PRAVASTATIN-10 TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PRAVASTATIN SODIUM

Sẵn có từ:

PRO DOC LIMITEE

Mã ATC:

C10AA03

INN (Tên quốc tế):

PRAVASTATIN

Liều dùng:

10MG

Dạng dược phẩm:

TABLET

Thành phần:

PRAVASTATIN SODIUM 10MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

HMG-COA REDUCTASE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0122563001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2001-06-13

Đặc tính sản phẩm

Page 1 of 41
PRODUCT MONOGRAPH
Pr
PRAVASTATIN
– 10
Pr
PRAVASTATIN
– 20
Pr
PRAVASTATIN
– 40
PRAVASTATIN SODIUM TABLETS USP
10 MG, 20 MG AND 40 MG
LIPID METABOLISM REGULATOR
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
March 2, 2021
Laval, Quebec
H7L 3W9
CONTROL NUMBER: 249000
Page 2 of 41
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
.......................................................................................................11
DRUG INTERACTIONS
.......................................................................................................16
DOSAGE AND ADMINISTRATION
......................................................................................18
OVERDOSAGE
....................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
......................................................................19
STORAGE AND STABILITY
................................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................22
PART II: SCIENTIFIC INFORMATION .................................................................................23
PHARMACEUTICAL INFORMATION
..................................................................................23
CLINICAL TRIALS
.........................................................................................