Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
IRBESARTAN; HYDROCHLOROTHIAZIDE
MYLAN PHARMACEUTICALS ULC
C09DA04
IRBESARTAN AND DIURETICS
150MG; 12.5MG
TABLET
IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG
ORAL
90
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0240086001; AHFS:
CANCELLED PRE MARKET
2016-11-02
1 PRODUCT MONOGRAPH PR MYLAN-IRBESARTAN HCTZ Irbesartan and Hydrochlorothiazide Tablets 150/12.5 mg, 300/12.5 mg and 300/25 mg Manufacturer’s Standard Angiotensin II AT 1 Receptor Blocker / Diuretic Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Submission Control No.: 189365 Date of Revision: November 24, 2015 2 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS ........................................................................................................... 9 DRUG INTERACTIONS ......................................................................................................... 14 DOSAGE AND ADMINISTRATION ..................................................................................... 20 OVERDOSAGE ....................................................................................................................... 22 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 22 STORAGE AND STABILITY ................................................................................................. 26 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 26 PART II: SCIENTIFIC INFORMATION ............................................................................... 27 PHARMACEUTICAL INFORMATION ................................................................................. 27 CLINICAL TRIALS ....................................................... Prečítajte si celý dokument