XIGDUO TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE); METFORMIN HYDROCHLORIDE

Saadav alates:

ASTRAZENECA CANADA INC

ATC kood:

A10BD15

INN (Rahvusvaheline Nimetus):

METFORMIN AND DAPAGLIFLOZIN

Annus:

5MG; 1000MG

Ravimvorm:

TABLET

Koostis:

DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 5MG; METFORMIN HYDROCHLORIDE 1000MG

Manustamisviis:

ORAL

Ühikuid pakis:

14/60

Retsepti tüüp:

Prescription

Terapeutiline ala:

BIGUANIDES

Toote kokkuvõte:

Active ingredient group (AIG) number: 0257650002; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2015-12-10

Toote omadused

XIGDUO
®
(dapagliflozin and metformin hydrochloride tablets)
Page 1 of 74
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION XIGDUO
®
dapagliflozin (as dapagliflozin propanediol monohydrate) and metformin
hydrochloride tablets
Tablets, 5 mg/850 mg, 5 mg/1000 mg, Oral use
Combination of oral blood glucose lowering drugs
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Submission Control Number: 277286
Date of Initial Authorization:
DEC 10, 2015
Date of Revision:
NOV 10, 2023
XIGDUO
®
and the AstraZeneca logo are registered trademarks of AstraZeneca AB,
used under
license by AstraZeneca Canada Inc.
© AstraZeneca Canada Inc. 2023
_ _
_XIGDUO_
_® _
_(dapagliflozin and metformin hydrochloride tablets) _
_Page 2 of 74_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
11/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES .............................................................................................
2
TABLE OF CONTENTS ....................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4
1
INDICATIONS .......................................................................................................................
4
1.1
Pediatrics
.............................................................................................................................
4
1.2
Geriatrics
.............................................................................................................................
4
2
CONTRAINDICATIONS .......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5
4
DOSAGE AND ADMINISTRATION .....................