PMS-BUPROPION SR TABLET (EXTENDED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

BUPROPION HYDROCHLORIDE

Boleh didapati daripada:

PHARMASCIENCE INC

Kod ATC:

N06AX12

INN (Nama Antarabangsa):

BUPROPION

Dos:

100MG

Borang farmaseutikal:

TABLET (EXTENDED-RELEASE)

Komposisi:

BUPROPION HYDROCHLORIDE 100MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

60

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS ANTIDEPRESSANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0131140002; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2009-04-28

Ciri produk

PRODUCT MONOGRAPH
PR
PMS-BUPROPION SR
Bupropion Hydrochloride Sustained Release Tablets, House Standard
100 mg and 150 mg
Antidepressant
PHARMASCIENCE INC.
Date of Revision:
6111 Royalmount Ave, Suite 100
April 25, 2017
Montréal, Québec
H4P 2T4
www.pharmascience.com
Control number: 204578
_Product Monograph pms-BUPROPION SR _
_Page 2 of 39 _
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
.....................................................................................................
11
DRUG INTERACTIONS
.....................................................................................................
16
DOSAGE AND ADMINISTRATION
.................................................................................
19
OVERDOSAGE
...................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 22
STORAGE AND STABILITY
.............................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 26
PART II: SCIENTIFIC INFORMATION
...........................................................................
27
PHARMACEUTICAL INFORMATION
.............................................................................
27
CLINICAL TRIALS
....................................................................................................