IPG-DULOXETINE CAPSULE (DELAYED RELEASE)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Pieejams no:

MARCAN PHARMACEUTICALS INC

ATĶ kods:

N06AX21

SNN (starptautisko nepatentēto nosaukumu):

DULOXETINE

Deva:

30MG

Zāļu forma:

CAPSULE (DELAYED RELEASE)

Kompozīcija:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

8/30/1000

Receptes veids:

Prescription

Ārstniecības joma:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2016-05-02

Produkta apraksts

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