安拿格力膠囊0.5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)
03-12-2021
公众评估报告 公众评估报告 (PAR)
03-12-2021

有效成分:

ANAGRELIDE HYDROCHLORIDE MONOHYDATE

可用日期:

台灣山德士藥業股份有限公司 臺北市中山區民生東路3段2號8樓 (90003886)

ATC代码:

L01XX35

药物剂型:

膠囊劑

组成:

ANAGRELIDE HYDROCHLORIDE MONOHYDATE (9200096410) (eq. to Anagrelide.....0.5mg)MG

每包单位数:

HDPE瓶裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

Noucor Health, S.A. AVDA. CAMI REIAL, 51-57, 08184 PALAU-SOLITA I PLEGAMANS, BARCELONA, SPAIN ES

治疗领域:

anagrelide

疗效迹象:

原發性血小板過多症。

產品總結:

有效日期: 2026/08/26; 英文品名: Anagrelide Sandoz Capsules 0.5mg

授权日期:

2021-08-26

资料单张

                                :
Anagrelide hydrochloride monohydrate (
anagrelide 0.5 mg) :
Lactose monohydrate, Microcrystalline cellulose,
Povidone, Crospovidone, Lactose, Magnesium stearate.
Titanium dioxide, Gelatin.
()
1.
anagrelide
1 1
0.5
2 2 0.5 1
anagrelide 0.5
2.
600,000/
L 150,000/
L
400,000/
L
0.5 / 10
2.5
(
)
1.5-3
/
3.
(Child Pugh score 7-9) 0.5
(
)
anagrelide
0.5 /
anagrelide
4.
anagrelide
7 ~ 14
( ≤ 600,000/L)
4 ~ 12
4
Anagrelide hydrochloride monohydrate
6,7-dichloro-1,5- dihydroimidazo [2,1-b]quinazolin-
2(3H)-one monohydrochloride monohydrate
C
10
H
7
Cl
2
N
3
OHClH
2
O 310.55
Anagrelide hydrochloride
dimethyl sulfoxide dimethylformamide
Anagrelide 0.5
anagrelide base ( anagrelide hydrochloride )
()
1.
anagrelide
anagrelide
GATA-1
FOG-1
(megakaryocytopoiesis)
2.
anagrelide
anagrelide
3-hydroxy anagrelide
anagrelide 3-hydroxy
anagrelide (
AUC
) anagrelide
Anagrelide
3-hydroxy anagrelide
3 (cyclic AMP phosphodiesterase 3)
3-hydroxy anagrelide anagrelide
40
(IC
50s
0.9 36 nM) PDE3 PDE3
anagrelide
PDE3
(CV)
anagrelide (0.5 2.5 )
60
QTc
(0.5 – 4 )
2 0.5 7.8
(+7.8 bpm) 2.5 +29.1 bpm
QTc
0.5 2.5 anagrelide
QTcI ()
(95%
) 7.0 (9.8) 13.0 (15.7)
3.
0.5 2.5
anagrelide 70%
anagrelide
anagrelide 1 anagrelide
(C
max
) 14 %
(AUC) 20% 3-hydroxy
anagrelide C
max
29 % AUC
Anagrelide
CYP1A2
3-hydroxy
anagrelide CYP1A2 RL603
1%
anagrelide
3-hydroxy-anagrelide
RL603
3% 16-20%
Anagrelide
3-hydroxy-anagrelide
1.5
2.5 anagrelide
3-hydroxy-anagrelide
Aspirin
anagrelide 1 aspirin 900
anagrelide 1 aspirin 75
aspirin
anagrelide 1 aspirin 900
(PT)
(aPTT)
Digoxin
warfarin
anagrelide
digoxin
warfarin digoxin
warfarin anagrelide
(
19-57
)
( 7-16
) anagrelide
C
max
AUC
17% 56%
(
22-50
)
( 65-75
)
anagrelide C
max
AUC 36%
61% 3-hydroxy anagrelide
C
max
AUC
42% 37%
1 anagrelide
(
<30 mL/min)
anagrelide
1 anagrelide
(Child Pugh score 7-9)
anagrelide C
max
(AUC)
8
3-hydroxy anagrelide C
max
24% 3-hydroxy
anagrelide AUC 77%
()
1.
30
mg/kg/day ( 1 AUC
174 )
3 mg/kg/
day 10 mg/kg/day
(
1 AUC
10
18
) (phaeochromotomas)
(Ames) (L5178Y, TK+/- )
anagrelide hydroc
                                
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