JAMP-DULOXETINE CAPSULE (DELAYED RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Disponible desde:

JAMP PHARMA CORPORATION

Código ATC:

N06AX21

Designación común internacional (DCI):

DULOXETINE

Dosis:

30MG

formulario farmacéutico:

CAPSULE (DELAYED RELEASE)

Composición:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0152350001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2016-05-02

Ficha técnica

______________________________________________________________________________
_JAMP-Duloxetine Product Monograph _
_ _
_ _
_ Page 1 of 81 _
PRODUCT MONOGRAPH
PR JAMP-DULOXETINE
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
Manufacturer’s standard
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Submission Control No: 256492 DATE OF REVISION: September 28, 2021
JAMP Pharma Corporation
1310 rue Nobel
Boucherville,
Québec
J4B 5H3, Canada
______________________________________________________________________________
_JAMP-Duloxetine Product Monograph _
_ _
_ _
_ Page 2 of 81 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT
INFORMATION......................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
5
WARNINGS AND PRECAUTIONS
...............................................................................
6
ADVERSE REACTIONS
................................................................................................
18
DRUG INTERACTIONS
................................................................................................
37
DOSAGE AND ADMINISTRATION
............................................................................
40
OVERDOSAGE
..............................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 44
STORAGE AND STABILITY
........................................................................................
47
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 47
PART II: SCIENTIFIC INFORMATION
..............................................................................
49
PHARMA