BOSENTAN TABLETS

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

BOSENTAN (BOSENTAN MONOHYDRATE)

Доступно од:

ACCORD HEALTHCARE INC

АТЦ код:

C02KX01

INN (Међународно име):

BOSENTAN

Дозирање:

125MG

Фармацеутски облик:

TABLET

Састав:

BOSENTAN (BOSENTAN MONOHYDRATE) 125MG

Пут администрације:

ORAL

Јединице у пакету:

56/100/500

Тип рецептора:

Prescription

Терапеутска област:

VASODILATING AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0145922002; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2015-06-02

Карактеристике производа

1
PRODUCT MONOGRAPH
Pr
Bosentan Tablets
Bosentan Monohydrate (film coated tablet)
Bosentan 62.5 mg and 125 mg
Professed standard
Endothelin Receptor Antagonist
Accord Healthcare Inc.
3535 boul. St. Charles, suite 704,
Kirkland, QC, H9H 5B9,
Canada
DATE OF PREPARATION:
June 13, 2014
SUBMISSION CONTROL NO: 169674
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
...............................................................................................................
7
DRUG INTERACTIONS
.............................................................................................................
15
DOSAGE AND ADMINISTRATION
.........................................................................................
17
OVERDOSAGE
...........................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
19
STORAGE AND STABILITY
.....................................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
..................................................................................
21
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................... 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
22
PHARMACEUTICAL INFORMATION
................