KOMBOGLYZE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE); METFORMIN HYDROCHLORIDE

Available from:

ASTRAZENECA CANADA INC

ATC code:

A10BD10

INN (International Name):

METFORMIN AND SAXAGLIPTIN

Dosage:

2.5MG; 850MG

Pharmaceutical form:

TABLET

Composition:

SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 2.5MG; METFORMIN HYDROCHLORIDE 850MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

BIGUANIDES

Product summary:

Active ingredient group (AIG) number: 0253208002; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-06-30

Summary of Product characteristics

_ _
KOMBOGLYZE
®
Product Monograph_ _
_Page 1 of 58_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
KOMBOGLYZE
®
saxagliptin and metformin hydrochloride tablets
(as saxagliptin hydrochloride and metformin hydrochloride)
Tablets, 2.5 mg/500 mg, 2.5 mg/850 mg, 2.5 mg/1000 mg, Oral use
Combination of oral blood glucose lowering drugs
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
JUL 09, 2012
Date of Revision:
NOV 23, 2023
Submission Control Number: 277042
KOMBOGLYZE
®
is a registered trademark of AstraZeneca AB, used under license by
AstraZeneca Canada Inc.
© AstraZeneca Canada Inc. 2023
_ _
KOMBOGLYZE
®
Product Monograph_ _
_Page 2 of 58_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
11/2023
2 CONTRAINDICATIONS
11/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
11/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
11/2023
7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery
11/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
11/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
11/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
11/2023
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
11/2023
7 WARNINGS AND PRECAUTIONS, Neurologic
11/2023
7 WARNINGS AND PRECAUTIONS, Renal
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
11/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS
................................................................................