MINT-ITRACONAZOLE CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

ITRACONAZOLE

から入手可能:

MINT PHARMACEUTICALS INC

ATCコード:

J02AC02

INN（国際名）:

ITRACONAZOLE

投薬量:

100MG

医薬品形態:

CAPSULE

構図:

ITRACONAZOLE 100MG

投与経路:

ORAL

パッケージ内のユニット:

30

処方タイプ:

Prescription

治療領域:

AZOLES

製品概要:

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

認証ステータス:

APPROVED

承認日:

2017-03-22

製品の特徴

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