SITAGLIPTIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE)

Commercializzato da:

SIVEM PHARMACEUTICALS ULC

Codice ATC:

A10BH01

INN (Nome Internazionale):

SITAGLIPTIN

Dosaggio:

100MG

Forma farmaceutica:

TABLET

Composizione:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 100MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Dettagli prodotto:

Active ingredient group (AIG) number: 0152414001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2023-01-05

Scheda tecnica

_Product Monograph – SITAGLIPTIN _
_Page 1 of 58_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SITAGLIPTIN
Sitagliptin Tablets
25 mg, 50 mg and 100 mg, Sitagliptin (as sitagliptin phosphate
monohydrate)
Manufacturer’s Standard
Dipeptidyl peptidase 4 (DPP-4) inhibitors
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Date of Initial Authorization:
July 14, 2022
Submission Control Number: 265197
_Product Monograph – SITAGLIPTIN _
_Page 2 of 58_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
....................................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
.............................................................. 5
4.4 Administration
.......................................................................