DIFLUCAN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUCONAZOLE

Available from:

PFIZER CANADA ULC

ATC code:

J02AC01

INN (International Name):

FLUCONAZOLE

Dosage:

2MG

Pharmaceutical form:

SOLUTION

Composition:

FLUCONAZOLE 2MG

Administration route:

INTRAVENOUS

Units in package:

100ML

Prescription type:

Prescription

Therapeutic area:

AZOLES

Product summary:

Active ingredient group (AIG) number: 0122529003; AHFS:

Authorization status:

MARKETED

Authorization date:

1990-12-31

Summary of Product characteristics

_DIFLUCAN – Product Monograph _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
DIFLUCAN
®
Fluconazole
Tablets 50 mg and 100 mg
Powder for Oral Suspension 50 mg/5 mL (when reconstituted)
Solution 100 mL vial (2 mg/mL intravenous infusion)
Antifungal Agent
Pfizer Canada ULC
17 300 Trans-Canada Highway
Kirkland, Québec. H9J 2M5
Date of Initial Authorization:
AUG 24 1990
Date of Revision:
FEB 7 2023
Submission Control Number: 268015
®
Pfizer Products Inc.
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC 2023
_ _
_DIFLUCAN – Product Monograph _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
WARNINGS AND PRECAUTIONS
11/2021
DRUG INTERACTIONS
02/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics (<18 years of age)
..............................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.3
Reconstitution
..........................................................