SOLU-MEDROL KIT

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE)

Boleh didapati daripada:

PFIZER CANADA ULC

Kod ATC:

H02AB04

INN (Nama Antarabangsa):

METHYLPREDNISOLONE

Dos:

125MG

Borang farmaseutikal:

KIT

Komposisi:

METHYLPREDNISOLONE (METHYLPREDNISOLONE SODIUM SUCCINATE) 125MG

Laluan pentadbiran:

INTRAMUSCULAR

Unit dalam pakej:

10X2ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ADRENALS

Ringkasan produk:

Active ingredient group (AIG) number: 0106290004; AHFS:

Status kebenaran:

MARKETED

Tarikh kebenaran:

2012-01-18

Ciri produk

_SOLU-MEDROL (methylprednisolone sodium succinate) Product Monograph _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SOLU-MEDROL
®
Methylprednisolone Sodium Succinate for Injection USP
Sterile Powder, 500 mg, 1 g Vials, intravenous and intramuscular
Pr
SOLU-MEDROL
® ACT-O-VIALS
®
Methylprednisolone Sodium Succinate for Injection USP
Sterile Powder and Diluent, 40 mg, 125 mg, 500 mg, 1 g ACT-O-VIALS,
intravenous and intramuscular
Glucocorticoid
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
March 20, 1991
Date of Revision:
MAR 14, 2024
Submission Control Number: 280527
® TM Pfizer Enterprises SARL
Pfizer Canada ULC, Licensee
® TM Pharmacia & Upjohn Company LLC
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC 2024
_ _
_SOLU-MEDROL (methylprednisolone sodium succinate) Product Monograph _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
01/2023
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
.........................................