MICAFUNGIN SODIUM FOR INJECTION POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

MICAFUNGIN (MICAFUNGIN SODIUM)

Tilgjengelig fra:

JUNO PHARMACEUTICALS CORP.

ATC-kode:

J02AX05

INN (International Name):

MICAFUNGIN

Dosering :

50MG

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

MICAFUNGIN (MICAFUNGIN SODIUM) 50MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2022-02-04

Preparatomtale

_Product Monograph - Micafungin Sodium for Injection_
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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_
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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
....................