SANDOZ FENOFIBRATE E TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

FENOFIBRATE

متاح من:

SANDOZ CANADA INCORPORATED

ATC رمز:

C10AB05

INN (الاسم الدولي):

FENOFIBRATE

جرعة:

48.0MG

الشكل الصيدلاني:

TABLET

تركيب:

FENOFIBRATE 48.0MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

FRIBIC ACID DERIVATIVES

ملخص المنتج:

Active ingredient group (AIG) number: 0118895005; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2012-08-02

خصائص المنتج

_Sandoz Fenofibrate E Page 1 of 43_
PRODUCT MONOGRAPH
PR
SANDOZ FENOFIBRATE E
Fenofibrate tablets
48 mg and 145 mg
Manufacturer’s standard
Lipid Metabolism Regulator
Sandoz Canada Inc. Date of Revision: November 17, 2017
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 204109
_ _
_Sandoz Fenofibrate E Page 2 of 43_
TABLE OF CONTENTS
PART 1: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................13
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
................................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARMACOLOGY
............