APO-VALSARTAN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

VALSARTAN

متاح من:

APOTEX INC

ATC رمز:

C09CA03

INN (الاسم الدولي):

VALSARTAN

جرعة:

80MG

الشكل الصيدلاني:

TABLET

تركيب:

VALSARTAN 80MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

ملخص المنتج:

Active ingredient group (AIG) number: 0131885001; AHFS:

الوضع إذن:

MARKETED

تاريخ الترخيص:

2012-07-12

خصائص المنتج

_APO-VALSARTAN Tablets Product Monograph_
_ _Page 1 of 41
PRODUCT MONOGRAPH
PR
APO-VALSARTAN
(VALSARTAN)
40 MG, 80 MG, 160 MG AND 320 MG TABLETS
Angiotensin II AT
1
Receptor Blocker
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE SEPTEMBER 16, 2015
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 187072
_APO-VALSARTAN Tablets Product Monograph_
_ _Page 2 of 41
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
.......................................................................................................
4
WARNINGS AND PRECAUTION
.........................................................................................
4
ADVERSE REACTIONS
......................................................................................................
8
DRUG INTERACTIONS
......................................................................................................12
DOSAGE AND ADMINISTRATION
.....................................................................................14
OVERDOSAGE
...................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
......................................................................16
STORAGE AND
STABILITY................................................................................................19
SPECIAL HANDLING INSTRUCTIONS
..............................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................19
PART II: SCIENTIFIC INFORMATION
....................................................................................21
PHARMACEUTICAL INFORMATION
...................................