DOM-CANDESARTAN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CANDESARTAN CILEXETIL

متاح من:

DOMINION PHARMACAL

ATC رمز:

C09CA06

INN (الاسم الدولي):

CANDESARTAN

جرعة:

4MG

الشكل الصيدلاني:

TABLET

تركيب:

CANDESARTAN CILEXETIL 4MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

ملخص المنتج:

Active ingredient group (AIG) number: 0135220001; AHFS:

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2019-02-07

خصائص المنتج

_Dom-CANDESARTAN Product Monograph_
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
DOM-CANDESARTAN
Candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
DOMINION PHARMACAL
6111 Av. Royalmount, Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION
:
October 19, 2016
Submission Control No: 198053
_Dom-CANDESARTAN Product Monograph_
_Page 2 of 38_
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
...................................................................................................
8
DRUG INTERACTIONS
..................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 22
PART II: SCIENTIFIC INFORMATION
.............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
.........................................................................................................