TEVA-ALFUZOSIN PR TABLET (EXTENDED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ALFUZOSIN HYDROCHLORIDE

제공처:

TEVA CANADA LIMITED

ATC 코드:

G04CA01

INN (국제 이름):

ALFUZOSIN

복용량:

10MG

약제 형태:

TABLET (EXTENDED-RELEASE)

구성:

ALFUZOSIN HYDROCHLORIDE 10MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

Selective Alfa-1-Adrenergic Blocking Agents

제품 요약:

Active ingredient group (AIG) number: 0146806001; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2018-05-02

제품 특성 요약

1
PRODUCT MONOGRAPH
PR
TEVA-ALFUZOSIN PR
Alfuzosin Hydrochloride
Prolonged-Release Tablets 10 mg
Pharmaceutical standard: Professed
SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
ADJUNCTIVE THERAPY IN ACUTE URINARY RETENTION (AUR)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
Date of Preparation:
May 31, 2011
Control No.: 147134
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL
USE.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND
PRECAUTIONS.........................................................................................
4
ADVERSE
REACTIONS...........................................................................................................
6
DRUG INTERACTIONS
...........................................................................................................
9
DOSAGE AND
ADMINISTRATION.....................................................................................
12
OVERDOSAGE
.......................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 13
STORAGE AND
STABILITY.................................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL
INFO