AURO-SITAGLIPTIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

SITAGLIPTIN (SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE)

から入手可能:

AURO PHARMA INC

ATCコード:

A10BH01

INN（国際名）:

SITAGLIPTIN

投薬量:

25MG

医薬品形態:

TABLET

構図:

SITAGLIPTIN (SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE) 25MG

投与経路:

ORAL

パッケージ内のユニット:

15G/50G

処方タイプ:

Prescription

製品概要:

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

認証ステータス:

APPROVED

承認日:

2023-01-05

製品の特徴

_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