CRESEMBA POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ISAVUCONAZOLE (ISAVUCONAZONIUM SULFATE)

Tersedia dari:

AVIR PHARMA INC.

Kode ATC:

J02AC05

INN (Nama Internasional):

ISAVUCONAZOLE

Dosis:

200MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

ISAVUCONAZOLE (ISAVUCONAZONIUM SULFATE) 200MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

AZOLES

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-12-19

Karakteristik produk

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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