MEDROL 16 MG TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
12-03-2024

유효 성분:

METHYLPREDNISOLONE

제공처:

PFIZER CANADA ULC

ATC 코드:

H02AB04

INN (국제 이름):

METHYLPREDNISOLONE

복용량:

16MG

약제 형태:

TABLET

구성:

METHYLPREDNISOLONE 16MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

ADRENALS

제품 요약:

Active ingredient group (AIG) number: 0106290006; AHFS:

승인 상태:

APPROVED

승인 날짜:

2003-09-19

제품 특성 요약

                                _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
........................................
                                
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