SPORANOX CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ITRACONAZOLE

Boleh didapati daripada:

JANSSEN INC

Kod ATC:

J02AC02

INN (Nama Antarabangsa):

ITRACONAZOLE

Dos:

100MG

Borang farmaseutikal:

CAPSULE

Komposisi:

ITRACONAZOLE 100MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

28/30

Jenis preskripsi:

Prescription

Kawasan terapeutik:

AZOLES

Ringkasan produk:

Active ingredient group (AIG) number: 0123311002; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2002-06-03

Ciri produk

_Non Ann PM SNDS SPOC 275453 09052023.docx _
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_EDMS-RIM-1034546 v4.0 _
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_Page 1 of 55_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SPORANOX
®
itraconazole
capsules, 100 mg, oral
Antimycotic for systemic use, triazole and tetrazole derivatives
ATC code: J02A C02
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Initial Authorization:
August 17, 1993
Date of Revision:
October 3, 2023
Control Number: 275453
All trademarks used under license.
© 2023 Janssen Inc.
_Non Ann PM SNDS SPOC 275453 09052023.docx _
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_EDMS-RIM-1034546 v4.0 _
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_Page 2 of 55_
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 ..........................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................... 6
4
DOSAGE AND ADMINISTRATION ..........................................................................
7
4.1
Dosing Considerations
..............................................................................
7
4.2
Recommended Dose and Dosage Adjustment
............................................ 7
4.4
Administration
.................................................................