PRAVASTATIN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

PRAVASTATIN SODIUM

متاح من:

SORRES PHARMA INC

ATC رمز:

C10AA03

INN (الاسم الدولي):

PRAVASTATIN

جرعة:

20MG

الشكل الصيدلاني:

TABLET

تركيب:

PRAVASTATIN SODIUM 20MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

HMG-COA REDUCTASE INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0122563002; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2014-06-20

خصائص المنتج

PRODUCT MONOGRAPH
PR
PRAVASTATIN
Pravastatin Sodium Tablets, House Standard
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
SORRES PHARMA INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
September 10, 2013
Submission Control No: 167054
_ _
_PRAVASTATIN 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
...................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
16
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.........................................................................
21
CLINICAL TRIALS
..........................................................................................................
22
DETAILED PHARMACOLOGY
........................