Ország: Kanada
Nyelv: angol
Forrás: Health Canada
TELMISARTAN
ACCORD HEALTHCARE INC
C09CA07
TELMISARTAN
80MG
TABLET
TELMISARTAN 80MG
ORAL
15G/50G
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0138223002; AHFS:
APPROVED
2021-03-05
ACH-Telmisartan - Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ Page 1 of 35 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ACH-TELMISARTAN Telmisartan Tablets Tablet, 40 mg and 80 mg, Oral Manufacturer’s Standard Angiotensin II AT 1 Receptor Blocker Accord Healthcare Inc. 3535 boul. St. Charles, Suite 704 Kirkland, QC, H9H 5B9 Canada Date of Initial Authorization: June 7, 2013 Date of Revision: June 26, 2023 SUBMISSION CONTROL NUMBER: 271374 ACH-Telmisartan - Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ Page 2 of 35 RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 06/2023 7 WARNINGS AND PRECAUTIONS 06/2023 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 ................................................. Olvassa el a teljes dokumentumot