ALEMBIC-BOSENTAN TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

BOSENTAN (BOSENTAN MONOHYDRATE)

MAH:

ALEMBIC PHARMACEUTICALS LIMITED

ATC_code:

C02KX01

INN:

BOSENTAN

dosage:

125MG

pharmaceutical_form:

TABLET

composition:

BOSENTAN (BOSENTAN MONOHYDRATE) 125MG

administration_route:

ORAL

units_in_package:

10/30/60/1000

prescription_type:

Prescription

therapeutic_area:

VASODILATING AGENTS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2021-12-16

SPC

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Alembic-Bosentan Page 1 of 42
PRODUCT MONOGRAPH
PR
ALEMBIC-BOSENTAN
Bosentan Tablets
62.5 mg and 125 mg Bosentan (as Bosentan Monohydrate)
Endothelin Receptor Antagonist
DATE OF REVISION:
December 13, 2021
MANUFACTURED BY:
Alembic Pharmaceuticals Limited
Alembic Road
Vadodara
–
390003
Gujarat, India
CANADIAN IMPORTER AND DISTRIBUTOR:
Alembic Pharmaceuticals Canada Ltd.
225
Gibraltar Road, Unit 5
Vaughn, Ontario
L4H 4P9
Control #
258718
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Alembic-Bosentan Page 2 of 42
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
..................................................................................................
17
DOSAGE AND ADMINISTRATION
..............................................................................
20
OVERDOSAGE
................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 22
STORAGE AND
STABILITY..........................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................