MYLAN-IRBESARTAN HCTZ TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

C09DA04

INN (Nama Internasional):

IRBESARTAN AND DIURETICS

Dosis:

300MG; 25MG

Bentuk farmasi:

TABLET

Komposisi:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG

Rute administrasi :

ORAL

Unit dalam paket:

90

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2016-11-02

Karakteristik produk

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