"五洲"巴森錠0.25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)
14-05-2020
公众评估报告 公众评估报告 (PAR)
27-03-2020

有效成分:

PRAMIPEXOLE ( PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE)

可用日期:

五洲製藥股份有限公司 桃園市新屋區赤欄里17之1號 (18560031)

ATC代码:

N04BC05

药物剂型:

錠劑

组成:

PRAMIPEXOLE ( PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE) (7600001520) (eq. to Pramipexole 0.18mg)MG

每包单位数:

ALU-ALU鋁箔盒裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

五洲製藥股份有限公司 桃園市新屋區赤欄村二鄰17號之1 TW

治疗领域:

pramipexole

疗效迹象:

治療自發性巴金森氏症的徵候及症狀。治療原發性腿部躁動症(Primary Restless Legs Syndrome)的症狀。

產品總結:

有效日期: 2028/07/31; 英文品名: PEXO Tablets 0.25mg

授权日期:

2013-07-31

资料单张

                                0.25
(S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-benzothiazole
dihydrochloride
monohydrate
pramipexole base 0.18
Pramipexole
(dopamine agonist)
D
2
D
3
Pramipexole
(striatum)
pramipexole
dopamine
Pramipexole
metamphetamine
Pramipexole
(Restless Legs Syndrome,RLS)
(positron emission
tomographic,PET)
pramipexole
levodopa
pramipexole
(
)
pramipexole
4.5
pramipexole
pramipexole
4
1000
pramipexole
12
9
Pramipexole
26
(IRLS)
pramipexole
13.7
11.1
-2.6
(p=0.008)
-
(Clinical Global Impression-Improvement , CGI-I)
(much improved)
(very much improved)
pramipexole
50.3%(80/159)
68.5%(111/162)(p=0.001)
(number needed to treat)
6
(95%CI:3.5, 13.4)
Pramipexole
90% 1
3
pramipexole
Pramipexole
pramipexole
(
20%)
(400
)
pramipexole
(
8
)
Pramipexole
pramipexole
80%
C14
90%
2%
Pramipexole
500
/
400
/
(t
)
1/2
pramipexole
pramipexole
pramipexole
30%
Pramipexole
(
65
)
(
40
)
40%
30%
pramipexole
(
)
pramipexole
30%
Pramipexole
pramipexole
pramipexole
90% pram pexole
pramipexole
(
20mL/min)
pramipexole
75%
(
40mL/min)
pramipexole
60%
(starting dose)
(maintenance dose)(
)
pramipexole
pramipexole
pramipexole
pramipexole
pramipexole
pramipexole
levodopa
levodopa
Citric Acid
Povidone
Starch
Mannitol
Microcrystalline Cellulose
Magnesium Stearate
0.25
PEXO
Tablets
0.25mg
pramipexole
levodopa
levodopa
levodopa
(Unified Parkinson's Disease
Rating Scale; UPDRS)
UPDRS
(part I)
(part II)
(part III)
(part IV)
UPDRS partII
13
0(
)
4
(
)
(
)
52
UPDRS partIII
27
(
)
partII
Part III
(
)
(
)
108
(N=599)
levodopa (
levodopa)
(on-off
phenomenon)
(N=335)
selegilina
(anticholinergics)
levodopa
amantadine
pramipexole
Pramipexole
0.375
4.5
/
(
)
pramipexole
(baseline)
UPDRS part II
1.9
-0.4
Pramipexole
UPDRS
part III
5.0
-0.8
UPDRS
part II
pramipexole
(
pramipexole
0.75
/
)
UPDRS part III
pramipexole
(
pramipexole
1.5
/
)
(N=264)
selegiline
amantadine
levodopa
1.5
3.0
4.5
6.0
pramipexole
(
)
UPDRS part II
1.8
0.3
Pramipexole
UPDRS part III
4.2
0.6
(dose-response)
Pramipexole
(
)
UPDRS part lI
partIII
pramipexole
selegiline
UPDRS
"
"
"
"
(N=360)
9
(
8
)
le
                                
                                阅读完整的文件
                                
                            

搜索与此产品相关的警报