CRESEMBA POWDER FOR SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ISAVUCONAZOLE (ISAVUCONAZONIUM SULFATE)

Доступно од:

AVIR PHARMA INC.

АТЦ код:

J02AC05

INN (Међународно име):

ISAVUCONAZOLE

Дозирање:

200MG

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

ISAVUCONAZOLE (ISAVUCONAZONIUM SULFATE) 200MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Терапеутска област:

AZOLES

Резиме производа:

Active ingredient group (AIG) number: 0161030002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2018-12-19

Карактеристике производа

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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
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