TEVA-SAXAGLIPTIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE)

Предлага се от:

TEVA CANADA LIMITED

АТС код:

A10BH03

INN (Международно Name):

SAXAGLIPTIN

дозиране:

5MG

Лекарствена форма:

TABLET

Композиция:

SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 5MG

Начин на приложение:

ORAL

Броя в опаковка:

30/100

Вид предписание :

Prescription

Терапевтична област:

DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2021-05-04

Данни за продукта

PRODUCT MONOGRAPH
PR
TEVA-SAXAGLIPTIN
saxagliptin (as saxagliptin hydrochloride)
2.5 mg and 5 mg Tablets
Oral Antihyperglycemic Agent
DPP-4 inhibitor
Incretin Enhancer
Teva Canada Limited
Date of Revision;
30 Novopharm Court
January 25, 2021
Toronto, Ontario
M1B 2K9
Control No.: 247036
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND PRECAUTIONS
...................................................................................
4
ADVERSE REACTIONS
....................................................................................................
8
DRUG INTERACTIONS
...................................................................................................
16
DOSAGE AND ADMINISTRATION
................................................................................
20
OVERDOSAGE
.................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 21
STORAGE AND STABILITY
...........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 25
PART II: SCIENTIFIC INFORMATION
PHARMACEUTICAL
INFORMATION............................................................................
26
CLINICAL TRIALS
..........................................................................................................
26
DETAILED PHARMACOLOGY
......................................................................................
37
TOXICOLOGY
......................