OSENI TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ALOGLIPTIN (ALOGLIPTIN BENZOATE); PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE)

זמין מ:

TAKEDA CANADA INC

קוד ATC:

A10BD09

INN (שם בינלאומי):

PIOGLITAZONE AND ALOGLIPTIN

כמות:

25MG; 45MG

טופס פרצבטיות:

TABLET

הרכב:

ALOGLIPTIN (ALOGLIPTIN BENZOATE) 25MG; PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 45MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30

סוג מרשם:

Prescription

איזור תרפויטי:

DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0255250006; AHFS:

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2018-01-19

מאפייני מוצר

_OSENI_
_TM_
_ Product Monograph _
_Page 1 of 51_
PRODUCT MONOGRAPH
Pr
OSENI™
alogliptin (as alogliptin benzoate) and pioglitazone (as pioglitazone
hydrochloride)
12.5 mg/15 mg, 12.5 mg/30 mg, 12.5 mg/45 mg, 25 mg/15 mg, 25 mg/30 mg
and 25 mg/45 mg
tablets
Oral Antihyperglycemic Agent
DPP-4 Inhibitor + Thiazolidinedione
Incretin Enhancer
Takeda Canada Inc.
Oakville, Ontario L6M 4X8
Date of Preparation:
January 16, 2014
SUBMISSION CONTROL NO: 156813
_OSENI_
_TM_
_ Product Monograph _
_Page 2 of 51_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STABILITY
..........................................................................................32
SPECIAL HANDLING INSTRUCTIONS
.......................................................................32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................32
PART II: SCIENTIFIC INFORMATION
...............................................................................