Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
ITRACONAZOLE
JANSSEN INC
J02AC02
ITRACONAZOLE
10MG
SOLUTION
ITRACONAZOLE 10MG
ORAL
150ML
Prescription
AZOLES
Active ingredient group (AIG) number: 0123311001; AHFS:
CANCELLED POST MARKET
2023-09-29
_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 .......................................... Soma hati kamili