RHOTRAL 200 TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ACEBUTOLOL HYDROCHLORIDE

Tersedia dari:

SANOFI-AVENTIS CANADA INC

Kode ATC:

C07AB04

INN (Nama Internasional):

ACEBUTOLOL

Dosis:

200MG

Bentuk farmasi:

TABLET

Komposisi:

ACEBUTOLOL HYDROCHLORIDE 200MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

BETA-ADRENERGIC BLOCKING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0112995003; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2010-10-26

Karakteristik produk

_ _
_ _
_Page 1 of 33_
PRODUCT MONOGRAPH
PR
RHOTRAL
®
(acebutolol hydrochloride)
_ _
_ _
_ _
100, 200, and 400 mg Tablets
Antiyhypertensive and Anti-anginal Agent
ATC Code: C07AB04
sanofi-aventis Canada Inc.
2150 St. Elzear Blvd. West
Laval, Quebec H7L 4A8
Date of Revision:
January 14, 2009
Submission Control No.: 125506
s-a Version dated
_ _
_ _
_Page 2 of 33_
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
.........................................................................................................
12
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
DETAILED
PHARMACOLOGY
....................