RIVA-DAPAGLIFLOZIN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DAPAGLIFLOZIN

Διαθέσιμο από:

LABORATOIRE RIVA INC.

Φαρμακολογική κατηγορία (ATC):

A10BK01

INN (Διεθνής Όνομα):

DAPAGLIFLOZIN

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

DAPAGLIFLOZIN 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0156370002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-05-15

Αρχείο Π.Χ.Π.

_ _
_RIVA-DAPAGLIFLOZIN (dapagliflozin) _
_Page 1 of 72 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
RIVA-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Date of Initial Authorization:
July 11, 2022
Submission Control Number: 254745
_ _
_RIVA-DAPAGLIFLOZIN (dapagliflozin) _
_Page 2 of 72 _
RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
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
.....................................................................................