TARO-PRAVASTATIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PRAVASTATIN SODIUM

Sẵn có từ:

SUN PHARMA CANADA INC

Mã ATC:

C10AA03

INN (Tên quốc tế):

PRAVASTATIN

Liều dùng:

40MG

Dạng dược phẩm:

TABLET

Thành phần:

PRAVASTATIN SODIUM 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: 0122563003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2022-12-09

Đặc tính sản phẩm

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_TARO-PRAVASTATIN Product Monograph_ Page 1 of 39
PRODUCT MONOGRAPH
Pr
TARO-PRAVASTATIN
Pravastatin Sodium Tablets, USP
10 mg, 20 mg and 40 mg
Lipid Metabolism Regulator
Sun Pharma Canada Inc.
126
East Drive
Brampton, Ontario
L6T 1C1
Control#
269572
Date of Preparation:
AUG 14, 2020
Date of Revision:
DEC
08, 2022
_Pr_
_TARO-PRAVASTATIN Product Monograph_ Page 2 of 39
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
........................................................................................................................
15
DOSAGE AND ADMINISTRATION
....................................................................................................
17
OVERDOSAGE
.......................................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
...................................................................................
18
STORAGE AND STABILITY
................................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................................
20
PART II: SCIENTIFIC INFORMATION
...................................