active ingredient group (AIG) number: 0106344002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2003-09-09

Karakteristik produk

_CORTEF (hydrocortisone) _
_Page 1 of 32 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CORTEF
Hydrocortisone Tablets
Tablet, 10 mg, 20 mg, Oral
The Anatomical Therapeutic Chemical (ATC) Code:
D07XA01
Corticosteroid
USP
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
December 31, 1954
Distributed by: TM Pharmacia Enterprises Sarl.
Pfizer Canada ULC, licensee
© Pfizer Canada ULC, 2023
Date of Revision:
September 18, 2023
Submission Control Number: 274963
_ _
_CORTEF (hydrocortisone) _
_Page 2 of 32 _
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
..................................................................................................................
5
1.2
Geriatrics
..................................................................................................................
5
2
CONTRAINDICATIONS
................................................................................................
5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 6
5
OVERDOSAGE
.............