CASPOFUNGIN POWDER FOR INJECTION POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CASPOFUNGIN (CASPOFUNGIN ACETATE)

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

J02AX04

INN (International Adı):

CASPOFUNGIN

Doz:

50MG

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

CASPOFUNGIN (CASPOFUNGIN ACETATE) 50MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

10ML

Reçete türü:

Prescription

Terapötik alanı:

ECHINOCANDINS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2017-04-18

Ürün özellikleri

_ _
_Caspofungin Powder for Injection _
_Page 1 of 54_
_ _
PRODUCT MONOGRAPH
PR
CASPOFUNGIN POWDER FOR INJECTION
caspofungin for injection, Professed Standard
50 mg or 70 mg caspofungin (as caspofungin acetate) per vial
Antifungal
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
www.tevacanada.com
Date of Revision:
July 21, 2017
SUBMISSION CONTROL NO: 207358
_ _
_Caspofungin Powder for Injection _
_Page 2 of 54_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
...................................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................................
4
ADVERSE REACTIONS
...............................................................................................................
8
DRUG INTERACTIONS
.............................................................................................................
23
DOSAGE AND ADMINISTRATION
.........................................................................................
24
OVERDOSAGE
...........................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
31
STORAGE AND STABILITY
.....................................................................................................
33
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................... 33
PART II: SCIENTIFIC
INFORMATION ............................................................................................
34
PHARM