SPORANOX CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ITRACONAZOLE

Dostopno od:

JANSSEN INC

Koda artikla:

J02AC02

INN (mednarodno ime):

ITRACONAZOLE

Odmerek:

100MG

Farmacevtska oblika:

CAPSULE

Sestava:

ITRACONAZOLE 100MG

Pot uporabe:

ORAL

Enote v paketu:

28/30

Tip zastaranja:

Prescription

Terapevtsko območje:

AZOLES

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2002-06-03

Lastnosti izdelka

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