SANDOZ PRAVASTATIN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

PRAVASTATIN SODIUM

متاح من:

SANDOZ CANADA INCORPORATED

ATC رمز:

C10AA03

INN (الاسم الدولي):

PRAVASTATIN

جرعة:

40MG

الشكل الصيدلاني:

TABLET

تركيب:

PRAVASTATIN SODIUM 40MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/100/250/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

HMG-COA REDUCTASE INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0122563003; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2017-05-29

خصائص المنتج

PRODUCT MONOGRAPH
PR
SANDOZ PRAVASTATIN
Pravastatin Sodium
10 mg, 20 mg and 40 mg tablets
Lipid Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: February 16, 2017
Boucherville, QC, Canada
J4B 7K8
Control No. 202280
Sandoz Pravastatin
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
.........................................................................................................
11
DRUG INTERACTIONS
..........................................................................................................
15
DOSAGE AND ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
18
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
............................................................................................................