RIVA-GLYBURIDE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

GLYBURIDE

متاح من:

PHARMEL INC

ATC رمز:

A10BB01

INN (الاسم الدولي):

GLIBENCLAMIDE

جرعة:

5MG

الشكل الصيدلاني:

TABLET

تركيب:

GLYBURIDE 5MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/100/300/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

SULFONYLUREAS

ملخص المنتج:

Active ingredient group (AIG) number: 0108708001; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2017-09-08

خصائص المنتج

PRODUCT MONOGRAPH
PR
RIVA-GLYBURIDE
Glyburide
Tablets, 5 mg
Manufacturer’s Standard
Oral Hypoglycaemic Agent
ATC Code: A10BB01
Pharmel Inc.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
November 21, 2013
Submission Control No.: 169284
_ _
_Product Monograph – Riva-GLYBURIDE_
_®_
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_Page 2 of 30_
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
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................17
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
..........................................................................................................22
DETAILED PHARMACOLOGY
.....................