CASPOFUNGIN FOR INJECTION POWDER FOR SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CASPOFUNGIN (CASPOFUNGIN ACETATE)

Tilgængelig fra:

JUNO PHARMACEUTICALS CORP.

ATC-kode:

J02AX04

INN (International Name):

CASPOFUNGIN

Dosering:

70MG

Lægemiddelform:

POWDER FOR SOLUTION

Sammensætning:

CASPOFUNGIN (CASPOFUNGIN ACETATE) 70MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

ECHINOCANDINS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2017-04-18

Produktets egenskaber

_Caspofungin for Injection_
_Page 1 of 50_
PRODUCT MONOGRAPH
Pr
.
CASPOFUNGIN FOR INJECTION
50 mg/vial, 70 mg/vial
Caspofungin (as caspofungin acetate)
Antifungal
JUNO PHARMACEUTICALS CORP.
402-2233 Argentia Road
Mississauga, ON
L5N 2X7
DATE OF PREPARATION:
May 21, 2021
SUBMISSION CONTROL NUMBER: 247611
_Caspofungin for Injection_
_Page 2 of 50_
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
.............................................................................................
7
DRUG INTERACTIONS
............................................................................................21
DOSAGE AND
ADMINISTRATION..........................................................................22
OVERDOSAGE..........................................................................................................28
ACTION AND CLINICAL PHARMACOLOGY
.........................................................29
STORAGE AND
STABILITY.....................................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................30
PART II: SCIENTIFIC
INFORMATION...........................................................................
32
PHARMACEUTICAL INFORMATION
.....................................................................32
CLINICAL
TRIALS...................................................................................