OSENI TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ALOGLIPTIN (ALOGLIPTIN BENZOATE); PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE)

Tersedia dari:

TAKEDA CANADA INC

Kode ATC:

A10BD09

INN (Nama Internasional):

PIOGLITAZONE AND ALOGLIPTIN

Dosis:

12.5MG; 30MG

Bentuk farmasi:

TABLET

Komposisi:

ALOGLIPTIN (ALOGLIPTIN BENZOATE) 12.5MG; PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 30MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0255250002; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2018-01-19

Karakteristik produk

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