GD-ANIDULAFUNGIN POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ANIDULAFUNGIN

Mevcut itibaren:

GENMED A DIVISION OF PFIZER CANADA ULC

ATC kodu:

J02AX06

INN (International Adı):

ANIDULAFUNGIN

Doz:

100MG

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

ANIDULAFUNGIN 100MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

ECHINOCANDINS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2021-01-15

Ürün özellikleri

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