REDDY-SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE); METFORMIN HYDROCHLORIDE

Предлага се от:

DR REDDY'S LABORATORIES LTD

АТС код:

A10BD07

INN (Международно Name):

METFORMIN AND SITAGLIPTIN

дозиране:

50MG; 850MG

Лекарствена форма:

TABLET

Композиция:

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

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2023-07-27

Данни за продукта

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