SITAGLIPTIN-METFORMIN TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
05-01-2023
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Aktiva substanser:
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE); METFORMIN HYDROCHLORIDE
Tillgänglig från:
SIVEM PHARMACEUTICALS ULC
ATC-kod:
A10BD07
INN (International namn):
METFORMIN AND SITAGLIPTIN
Dos:
50MG; 850MG
Läkemedelsform:
TABLET
Sammansättning:
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 50MG; METFORMIN HYDROCHLORIDE 850MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Produktsammanfattning:
Active ingredient group (AIG) number: 0252656002; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2023-01-05
Produktens egenskaper
_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
...........
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