APO-SITAGLIPTIN/METFORMIN XR TABLET (EXTENDED-RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE); METFORMIN HYDROCHLORIDE

متاح من:

APOTEX INC

ATC رمز:

A10BD07

INN (الاسم الدولي):

METFORMIN AND SITAGLIPTIN

جرعة:

100MG; 1000MG

الشكل الصيدلاني:

TABLET (EXTENDED-RELEASE)

تركيب:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 100MG; METFORMIN HYDROCHLORIDE 1000MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

ملخص المنتج:

Active ingredient group (AIG) number: 0252656004; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2022-10-24

خصائص المنتج

APO-SITAGLIPTIN/METFORMIN XR
Page 1 of 75
(Sitagliptin and metformin hydrochloride modified-release tablets)
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-SITAGLIPTIN/METFORMIN XR
Sitagliptin (as sitagliptin phosphate monohydrate) and metformin
hydrochloride
modified-release
Tablets, 50 mg/500 mg, 50 mg/1000 mg, and 100 mg/1000 mg, Oral
Combinations of oral blood glucose lowering drugs
APOTEX INC.
Date of Initial Authorization
150 Signet Drive
October 6, 2020
Toronto, Ontario
Date of Revision
M9L 1T9
February 25, 2022
Submission Control No: 257179
APO-SITAGLIPTIN/METFORMIN XR
Page 2 of 75
(Sitagliptin and metformin hydrochloride modified-release tablets)
RECENT MAJOR LABEL CHANGES
1 Indications
02/2022
4 Dosage and Administration
02/2022
7 Warnings and Precautions
02/2022
Sections or subsections that are not applicable at the time of
authorization are not
listed.
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
........................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ................................................. 4
1
INDICATIONS......................................................................................................
4
1.1
Pediatrics......................................................................................................
4
1.2 Geriatrics
......................................................................................................
4
2 CONTRAINDICATIONS
.......................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS
BOX.............................................. 5
4 DOSAGE AND ADMINISTRATION
......................................................................
6
4.1 Dosing Considerations
..................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
............................................... 6
4.4 Administration
..............................................................