TARO-SITAGLIPTIN FUMARATE TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

SITAGLIPTIN (SITAGLIPTIN FUMARATE)

Beszerezhető a:

TARO PHARMACEUTICALS INC

ATC-kód:

A10BH01

INN (nemzetközi neve):

SITAGLIPTIN

Adagolás:

50MG

Gyógyszerészeti forma:

TABLET

Összetétel:

SITAGLIPTIN (SITAGLIPTIN FUMARATE) 50MG

Az alkalmazás módja:

ORAL

db csomag:

15G/50G

Recept típusa:

Prescription

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2023-01-05

Termékjellemzők

_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
...........................