DEPO-MEDROL (WITH PRESERVATIVE) 40 MG/ML SUSPENSION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

METHYLPREDNISOLONE ACETATE

זמין מ:

PFIZER CANADA ULC

קוד ATC:

H02AB04

INN (שם בינלאומי):

METHYLPREDNISOLONE

כמות:

40MG

טופס פרצבטיות:

SUSPENSION

הרכב:

METHYLPREDNISOLONE ACETATE 40MG

מסלול נתינה (של תרופות):

INTRA-ARTICULAR

יחידות באריזה:

2/5ML

סוג מרשם:

Prescription

איזור תרפויטי:

ADRENALS

leaflet_short:

Active ingredient group (AIG) number: 0106292002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2003-10-03

מאפייני מוצר

DEPO-MEDROL (methylprednisolone acetate) - Product Monograph
_ _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DEPO-MEDROL
®
methylprednisolone acetate injectable suspension
20 mg/mL, 40 mg/mL, 80 mg/mL with Benzyl Alcohol injectable
suspension, for intramuscular, intra-
articular, intra-synovial and intralesional injection
40 mg/mL, 80 mg/mL with MGPC injectable suspension, for intramuscular,
intra-articular, intra-synovial
and intralesional injection
USP
Glucocorticoid
Pfizer Canada ULC
17 300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
OCT 03, 2003
Date of Revision:
MAR 15, 2024
Submission Control Number: 280641
®
TM Pfizer Enterprises, SARL
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC, 2024
_ _
DEPO-MEDROL (methylprednisolone acetate) - Product Monograph
_ _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
4
DOSAGE AND ADMINISTRATION
03/2024
7 WARNINGS AND PRECAUTIONS, General and Endocrine and
Metabolism
08/2023
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
................................................................................................................
6
1.2
Geriatrics
................................................................................................................
6
2.
CONTRAINDICATIONS
.................................................................................................
6
4
DOSAGE AND ADMINISTRATION
..........