Kraj: Kanada
Język: angielski
Źródło: Health Canada
CARVEDILOL
APOTEX INC
C07AG02
CARVEDILOL
12.5MG
TABLET
CARVEDILOL 12.5MG
ORAL
100
Prescription
BETA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0122683005; AHFS:
APPROVED
2003-08-05
_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 ........... Przeczytaj cały dokument