MICAFUNGIN SODIUM FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MICAFUNGIN (MICAFUNGIN SODIUM)

Available from:

JUNO PHARMACEUTICALS CORP.

ATC code:

J02AX05

INN (International Name):

MICAFUNGIN

Dosage:

50MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

MICAFUNGIN (MICAFUNGIN SODIUM) 50MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-02-04

Summary of Product characteristics

_Product Monograph - Micafungin Sodium for Injection_
_ _
Page 1 of 39_ _
PRODUCT MONOGRAPH
PR
MICAFUNGIN SODIUM FOR INJECTION
50 mg and 100 mg micafungin (as micafungin sodium) per vial
Sterile Powder for Injection
Antifungal
Juno Pharmaceuticals Corp.
402-2233 Argentia Road,
Mississauga, ON L5N 2X7
CONTROL NUMBER: 240052
Date of Preparation:
February 04, 2022
_Product Monograph - Micafungin Sodium for Injection_
_ _
Page 2 of 39_ _
_Product Monograph - Micafungin Sodium for Injection_
_ _
Page 3 of 39_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 4
SUMMARY PRODUCT INFORMATION
...................................................................................
4
INDICATIONS AND CLINICAL USE
.........................................................................................
4
CONTRAINDICATIONS
..............................................................................................................
5
WARNINGS AND PRECAUTIONS
.............................................................................................
5
ADVERSE REACTIONS
...............................................................................................................
7
DRUG INTERACTIONS
.............................................................................................................
13
DOSAGE AND ADMINISTRATION
.........................................................................................
14
OVERDOSAGE
...........................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
18
STORAGE AND STABILITY
.....................................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
..................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................