ALEMBIC-BOSENTAN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

BOSENTAN (BOSENTAN MONOHYDRATE)

Disponible depuis:

ALEMBIC PHARMACEUTICALS LIMITED

Code ATC:

C02KX01

DCI (Dénomination commune internationale):

BOSENTAN

Dosage:

62.5MG

forme pharmaceutique:

TABLET

Composition:

BOSENTAN (BOSENTAN MONOHYDRATE) 62.5MG

Mode d'administration:

ORAL

Unités en paquet:

10/30/60/1000

Type d'ordonnance:

Prescription

Domaine thérapeutique:

VASODILATING AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2021-12-16

Résumé des caractéristiques du produit

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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
.......................