HYTRIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

即購入

製品の特徴 製品の特徴 (SPC)
08-01-2015

有効成分:

TERAZOSIN HYDROCHLORIDE

から入手可能:

BGP PHARMA ULC

ATCコード:

G04CA03

INN(国際名):

TERAZOSIN

投薬量:

1MG

医薬品形態:

TABLET

構図:

TERAZOSIN HYDROCHLORIDE 1MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

ALPHA-ADRENERGIC BLOCKING AGENTS

製品概要:

Active ingredient group (AIG) number: 0121210003; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2016-02-19

製品の特徴

                                _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
.............................................................
                                
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