PRAVASTATIN-20 TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

PRAVASTATIN SODIUM

متاح من:

PRO DOC LIMITEE

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:

APPROVED

تاريخ الترخيص:

2001-06-13

خصائص المنتج

Page 1 of 41
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
– 10
Pr
PRAVASTATIN
– 20
Pr
PRAVASTATIN
– 40
PRAVASTATIN SODIUM TABLETS USP
10 MG, 20 MG AND 40 MG
LIPID METABOLISM REGULATOR
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
March 2, 2021
Laval, Quebec
H7L 3W9
CONTROL NUMBER: 249000
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
.......................................................................................................16
DOSAGE AND ADMINISTRATION
......................................................................................18
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
.........................................................................................