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

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE); METFORMIN HYDROCHLORIDE

Dostępny od:

APOTEX INC

Kod ATC:

A10BD07

INN (International Nazwa):

METFORMIN AND SITAGLIPTIN

Dawkowanie:

100MG; 1000MG

Forma farmaceutyczna:

TABLET (EXTENDED-RELEASE)

Skład:

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

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2022-10-24

Charakterystyka produktu

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