APO-SITAGLIPTIN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE)

Beszerezhető a:

APOTEX INC

ATC-kód:

A10BH01

INN (nemzetközi neve):

SITAGLIPTIN

Adagolás:

25MG

Gyógyszerészeti forma:

TABLET

Összetétel:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 25MG

Az alkalmazás módja:

ORAL

db csomag:

30/100 AND BLISTERS OF 100

Recept típusa:

Prescription

Termék összefoglaló:

Active ingredient group (AIG) number: 0152414002; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2022-10-24

Termékjellemzők

_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
........