البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
TELMISARTAN (TELMISARTAN SODIUM); HYDROCHLOROTHIAZIDE
TEVA CANADA LIMITED
C09DA07
TELMISARTAN AND DIURETICS
80.0MG; 12.5MG
TABLET
TELMISARTAN (TELMISARTAN SODIUM) 80.0MG; HYDROCHLOROTHIAZIDE 12.5MG
ORAL
30/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0244783001; AHFS:
CANCELLED PRE MARKET
2017-06-13
_ _ _NTP-TELMISARTAN HCTZ _ _Page 1 of 50_ PRODUCT MONOGRAPH PR NTP-TELMISARTAN HCTZ Telmisartan (as Telmisartan Sodium) and Hydrochlorothiazide Tablets 80 mg/12.5 mg and 80 mg/25 mg NTP standard Angiotensin II AT 1 Receptor Blocker/Diuretic Teva Canada Ltd. 30 Novopharm Court Toronto, Ontario Canada, M1B 2K9 Date of Preparation: September 23, 2013 Submission Control No: 167610 _ _ _NTP-TELMISARTAN HCTZ _ _Page 2 of 50_ 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 ................................................................................................... 9 DRUG INTERACTIONS ................................................................................................. 20 DOSAGE AND ADMINISTRATION ............................................................................. 23 OVERDOSAGE ............................................................................................................... 25 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 25 STORAGE AND STABILITY ......................................................................................... 31 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 31 PART II: SCIENTIFIC INFORMATION .............................................................................. 32 PHARMACEUTICAL INFORMATION ......................................................................... 32 CLINICAL TRIALS ............................................................... اقرأ الوثيقة كاملة