RAN-FOSINOPRIL TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

FOSINOPRIL SODIUM

متاح من:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC رمز:

C09AA09

INN (الاسم الدولي):

FOSINOPRIL

جرعة:

10MG

الشكل الصيدلاني:

TABLET

تركيب:

FOSINOPRIL SODIUM 10MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0122777001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2007-05-03

خصائص المنتج

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_Page 1 of 34_
PRODUCT MONOGRAPH
Pr
RAN-FOSINOPRIL
Fosinopril Sodium Tablets USP
10 mg and 20 mg
Angiotensin Converting Enzyme Inhibitor
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200
Mississauga, ON L4W 0A5
Canada
Date of Revision:
April 27, 2009
Submission Control No: 127034
_ _
_ _
_Page 2 of 34_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND
PRECAUTIONS.................................................................................
4
ADVERSE
REACTIONS...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND
ADMINISTRATION.............................................................................
14
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND
STABILITY.........................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
21
PHARMACEUTICAL
INFORMATION.........................................................................
21
CLINICAL
TRIALS.........................................................................................................
21
DETAILED
PHARMACOLOGY...................................