沙立膠囊50毫克

国: 台湾

言語: 中国語

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

有効成分:

THALIDOMIDE

から入手可能:

美時化學製藥股份有限公司 台北市信義區松仁路277號17樓 (11456110)

ATCコード:

L04AX02

医薬品形態:

膠囊劑

構図:

THALIDOMIDE (9200028000) MG

パッケージ内のユニット:

鋁箔盒裝;;塑膠瓶裝

クラス:

製　劑

処方タイプ:

須由醫師處方使用

製:

美時化學製藥股份有限公司南投廠 南投縣南投市新興里成功一路３０號 TW

治療領域:

thalidomide

適応症:

治療新診斷多發性骨髓瘤。使用時須和prednisolone及oral melphalan併用，或和骨髓移植併用，或和palmidronate併用於骨髓移植後之治療。

製品概要:

有效日期: 2027/06/28; 英文品名: Thali Capsules 50mg

承認日:

2012-06-28

情報リーフレット

膠囊
50
毫克
Capsules
50mg
GMP
G-11630
0 5 7 2 6 9
Note:*=asymmetric
Carbon
[
:Thalidomide
(%CV)]
AUC
(µg*hr/mL)
Cmax
(µg/mL)
Tmax
(hrs)
Half-life(hrs)
(14
)
Hansen
(6
)
50mg
200mg
400mg
400mg
4.9(16%)
18.9(17%)
36.4(26%)
46.4(44.1%)
0.62(52%)
1.76(30%)
2.82(28%)
3.44(52.6%)
2.9(66%)
3.5(57%)
4.3(37%)
5.7(27%)
5.52(37%)
5.53(25%)
7.29(36%)
6.86(17%)
[
]
Thal+Dex(N=103)
1
2
Dex alone(N=104)
65
68
53(51%)
61(59%)
50(49%)
42(40%)
90(87%)
90(87%)
11(11%)
11(11%)
1(1%)
2(2%)
37-83
38-83
1.Dex alone
1
2 .
1
[
]
Thal+Dex(N=103)
(Durie-Salmon), N(%)
1
Dex alone(N=104)
I
14(13.6%)
17(16.3%)
II
47(45.6%)
44(42.3%)
II
41(39.8
)
43(41.3%)
,N(%)
2
IgA
21(20.4%)
22(21.2%)
IgG
63(61.2%)
60(57.7%)
IgM
0(0%)
1(1%)
Biclonal
0(0%)
1(1%)
(Lytic lesion)
3
(Serum light chain)
4
28(27.1%)
14(13.5%)
1-3
24(23.3%)
19(18.3%)
>3
34(33.0%)
41(39.4%)
Kappa
59(57.3%)
53(51.0%)
Lamba
28(27.287%)
40(38.5%)
1.Thal+Dex
1
2.Thal+Dex
19 Dex alone
29
3.Thal+Dex
17 Dex alone
30
4.Thal+Dex
16 Dex alone
11
Thalidomide
:
24
(
50mlU/mL)
(-)
thalidomide
thalidomide
Thalidomide
(
:
02-23960100)
Thalidomide
:
(Amelia)
(phocomelia)
(
)
(
)
40%
thalidomide
Thali
Thali
thalidomide
thalidomide
thalidomide
thalidomide
24
(
24
)
1.
2.
3.
Thalidomide
thalidomide
thalidomide
Thali
Thali
thalidomide
Thali
Thali
Thali
thalidomide 50mg
Thalidomide
:-(N-phthalimido) glutarimide
(immunomodulatory agent)
C
13
H
10
N
2
O
4
258.2CSA
50-35-1
25
(dimethyl sulfoxide)
酰
(glutarimide)
S-(-)
R-(+)
Thalidomide
S-(-)
R-(+)
(optical rotation)
Thalidomide
50
Thalidomide Thalidomide
(tumor
necrosis factor-,TNF-
)
(down-modulation)
thalidomide
(erythema nodosum leprosum, ENL)
TNF-
HIV
TNF-
Thalidomide
interleukin-10
interleukin-12
Thalidomide
interleukin-2
interferon-
(
T
)
thalidomide
Thalidomide
thalidomide
PEG
90%
thalidomide thalidomide
(Tmax)
2.9~5.7
AUC
(area under the curve)
(Cmax)
Tmax
Thalidomide (
)
Thalidomide Tmax
6 AUC
Cmax
(<10%)
(+)-(R)-
(-)-(S)-thalidomide
55%
66%
HIV
100mg
thalidomide
thalidomide
Thalidomide
thalidomide
10
thalidomide 200mg
18
thalidomide
thal