REDDY-SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE); METFORMIN HYDROCHLORIDE

זמין מ:

DR REDDY'S LABORATORIES LTD

קוד ATC:

A10BD07

INN (שם בינלאומי):

METFORMIN AND SITAGLIPTIN

כמות:

50MG; 850MG

טופס פרצבטיות:

TABLET

הרכב:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 50MG; METFORMIN HYDROCHLORIDE 850MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

leaflet_short:

Active ingredient group (AIG) number: 0252656002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2023-07-27

מאפייני מוצר

Page 1 of 68
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
REDDY-SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sitagliptin (as Sitagliptin Phosphate) and Metformin Hydrochloride
Tablets
Tablets, 50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg, Oral
Combinations of oral blood glucose lowering drugs
MANUFACTURED BY:
Dr. Reddy’s Laboratories Ltd.,
Bachupally – 500 090 India
IMPORTED AND DISTRIBUTED BY:
Dr. Reddy’s Laboratories Canada Inc.
Mississauga, ON L4W 4Y1
Canada
Date of Preparation:
July 27, 2023
SUBMISSION CONTROL NUMBER : 246541
Page 2 of 68
RECENT MAJOR LABEL CHANGES
None at time of authorization
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES ......................................................................................
2
TABLE OF CONTENTS
………………………………………………………………………………..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 ........................................................................................
5
4.1 Dosing Considerations
...............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.................................................