ODAN ITRACONAZOLE SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ITRACONAZOLE

Sẵn có từ:

ODAN LABORATORIES LTD

Mã ATC:

J02AC02

INN (Tên quốc tế):

ITRACONAZOLE

Liều dùng:

10MG

Dạng dược phẩm:

SOLUTION

Thành phần:

ITRACONAZOLE 10MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

AZOLES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0123311001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-01-31

Đặc tính sản phẩm

_Product Monograph: _
_Odan Itraconazole _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ODAN ITRACONAZOLE
Itraconazole Oral Solution, BP
Solution, 10 mg / mL, Oral
Antimycotic for systemic use, triazole and tetrazole derivatives.
ATC code: J02A C02.
Odan Laboratories Ltd
325, Stillview Ave Pointe-
Claire, QC H9R 2Y6
www.odanlab.com
Date of Initial Authorization:
January 31, 2020
Date of Revision:
January 11, 2024
Submission Control Number: 278040
_Product Monograph: _
_Odan Itraconazole _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2022
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
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 6
4
DOSAGE AND
ADMINISTRATION................................................................................
6
4.1
Dosing Considerations
..................................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
..............................................................