APO-FLUCONAZOLE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FLUCONAZOLE

Disponibil de la:

APOTEX INC

Codul ATC:

J02AC01

INN (nume internaţional):

FLUCONAZOLE

Dozare:

50MG

Forma farmaceutică:

TABLET

Compoziție:

FLUCONAZOLE 50MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

AZOLES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

1998-10-09

Caracteristicilor produsului

_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
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4
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
.....................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
................................................................ 5
4.5 Missed Dose
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8
5