CASPOFUNGIN FOR INJECTION POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CASPOFUNGIN (CASPOFUNGIN ACETATE)

Mevcut itibaren:

FRESENIUS KABI CANADA LTD

ATC kodu:

J02AX04

INN (International Adı):

CASPOFUNGIN

Doz:

50MG

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

CASPOFUNGIN (CASPOFUNGIN ACETATE) 50MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

ECHINOCANDINS

Ürün özeti:

Active ingredient group (AIG) number: 0144763001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2019-04-02

Ürün özellikleri

Caspofungin for Injection - Product Monograph
Page 1 of 48
PRODUCT MONOGRAPH
PPR
CASPOFUNGIN FOR INJECTION
(as caspofungin acetate)
Powder for Solution
50 mg / vial and 70 mg / vial
Antifungal
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite 100
February 2, 2021
Toronto, ON M9W 0C8
Submission
Control Number: 243668
Caspofungin for Injection - Product Monograph
Page 2 of 48
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
DESCRIPTION....................................................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS.....................................................................................................
4
WARNINGS AND PRECAUTIONS
....................................................................................
4
ADVERSE REACTIONS
.....................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
21
DOSAGE AND ADMINISTRATION
................................................................................
22
OVERDOSAGE.................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 28
STORAGE AND STABILITY
...........................................................................................
30
DOSAGE FORMS, COMPOSITION AND
PACKAGING.................................................. 30
PART II: SCIENTIFIC
INFORMATION...........................................................................31
PHARMACEUTICAL INFORMATION
...............................