ACH-METFORMIN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

METFORMIN HYDROCHLORIDE

متاح من:

ACCORD HEALTHCARE INC

ATC رمز:

A10BA02

INN (الاسم الدولي):

METFORMIN

جرعة:

500MG

الشكل الصيدلاني:

TABLET

تركيب:

METFORMIN HYDROCHLORIDE 500MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

BIGUANIDES

ملخص المنتج:

Active ingredient group (AIG) number: 0101773001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2021-03-01

خصائص المنتج

PRODUCT MONOGRAPH
PR
ACH-METFORMIN
Metformin Hydrochloride Tablets, Mfr Std
500 mg and 850 mg tablets
Oral Antihyperglycemic Agent
Accord Healthcare Inc.
3535 Boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
DATE OF REVISION:
FEBRUARY 23, 2021
SUBMISSION CONTROL NO.: 244440
_Page 2 of 37_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
19
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL
INFORMATION..................................................................................
21
CLINICAL TRIALS
........................................................................................