HYTRIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TERAZOSIN HYDROCHLORIDE

제공처:

BGP PHARMA ULC

ATC 코드:

G04CA03

INN (국제 이름):

TERAZOSIN

복용량:

5MG

약제 형태:

TABLET

구성:

TERAZOSIN HYDROCHLORIDE 5MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

ALPHA-ADRENERGIC BLOCKING AGENTS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2017-05-16

제품 특성 요약

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