DOM-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

MAH:

DOMINION PHARMACAL

ATC_code:

N06AX16

INN:

VENLAFAXINE

dosage:

75MG

pharmaceutical_form:

CAPSULE (EXTENDED RELEASE)

composition:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 75MG

administration_route:

ORAL

units_in_package:

500

prescription_type:

Prescription

therapeutic_area:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2013-05-17

SPC

PRODUCT MONOGRAPH
PR
DOM-VENLAFAXINE XR
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
37.5 MG, 75 MG AND 150 MG VENLAFAXINE, AS VENLAFAXINE HYDROCHLORIDE
Antidepressant
DOMINION PHARMACAL
6111 Royalmount Ave, Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
February 28, 2013
Submission Control No: 116569, 151422, 162398
_ _
_Dom-VENLAFAXINE XR Product Monograph _
_Page 2 of 54 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................30
OVERDOSAGE
................................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
............................................................34
STORAGE AND STABILITY
..........................................................................................37
SPECIAL HANDLING INSTRUCTIONS
.......................................................................37
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................38
PART II: SCIENTIFIC INFORMATION
...............................................................................39
PHARMACEUTICAL INFORMATION
..........................................................................39
CLINI