REDDY-SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE); METFORMIN HYDROCHLORIDE

Dostupno od:

DR REDDY'S LABORATORIES LTD

ATC koda:

A10BD07

INN (International ime):

METFORMIN AND SITAGLIPTIN

Doziranje:

50MG; 1000MG

Farmaceutski oblik:

TABLET

Sastav:

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

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2023-07-27

Svojstava lijeka

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