TARO-FLUCONAZOLE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

FLUCONAZOLE

Dostupno od:

TARO PHARMACEUTICALS INC

ATC koda:

J02AC01

INN (International ime):

FLUCONAZOLE

Doziranje:

200MG

Farmaceutski oblik:

TABLET

Sastav:

FLUCONAZOLE 200MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

AZOLES

Proizvod sažetak:

Active ingredient group (AIG) number: 0122529006; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2004-02-27

Svojstava lijeka

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
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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
..