ACH-SITAGLIPTIN TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE)

Pieejams no:

ACCORD HEALTHCARE INC

ATĶ kods:

A10BH01

SNN (starptautisko nepatentēto nosaukumu):

SITAGLIPTIN

Deva:

100MG

Zāļu forma:

TABLET

Kompozīcija:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2023-01-05

Produkta apraksts

_ _
_Product Monograph - ACH-SITAGLIPTIN _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACH-SITAGLIPTIN
sitagliptin tablets
Tablets, 25, 50 and 100 mg sitagliptin (as sitagliptin phosphate
anhydrous), Oral
House Standard
ATC Code: A10BH01
Dipeptidyl peptidase 4 (DPP-4) inhibitors
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Initial Authorization:
February 15, 2021
Date of Revision:
September 22, 2022
Submission Control Number: 263618
_Product Monograph - ACH-SITAGLIPTIN Page _2_ of _57
RECENT MAJOR LABEL CHANGES
1 Indications
09/2022
4 Dosage and Administration
09/2022
7 Warnings and Precautions
09/2022
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
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
...........................................................................................................
4
1.2
Geriatrics............................................................................................................
4
2
CONTRAINDICA TIONS
...................................................................................................4
4
DOSAGE AND ADMINISTRATION
..................................................................................4
4.1
Dosing Considerations
........................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment...................................................... 5
4.4
Administration................................