ACT IRBESARTAN/HCT TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Tilgjengelig fra:

ACTAVIS PHARMA COMPANY

ATC-kode:

C09DA04

INN (International Name):

IRBESARTAN AND DIURETICS

Dosering :

150MG; 12.5MG

Legemiddelform:

TABLET

Sammensetning:

IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100/500

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2018-06-12

Preparatomtale

Page 1 of 43
PRODUCT MONOGRAPH
PR
ACT IRBESARTAN/HCT
Irbesartan and Hydrochlorothiazide Tablets USP
150/12.5 mg, 300/12.5 mg and 300/25 mg
Angiotensin II AT
1
Receptor Blocker / Diuretic
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Submission Control No: 207407
Date of Revision:
July 24, 2017
Page 2 of 43
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
.............................................................................
17
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
DETAILED PHARMACOLOGY
....................................................................................
30
TOXICOLOGY
.................................