Страна: Канада
мова: англійська
Джерело: Health Canada
IRBESARTAN; HYDROCHLOROTHIAZIDE
JAMP PHARMA CORPORATION
C09DA04
IRBESARTAN AND DIURETICS
300MG; 25MG
TABLET
IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG
ORAL
28/100
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0240086003; AHFS:
CANCELLED POST MARKET
2022-09-06
_Jamp-Irbesartan and Hydrochlorothiazide _ _Page 1 of 40_ PRODUCT MONOGRAPH PR JAMP-IRBESARTAN AND HYDROCHLOROTHIAZIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS (House Standard) 150/12.5 mg, 300/12.5 mg and 300/25 mg Angiotensin II AT 1 Receptor Blocker / Diuretic JAMP PHARMA CORPORATION DATE OF PREPARATION: 1380-203 NEWTON, BOUCHERVILLE, QUÉBEC, J4B 5H2 December 11, 2013 SUBMISSION CONTROL NO.: 170093 _Jamp-Irbesartan and Hydrochlorothiazide _ _Page 2 of 40_ 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 ............................................................................................................ 13 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 ....................................................................................... Прочитайте повний документ