SANDOZ DULOXETINE CAPSULE (DELAYED RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Tersedia dari:

SANDOZ CANADA INCORPORATED

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:

30/100

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:

2016-05-02

Karakteristik produk

______________________________________________________________________________
_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
..........