得益淨凝膠

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)

下载 资料单张 (PIL)
06-06-2021
下载 公众评估报告 (PAR)
21-04-2020

有效成分:

CALCIPOTRIOL HYDRATE;;BETAMETHASONE DIPROPIONATE

可用日期:

培力藥品工業股份有限公司 台中市西屯區工業區六路11號 (52260152)

ATC代码:

D05AX52

药物剂型:

外用凝膠劑

组成:

BETAMETHASONE DIPROPIONATE (6804000220) (Betamethasone 0.5mg)MG; CALCIPOTRIOL HYDRATE (9200035910) (calcipotriol 0.05mg)MG

每包单位数:

軟管裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

培力藥品工業股份有限公司 台中市西屯區工業區六路11號 TW

治疗领域:

calcipotriol, combinations

疗效迹象:

治療頭皮牛皮癬 治療非頭皮部位之輕度至中度尋常性牛皮癬。

產品總結:

有效日期: 2024/10/13; 英文品名: Daichiu gel

授权日期:

2014-10-13

资料单张

                                HO
OH
H
H
OH
H O
2
HO
H
H
O
O
O
O
O
O
F
Calcipotriol 0.05mg (as hydrate), Betamethasone 0.5mg (as
dipropionate)
Calcipotriol hydrate
Betamethasone dipropionate
Calcipotriol hydrate
D
Calcipotriol hydrate
9,10-Secochola-5,7,10(19),22-tetraene-1,3,24-triol,24-cyclo-propyl,
monohydrate,
α,3β,5Z7E,22E,24S
C
H
O H
O
430.6
Calcipotriene hydrate
Betamethasone dipropionate
Betamethasone dipropionate
Pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-
17,21-bis 1-oxypropoxy
11β,16β
C
H
FO
504.6
Betamethasone dipropionate
Liquid Paraffin, Polyoxypropylene-15-stearyl Ether, Butylated
Hydroxytoluene, α-Tocopherol, Castor Oil
Hydrogenated
2
4
8
1
4
4
calcipotriol
15
100
calcipotriol
30%
1~4g
1.
2.
3.
1~3
1
2
calcipotriol
Ointment
calcipotriol & betamethasone dipropionate
4
32
5
ACTH
cortisol
calcipotriol
100
calcipotriol
III
rebound
UV
Ointment
alcipotriol & betamethasone dipropionate
/ Ointment
calcipotriol & betamethasone dipropionate
calcipotriol
UVR
butylated hydroxytoluene
Betamethasone
calcipotriol
calcipotriol
betamethasone dipropionate
18
12
17
MedDRA SOC
≥1/10
≥1/100 and <1/10
≥1/1,000 and <1/100
≥1/10,000 and <1/1,000
<1/10,000
058409
27
40 3
2
28
37 7
CBG-D-1_01
Calcipotriol
Betamethasone
Calcipotriol
Betamethasone
as dipropionate
colloid milia
109
12
17
240
Ointment
calcipotriol & betamethasone dipropionate
34
5
15
Calcipotriol
D
calcipotriol
betamethasone dipropionate
Ointment
calcipotriol & betamethasone dipropionate
106
cortisol
ACTH
32
5
15.6%
11
8
2
18.2%
30
60
Ointment
calcipotriol & betamethasone dipropionate
Hypothalamic-pituitary -adrenal axis, HPA
8
2,900
Investigator’s Global Assessment, IGA
betamethasone dipropionate
calcipotriol
2
P<0.001
8
296
IGA
betamethasone dipropionate
calcipotriol
IGA
4
8
“
”
“
”
“
”
4
8
PASI
P<0.05
P<0.05
312
IGA
Scalp solution
calcipotriol & betamethasone dipropionate
8
Scalp Solution calcipotriol &
betamethasone dipropionate
Xamiol Gel
P<0.001
873
IGA
calcipotriol
52
2.6%
,
calcipotriol
3.0%
;
P=0.73
calcipotriol
betamethasone dipropiona
                                
                                阅读完整的文件