VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Last ned Preparatomtale (SPC)
08-11-2022

Aktiv ingrediens:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Tilgjengelig fra:

PHARMASCIENCE INC

ATC-kode:

N06AX16

INN (International Name):

VENLAFAXINE

Dosering :

37.5MG

Legemiddelform:

CAPSULE (EXTENDED RELEASE)

Sammensetning:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG

Administreringsrute:

ORAL

Enheter i pakken:

100/500

Resept typen:

Prescription

Terapeutisk område:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0131294002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2007-08-02

Preparatomtale

                                _VENLAFAXINE XR (venlafaxine hydrochloride) _
_Page 1 of 84 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VENLAFAXINE XR
Venlafaxine Hydrochloride Extended Release Capsules
Extended Release Capsules, 37.5 mg, 75 mg and 150 mg venlafaxine (as
venlafaxine hydrochloride), Oral
Antidepressant / Anxiolytic
PHARMASCIENCE INC.
6111 Royalmount Ave, Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 265116
Date of Initial Authorization:
July 20, 2012
Date of Revision:
November 8, 2022
_VENLAFAXINE XR (venlafaxine hydrochloride) _
_Page 2 of 84 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
11/2022
7 Warnings and Precautions, 7.1 Special Populations, 7.1.1 Pregnant
Women
04/2020
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics................................................................................................................
4
2
CONTRAINDICATIONS........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment Adults
.......................
                                
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