ACH-SITAGLIPTIN TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE)

Disponível em:

ACCORD HEALTHCARE INC

Código ATC:

A10BH01

DCI (Denominação Comum Internacional):

SITAGLIPTIN

Dosagem:

50MG

Forma farmacêutica:

TABLET

Composição:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 50MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Resumo do produto:

Active ingredient group (AIG) number: 0152414003; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2023-01-05

Características técnicas

_ _
_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................................