国: カナダ
言語: 英語
ソース: Health Canada
ITRACONAZOLE
JANSSEN INC
J02AC02
ITRACONAZOLE
100MG
CAPSULE
ITRACONAZOLE 100MG
ORAL
28/30
Prescription
AZOLES
Active ingredient group (AIG) number: 0123311002; AHFS:
APPROVED
2002-06-03
_Non Ann PM SNDS SPOC 275453 09052023.docx _ _ _ _EDMS-RIM-1034546 v4.0 _ _ _ _ _ _Page 1 of 55_ _ _ 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 _ _ _ _EDMS-RIM-1034546 v4.0 _ _ _ _ _ _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 ................................................................. 完全なドキュメントを読む