Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
TELMISARTAN
APOTEX INC
C09CA07
TELMISARTAN
40MG
TABLET
TELMISARTAN 40MG
ORAL
30/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0138223001; AHFS:
APPROVED
2014-01-24
_APO-TELMISARTAN Product Monograph_ Page 1 of 30 PRODUCT MONOGRAPH Pr APO-TELMISARTAN (TELMISARTAN TABLETS, USP) 40 MG AND 80 MG ANGIOTENSIN II AT1 RECEPTOR BLOCKER APOTEX INC. DATE OF PREPARATION: 150 SIGNET DRIVE JANUARY 24, 2014 TORONTO, ONTARIO M9L 1T9 CONTROL NUMBER: 149368 _APO-TELMISARTAN Product Monograph_ Page 2 of 30 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS ....................................................................................................... 3 WARNINGS AND PRECAUTIONS ....................................................................................... 4 ADVERSE REACTIONS ...................................................................................................... 8 DRUG INTERACTIONS ......................................................................................................13 DOSAGE AND ADMINISTRATION .....................................................................................15 OVERDOSAGE ...................................................................................................................15 ACTION AND CLINICAL PHARMACOLOGY ......................................................................16 STORAGE AND STABILITY................................................................................................18 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................18 PART II: SCIENTIFIC INFORMATION ...................................................................................20 PHARMACEUTICAL INFORMATION ..................................................................................20 CLINICAL TRIALS ........................................................................ Aqra d-dokument sħiħ