IPG-DULOXETINE CAPSULE (DELAYED RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Prieinama:

MARCAN PHARMACEUTICALS INC

ATC kodas:

N06AX21

INN (Tarptautinis Pavadinimas):

DULOXETINE

Dozė:

60MG

Vaisto forma:

CAPSULE (DELAYED RELEASE)

Sudėtis:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

8/30/1000

Recepto tipas:

Prescription

Gydymo sritis:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2016-05-02

Prekės savybės

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