SITAGLIPTIN-METFORMIN TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE); METFORMIN HYDROCHLORIDE

Pieejams no:

SIVEM PHARMACEUTICALS ULC

ATĶ kods:

A10BD07

SNN (starptautisko nepatentēto nosaukumu):

METFORMIN AND SITAGLIPTIN

Deva:

50MG; 1000MG

Zāļu forma:

TABLET

Kompozīcija:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 50MG; METFORMIN HYDROCHLORIDE 1000MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Produktu pārskats:

Active ingredient group (AIG) number: 0252656003; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2023-01-05

Produkta apraksts

_ _
_SITAGLIPTIN-METFORMIN (Sitagliptin and metformin hydrochloride
tablets) _
_Page 1 of 72_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SITAGLIPTIN-METFORMIN
Sitagliptin and metformin hydrochloride tablets
Tablets, 50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg sitagliptin (as
sitagliptin phosphate
monohydrate) / metformin hydrochloride, Oral
Combinations of oral blood glucose lowering drugs
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Submission Control Number: 279764
Date of Initial Authorization:
JAN 5, 2023
Date of Revision:
OCT 20, 2023
_ _
_SITAGLIPTIN-METFORMIN (Sitagliptin and metformin hydrochloride
tablets) _
_Page 2 of 72_
RECENT MAJOR LABEL CHANGES
1 Indications
10/2023
4 Dosage and Administration
10/2023
7 Warnings and Precautions
10/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
..............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
......................