好脂定膜衣錠2毫克

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

资料单张 资料单张 (PIL)
13-06-2021
公众评估报告 公众评估报告 (PAR)
30-05-2020

有效成分:

PITAVASTATIN CALCIUM

可用日期:

永信藥品工業股份有限公司 台中市大甲區頂店里中山路一段1191號 (56065601)

ATC代码:

C10AA08

药物剂型:

膜衣錠

组成:

PITAVASTATIN CALCIUM (2406003310) MG

每包单位数:

PTP鋁箔,置入PE鋁箔袋後紙盒裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

永信藥品工業股份有限公司台中幼獅廠 台中市大甲區工七路9號、工九路27號 TW

治疗领域:

pitavastatin

疗效迹象:

原發性高膽固醇血症及混合型血脂異常與10歲以上兒童家族性高膽固醇血症。

產品總結:

有效日期: 2028/09/17; 英文品名: Lavitol Film Coated Tablets 2mg

授权日期:

2018-09-17

资料单张

                                2140072
2 mg
30
59 mL/min/1.73 m
2
15
29 mL/min/1.73 m
2
Pitavastatin Calcium1 mg
2 mg
1 mg2 mg
1 mg
Erythromycin
ErythromycinPitavastatin Calcium1 mg
(Rifampin)
Rifampin
RifampinPitavastatin Calcium2 mg
(Gemfibrozil)
PITAVASTATIN CALCIUM
PITAVASTATIN CALCIUM
HMG-COA
PITAVASTATIN CALCIUM
PITAVASTATIN CALCIUMHMG-COA
PITAVASTATIN CALCIUM
HMG-COA
CYCLOSPORINE
Cyclosporine
HMG-COA
PITAVASTATIN CALCIUM
(MYOGLOBINURIA)
PITAVASTATIN CALCIUM (PITAVASTATIN)
>65
FIBRATENIACINPITAVASTATIN CALCIUM
FIBRATENIACIN
(
Niacin)
HMG-COA
COLCHICINE
PITAVASTATIN CALCIUMCOLCHICINE
(Colchicine)
STATIN(IMMUNE-MEDIATED NECROTIZING MYOPATHY)
(CK)
ANTI-HMG-COA REDUCTASE (HMGCR)STATIN
(CK)PITAVASTATIN
CALCIUM
PITAVASTATIN CALCIUM
HMG-COA
PITAVASTATIN CALCIUM
[ASPARTATE AMINOTRANSFERASE, AST][SERUM
GLUTAMATIC-OXALOACETIC TRANSAMINASE]
[ALANINE AMINOTRANSFEREASE,
ALT][SERUM GLUTAMIC-PYRUVIC TRANSAMINASE]
2
PITAVASTATIN CALCIUM 1 MG
PITAVASTATIN CALCIUM 2 MG
ALT3
2021
(0.5%)PITAVASTATIN CALCIUM 4 MG
ALT
3
1212
ALT
AST3
PITAVASTATIN CALCIUM
STATINPITAVASTATIN
PITAVASTATIN CALCIUM
PITAVASTATIN CALCIUM
HMG-COA
PITAVASTATIN CALCIUM
PITAVASTATIN CALCIUM
(HBA1C)
HMG-COA
STATIN
PITAVASTATIN
STATIN
1
3
104
(OPEN-LABEL EXTENSION)4,798
3,2911 MG
4 MG
PITAVASTATIN
PITAVASTATIN
1 MG
4 MG36.751.160.918
89
48%52%93%7%0.2%
0.3%
PITAVASTATIN CALCIUM
PITAVASTATIN CALCIUMHMG-COA
1≥2.0%
12
1. PITAVASTATIN CALCIUM≥2.0%
* MEDDRA
PITAVASTATIN3.9% (1 MG)
3.3% (2 MG)3.7% (4 MG)
(0.6%/4 MG)(0.5%/
4 MG)
PITAVASTATIN CALCIUM
52252
HIV
PITAVASTATIN CALCIUM 4 MG(N=126)STATIN(N=126)
DARUNAVIRHIV-1
RNA200 COPIES/ML
CD4200 CELL/ΜL
PITAVASTATIN CALCIUM
PITAVASTATIN CALCIUM
(0.8%)
(CREATINE PHOSPHOKINASE)
10
(10X UPPER LIMIT OF NORMAL)PITAVASTATIN CALCIUM
(3%)
(ALT)3
5
PITAVASTATIN CALCIUM(3%)
(VIROLOGIC FAILURE)HIV-1 RNA200 COPIES/ML
(BASELINE)2
886197 (22.2%)
50
(5.6%)
167
(18.8%)Γ-GTPCK (CPK)
ALT (GPT)AST (GOT)
20,0021,210 (6.0%)
5
CK (CPK)
(MYOPATHY)
CK (CPK)
0.1%
AST (GOT)
ALT (GPT)
0.1%
X
1)
2)
3)
14
1282015.6%
PITAVASTATIN CALCIUM
PITAVASTATIN CALCIUM
STATIN
STATIN
                                
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