CASPOFUNGIN FOR INJECTION POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CASPOFUNGIN (CASPOFUNGIN ACETATE)

Disponibil de la:

FRESENIUS KABI CANADA LTD

Codul ATC:

J02AX04

INN (nume internaţional):

CASPOFUNGIN

Dozare:

70MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

CASPOFUNGIN (CASPOFUNGIN ACETATE) 70MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ECHINOCANDINS

Rezumat produs:

Active ingredient group (AIG) number: 0144763002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2019-04-02

Caracteristicilor produsului

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
...............................