Ország: Kanada
Nyelv: angol
Forrás: Health Canada
ERTUGLIFLOZIN
MERCK CANADA INC
A10BK04
ERTUGLIFLOZIN
5MG
TABLET
ERTUGLIFLOZIN 5MG
ORAL
7/14/30
Prescription
Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors
Active ingredient group (AIG) number: 0160211001; AHFS:
CANCELLED POST MARKET
2021-02-03
_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 Olvassa el a teljes dokumentumot