País: Canadà
Idioma: anglès
Font: Health Canada
CASPOFUNGIN (CASPOFUNGIN ACETATE)
FRESENIUS KABI CANADA LTD
J02AX04
CASPOFUNGIN
70MG
POWDER FOR SOLUTION
CASPOFUNGIN (CASPOFUNGIN ACETATE) 70MG
INTRAVENOUS
15G/50G
Prescription
ECHINOCANDINS
Active ingredient group (AIG) number: 0144763002; AHFS:
APPROVED
2019-04-02
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 ............................... Llegiu el document complet