Riik: Kanada
keel: inglise
Allikas: Health Canada
TELMISARTAN; HYDROCHLOROTHIAZIDE
NORA PHARMA INC
C09DA07
TELMISARTAN AND DIURETICS
80MG; 12.5MG
TABLET
TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 12.5MG
ORAL
15G/50G
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0244783001; AHFS:
APPROVED
2020-08-25
_NRA-Telmisartan - Product Monograph _ _1 of 31 _ PRODUCT MONOGRAPH PR NRA-TELMISARTAN Telmisartan Tablets 40 mg and 80 mg Manufacturer’s Standard Angiotensin II AT 1 Receptor Blocker Nora Pharma Inc. 1565 Lionel-Boulet Blvd. Varennes, Québec J3X 1P7 Canada SUBMISSION CONTROL NO.: 266032 Date of Revision: August 9, 2022 _NRA-Telmisartan - Product Monograph _ _2 of 31 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 4 ADVERSE REACTIONS ........................................................................................................... 8 DRUG INTERACTIONS ......................................................................................................... 14 DOSAGE AND ADMINISTRATION ..................................................................................... 16 OVERDOSAGE ....................................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 17 STORAGE AND STABILITY ................................................................................................. 20 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 20 PART II: SCIENTIFIC INFORMATION ............................................................................... 21 PHARMACEUTICAL INFORMATION ................................................................................. 21 CLINICAL TRIALS .............. Lugege kogu dokumenti