IPG-DULOXETINE CAPSULE (DELAYED RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Disponible desde:

MARCAN PHARMACEUTICALS INC

Código ATC:

N06AX21

Designación común internacional (DCI):

DULOXETINE

Dosis:

60MG

formulario farmacéutico:

CAPSULE (DELAYED RELEASE)

Composición:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Vía de administración:

ORAL

Unidades en paquete:

8/30/1000

tipo de receta:

Prescription

Área terapéutica:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0152350002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2016-05-02

Ficha técnica

Page 1 of 77
PRODUCT MONOGRAPH
PR
IPG-DULOXETINE
Duloxetine Delayed - Release Capsules, Mfr. Std.
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
MARCAN PHARMACEUTICALS INC. DATE OF REVISION:
77 AURIGA DRIVE, UNIT# 4 APRIL 25, 2017
OTTAWA, ON
CANADA K2E 7Z7
Control # 204721
Page 2 of 77
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................................
3
SUMMARY PRODUCT INFORMATION
..............................................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................................
3
CONTRAINDICATIONS
.........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................................
5
ADVERSE REACTIONS
.......................................................................................................................
17
DRUG INTERACTIONS
.......................................................................................................................
35
DOSAGE AND ADMINISTRATION
...................................................................................................
38
OVERDOSAGE
......................................................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
42
STORAGE AND STABILITY
...............................................................................................................
45
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 46
PART II: SCIENTIFIC INFORMATION
.........................................................................................