DOM-ATORVASTATIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Sẵn có từ:

DOMINION PHARMACAL

Mã ATC:

C10AA05

INN (Tên quốc tế):

ATORVASTATIN

Liều dùng:

40MG

Dạng dược phẩm:

TABLET

Thành phần:

ATORVASTATIN (ATORVASTATIN CALCIUM) 40MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

HMG-COA REDUCTASE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0133055003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2012-01-10

Đặc tính sản phẩm

_ _
PRODUCT MONOGRAPH
PR
DOM-ATORVASTATIN
(atorvastatin calcium tablets)
10 mg, 20 mg, 40 mg and 80 mg atorvastatin
LIPID METABOLISM REGULATOR
DOMINION PHARMACAL
Date of Revision:
6111 Royalmount Ave., Suite #100
September 13, 2018
Montréal, Québec
H4P 2T4
Submission Control No.: 219990
_Dom-ATORVASTATIN Product Monograph _
_ _
_Page 2 of 49 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
....................................................................................
18
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 20
STORAGE AND STABILITY
................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
................................................................................24
PHARMACEUTICAL INFORMATION
...................................