HYTRIN-7 TABS 1MG-7 TABS 2MG-14 TABS 5MG KIT

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TERAZOSIN (TERAZOSIN HYDROCHLORIDE); TERAZOSIN (TERAZOSIN HYDROCHLORIDE); TERAZOSIN (TERAZOSIN HYDROCHLORIDE)

Tersedia dari:

ABBOTT LABORATORIES, LIMITED

Kode ATC:

G04CA03

INN (Nama Internasional):

TERAZOSIN

Dosis:

1MG; 2MG; 5MG

Bentuk farmasi:

KIT

Komposisi:

TERAZOSIN (TERAZOSIN HYDROCHLORIDE) 1MG; TERAZOSIN (TERAZOSIN HYDROCHLORIDE) 2MG; TERAZOSIN (TERAZOSIN HYDROCHLORIDE) 5MG

Rute administrasi :

ORAL

Unit dalam paket:

1 EA

Jenis Resep:

Prescription

Area terapi:

ALPHA-ADRENERGIC BLOCKING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0336814001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2006-10-17

Karakteristik produk

_ _
_HYTRIN® Product Monograph _
_Page 1 of 37_
PRODUCT MONOGRAPH
Pr
HYTRIN
®
terazosin hydrochloride
1, 2, 5 and 10 mg tablets
Antihypertensive Agent
Symptomatic Treatment of Benign Prostatic Hyperplasia (BPH)
Abbott Laboratories, Limited
8401 Trans-Canada Highway
St. Laurent (Quebec) Canada
H4S 1Z1
Date of Preparation:
May 15, 1997
Date of Revision:
June 15, 2006
Submission Control No: 104433
_ _
_HYTRIN® Product Monograph _
_Page 2 of 37_
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND
ADMINISTRATION..............................................................................15
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND
STABILITY..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL
INFORMATION..........................................................................20
CLINICAL
TRIALS..........................................................................................................21
DETAILED
PHARMACOLOGY....................................