AVA-IRBESARTAN/HCTZ TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Dostupné s:

AVANSTRA INC

ATC kód:

C09DA04

INN (Mezinárodní Name):

IRBESARTAN AND DIURETICS

Dávkování:

150MG; 12.5MG

Léková forma:

TABLET

Složení:

IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Přehled produktů:

Active ingredient group (AIG) number: 0240086001; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2014-08-21

Charakteristika produktu

PRODUCT MONOGRAPH
PR
AVA-IRBESARTAN/HCTZ
(irbesartan/hydrochlorothiazide)
tablets 150/12.5 mg, 300/12.5 mg and 300/25 mg
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
Avanstra Inc.
10761 – 25th Street NE, Suite 110
Calgary, Alberta
T3N 0A4
Canada
Submission Control No: 149729
Date of Preparation:
September 13, 2011
2
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...........................................................................................................
7
DOSAGE AND
ADMINISTRATION.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND
STABILITY.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC
INFORMATION...............................................................................
21
PHARMACEUTICAL
INFORMATION.................................................................................
21
CLINICAL
TRIALS.................................................................................................................
22
DETAILED
PHARMACOLOGY......................................