Страна: Канада
мова: англійська
Джерело: Health Canada
ISAVUCONAZOLE (ISAVUCONAZONIUM SULFATE)
AVIR PHARMA INC.
J02AC05
ISAVUCONAZOLE
100MG
CAPSULE
ISAVUCONAZOLE (ISAVUCONAZONIUM SULFATE) 100MG
ORAL
15G/50G
Prescription
AZOLES
Active ingredient group (AIG) number: 0161030001; AHFS:
APPROVED
2018-12-19
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CRESEMBA® Isavuconazole Capsules Capsules, 100 mg isavuconazole (as isavuconazonium sulfate) Oral Isavuconazole for injection Powder for solution, 200 mg/vial isavuconazole (as isavuconazonium sulfate) Intravenous Antifungal Agent J02AC05 AVIR PHARMA INC. 660 Boul. Industriel Blainville, Quebec J7C 3V4 www.avirpharma.com Date of Initial Authorization: December 19, 2018 Date of Revision: April 12, 2022 Submission Control Number: 256812 CRESEMBA® is a registered trademark of Basilea Pharmaceutica International AG; used under license by AVIR Pharma Inc. _ _ _CRESEMBA (isavuconazole as isavuconazonium sulfate) _ _Page 2 of 49_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 04/2022 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 ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 5 4.1 Dosing Considerations ......................................................... Прочитайте повний документ