VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

N06AX16

INN (Nama Internasional):

VENLAFAXINE

Dosis:

75MG

Bentuk farmasi:

CAPSULE (EXTENDED RELEASE)

Komposisi:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 75MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0131294001; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2015-10-16

Karakteristik produk

PRODUCT MONOGRAPH
PR
VENLAFAXINE XR
(venlafaxine hydrochloride extended release capsules)
37.5 mg, 75 mg and 150 mg venlafaxine (as venlafaxine hydrochloride)
Antidepressant / Anxiolytic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 155222
Date of Preparation: May 11, 2012
_Page 2_
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
..................................................................................................38
DOSAGE AND ADMINISTRATION
..............................................................................43
OVERDOSAGE.................................................................................................................47
ACTION AND CLINICAL
PHARMACOLOGY.............................................................49
STORAGE AND STABILITY
..........................................................................................52
SPECIAL HANDLING
INSTRUCTIONS........................................................................52
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................52
PART II: SCIENTIFIC INFORMATION
...............................................................................53
PHARMACEUTICAL
INFORMATION..........................................................................53
CLINICAL TRIALS
..............................................................