PMS-BUPROPION SR TABLET (EXTENDED-RELEASE)
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
28-04-2017
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
BUPROPION HYDROCHLORIDE
Fáanlegur frá:
PHARMASCIENCE INC
ATC númer:
N06AX12
INN (Alþjóðlegt nafn):
BUPROPION
Skammtar:
100MG
Lyfjaform:
TABLET (EXTENDED-RELEASE)
Samsetning:
BUPROPION HYDROCHLORIDE 100MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
60
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS ANTIDEPRESSANTS
Vörulýsing:
Active ingredient group (AIG) number: 0131140002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2009-04-28
Vara einkenni
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
....................................................................................................
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