Riik: Kanada
keel: inglise
Allikas: Health Canada
TELMISARTAN; AMLODIPINE (AMLODIPINE BESYLATE)
APOTEX INC
C09DB04
TELMISARTAN AND AMLODIPINE
80MG; 10MG
TABLET
TELMISARTAN 80MG; AMLODIPINE (AMLODIPINE BESYLATE) 10MG
ORAL
30/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0252947004; AHFS:
APPROVED
2020-09-04
_Product Monograph _ _APO-TELMISARTAN-AMLODIPINE (telmisartan/amlodipine) _ _Page 1 of 59 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-TELMISARTAN-AMLODIPINE Telmisartan / Amlodipine Tablets Tablets, 40/5 mg, 40/10 mg, 80/5 mg and 80/10 mg telmisartan / amlodipine (as amlodipine besylate), Oral House Standard Angiotensin II AT1 Receptor Blocker / Calcium Channel Blocker APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization FEB 27, 2018 Date of Revision: OCT 16, 2023 Submission Control Number: 274810 _Product Monograph _ _APO-TELMISARTAN-AMLODIPINE (telmisartan/amlodipine) _ _Page 2 of 59 _ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION 10/2023 7 WARNINGS AND PRECAUTIONS 10/2023 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 ...................... Lugege kogu dokumenti