TARO-FLUCONAZOLE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

FLUCONAZOLE

Tersedia dari:

TARO PHARMACEUTICALS INC

Kode ATC:

J02AC01

INN (Nama Internasional):

FLUCONAZOLE

Dosis:

50MG

Bentuk farmasi:

TABLET

Komposisi:

FLUCONAZOLE 50MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

AZOLES

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2004-02-27

Karakteristik produk

Taro-Fluconazole (Fluconazole Tablets)
Page 1 of 55
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TARO-FLUCONAZOLE
Fluconazole Tablets
Tablets, 50 mg, 100 mg and 200 mg, oral
Antifungal Agent
Taro Pharmaceuticals Inc.
Date of Initial Authorization
130 East Drive
February 27, 2004
Brampton, Ontario
L6T 1C1
Date of Revision:
October 25, 2022
Control Number: 267711
Taro-Fluconazole (Fluconazole Tablets)
Page 2 of 55
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
10/2022
2 CONTRAINDICATIONS
10/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Missed Dose
10/2022
7 WARNINGS AND PRECAUTIONS
10/2022
9 DRUG INTERACTIONS
10/2022
13 PHARMACEUTICAL INFORMATION
10/2022
15 MICROBIOLOGY
10/2022
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
..................................................................................................................
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
4.4
Missed Dose
..