SANDOZ SAXAGLIPTIN TABLET

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE)

Disponibbli minn:

SANDOZ CANADA INCORPORATED

Kodiċi ATC:

A10BH03

INN (Isem Internazzjonali):

SAXAGLIPTIN

Dożaġġ:

2.5MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 2.5MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0152653002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2021-03-08

Karatteristiċi tal-prodott

_Sandoz Saxagliptin _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR
SANDOZ SAXAGLIPTIN
Saxagliptin Tablets
Saxagliptin (as saxagliptin hydrochloride dihydrate)
2.5 mg and 5 mg
Oral Antihyperglycemic Agent
DPP-4 inhibitor
Incretin Enhancer
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Québec
J4B 1E6
Date of Revision:
February 25, 2019
Submission Control No: 224039
_Sandoz Saxagliptin _
_Page 2 of 43_
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
........................................................................................................
7
DRUG INTERACTIONS
......................................................................................................
15
DOSAGE AND ADMINISTRATION
..................................................................................
19
OVERDOSAGE
....................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 20
STORAGE AND STABILITY
..............................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 24
PART II: SCIENTIFIC INFORMATION
....................................................................................
25
PHARMACEUTICAL INFORMATION
..............................................................................
25
CLINICAL TRIALS
................