ACT IRBESARTAN/HCT TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Dostupné s:

ACTAVIS PHARMA COMPANY

ATC kód:

C09DA04

INN (Mezinárodní Name):

IRBESARTAN AND DIURETICS

Dávkování:

300MG; 25MG

Léková forma:

TABLET

Složení:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG

Podání:

ORAL

Jednotky v balení:

30/100/500

Druh předpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Přehled produktů:

Active ingredient group (AIG) number: 0240086003; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2018-06-12

Charakteristika produktu

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
.................................