SANDOZ DULOXETINE CAPSULE (DELAYED RELEASE)

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Доступно од:

SANDOZ CANADA INCORPORATED

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:

30/100

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:

2016-05-02

Карактеристике производа

______________________________________________________________________________
_Sandoz Duloxetine Product Monograph_
_ Page 1 of 84_
PRODUCT MONOGRAPH
PR SANDOZ DULOXETINE
Duloxetine Delayed-Release Capsules
30 mg and 60 mg duloxetine (as duloxetine hydrochloride)
Manufacturer’s standard
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville,
Quebec
J4B 1E6
Submission
Control No: 259736 DATE OF REVISION: June 3, 2022
______________________________________________________________________________
_Sandoz Duloxetine Product Monograph_
_ Page 2 of 84_
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............................................ 49
PART II: SCIENTIFIC INFORMATION
..............................................................................
51
PHARMACEUTICAL INFORMATION
..........