DAKLINZA TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE)

Disponible desde:

BRISTOL-MYERS SQUIBB CANADA

Código ATC:

J05AP07

Designación común internacional (DCI):

DACLATASVIR

Dosis:

60MG

formulario farmacéutico:

TABLET

Composición:

DACLATASVIR (DACLATASVIR DIHYDROCHLORIDE) 60MG

Vía de administración:

ORAL

Unidades en paquete:

28

tipo de receta:

Prescription

Área terapéutica:

HCV Replication Complex Inhibitors

Resumen del producto:

Active ingredient group (AIG) number: 0157290002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2019-12-03

Ficha técnica

_Pr_
_DAKLINZA (daclatasvir) _
_Page 1 of 56_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
DAKLINZA
®
daclatasvir tablets, 30 and 60 mg
(as daclatasvir dihydrochloride)
Antiviral Agent
Bristol-Myers Squibb Canada
Montréal, Canada
Date of Preparation:
12 August 2015
Date of Revision
July 5, 2019
DAKLINZA is a registered trademark of Bristol-Myers Squibb Holdings
Ireland used under
licence by Bristol-Myers Squibb Canada.
Submission Control No: 226078
_Pr_
_DAKLINZA (daclatasvir) _
_Page 2 of 56_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................23
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
.......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
...................................................................