PMS-DAPAGLIFLOZIN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DAPAGLIFLOZIN

Dostępny od:

PHARMASCIENCE INC

Kod ATC:

A10BK01

INN (International Nazwa):

DAPAGLIFLOZIN

Dawkowanie:

5MG

Forma farmaceutyczna:

TABLET

Skład:

DAPAGLIFLOZIN 5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Podsumowanie produktu:

Active ingredient group (AIG) number: 0156370001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2023-05-15

Charakterystyka produktu

pms-DAPAGLIFLOZIN (dapagliflozin)
Page 1 of 78
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
pms-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablet, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Pharmascience Inc.
6111 Royalmount, Suite 100
Montreal, Canada, H4P 2T4
Date of Initial Authorization:
SEP 29, 2022
Submission Control Number: 257964
pms-DAPAGLIFLOZIN (dapagliflozin)
Page 2 of 78
RECENT MAJOR LABEL CHANGES
_None at time of authorization._
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
............................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................................................
4
1
INDICATIONS
...........................................................................................................................
4
1.1
Pediatrics
.............................................................................................................................
4
1.2
Geriatrics
.............................................................................................................................
5
2
CONTRAINDICATIONS
...............................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...........................................................................
5
4
DOSAGE AND ADMINISTRATION
...............................................................................................
5
4.1
Dosing Considerations
.........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................................... 6
4.5
Missed Dose
...............................................................................................