APO-CARVEDILOL TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CARVEDILOL

Dostępny od:

APOTEX INC

Kod ATC:

C07AG02

INN (International Nazwa):

CARVEDILOL

Dawkowanie:

3.125MG

Forma farmaceutyczna:

TABLET

Skład:

CARVEDILOL 3.125MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

BETA-ADRENERGIC BLOCKING AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2003-08-05

Charakterystyka produktu

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