TARO-FLUCONAZOLE TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

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Download Vara einkenni (SPC)
25-10-2022

Virkt innihaldsefni:

FLUCONAZOLE

Fáanlegur frá:

TARO PHARMACEUTICALS INC

ATC númer:

J02AC01

INN (Alþjóðlegt nafn):

FLUCONAZOLE

Skammtar:

50MG

Lyfjaform:

TABLET

Samsetning:

FLUCONAZOLE 50MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

30

Gerð lyfseðils:

Prescription

Lækningarsvæði:

AZOLES

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2004-02-27

Vara einkenni

                                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
..
                                
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