MINT-ITRACONAZOLE CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ITRACONAZOLE

זמין מ:

MINT PHARMACEUTICALS INC

קוד ATC:

J02AC02

INN (שם בינלאומי):

ITRACONAZOLE

כמות:

100MG

טופס פרצבטיות:

CAPSULE

הרכב:

ITRACONAZOLE 100MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30

סוג מרשם:

Prescription

איזור תרפויטי:

AZOLES

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2017-03-22

מאפייני מוצר

_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
......................................