APO-CARVEDILOL TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CARVEDILOL

Disponible depuis:

APOTEX INC

Code ATC:

C07AG02

DCI (Dénomination commune internationale):

CARVEDILOL

Dosage:

3.125MG

forme pharmaceutique:

TABLET

Composition:

CARVEDILOL 3.125MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

BETA-ADRENERGIC BLOCKING AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2003-08-05

Résumé des caractéristiques du produit

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