BOSENTAN TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

BOSENTAN (BOSENTAN MONOHYDRATE)

Dostupné z:

ACTELION PHARMACEUTICALS LTD

ATC kód:

C02KX01

INN (Medzinárodný Name):

BOSENTAN

Dávkovanie:

125MG

Forma lieku:

TABLET

Zloženie:

BOSENTAN (BOSENTAN MONOHYDRATE) 125MG

Spôsob podávania:

ORAL

Počet v balení:

56

Typ predpisu:

Prescription

Terapeutické oblasti:

VASODILATING AGENTS

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2018-09-28

Súhrn charakteristických

_ _
PRODUCT MONOGRAPH
Pr
BOSENTAN
BOSENTAN monohydrate (film coated) tablet
BOSENTAN 62.5, 125 mg
Professed standard
Endothelin Receptor Antagonist
Actelion Pharmaceuticals Ltd.
Allschwil, Switzerland
www.actelion.com
Actelion Pharmaceuticals Canada Inc.
2550 Daniel-Johnson Blvd., Suite 701
Laval, Quebec
H7T 2L1
Date of Revision:
May 9, 2017
Submission Control No.: 203871
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
CLINICAL TRIALS
...