STEGLATRO TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
08-05-2018
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Aktiva substanser:
ERTUGLIFLOZIN
Tillgänglig från:
MERCK CANADA INC
ATC-kod:
A10BK04
INN (International namn):
ERTUGLIFLOZIN
Dos:
5MG
Läkemedelsform:
TABLET
Sammansättning:
ERTUGLIFLOZIN 5MG
Administreringssätt:
ORAL
Enheter i paketet:
7/14/30
Receptbelagda typ:
Prescription
Terapiområde:
Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors
Produktsammanfattning:
Active ingredient group (AIG) number: 0160211001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2021-02-03
Produktens egenskaper
_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
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