ALEMBIC-BOSENTAN TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
13-12-2021
Alguns documents d’aquest producte actualment no estan disponibles, podeu enviar una sol·licitud al nostre servei d’atenció al client i us ho notificarem tan bon punt puguem obtenir-los.
Enviar sol.licitud.
Enviar sol.licitud.
ingredients actius:
BOSENTAN (BOSENTAN MONOHYDRATE)
Disponible des:
ALEMBIC PHARMACEUTICALS LIMITED
Codi ATC:
C02KX01
Designació comuna internacional (DCI):
BOSENTAN
Dosis:
125MG
formulario farmacéutico:
TABLET
Composición:
BOSENTAN (BOSENTAN MONOHYDRATE) 125MG
Vía de administración:
ORAL
Unidades en paquete:
10/30/60/1000
tipo de receta:
Prescription
Área terapéutica:
VASODILATING AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0145922002; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2021-12-16
Fitxa tècnica
______________________________________________________________________________
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
.......................
Llegiu el document complet
