TARO-SITAGLIPTIN FUMARATE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

SITAGLIPTIN (SITAGLIPTIN FUMARATE)

Pieejams no:

TARO PHARMACEUTICALS INC

ATĶ kods:

A10BH01

SNN (starptautisko nepatentēto nosaukumu):

SITAGLIPTIN

Deva:

50MG

Zāļu forma:

TABLET

Kompozīcija:

SITAGLIPTIN (SITAGLIPTIN FUMARATE) 50MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Produktu pārskats:

Active ingredient group (AIG) number: 0152414003; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2023-01-05

Produkta apraksts

_P r_
_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
_P r_
_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
...........................