INVOKAMET TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Dostupné s:

JANSSEN INC

ATC kód:

A10BD16

INN (Mezinárodní Name):

METFORMIN AND CANAGLIFLOZIN

Dávkování:

50MG; 850MG

Léková forma:

TABLET

Složení:

CANAGLIFLOZIN 50MG; METFORMIN HYDROCHLORIDE 850MG

Podání:

ORAL

Jednotky v balení:

60

Druh předpisu:

Prescription

Terapeutické oblasti:

BIGUANIDES

Přehled produktů:

Active ingredient group (AIG) number: 0258190002; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2022-09-06

Charakteristika produktu

Approved Product Monograph 1.docx
EDMS-ERI-188761171 v15.0
_ Page 1 of 89 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
INVOKAMET
®
canagliflozin and metformin hydrochloride tablets
(canagliflozin (as anhydrous canagliflozin) and metformin
hydrochloride)
50 mg/500 mg, 50 mg/850 mg, 50 mg/1000 mg, 150 mg/500 mg, 150 mg/850
mg and 150
mg/1000 mg
ATC Code: A10BD16
Combinations of oral blood glucose lowering drugs excl. insulins
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Preparation:
June 1, 2016
Date of Revision:
August 18, 2020
Submission Control No: 232307
All trademarks used under license.
© 2020 Janssen Inc.
Approved Product Monograph 1.docx
EDMS-ERI-188761171 v15.0
_ Page 2 of 89 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................17
DRUG INTERACTIONS
..................................................................................................35
DOSAGE AND ADMINISTRATION
..............................................................................41
OVERDOSAGE
................................................................................................................43
ACTION AND CLINICAL PHARMACOLOGY
............................................................44
STORAGE AND STABILITY
..........................................................................................51
SPECIAL HANDLING INSTRUCTIONS
.....................