ALEMBIC-BOSENTAN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BOSENTAN (BOSENTAN MONOHYDRATE)

Disponibil de la:

ALEMBIC PHARMACEUTICALS LIMITED

Codul ATC:

C02KX01

INN (nume internaţional):

BOSENTAN

Dozare:

62.5MG

Forma farmaceutică:

TABLET

Compoziție:

BOSENTAN (BOSENTAN MONOHYDRATE) 62.5MG

Calea de administrare:

ORAL

Unități în pachet:

10/30/60/1000

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

VASODILATING AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-12-16

Caracteristicilor produsului

______________________________________________________________________________
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
.......................