QTERN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE); DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE)

Disponibil de la:

ASTRAZENECA CANADA INC

Codul ATC:

A10BD21

INN (nume internaţional):

SAXAGLIPTIN AND DAPAGLIFLOZIN

Dozare:

5MG; 10MG

Forma farmaceutică:

TABLET

Compoziție:

SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 5MG; DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 10MG

Calea de administrare:

ORAL

Unități în pachet:

30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0258571002; AHFS:

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2022-09-26

Caracteristicilor produsului

COPYRIGHT 2021 ASTRAZENECA CANADA INC.
Page 1 of 57
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
QTERN
®
saxagliptin
and dapagliflozin
tablets
(as saxagliptin
hydrochloride
and dapagliflozin
propanediol monohydrate)
5 mg/5 mg and 5 mg/10 mg
ATC Code: A10BD21
Combinations
of oral blood glucose lowering drugs
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Revision:
June 29, 2021
Submission Control No: 249090
QTERN
®
is a registered trademark of AstraZeneca AB, used under license by
AstraZeneca
Canada Inc.
COPYRIGHT 2021 ASTRAZENECA CANADA INC.
Page 2 of 57
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
.........................................................................................
11
DRUG
INTERACTIONS..........................................................................................
21
DOSAGE AND
ADMINISTRATION.......................................................................
29
OVERDOSAGE
.......................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
...................................................... 31
STORAGE AND
STABILITY..................................................................................
39
SPECIAL HANDLING INSTRUCTIONS
................................................................ 39
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 40
PART II: SCIENTIFIC INFORMATION
........................................