IPG-DULOXETINE CAPSULE (DELAYED RELEASE)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Dostupno od:

MARCAN PHARMACEUTICALS INC

ATC koda:

N06AX21

INN (International ime):

DULOXETINE

Doziranje:

60MG

Farmaceutski oblik:

CAPSULE (DELAYED RELEASE)

Sastav:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Administracija rute:

ORAL

Jedinice u paketu:

8/30/1000

Tip recepta:

Prescription

Područje terapije:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2016-05-02

Svojstava lijeka

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
.........................................................................................