DULOXETINE CAPSULE (DELAYED RELEASE)

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Saadav alates:

ALTAMED PHARMA

ATC kood:

N06AX21

INN (Rahvusvaheline Nimetus):

DULOXETINE

Annus:

60MG

Ravimvorm:

CAPSULE (DELAYED RELEASE)

Koostis:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Manustamisviis:

ORAL

Ühikuid pakis:

30/100/1000

Retsepti tüüp:

Prescription

Terapeutiline ala:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2023-02-06

Toote omadused

______________________________________________________________________________
_Duloxetine Product Monograph_
_ Page 1 of 82_
PRODUCT MONOGRAPH
PR DULOXETINE
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
Manufacturer’s standard
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Altamed Pharma
1565, boul. Lionel-Boulet
Varennes, Quebec
J3X 1P7
Submission Control No.: 271223
DATE OF REVISION:
FEB
06,
2023
______________________________________________________________________________
_Duloxetine Product Monograph_
_ Page 2 of 82_
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
................................................................................................
18
DRUG INTERACTIONS
................................................................................................
37
DOSAGE AND ADMINISTRATION
............................................................................
40
OVERDOSAGE
..............................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 44
STORAGE AND STABILITY
........................................................................................
47
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 47
PART II: SCIENTIFIC INFORMATION
..............................................................................
49
PHARMACEUTICAL INFORMATION
..............................