BOSENTAN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

BOSENTAN (BOSENTAN MONOHYDRATE)

זמין מ:

ACTELION PHARMACEUTICALS LTD

קוד ATC:

C02KX01

INN (שם בינלאומי):

BOSENTAN

כמות:

62.5MG

טופס פרצבטיות:

TABLET

הרכב:

BOSENTAN (BOSENTAN MONOHYDRATE) 62.5MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

56

סוג מרשם:

Prescription

איזור תרפויטי:

VASODILATING AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0145922001; AHFS:

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2018-09-28

מאפייני מוצר

_ _
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
...