Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
PHARMASCIENCE INC
C09DA08
OLMESARTAN MEDOXOMIL AND DIURETICS
25MG; 40MG
TABLET
HYDROCHLOROTHIAZIDE 25MG; OLMESARTAN MEDOXOMIL 40MG
ORAL
30/100/1000
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0252502003; AHFS:
CANCELLED PRE MARKET
2019-02-07
PRODUCT MONOGRAPH Pr PMS-OLMESARTAN-HCTZ Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg Angiotensin II AT 1 Receptor Blocker - Diuretic PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Quebec H4P 2T4 www.pharmascience.com DATE OF REVISION: June 28, 2017 Submission Control No.: 205707, 200930 _ _ _pms-OLMESARTAN-HCTZ Product Monograph _ _Page 2 of 35_ 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 ....................................................................................................9 DRUG INTERACTIONS ..................................................................................................12 DOSAGE AND ADMINISTRATION ..............................................................................16 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................22 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................22 PART II: SCIENTIFIC INFORMATION ...............................................................................23 PHARMACEUTICAL INFORMATION ..........................................................................23 CLINICAL TRIALS ..................................................................... Baca dokumen lengkap