"健亞"阿立批挫錠15毫克

Krajina: Taiwan

Jazyk: čínština

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

Aktívna zložka:

ARIPIPRAZOLE

Dostupné z:

健亞生物科技股份有限公司 新竹縣湖口鄉中興村工業一路１號 (84149006)

ATC kód:

N05AX12

Forma lieku:

錠劑

Zloženie:

ARIPIPRAZOLE (9200095400) MG

Počet v balení:

鋁箔盒裝;;塑膠瓶裝

Trieda:

製　劑

Typ predpisu:

須由醫師處方使用

Výrobca:

健亞生物科技股份有限公司 新竹縣湖口鄉新竹工業區工業一路１號 TW

Terapeutické oblasti:

aripiprazole

Terapeutické indikácie:

成人和青少年(13至17歲)的思覺失調症。

Prehľad produktov:

有效日期: 2027/09/18; 英文品名: Aripiprazole Tablets 15mg "Genovate"

Dátum Autorizácia:

2012-09-18

Príbalový leták

2.1
Aripiprazole1015
Aripiprazole10~3010~15
22
[(14.1)]
-
Aripiprazole 15
(14.1)
(1317)
1
2
AripiprazoleAripiprazole
[
(6)]
/
Aripiprazole
(
)
(ketoacidosis)
(Hyperglycemic Hyperosmolar Nonketotic Coma)
(
:)
(
)
5.6
Aripiprazole
(1)(2)
Aripiprazole
Aripiprazole
13
Aripiprazole
(+4.4mg/dL
()
25N=1057)(+2.5 mg/dL
()
22N=799)4
Aripiprazole
((
)25
()22(borderline)
5.10
/
(
Aripiprazole)
(WBC)
/
(ANC)
(WBC)
/ANC
(CBC)
(WBC)Aripiprazole
(
<1000/mm
3
)
AripiprazoleWBC
5.11
/
Aripiprazole
0.1% (3/2467) (6
18
)
0.1% (1/732)
Aripiprazole
65
5.12
Aripiprazole
()(Aripiprazole
)
Aripiprazole
(n=2467)(11%
6%)6
17
(n=611)(24%
6%)(
)
Aripiprazole0.3%
(8/2467)
(618)3% (20/732)
()Aripiprazole
5.13
Aripiprazole
(
)
[(6)]
5.14
Aripiprazole
[(6)]
5.15
(6)]
(
Aripiprazole)
Aripiprazole
[(5.1)
(1317)
6
Aripiprazole2
30
(1317)Aripiprazole
5%2%
Aripiprazole(5%[]
Aripiprazole )
(≥10%)
(≥10%)
Aripiprazole13543
Aripiprazole7619-
[patient-year]3390
Aripiprazole1801933Aripiprazole
Aripiprazole1686(6
18
)
Aripiprazole
1342-959
Aripiprazole180556Aripiprazole
6.1
5(44
1
6
)Aripiprazole
2~30
Aripiprazole(5%[]
Aripiprazole)(akathisia)(Aripiprazole
8%4%)
15(
6
)
(
)
Aripiprazole≥2)
2%(
)
Aripiprazole
(RANDOMIZED CONTROLLED TRIAL
RCT)
(RRTROSPECTIVE COHORT STUDY)(CONVENTIONAL)
(ATYPICAL)(DEMENTIA-RELATED PSYCHOSIS)
ARIPIPRAZOLE
[(5.1)]
13(
)
21~25Aripiprazole+0.3(N=1673)-0.1
(N=1100)24Aripiprazole-1.5(N=73)
-0.2(N=46)
2
(13~17
)(
)42~43
Aripiprazole
+1.6
(N=381)
+0.3
(N=187)
24
Aripiprazole
+5.8(N=62)+1.4
(N=13)
13Aripiprazole≥7%
(NMS)
/
[(5.4)
]
[
(5.5)]
[
(5.6)]
[
(5.7)]
[
(5.8)]
[
(5.9)]
[
(5.10)]
[
(5.11)]
[
(5.12)]
[
(5.13)]
[
(5.14)]
[
(5.15)]
[(5.2)]
[
(5.1)]
6
ARIPIPRAZOLE
CYP2D6
CYP2D6CYP3A4
(itraconazole, clarithromycin)
CYP2D6(quinidine, fluoxetine,
paroxetine)CYP3A4(itraconazole,
clarithromycin)
CYP2D6CYP3A4
CYP3A4(:carbamazepine, rifampin)
1CYP2D6(POOR METABOLIZERS)
CYP2D6CYP3A4
/CYP3A4ARIPIPRAZOLE
3
Aripiprazole
10
15
5.2
(
)
Aripiprazole
(
84
78-88
)
(
)
Aripiprazole
Aripiprazole
4
Aripiprazole/
5
5.1
ARIPIPRAZOLE
(n=938
82.4