GD-ANIDULAFUNGIN POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ANIDULAFUNGIN

Commercializzato da:

GENMED A DIVISION OF PFIZER CANADA ULC

Codice ATC:

J02AX06

INN (Nome Internazionale):

ANIDULAFUNGIN

Dosaggio:

100MG

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

ANIDULAFUNGIN 100MG

Via di somministrazione:

INTRAVENOUS

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

ECHINOCANDINS

Dettagli prodotto:

Active ingredient group (AIG) number: 0152373001; AHFS:

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2021-01-15

Scheda tecnica

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_GD-Anidulafungin (anidulafungin) - Product Monograph _
_Page 1 of 28_
PRODUCT MONOGRAPH
PR
GD*-ANIDULAFUNGIN
Anidulafungin For Injection
100 mg / Vial
ANTIFUNGAL AGENT
GenMed, a Division of Pfizer Canada Inc.
17 300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Preparation:
May 26, 2015
Submission Control No: 183521
* GD is a trademark of Pfizer Canada Inc.
GenMed, a division of Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc., 2015
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_GD-Anidulafungin (anidulafungin) - Product Monograph _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
ADVERSE REACTIONS
...................................................................................................
4
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 13
STORAGE AND STABILITY
.........................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 16
PART II: SCIENTIFIC INFORMATION
...................................................