SANDOZ RIVASTIGMINE PATCH 5

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RIVASTIGMINE

Sẵn có từ:

SANDOZ CANADA INCORPORATED

Mã ATC:

N06DA03

INN (Tên quốc tế):

RIVASTIGMINE

Liều dùng:

4.6MG

Dạng dược phẩm:

PATCH

Thành phần:

RIVASTIGMINE 4.6MG

Tuyến hành chính:

TRANSDERMAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0140521007; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2014-07-11

Đặc tính sản phẩm

_ _
SANDOZ RIVASTIGMINE PATCH (Rivastigmine Hydrogen Tartrate)
_ _
_Page 1 of 58_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SANDOZ RIVASTIGMINE PATCH 5
Pr
SANDOZ RIVASTIGMINE PATCH 10
Rivastigmine Transdermal Patch
Patch, 4.6 mg/24 h and 9.5 mg/24h, Transdermal
Cholinesterase Inhibitor
Submission Control Number:
280181
Sandoz Canada
Inc. Date of InitialAuthorization:
110, rue de Lauzon JUL 11, 2014
Boucherville, QC
Canada
J4B 1E6 Date of Revision:
NOV 27, 2023
_ _
SANDOZ RIVASTIGMINE PATCH (Rivastigmine Hydrogen Tartrate)
_ _
_Page 2 of 58_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
11/2023
7 WARNINGS AND PRECAUTIONS, Cardiovascular
11/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
.................