SPORANOX SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ITRACONAZOLE

Pieejams no:

JANSSEN INC

ATĶ kods:

J02AC02

SNN (starptautisko nepatentēto nosaukumu):

ITRACONAZOLE

Deva:

10MG

Zāļu forma:

SOLUTION

Kompozīcija:

ITRACONAZOLE 10MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

150ML

Receptes veids:

Prescription

Ārstniecības joma:

AZOLES

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2023-09-29

Produkta apraksts

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