RIVA-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Boleh didapati daripada:

LABORATOIRE RIVA INC.

Kod ATC:

N06AX16

INN (Nama Antarabangsa):

VENLAFAXINE

Dos:

150MG

Borang farmaseutikal:

CAPSULE (EXTENDED RELEASE)

Komposisi:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 150MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0131294005; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2019-11-08

Ciri produk

_RIVA-VENLAFAXINE XR - Product Monograph _
_Page 1 of 71 _
PRODUCT MONOGRAPH
PR
RIVA-VENLAFAXINE XR
(venlafaxine hydrochloride extended release capsules)
venlafaxine (as venlafaxine hydrochloride)
USP
37.5 mg, 75 mg and 150 mg
Antidepressant / Anxiolytic
www.labriva.com
Submission Control No.: 240095
J7C 3V4
Blainville, Québec
660
Boul.
Industriel
LABORATOIRE RIVA INC.
July 8,
2020
Date of Revision:
_RIVA-VENLAFAXINE XR - Product Monograph _
_Page 2 of 71 _
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
..................................................................................................
20
DRUG INTERACTIONS
..................................................................................................
37
DOSAGE AND ADMINISTRATION
..............................................................................
44
OVERDOSAGE
.................................................................................................................
48
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 49
STORAGE AND STABILITY
..........................................................................................
52
SPECIAL HANDLING INSTRUCTIONS
........................................................................
53
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................. 53
PART II: SCIENTIFIC INFORMATION
................................................................................
54
PHARMACEUTICAL INFORM