APO-FLUCONAZOLE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FLUCONAZOLE

Boleh didapati daripada:

APOTEX INC

Kod ATC:

J02AC01

INN (Nama Antarabangsa):

FLUCONAZOLE

Dos:

50MG

Borang farmaseutikal:

TABLET

Komposisi:

FLUCONAZOLE 50MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

AZOLES

Ringkasan produk:

Active ingredient group (AIG) number: 0122529001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

1998-10-09

Ciri produk

_APO-FLUCONAZOLE (Fluconazole Tablets) _
_ _
_Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-FLUCONAZOLE
Fluconazole Tablets
Tablets, 50 mg, 100 mg and 200 mg, oral
Apotex Standard
Antifungal Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
OCT 09, 1998
Date of Revision:
AUG 22, 2023
Submission Control Number: 274760
_APO-FLUCONAZOLE (Fluconazole Tablets) _
_ _
_Page 2 of 56 _
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
11/2022
9. DRUG INTERACTIONS
08/2023
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