ERAXIS POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ANIDULAFUNGIN

Available from:

PFIZER CANADA ULC

ATC code:

J02AX06

INN (International Name):

ANIDULAFUNGIN

Dosage:

100MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

ANIDULAFUNGIN 100MG

Administration route:

INTRAVENOUS

Units in package:

30ML

Prescription type:

Prescription

Therapeutic area:

ECHINOCANDINS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2009-07-28

Summary of Product characteristics

_ERAXIS_

_ (anidulafungin) - Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ERAXIS
®
Anidulafungin For Injection
Powder for solution, 100 mg / Vial, Intravenous
Antifungal Agent
Pfizer Canada ULC
17 300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
November 14, 2007
Date of Revision:
8 May 2023
Submission Control Number: 262044
® Vicuron Holdings LLC
Pfizer Canada ULC, Licensee
© Pfizer Canada ULC, 2023
_ _
_ERAXIS® (anidulafungin) - Product Monograph _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
1 Indication
05/2023
1 Indications, 1.1 Pediatrics
05/2023
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
05/2023
7 Warnings and Precautions, 7.1.3 Pediatrics
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
...........................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................................................
4
1
INDICATIONS
..........................................................................................................................
4
1.1 Pediatrics
...................................................................................................................................4
1.2 Geriatrics
...................................................................................................................................4
2
CONTRAINDICATIONS
.............................................................................................................
4
4.DOSAGE AND ADMINISTRATION
......................................................................................................
4
4.1 Dosing Considerations
..............................................................................................................4
4.2 Recommended Dose and Dosage Adjustment
......