MICAFUNGIN FOR INJECTION POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

MICAFUNGIN (MICAFUNGIN SODIUM)

Verfügbar ab:

ACCORD HEALTHCARE INC

ATC-Code:

J02AX05

INN (Internationale Bezeichnung):

MICAFUNGIN

Dosierung:

50MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

MICAFUNGIN (MICAFUNGIN SODIUM) 50MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Produktbesonderheiten:

Active ingredient group (AIG) number: 0163379001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2023-11-17

Fachinformation

_Product Monograph Micafungin for Injection_ _Page 1 of 37_
_ _
PRODUCT MONOGRAPH
PR
MICAFUNGIN FOR INJECTION
Lyophilised powder for infusion upon reconstitution and dilution,
50 mg and 100 mg Micafungin (as micafungin sodium) per vial,
intravenous.
Manufacturer’s Standard
ANTIFUNGAL
Accord Healthcare Inc.
3535 boul. St. Charles suite 704
Kirkland, QC, H9H 5B9
Canada
Date of preparation:
November 15, 2023
Submission Control Number: 262514
_Product Monograph Micafungin for Injection_ _Page 2 of 37_
_ _
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
................................................................................................
6
DRUG INTERACTIONS
...............................................................................................
12
DOSAGE AND ADMINISTRATION
...........................................................................
13
OVERDOSAGE
.............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 16
STORAGE AND STABILITY
......................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
....................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 20
PART II: SCIENTIFIC INFORMATION
.............................................................................
21
PHARMACEUTICAL INFORMATIO