APO-CARVEDILOL TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

CARVEDILOL

から入手可能:

APOTEX INC

ATCコード:

C07AG02

INN（国際名）:

CARVEDILOL

投薬量:

3.125MG

医薬品形態:

TABLET

構図:

CARVEDILOL 3.125MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

BETA-ADRENERGIC BLOCKING AGENTS

製品概要:

Active ingredient group (AIG) number: 0122683003; AHFS:

認証ステータス:

APPROVED

承認日:

2003-08-05

製品の特徴

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