SITAGLIPTIN-METFORMIN TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE); METFORMIN HYDROCHLORIDE

Inapatikana kutoka:

SIVEM PHARMACEUTICALS ULC

ATC kanuni:

A10BD07

INN (Jina la Kimataifa):

METFORMIN AND SITAGLIPTIN

Kipimo:

50MG; 850MG

Dawa fomu:

TABLET

Tungo:

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

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2023-01-05

Tabia za bidhaa

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