MICAFUNGIN SODIUM FOR INJECTION POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

MICAFUNGIN (MICAFUNGIN SODIUM)

Commercializzato da:

JUNO PHARMACEUTICALS CORP.

Codice ATC:

J02AX05

INN (Nome Internazionale):

MICAFUNGIN

Dosaggio:

50MG

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

MICAFUNGIN (MICAFUNGIN SODIUM) 50MG

Via di somministrazione:

INTRAVENOUS

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2022-02-04

Scheda tecnica

_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_
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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
....................