SANDOZ ROSUVASTATIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Sẵn có từ:

SANDOZ CANADA INCORPORATED

Mã ATC:

C10AA07

INN (Tên quốc tế):

ROSUVASTATIN

Liều dùng:

40MG

Dạng dược phẩm:

TABLET

Thành phần:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 40MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

HMG-COA REDUCTASE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0148963003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2012-03-15

Đặc tính sản phẩm

_Sandoz Rosuvastatin (rosuvastatin calcium) Product Monograph _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ ROSUVASTATIN
Rosuvastatin Calcium Tablets
Tablets, 5, 10, 20 and 40 mg rosuvastatin (as rosuvastatin calcium),
Oral
Manufacturer’s Standard
Lipid Metabolism Regulator
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, (Québec), Canada
J4B 1K6
Date of Initial Authorization:
SEP 29, 2020
Date of Revision:
December 13, 2023
Submission Control Number: 278851
_Sandoz Rosuvastatin (rosuvastatin calcium) Product Monograph _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
02/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
12/2023
4.2 Recommended Dose and Dosage Adjustment
12/2023
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
4
DOSAGE AND ADMINISTRATION
.............................................................................................
5
4.1
Dosing Considerations
..............................................................................