STEGLATRO TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ERTUGLIFLOZIN

Tilgjengelig fra:

MERCK CANADA INC

ATC-kode:

A10BK04

INN (International Name):

ERTUGLIFLOZIN

Dosering :

15MG

Legemiddelform:

TABLET

Sammensetning:

ERTUGLIFLOZIN 15MG

Administreringsrute:

ORAL

Enheter i pakken:

7/14/30

Resept typen:

Prescription

Terapeutisk område:

Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors

Produkt oppsummering:

Active ingredient group (AIG) number: 0160211002; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2021-02-03

Preparatomtale

_STEGLATRO_™_ (ertugliflozin tablets) _
_Page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
STEGLATRO™
ertugliflozin tablets
5 mg and 15 mg ertugliflozin, tablets, oral
ATC Code: A10BK04
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Merck Canada Inc.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
www.merck.ca
Date of Preparation:
May 8, 2018
Submission Control No: 204724
_STEGLATRO_™_ (ertugliflozin tablets) _
_Page 2 of 39 _
TABLE OF CONTENTS
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
..............................................................................5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.3
Administration
.........................................................................................................
6
4.4
Reconstitution
..........................................................................................................
6
4.5
Missed Dose
............................................................................................................
6
5
OVERDOSAGE
.................................................................................................................7
6
DOSAGE FOR