REDDY-SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE); METFORMIN HYDROCHLORIDE

Disponible des:

DR REDDY'S LABORATORIES LTD

Codi ATC:

A10BD07

Designació comuna internacional (DCI):

METFORMIN AND SITAGLIPTIN

Dosis:

50MG; 1000MG

formulario farmacéutico:

TABLET

Composición:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 50MG; METFORMIN HYDROCHLORIDE 1000MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Resumen del producto:

Active ingredient group (AIG) number: 0252656003; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2023-07-27

Fitxa tècnica

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
.................................................