TEVA-IRBESARTAN/HCTZ TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

C09DA04

INN (International Adı):

IRBESARTAN AND DIURETICS

Doz:

300MG; 25MG

Farmasötik formu:

TABLET

Kompozisyon:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2018-04-10

Ürün özellikleri

PRODUCT MONOGRAPH
PR
TEVA-IRBESARTAN/HCTZ
(irbesartan/hydrochlorothiazide)
tablets 150/12.5 mg, 300/12.5 mg and 300/25 mg
Teva Standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 190673
Date of Revision:
January 18, 2016
2
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
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
.................................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
.................................................................................
27
CLINICAL TRIALS
.................................................................................................................
28
DETAILED PHARMACOLOGY
..............................................................