AG-SITAGLIPTIN TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

SITAGLIPTIN (SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE)

Доступна з:

ANGITA PHARMA INC.

Код атс:

A10BH01

ІПН (Міжнародна Ім'я):

SITAGLIPTIN

Дозування:

100MG

Фармацевтична форма:

TABLET

Склад:

SITAGLIPTIN (SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE) 100MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2023-02-16

Характеристики продукта

_AG-Sitagliptin (Sitagliptin Tablets)_
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-SITAGLIPTIN
Sitagliptin Tablets
Sitagliptin (as sitagliptin hydrochloride monohydrate)
Tablets, 25, 50 and 100 mg, Oral
Dipeptidyl peptidase 4 (DPP-4) inhibitors
ANGITA PHARMA INC.
1310, rue Nobel
Boucherville, Quebec
Canada, J4B 5H3
Date of Initial Authorization:
FEB 15, 2023
Submission Control Number: 271243
_AG-Sitagliptin_ _(Sitagliptin Tablets)_
_ (sitagliptin)_
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
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
......................................................................................................
5
4.5
Missed Dose
........................................................................................................
6
5
OVERDOSAGE
...............................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 6
7
WARNINGS