TARO-PRAVASTATIN TABLET
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
08-12-2022
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有效成分:
PRAVASTATIN SODIUM
可用日期:
SUN PHARMA CANADA INC
ATC代码:
C10AA03
INN（国际名称）:
PRAVASTATIN
剂量:
40MG
药物剂型:
TABLET
组成:
PRAVASTATIN SODIUM 40MG
给药途径:
ORAL
每包单位数:
30/100
处方类型:
Prescription
治疗领域:
HMG-COA REDUCTASE INHIBITORS
產品總結:
Active ingredient group (AIG) number: 0122563003; AHFS:
授权状态:
APPROVED
授权日期:
2022-12-09
产品特点
_Pr_
_TARO-PRAVASTATIN Product Monograph_ Page 1 of 39
PRODUCT MONOGRAPH
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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
...................................
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