CYMBALTA CAPSULE (DELAYED RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Tersedia dari:

ELI LILLY CANADA INC

Kode ATC:

N06AX21

INN (Nama Internasional):

DULOXETINE

Dosis:

60MG

Bentuk farmasi:

CAPSULE (DELAYED RELEASE)

Komposisi:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Rute administrasi :

ORAL

Unit dalam paket:

7/28

Jenis Resep:

Prescription

Area terapi:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2007-11-01

Karakteristik produk

_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
..........................................................................