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

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE); METFORMIN HYDROCHLORIDE

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

A10BD07

INN (Isem Internazzjonali):

METFORMIN AND SITAGLIPTIN

Dożaġġ:

100MG; 1000MG

Għamla farmaċewtika:

TABLET (EXTENDED-RELEASE)

Kompożizzjoni:

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

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2022-10-24

Karatteristiċi tal-prodott

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