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; 850MG

Zāļu forma:

TABLET

Kompozīcija:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 50MG; METFORMIN HYDROCHLORIDE 850MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Produktu pārskats:

Active ingredient group (AIG) number: 0252656002; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2023-01-05

Produkta apraksts

_SITAGLIPTIN-METFORMIN Product Monograph _
_Page 1 of 61 _
PRODUCT MONOGRAPH
Pr
SITAGLIPTIN-METFORMIN
sitagliptin and metformin hydrochloride tablets
50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg
sitagliptin (as sitagliptin phosphate monohydrate)/metformin
hydrochloride, tablets, oral
ATC Code: A10BD07
Combinations of oral blood glucose lowering drugs
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec
Canada H4R 2P7
www.sivem.ca
SUBMISSION CONTROL NO.: 271106
Date of
Revision:
JAN 5, 2023
_SITAGLIPTIN-METFORMIN Product Monograph _
_Page 2 of 61 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................25
DOSAGE AND ADMINISTRATION
..............................................................................29
OVERDOSAGE
................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
............................................................31
STORAGE AND STABILITY
..........................................................................................38
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................38
PART II : SCIENTIFIC INFORMATION
...............................................................................40
PHARMACEUTICAL INFORMATION
...........