PMS-GLIMEPIRIDE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

GLIMEPIRIDE

متاح من:

PHARMASCIENCE INC

ATC رمز:

A10BB12

INN (الاسم الدولي):

GLIMEPIRIDE

جرعة:

1MG

الشكل الصيدلاني:

TABLET

تركيب:

GLIMEPIRIDE 1MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

SULFONYLUREAS

ملخص المنتج:

Active ingredient group (AIG) number: 0146247001; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2016-10-28

خصائص المنتج

PRODUCT MONOGRAPH
PR
PMS-GLIMEPIRIDE
Glimepiride Tablets, House Standard
1 mg, 2 mg and 4 mg
Oral Hypoglycemic (Sulfonylurea)
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
February 12, 2014
www.pharmascience.com
Submission Control No: 167575
_pms-GLIMEPIRIDE Product Monograph _
_Page 2 of 48_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY
PRODUCT
INFORMATION
.........................................................................
3
INDICATIONS
AND
CLINICAL
USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS
AND
PRECAUTIONS
..................................................................................
4
ADVERSE
REACTIONS
....................................................................................................
8
DRUG
INTERACTIONS
..................................................................................................
11
DOSAGE
AND
ADMINISTRATION
..............................................................................
14
OVERDOSAGE
................................................................................................................
16
ACTION
AND
CLINICAL
PHARMACOLOGY
............................................................. 17
STORAGE
AND
STABILITY
..........................................................................................
20
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING .............................................. 21
PART II: SCIENTIFIC INFORMATION
...................................................................................
22
PHARMACEUTICAL
INFORMATION
..........................................................................
22
CLINICAL
TRIALS
..........................................................................................................
23
DETAILED