SPORANOX SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ITRACONAZOLE

Available from:

JANSSEN INC

ATC code:

J02AC02

INN (International Name):

ITRACONAZOLE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

ITRACONAZOLE 10MG

Administration route:

ORAL

Units in package:

150ML

Prescription type:

Prescription

Therapeutic area:

AZOLES

Product summary:

Active ingredient group (AIG) number: 0123311001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2023-09-29

Summary of Product characteristics

_Non-Approved Product Monograph 1.docx _
_EDMS-RIM-1034529 v6.0 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SPORANOX
®
itraconazole
oral solution 10 mg/mL
Antimycotic for systemic use, triazole and tetrazole derivatives.
TC code: J02A C02.
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Initial Authorization:
May 20, 1997
Date of Revision:
October 3, 2023
Control Number: 275526
All trademarks used under license.
© 2023 Janssen Inc.
_Non-Approved Product Monograph 1.docx _
_EDMS-RIM-1034529 v6.0 _
RECENT MAJOR LABEL CHANGES
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
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics
...........................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 6
4
DOSAGE AND ADMINISTRATION
..................................................................................
6
4.1
Dosing Considerations
......................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
................................................. 7
4.4
Administration
..........................................