IRBESARTAN/HCT TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Dostupné z:

ACTAVIS PHARMA COMPANY

ATC kód:

C09DA04

INN (Medzinárodný Name):

IRBESARTAN AND DIURETICS

Dávkovanie:

300MG; 25MG

Forma lieku:

TABLET

Zloženie:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG

Spôsob podávania:

ORAL

Počet v balení:

30/100/500

Typ predpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2017-09-01

Súhrn charakteristických

Page 1 of 43
PRODUCT MONOGRAPH
PR
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: 179270
Date of Preparation:
November 7, 2014
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
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
DETAILED PHARMACOLOGY
....................................................................................
29
TOXICOLOGY
...............................