APO-SITAGLIPTIN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE)

זמין מ:

APOTEX INC

קוד ATC:

A10BH01

INN (שם בינלאומי):

SITAGLIPTIN

כמות:

100MG

טופס פרצבטיות:

TABLET

הרכב:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 100MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30/100 AND BLISTERS OF 30

סוג מרשם:

Prescription

leaflet_short:

Active ingredient group (AIG) number: 0152414001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2022-10-24

מאפייני מוצר

_APO-SITAGLIPTIN(sitagliptin)_
_Page 1 of 54 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-SITAGLIPTIN
Sitagliptin (as sitagliptin phosphate monohydrate)
Tablets, 25 mg, 50 mg and 100 mg, Oral
Dipeptidyl peptidase 4 (DPP-4) inhibitors
Apotex Inc.
150 Signet Drive
Toronto, Ontario
Canada, M9L 1T9
Date of initial authorization:
August 08, 2017
Date of Revision:
March 15, 2022
Submission Control Number: 257241
_APO-SITAGLIPTIN(sitagliptin)_
_Page 2 of 54 _
RECENT MAJOR LABEL CHANGES
1 Indications
03/2022
4 Dosage and Administration
03/2022
7 Warnings and Precautions
03/2022
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..................................................................................5
1
INDICATIONS
..........................................................................................................................5
1.1
Pediatrics
.........................................................................................................................5
1.2
Geriatrics
.........................................................................................................................5
2
CONTRAINDICATIONS
..............................................................................................................5
4
DOSAGE AND ADMINISTRATION
...............................................................................................5
4.1
Dosing
Considerations........................................................................................................5
4.2
Recommended Dose and Dosage
Adjustment........................................................................6
4.4
Administration
........