ALEMBIC-BOSENTAN TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
13-12-2021
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Aktiva substanser:
BOSENTAN (BOSENTAN MONOHYDRATE)
Tillgänglig från:
ALEMBIC PHARMACEUTICALS LIMITED
ATC-kod:
C02KX01
INN (International namn):
BOSENTAN
Dos:
125MG
Läkemedelsform:
TABLET
Sammansättning:
BOSENTAN (BOSENTAN MONOHYDRATE) 125MG
Administreringssätt:
ORAL
Enheter i paketet:
10/30/60/1000
Receptbelagda typ:
Prescription
Terapiområde:
VASODILATING AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0145922002; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2021-12-16
Produktens egenskaper
______________________________________________________________________________
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
______________________________________________________________________________
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
.......................
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