RYLOSOL TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

SOTALOL HYDROCHLORIDE

Доступно од:

VALEANT CANADA LP / VALEANT CANADA S.E.C.

АТЦ код:

C07AA07

INN (Међународно име):

SOTALOL

Дозирање:

240MG

Фармацеутски облик:

TABLET

Састав:

SOTALOL HYDROCHLORIDE 240MG

Пут администрације:

ORAL

Јединице у пакету:

100/500

Тип рецептора:

Prescription

Терапеутска област:

BETA-ADRENERGIC BLOCKING AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0113778004; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2014-07-30

Карактеристике производа

_ _
_Rylosol Product Monograph – November 25, 2005 _
_Page 1 of 30_
PRODUCT MONOGRAPH
Pr
RYLOSOL

Sotalol Hydrochloride
80 mg, 160 mg, 240 mg Tablets
BP
Anti-arrhythmic
Valeant Canada limitée/Limited
4787, Levy Street
Montreal, Quebec
H4R 2P9
Date of Preparation:
November 25, 2005
Revision:
June 14, 2006
Submission Control No: 102836
_ _
_Rylosol Product Monograph – November 25, 2005 _
_Page 2 of 30_
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..................................................................................................10
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND
ADMINISTRATION..............................................................................14
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND
STABILITY..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL
INFORMATION..........................................................................20
CLINICAL
TRIALS....................................................................................