DOM-BUPROPION SR TABLET (EXTENDED-RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

BUPROPION HYDROCHLORIDE

متاح من:

DOMINION PHARMACAL

ATC رمز:

N06AX12

INN (الاسم الدولي):

BUPROPION

جرعة:

100MG

الشكل الصيدلاني:

TABLET (EXTENDED-RELEASE)

تركيب:

BUPROPION HYDROCHLORIDE 100MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

60

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS ANTIDEPRESSANTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2009-11-30

خصائص المنتج

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