MINT-ITRACONAZOLE CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ITRACONAZOLE

Boleh didapati daripada:

MINT PHARMACEUTICALS INC

Kod ATC:

J02AC02

INN (Nama Antarabangsa):

ITRACONAZOLE

Dos:

100MG

Borang farmaseutikal:

CAPSULE

Komposisi:

ITRACONAZOLE 100MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30

Jenis preskripsi:

Prescription

Kawasan terapeutik:

AZOLES

Ringkasan produk:

Active ingredient group (AIG) number: 0123311002; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2017-03-22

Ciri produk

_Approved Product Monograph _
MINT-ITRACONAZOLE (itraconazole)
_ _
_Page 1 of 55_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATIO N
PR
MINT-ITRACONAZOLE
Itraconazole Capsules
Capsule, 100 mg, Oral
Antimycotic for systemic use, triazole and tetrazole derivatives
Mint Pharmaceuticals Inc.
6575 Davand Drive,
Mississauga, Ontario,
L5T 2M3
Date of Initial Authorization:
March 22, 2017
Date of Revision:
May 17, 2023
Submission Control Number: 270537
_Approved Product Monograph _
MINT-ITRACONAZOLE (itraconazole)
_ _
_Page 2 of 55_
_ _
RECENT MAJOR LABEL CHANGES
2. CONTRAINDICATIONS
05/2023
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
.........................................................................................................
4
1.2
Geriatrics
.........................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.........................................................
6
4
DOSAGE AND ADMINISTRATION
.................................................................................
7
4.1
Dosing Considerations
.....................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
.................................................
7
4.4
Administration
......................................