Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
TELMISARTAN; HYDROCHLOROTHIAZIDE
AURO PHARMA INC
C09DA07
TELMISARTAN AND DIURETICS
80MG; 12.5MG
TABLET
TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 12.5MG
ORAL
30/100/500/1000
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0244783001; AHFS:
APPROVED
2016-07-18
_Auro-Telmisartan HCTZ Product Monograph _Page 1 of 64 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AURO-TELMISARTAN HCTZ Telmisartan and Hydrochlorothiazide Tablets, USP Tablet, 80 mg/12.5 mg and 80 mg/25 mg, Oral Angiotensin II AT 1 Receptor Blocker/ Diuretic Auro Pharma Inc. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, Canada Date of initial Authorization: July 18, 2016 Date of Revision: January 26, 2023 Submission Control No: 267665 _Auro-Telmisartan HCTZ Product Monograph _Page 2 of 64 RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 01 / 2023 7 WARNINGS AND PRECAUTIONS 01 / 2023 4 DOSAGE AND ADMINISTRATION 01 / 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 ................................................... Soma hati kamili