MAXIDEX OINTMENT

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DEXAMETHASONE

Sẵn có từ:

NOVARTIS PHARMACEUTICALS CANADA INC

Mã ATC:

S01BA01

INN (Tên quốc tế):

DEXAMETHASONE

Liều dùng:

0.1%

Dạng dược phẩm:

OINTMENT

Thành phần:

DEXAMETHASONE 0.1%

Tuyến hành chính:

OPHTHALMIC

Các đơn vị trong gói:

3.5G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

CORTICOSTEROIDS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0106303004; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2017-02-15

Đặc tính sản phẩm

_MAXIDEX_
_®_
_ (Dexamethasone) Product Monograph _
_Page 1 of 23_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MAXIDEX
®
Dexamethasone Ophthalmic Ointment, USP
Ointment, 0.1% w/w, Ophthalmic
Pr
MAXIDEX
®
Dexamethasone Ophthalmic Suspension, BP
Suspension, 0.1% w/v, Ophthalmic
Sterile
Corticosteroid
Novartis Pharmaceuticals Canada Inc.
700 Saint-Hubert St., Suite 100
Montreal, Quebec H2Y 0C1
www.novartis.ca
Date of Initial Authorization:
April 01, 2001
Date of Revision:
July 31, 2023
Novartis Version: June 12,
2020
Submission Control Number: 269311
MAXIDEX is a registered trademark.
_MAXIDEX_
_®_
_ (Dexamethasone) Product Monograph _
_Page 2 of 23_
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
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
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
............................................................ 4
4.4 Administration
.............................................................................................................
5
4.5 Missed Dose
....................................................................