IPG-DULOXETINE CAPSULE (DELAYED RELEASE)
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
28-04-2017
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ingredients actius:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Disponible des:
MARCAN PHARMACEUTICALS INC
Codi ATC:
N06AX21
Designació comuna internacional (DCI):
DULOXETINE
Dosis:
30MG
formulario farmacéutico:
CAPSULE (DELAYED RELEASE)
Composición:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG
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: 0152350001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2016-05-02
Fitxa tècnica
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
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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
.........................................................................................
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