APO-CARVEDILOL TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CARVEDILOL

Tilgængelig fra:

APOTEX INC

ATC-kode:

C07AG02

INN (International Name):

CARVEDILOL

Dosering:

25MG

Lægemiddelform:

TABLET

Sammensætning:

CARVEDILOL 25MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

BETA-ADRENERGIC BLOCKING AGENTS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2003-08-05

Produktets egenskaber

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