PMS-FLUCONAZOLE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FLUCONAZOLE

Disponible depuis:

PHARMASCIENCE INC

Code ATC:

J02AC01

DCI (Dénomination commune internationale):

FLUCONAZOLE

Dosage:

100MG

forme pharmaceutique:

TABLET

Composition:

FLUCONAZOLE 100MG

Mode d'administration:

ORAL

Unités en paquet:

50

Type d'ordonnance:

Prescription

Domaine thérapeutique:

AZOLES

Descriptif du produit:

Active ingredient group (AIG) number: 0122529002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2002-06-05

Résumé des caractéristiques du produit

_pms-FLUCONAZOLE – Product Monograph _
_ _
_Page 1 of 56_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-FLUCONAZOLE
Fluconazole Tablets
Tablets, 50 mg and 100 mg, Oral
House Standard
Antifungal Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
June 5, 2002
Date of Revision:
May 16, 2023
Submission Control Number: 273867
_pms-FLUCONAZOLE – Product Monograph _
_ _
_Page 2 of 56_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
10/2022
9 DRUG INTERACTIONS
05/2023
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
..............................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.5
Missed Dose
............................................................................................................
8
5
OVERDOSAGE
....................................