MYLAN-IRBESARTAN HCTZ TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

C09DA04

INN (International Name):

IRBESARTAN AND DIURETICS

Dosering :

300MG; 12.5MG

Legemiddelform:

TABLET

Sammensetning:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 12.5MG

Administreringsrute:

ORAL

Enheter i pakken:

90/500

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0240086002; AHFS:

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2016-11-02

Preparatomtale

1
PRODUCT MONOGRAPH
PR MYLAN-IRBESARTAN HCTZ
Irbesartan and Hydrochlorothiazide Tablets
150/12.5 mg, 300/12.5 mg and 300/25 mg
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 189365
Date of Revision: November 24, 2015
2
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
.....................................................................................
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
.......................................................