NESINA TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALOGLIPTIN (ALOGLIPTIN BENZOATE)

Available from:

TAKEDA CANADA INC

ATC code:

A10BH04

INN (International Name):

ALOGLIPTIN

Dosage:

6.25MG

Pharmaceutical form:

TABLET

Composition:

ALOGLIPTIN (ALOGLIPTIN BENZOATE) 6.25MG

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: 0155071001; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-11-27

Summary of Product characteristics

_NESINA_
_®_
_ alogliptin (as alogliptin benzoate) _
_Page 1 of 52_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NESINA®
Alogliptin Tablets
Tablets, 6.25 mg, 12.5 mg and 25 mg alogliptin (as alogliptin
benzoate), Oral
ATC CODE: A10BH04
DIPEPTIDYL PEPTIDASE 4 (DPP-4) INHIBITORS
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario M5H 4E3
Date of Initial Authorization:
NOV 27, 2013
Date of Revision:
FEB 25, 2022
Submission Control Number: 255706
NESINA® is a registered trademark of Takeda Pharmaceutical Company
Limited.
TAKEDA™ and the TAKEDA Logo® are trademarks of Takeda
Pharmaceutical Company Limited,
used under license.
_ _
_NESINA_
_®_
_ alogliptin (as alogliptin benzoate) _
_Page 2 of 52_
RECENT MAJOR LABEL CHANGES
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02/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
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4
4.2
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