STEGLATRO TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ERTUGLIFLOZIN

Disponible des:

MERCK CANADA INC

Codi ATC:

A10BK04

Designació comuna internacional (DCI):

ERTUGLIFLOZIN

Dosis:

15MG

formulario farmacéutico:

TABLET

Composición:

ERTUGLIFLOZIN 15MG

Vía de administración:

ORAL

Unidades en paquete:

7/14/30

tipo de receta:

Prescription

Área terapéutica:

Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2021-02-03

Fitxa tècnica

_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