DULOXETINE CAPSULE (DELAYED RELEASE)

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Доступно од:

LABORATOIRE RIVA INC.

АТЦ код:

N06AX21

INN (Међународно име):

DULOXETINE

Дозирање:

60MG

Фармацеутски облик:

CAPSULE (DELAYED RELEASE)

Састав:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Пут администрације:

ORAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Терапеутска област:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2019-12-19

Карактеристике производа

PRODUCT MONOGRAPH
PR DULOXETINE
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
Mfr. Std.
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
DATE OF REVISION:
September 22, 2021
Submission Control No.: 256198
_DULOXETINE _
_–_
_ Product Monograph_
_Page 2 of 87_
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
.................................................................................................
19
DRUG INTERACTIONS
.................................................................................................
39
DOSAGE AND ADMINISTRATION
.............................................................................
42
OVERDOSAGE
...............................................................................................................
45
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 46
STORAGE AND STABILITY
.........................................................................................
49
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 50
PART II: SCIENTIFIC INFORMATION
...............................................................................
51
PHARMACEUTICAL INFORMATION
.........................................................................
51
CLINICAL TRIALS
.........................................................................................................