Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
TELMISARTAN; AMLODIPINE (AMLODIPINE BESYLATE)
BOEHRINGER INGELHEIM (CANADA) LTD LTEE
C09DB04
TELMISARTAN AND AMLODIPINE
40MG; 5MG
TABLET
TELMISARTAN 40MG; AMLODIPINE (AMLODIPINE BESYLATE) 5MG
ORAL
14/28
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0252947001; AHFS:
APPROVED
2011-08-03
_ _ _Product Monograph _ _ _ _TWYNSTA (telmisartan/amlodipine) _ _Page 1 of 54 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TWYNSTA ® Telmisartan / Amlodipine (as Amlodipine Besylate) Tablets Tablet, 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg, Oral Angiotensin II AT1 Receptor Blocker / Calcium Channel Blocker Boehringer Ingelheim (Canada) Ltd. 5180 South Service Road Burlington, Ontario L7L 5H4 Date of Initial Authorization: AUG 11, 2011 Date of Revision: October 4, 2022 Submission Control Number: 264045 BICL CCDS# 0275-08 Twynsta ® is a registered trademark used under license by Boehringer Ingelheim (Canada) Ltd. _ _ _Product Monograph _ _ _ _TWYNSTA (telmisartan/amlodipine) _ _Page 2 of 54 _ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION 10/2022 7 WARNINGS AND PRECAUTIONS 10/2022 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 4.2 Recommended Dose and Dosage Adjustment....... Perskaitykite visą dokumentą