ONGLYZA TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE)

Доступно од:

ASTRAZENECA CANADA INC

АТЦ код:

A10BH03

INN (Међународно име):

SAXAGLIPTIN

Дозирање:

5MG

Фармацеутски облик:

TABLET

Састав:

SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 5MG

Пут администрације:

ORAL

Јединице у пакету:

30/90/100/500

Тип рецептора:

Prescription

Терапеутска област:

DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0152653001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2009-09-14

Карактеристике производа

COPYRIGHT 2009-2021 ASTRAZENECA CANADA INC. Page 1 of 44
PRODUCT MONOGRAPH
ONGLYZA
®
saxagliptin
tablets
(as saxagliptin
hydrochloride)
2.5 and 5 mg
Oral Antihyperglycemic Agent
DPP-4 inhibitor
Incretin Enhancer
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Revision:
June 29, 2021
Submission Control No: 249068
ONGLYZA
®
is a registered trademark of AstraZeneca AB, used under license by
AstraZeneca
Canada Inc.
COPYRIGHT 2009-2021 ASTRAZENECA CANADA INC. Page 2 of 44
TABLE OF CONTENTS
TABLE OF CONTENTS
...................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION..................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................. 3
INDICATIONS AND CLINICAL
USE.......................................................................
3
CONTRAINDICATIONS
...........................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................
4
ADVERSE REACTIONS
...........................................................................................
7
DRUG
INTERACTIONS..........................................................................................
17
DOSAGE AND
ADMINISTRATION.......................................................................
21
OVERDOSAGE
.......................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
...................................................... 22
STORAGE AND
STABILITY..................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 26
PART II: SCIENTIFIC
INFORMATION.........................................................................
27
PHARMACEUTICAL
INFORMATION...................