MEDROL 4 MG TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

METHYLPREDNISOLONE

Tersedia dari:

PFIZER CANADA ULC

Kode ATC:

H02AB04

INN (Nama Internasional):

METHYLPREDNISOLONE

Dosis:

4MG

Bentuk farmasi:

TABLET

Komposisi:

METHYLPREDNISOLONE 4MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

ADRENALS

Ringkasan produk:

Active ingredient group (AIG) number: 0106290007; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2003-09-19

Karakteristik produk

_MEDROL (methylprednisolone) – Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MEDROL*
methylprednisolone
4mg & 16mg tablets, for oral use
USP
Glucocorticoid
Pfizer Canada ULC
17 300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
May 30, 2001
Date of Revision:
MAR 12, 2024
Submission Control Number: 280540
* TM Pharmacia Enterprises S.A.
Pfizer Canada ULC, licensee
© Pfizer Canada ULC, 2023
_MEDROL (methylprednisolone) – Product Monograph _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General, Endocrine and
Metabolism
07/2023
8 ADVERSE REACTIONS
03/2024
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
.................................................................................
6
4.1
Dosing Considerations
............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4.5
Missed Dose
........................................