ACCUTANE ROCHE CAPSULE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ISOTRETINOIN

Sẵn có từ:

HOFFMANN-LA ROCHE LIMITED

Mã ATC:

D10BA01

INN (Tên quốc tế):

ISOTRETINOIN

Liều dùng:

40MG

Dạng dược phẩm:

CAPSULE

Thành phần:

ISOTRETINOIN 40MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0115751002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2001-04-02

Đặc tính sản phẩm

_Pr_
_ACCUTANE™ ROCHE_
_®_
_ (isotretinoin) _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACCUTANE™ ROCHE
®
isotretinoin
Capsule, USP
10 mg, 40 mg
Retinoid for Treatment of Acne
ATC Code: D10BA01
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, ON L5N 5M8
www.rochecanada.com
Date of Initial Approval:
December 02, 1982
Date of Revision:
August 21, 2019
Submission Control No: 226870
ACCUTANE™ ROCHE
®
trade-mark of Hoffmann-La Roche Limited
©
Copyright 1982 – 2019 Hoffmann-La Roche Limited
_ _
_Pr_
_ACCUTANE™ ROCHE_
_®_
_ (isotretinoin) _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
ADVERSE REACTIONS, Clinical Trial Adverse Reaction [8.2]
Nov-2016
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
..................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 6
4
DOSAGE AND ADMINISTRATION
................................................................................
6
4.1
Dosing Considerations
...........................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
....................................................... 7
4.3
Administration
......