APO-CARVEDILOL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CARVEDILOL

제공처:

APOTEX INC

ATC 코드:

C07AG02

INN (International Name):

CARVEDILOL

복용량:

25MG

약제 형태:

TABLET

구성:

CARVEDILOL 25MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

BETA-ADRENERGIC BLOCKING AGENTS

제품 요약:

Active ingredient group (AIG) number: 0122683001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2003-08-05

제품 특성 요약

_APO-CARVEDILOL (Carvedilol Tablets) _
_ _
_Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-CARVEDILOL
Carvedilol Tablets
Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg, Oral
USP
Congestive Heart Failure Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
AUG 05, 2003
Date of Revision:
MAR 22, 2024
Submission Control Number: 280604
_APO-CARVEDILOL (Carvedilol Tablets) _
_ _
_Page 2 of 40 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
03/2024
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
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
...........................................................................................................
4
1.2
Geriatrics
...........................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 5
4
DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................. 5
4.4
Administration
...........