HYTRIN TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

TERAZOSIN HYDROCHLORIDE

Доступна з:

BGP PHARMA ULC

Код атс:

G04CA03

ІПН (Міжнародна Ім'я):

TERAZOSIN

Дозування:

5MG

Фармацевтична форма:

TABLET

Склад:

TERAZOSIN HYDROCHLORIDE 5MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

ALPHA-ADRENERGIC BLOCKING AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0121210001; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2017-05-16

Характеристики продукта

_HYTRIN_
_®_
_ Product Monograph _
_Page 1 of 40 _
_ _
PRODUCT MONOGRAPH
PR
HYTRIN
®
terazosin hydrochloride tablets
1 mg, 2 mg, 5 mg and 10 mg
Antihypertensive Agent_ _
Symptomatic Treatment of Benign Prostatic Hyperplasia (BPH)
Date of Preparation:
January 7, 2015
BGP Pharma Inc.
8401 Trans-Canada Highway
St. Laurent, Qc H4S 1Z1
Submission Control Number: 180585
_HYTRIN_
_®_
_ Product Monograph _
_Page 2 of 40 _
_ _
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
..................................................................................................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
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
.............................................................