البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
TELMISARTAN; HYDROCHLOROTHIAZIDE
VANC PHARMACEUTICALS INC
C09DA07
TELMISARTAN AND DIURETICS
80MG; 25MG
TABLET
TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 25MG
ORAL
28/30/100
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0244783002; AHFS:
CANCELLED PRE MARKET
2019-07-31
_VAN-Telmisartan-HCTZ Product Monograph _ _ _ _ Page 1 of 53_ PRODUCT MONOGRAPH Pr VAN-TELMISARTAN-HCTZ Telmisartan / Hydrochlorothiazide Tablets 80 mg/12.5 mg and 80 mg/25 mg Manufacturer’s Standard Angiotensin II AT 1 Receptor Blocker/Diuretic MANUFACTURER AND DISTRIBUTOR: Vanc Pharmaceuticals Inc. Building 152, 11782 River Road Richmond, BC V6X 1Z7 www.vancpharm.com Date of Preparation: November 7, 2014 Submission Control No: 179134 _VAN-Telmisartan-HCTZ Product Monograph _ _ _ _ Page 2 of 53_ 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 ............................................................................................... 11 DRUG INTERACTIONS ................................................................................................ 21 DOSAGE AND ADMINISTRATION ........................................................................... 25 OVERDOSAGE ............................................................................................................... 27 ACTION AND CLINICAL PHARMACOLOGY ........................................................ 28 STORAGE AND STABILITY ....................................................................................... 33 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................ 34 PART II: SCIENTIFIC INFORMATION ....................................................................... 35 PHARMACEUTICAL INFORMATION ..................................................................... 35 CLINICAL TRIALS ....................... اقرأ الوثيقة كاملة