善思達持續性藥效肌肉注射懸浮劑１００毫克╱毫升

Country: Թայվան

language: չինարեն

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

active_ingredient:

PALIPERIDONE PALMITATE

MAH:

嬌生股份有限公司 台北市中山區民生東路三段2號10樓及11樓 (30814854)

ATC_code:

N05AX13

pharmaceutical_form:

持續性藥效肌肉注射用懸浮液

composition:

主成分 () ; PALIPERIDONE PALMITATE (2816100710) EQ. TO 100MG PALIPERIDONEMG

units_in_package:

注射針筒裝附2支安全針頭及backstopper

class:

製　劑

prescription_type:

限由醫師使用

manufactured_by:

JANSSEN PHARMACEUTICA N.V. TURNHOUTSEWEG 30, B-2340, BEERSE BELGIUM BE

therapeutic_area:

paliperidone

therapeutic_indication:

治療思覺失調症。分裂情感障礙症之急性治療的單一治療藥物或作為情緒穩定劑及（或）抗憂鬱劑的輔助用藥。

leaflet_short:

有效日期: 2026/04/14; 英文品名: INVEGA SUSTENNA PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR INJECTION 100MG/ML

authorization_date:

2011-04-14

PIL

100/
INVEGA SUSTENNA
®
PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR INJECTION 100MG/ML
025394
INVEGA SUSTENNA
®
(paliperidone palmitate)
(5.1)
1
•
• ()
2
2.1
INVEGA SUSTENNA
®
INVEGA SUSTENNA
®
INVEGA SUSTENNA
®
INVEGA SUSTENNA
®
• 90123
• 90()1½22
•
INVEGA SUSTENNA
®
1½22
2.2
paliperidone
risperidone
INVEGA SUSTENNA
®
paliperidone
risperidone
INVEGA SUSTENNA
®
1INVEGA SUSTENNA
®
234(paliperidone 150)
156(paliperidone 100)
1. INVEGA SUSTENNA
®
()
A
()
1
8
234
156
39-234
b
234
234
156
78-234
c
234
a
5
b
117
(3978156234)
c
/39
INVEGA SUSTENNA
®
(12.3)
2.3
INVEGA SUSTENNA
®
(one-week time point)
4
7
INVEGA SUSTENNA
®
(
±
4
)
2
2.
4
(156)
1. 5
(
)
(117
)
2.
47
156
1.
2.
3.
7
(2.21)
1. 1234
2. 1156
3.
3
3.
46
6
6
(
234
156)
1.
2. ()
3.
6
(2.21)
1. 1234
2. 1156
3.
2.4 PaliperidoneRisperidone
paliperidone
risperidoneINVEGA SUSTENNA
®
risperidonepaliperidone
INVEGA SUSTENNA
®
2.5
INVEGA SUSTENNA
®
(12.3)
(
≥50/
<80
/
Cockcroft-Gault)
INVEGA SUSTENNA
®
1
156
117
78
(8.6)
(12.3)
INVEGA SUSTENNA
®
(
<50/
)
(8.6)
(12.3)
CYP3A4/P-(P-gp)
INVEGA SUSTENNA
®
1CYP3A4
/
P-gp(
carbamazepine
rifampin
St John's Wort)paliperidone
(7.1)
(12.3)
2.6
INVEGA SUSTENNA
®
paliperidone
risperidone
INVEGA SUSTENNA
®
paliperidone
risperidone
INVEGA SUSTENNA
®
INVEGA SUSTENNA
®
234156
(2.2)
INVEGA
®
4INVEGA SUSTENNA
®
paliperidone
100/
INVEGA SUSTENNA
®
PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR
INJECTION 100MG/ML 025394
100/
INVEGA SUSTENNA
®
PROLONGED RELEASE SUSPENSION FOR INTRAMUSCULAR
INJECTION 100MG/ML 025394
4. PALIPERIDONEINVEGA
®
INVEGA SUSTENNA
®
INVEGA
®
INVEGA SUSTENNA
®
4
()
12
234
9
156
6
117
3
39-78
paliperidone
risperidone
INVEGA SUSTENNA
®
paliperidone
risperidone
INVEGA SUSTENNA
®
INVEGA SUSTENNA
®
2.2
1
/
(3978117
156234
)
39
(2.2)
INVEGA SUSTENNA
®
(EPS)
2.7
2(1½22123)
22
1½
A
D
E
B
C
23
1
bub
INVEGA SUSTENNA
®
a. 10
c.
e.
h. (h1
h2)(h3)
g.
b.
• 901
23
(
)
• 90()1½
22
()
1½
22
(
)
d.
(luer connection)
f.
h1
h2
h3
3.
INVEGA SUSTENNA
®
3978117
156
234paliperidone