TARO-SITAGLIPTIN FUMARATE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

SITAGLIPTIN (SITAGLIPTIN FUMARATE)

Disponible des:

TARO PHARMACEUTICALS INC

Codi ATC:

A10BH01

Designació comuna internacional (DCI):

SITAGLIPTIN

Dosis:

25MG

formulario farmacéutico:

TABLET

Composición:

SITAGLIPTIN (SITAGLIPTIN FUMARATE) 25MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Resumen del producto:

Active ingredient group (AIG) number: 0152414002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2023-01-05

Fitxa tècnica

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_TARO-SITAGLIPTIN FUMARATE (Sitagliptin Tablets) Product Monograph
Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-SITAGLIPTIN FUMARATE
Sitagliptin Tablets
Tablets, 25, 50 and 100 mg sitagliptin (as sitagliptin fumarate), Oral
Dipeptidyl peptidase 4 (DPP-4) inhibitors
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario, Canada
L6T 1C1
Date of Initial Authorization:
October 3, 2022
Submission Control Number: 260645
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_TARO-SITAGLIPTIN FUMARATE (Sitagliptin Tablets) Product Monograph
Page 2 of 63 _
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................................4
1 INDICATIONS
............................................................................................................................4
1.1 PEDIATRICS
...........................................................................................................................4
1.2 GERIATRICS
...........................................................................................................................4
2 CONTRAINDICATIONS
..............................................................................................................4
4 DOSAGE AND
ADMINISTRATION..............................................................................................4
4.1 DOSING CONSIDERATIONS
........................................................................................................4
4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
.....................................................................4
4.4
ADMINISTRATION....................................................................................................................5
4.5 MISSED DOSE
.......................................................................................................................5
5 OVERDOSAGE
...........................