OSENI TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-01-2014
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
ALOGLIPTIN (ALOGLIPTIN BENZOATE); PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE)
Available from:
TAKEDA CANADA INC
ATC code:
A10BD09
INN (International Name):
PIOGLITAZONE AND ALOGLIPTIN
Dosage:
12.5MG; 45MG
Pharmaceutical form:
TABLET
Composition:
ALOGLIPTIN (ALOGLIPTIN BENZOATE) 12.5MG; PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 45MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0255250003; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2018-01-19
Summary of Product characteristics
_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
...............................................................................
Read the complete document
