APO-FLUCONAZOLE TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

FLUCONAZOLE

Beszerezhető a:

APOTEX INC

ATC-kód:

J02AC01

INN (nemzetközi neve):

FLUCONAZOLE

Adagolás:

200MG

Gyógyszerészeti forma:

TABLET

Összetétel:

FLUCONAZOLE 200MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

AZOLES

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

1998-10-09

Termékjellemzők

_APO-FLUCONAZOLE (Fluconazole Tablets) _
_ _
_Page 1 of 58 _
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:
NOV 16, 2022
Submission Control Number: 264805
_APO-FLUCONAZOLE (Fluconazole Tablets) _
_ _
_Page 2 of 58 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
11/2022
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
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...................................................................................................................
8
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND P