CYMBALTA CAPSULE (DELAYED RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Dostępny od:

ELI LILLY CANADA INC

Kod ATC:

N06AX21

INN (International Nazwa):

DULOXETINE

Dawkowanie:

60MG

Forma farmaceutyczna:

CAPSULE (DELAYED RELEASE)

Skład:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Droga podania:

ORAL

Sztuk w opakowaniu:

7/28

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2007-11-01

Charakterystyka produktu

_CYMBALTA_
_®_
_ Product Monograph _
_Page 1 of 79 _
PRODUCT MONOGRAPH
PR CYMBALTA
®
Duloxetine Delayed Release Capsules, Mfr. Std.
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Eli Lilly Canada Inc.
Date of Initial Approval:
Exchange Tower
October 31, 2007
130 King Street West, Suite 900
PO Box 73
Date of Revision:
Toronto, Ontario
March 25, 2021
M5X 1B1
1-866-364-4043
www.lilly.ca
Control
№
: 245810
© CYMBALTA is a trademark owned or licensed by Eli Lilly and Company,
its subsidiaries or affiliates
_CYMBALTA_
_®_
_ Product Monograph _
_Page 2 of 79 _
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
.................................................................................................
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
..........................................................................