PHL-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Tersedia dari:

PHARMEL INC

Kode ATC:

N06AX16

INN (Nama Internasional):

VENLAFAXINE

Dosis:

37.5MG

Bentuk farmasi:

CAPSULE (EXTENDED RELEASE)

Komposisi:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2017-09-13

Karakteristik produk

PRODUCT MONOGRAPH
PR
PHL-VENLAFAXINE XR
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
37.5 MG, 75 MG AND 150 MG VENLAFAXINE, AS VENLAFAXINE HYDROCHLORIDE
Antidepressant
PHARMEL INC.
6111 Royalmount Ave, Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
February 28, 2013
Submission Control No: 116572, 151423, 162397
_ _
_phl-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
CLINICAL TR