TARO-SITAGLIPTIN FUMARATE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

SITAGLIPTIN (SITAGLIPTIN FUMARATE)

Доступно од:

TARO PHARMACEUTICALS INC

АТЦ код:

A10BH01

INN (Међународно име):

SITAGLIPTIN

Дозирање:

25MG

Фармацеутски облик:

TABLET

Састав:

SITAGLIPTIN (SITAGLIPTIN FUMARATE) 25MG

Пут администрације:

ORAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2023-01-05

Карактеристике производа

_P r_
_TARO-SITAGLIPTIN FUMARATE (Sitagliptin Tablets) Product Monograph
Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-SITAGLIPTIN FUMARATE
Sitagliptin Tablets
Tablets, 25, 50 and 100 mg sitagliptin (as sitagliptin fumarate), Oral
Dipeptidyl peptidase 4 (DPP-4) inhibitors
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario, Canada
L6T 1C1
Date of Initial Authorization:
October 3, 2022
Submission Control Number: 260645
_P r_
_TARO-SITAGLIPTIN FUMARATE (Sitagliptin Tablets) Product Monograph
Page 2 of 63 _
RECENT MAJOR LABEL CHANGES
N/A
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
.....................................................................4
4.4
ADMINISTRATION....................................................................................................................5
4.5 MISSED DOSE
.......................................................................................................................5
5 OVERDOSAGE
...........................