PMS-BUPROPION SR TABLET (EXTENDED-RELEASE)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

BUPROPION HYDROCHLORIDE

Dostupno od:

PHARMASCIENCE INC

ATC koda:

N06AX12

INN (International ime):

BUPROPION

Doziranje:

100MG

Farmaceutski oblik:

TABLET (EXTENDED-RELEASE)

Sastav:

BUPROPION HYDROCHLORIDE 100MG

Administracija rute:

ORAL

Jedinice u paketu:

60

Tip recepta:

Prescription

Područje terapije:

MISCELLANEOUS ANTIDEPRESSANTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2009-04-28

Svojstava lijeka

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
....................................................................................................