MYLAN-BOSENTAN TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

BOSENTAN (BOSENTAN MONOHYDRATE)

Disponible des:

MYLAN PHARMACEUTICALS ULC

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:

56/100

tipo de receta:

Prescription

Área terapéutica:

VASODILATING AGENTS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2018-07-12

Fitxa tècnica

1
PRODUCT MONOGRAPH
Pr
MYLAN-BOSENTAN
Bosentan monohydrate (film coated) tablet
Bosentan 62.5 mg and 125 mg
Endothelin Receptor Antagonist
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 218925
Date of Revision: August 28, 2018
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 ............................
22
PART II: SCIENTIFIC INFORMATION
................................................................... 23
PHARMACEUTICAL
INFORMATION..........................................................
23
CLINICAL TRIALS
...........................................................................................
24
DETAILED
PHARMACOLOGY......................................................................
31
MICROBIOLOGY
..............................................................................................
32
TOXICOLOGY
.................