PMS-SITAGLIPTIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE)

Предлага се от:

PHARMASCIENCE INC

АТС код:

A10BH01

INN (Международно Name):

SITAGLIPTIN

дозиране:

50MG

Лекарствена форма:

TABLET

Композиция:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 50MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2023-01-05

Данни за продукта

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-SITAGLIPTIN
Sitagliptin Tablets
Tablets, 25, 50 and 100 mg sitagliptin (as sitagliptin phosphate
monohydrate) Oral
House Standard
Dipeptidyl peptidase 4 (DPP-4) inhibitors
PHARMASCIENCE INC
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Initial Authorization:
August 18, 2020
Date of Revision:
December 14, 2021
www.pharmascience.com
Submission Control Number: 254974
_pms-SITAGLIPTIN (sitagliptin) Page 2 of 56 _
RECENT MAJOR LABEL CHANGES
1 Indications
12/2021
4 Dosage and Administration
12/2021
7 Warnings and Precautions
12/2021
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
............................................