BOSENTAN TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

BOSENTAN (BOSENTAN MONOHYDRATE)

Disponible des:

PANDA PHARMACEUTICALS INC.

Codi ATC:

C02KX01

Designació comuna internacional (DCI):

BOSENTAN

Dosis:

62.5MG

formulario farmacéutico:

TABLET

Composición:

BOSENTAN (BOSENTAN MONOHYDRATE) 62.5MG

Vía de administración:

ORAL

Unidades en paquete:

30/60/100

tipo de receta:

Prescription

Área terapéutica:

VASODILATING AGENTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2017-09-22

Fitxa tècnica

1
PRODUCT MONOGRAPH PR
BOSENTAN
62.5 mg and 125 mg Bosentan (as monohydrate)
(film coated) Tablet
Endothelin Receptor Antagonist
PANDA Pharmaceuticals Inc.
35 Nixon Road, Unit 10
Caledon, Ontario
L7E 1K1
Date of Preparation: SEPTEMBER 21, 2017
Submission Control No: 200531
2
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
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
18
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
19
STORAGE AND STABILITY
.................................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFORMATION
.................................................................................
23
CLINICAL TRIAL