DOM-BUPROPION SR TABLET (EXTENDED-RELEASE)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

BUPROPION HYDROCHLORIDE

Pieejams no:

DOMINION PHARMACAL

ATĶ kods:

N06AX12

SNN (starptautisko nepatentēto nosaukumu):

BUPROPION

Deva:

100MG

Zāļu forma:

TABLET (EXTENDED-RELEASE)

Kompozīcija:

BUPROPION HYDROCHLORIDE 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

60

Receptes veids:

Prescription

Ārstniecības joma:

MISCELLANEOUS ANTIDEPRESSANTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2009-11-30

Produkta apraksts

PRODUCT MONOGRAPH
PR
DOM-BUPROPION SR
Bupropion Hydrochloride Sustained Release Tablets, House Standard
100 mg and 150 mg
Antidepressant
DOMINION PHARMACAL
Date of Revision:
6111 Royalmount Ave, Suite 100
February 13, 2014
Montréal, Québec
H4P 2T4
Control number: 171397
_Product Monograph Dom-BUPROPION SR _
_Page 2 of 37 _
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
.....................................................................................................
10
DRUG INTERACTIONS
.....................................................................................................
15
DOSAGE AND ADMINISTRATION
.................................................................................
17
OVERDOSAGE
...................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 20
STORAGE AND STABILITY
.............................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 24
PART II: SCIENTIFIC INFORMATION
...........................................................................
25
PHARMACEUTICAL INFORMATION
.............................................................................
25
CLINICAL TRIALS
.............................................................................................................
26
DETAIL