AURO-SITAGLIPTIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

SITAGLIPTIN (SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE)

Tilgængelig fra:

AURO PHARMA INC

ATC-kode:

A10BH01

INN (International Name):

SITAGLIPTIN

Dosering:

50MG

Lægemiddelform:

TABLET

Sammensætning:

SITAGLIPTIN (SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE) 50MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2023-01-05

Produktets egenskaber

_AURO-SITAGLIPTIN PRODUCT MONOGRAPH _Page 1 of 56
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-SITAGLIPTIN
Sitagliptin Tablets
Sitagliptin (as sitagliptin hydrochloride monohydrate)
Tablets, 25, 50 and 100 mg, Oral
House Standard
Dipeptidyl peptidase 4 (DPP-4) inhibitors
AURO PHARMA INC.,
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial Authorization:
August 17, 2022
Submission Control Number: 251317
_AURO-SITAGLIPTIN PRODUCT MONOGRAPH _Page 2 of 56
RECENT MAJOR LABEL CHANGES
NONE AT THE TIME OF AUTHORIZATION
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS....................................................................................................................
4
1.1 Pediatrics
...........................................................................................................
4
1.2
Geriatrics............................................................................................................
4
2 CONTRAINDICATIONS
......................................................................................................
4
4 DOSAGE AND ADMINISTRATION
......................................................................................
4
4.1 Dosing Considerations
........................................................................................
4
4.2 Recommended Dose and Dosage
Adjustment...................................................... 5
4.4
Administration....................................................................................................
6
4.5 Missed Dose
.......................................................................................................
6
5
OVERDOSAGE...................................................................................................................
6
6 DOSAGE FORMS, STRENGTHS, COMPOSITI