Ország: Kanada
Nyelv: angol
Forrás: Health Canada
TELMISARTAN
AURO PHARMA INC
C09CA07
TELMISARTAN
40MG
TABLET
TELMISARTAN 40MG
ORAL
30/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0138223001; AHFS:
APPROVED
2016-04-04
AURO-TELMISARTAN Product Monograph Page 1 of 39 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr AURO-TELMISARTAN Telmisartan Tablets, USP Tablets, 40 mg and 80 mg, Oral Angiotensin II AT1 Receptor Blocker Auro Pharma Inc. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, Canada. Date of Initial Authorization: April 04, 2016 Date of Revision: June 02, 2023 Submission Control Number: 270620 AURO-TELMISARTAN Product Monograph Page 2 of 39 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. 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 ....................................................................................................... Olvassa el a teljes dokumentumot