OSENI TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ALOGLIPTIN (ALOGLIPTIN BENZOATE); PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE)

Sẵn có từ:

TAKEDA CANADA INC

Mã ATC:

A10BD09

INN (Tên quốc tế):

PIOGLITAZONE AND ALOGLIPTIN

Liều dùng:

12.5MG; 15MG

Dạng dược phẩm:

TABLET

Thành phần:

ALOGLIPTIN (ALOGLIPTIN BENZOATE) 12.5MG; PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 15MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0255250001; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2018-01-29

Đặc tính sản phẩm

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