應治凝注射液 0.75 公絲/公撮

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)
18-12-2020
公众评估报告 公众评估报告 (PAR)
15-04-2020

有效成分:

EPTIFIBATIDE

可用日期:

美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)

ATC代码:

B01AC16

药物剂型:

注射劑

组成:

EPTIFIBATIDE (9200050400) MG

每包单位数:

小瓶;;盒裝

类:

製 劑

处方类型:

限由醫師使用

厂商:

PATHEON ITALIA S.P.A. VIA MOROLENSE 87, 03013 FERENTINO, ITALY IT

治疗领域:

eptifibatide

疗效迹象:

預防不穩定性心絞痛及非Q 波心肌梗塞病人的惡化。經皮腔間冠狀動脈血管擴張術的輔助治療,以預防突發性動脈血管閉塞及相關的急性缺血併發症。

產品總結:

註銷日期: 2017/05/11; 註銷理由: 自請註銷; 有效日期: 2017/06/18; 英文品名: INTEGRILIN INJECTION 0.75MG/ML

授权状态:

已註銷

授权日期:

2002-06-18

资料单张

                                2 /0.75 /
INTEGRILIN IV BOLUS 2 MG/ML & IV INFUSION 0.75 MG/ML
023459
023468
Integrilin
eptifibatide
cysteine amide
mercaptopropionyl
Integrilin
10 ml2 mg/ml eptifibatide100 ml
0.75 mg/ml eptifibatide
EptifibatideRGD (arginine - glycine -aspartate)
Eptifibatide
fibrinogen
von-Willebrand
GP
IIb/IIIa
eptifibatide
ADP (adenosine diphosphate)
Eptifibatide
180 mcg/ kg
2.0 mcg/kg-minADP80 %80 %
2.0 mcg/ kg-min
50 %
PPACK (D-phenylalanyl-L-prolyl-L-arginine
chloromethyl ketone)Qeptifibatide
ADP50%(IC
50
)557 ng/ml80%
(IC
80
)1100 ng/ml
Integrilin
5
2-6
eptifibatide(PT)(aPTT)
eptifibatide
eptifibatide
Integrilin
Eptifibatide90-250 mcg/kg0.5-3.0 mcg/kg-min
2.0 mcg/kg-min
eptifibatide
1.5-2.2 mcg/ml
180 mcg/kg
Eptifibatide
25%2.555-80 ml/kg/hr185-260 ml/kg
(
74
)
/
(CrCl)
(
Cockcroft-Gault
CrCl
50 ml/min*)
(
Cockcroft-Gault
CrCl
50 ml/min*)
Eptifibatide(CrCl50 ml/min)50%
()
PURSUIT
(UA)
ST
(NSTEMI)
PURSUIT
27
726
10948
UA
NSTEMI
24(10)
ST
ST
0.5 mm
30
ST
0.5 mm
T(1 mm)
CK-MB
Integrilin 180 mcg/kg
2.0 mcg/kg/min
(180/2.0)
Integrilin
180 mcg/kg1.3 mcg/kg/min(180/1.3)
(CABG)
72
PCI
Integrilin2496
180/1.3
PCI
CABG
PURSUIT13%Integrilin(percutaneous
Coronary
Intervention, PCI)50%(intracoronary stent)87%(Integrilin
PCI)
acetylsalicylic acid (75-325 mg)
(unfractionated heparin)5000 unit
1000 unit/hr
aPTT
50-70
1250
72
PCIheparin(ACT)200-350
30
(MI) (
)MICK-MBQ
Integrilin 180/2.0
(1)1000
15
Integrilin
(
72-96
)6
Integrilin3-4
ECG(ST)
(CK-MBtroponins)
ESPRIT
ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with
Integrilin TherapyIntegrilin
IIb/IIIa
)
PCI
922064PCI
PCIGP
IIb/IIIa
24
(
)
90
PCI
Integrilin
ESPRIT
Integrilin
180 mcg/kg
18-24
PERIGEE
PRIDEPERIGEEPRIDE/
PERIGEE
PURSUIT
PRIDE
PCI
PERIGEE
PRIDE
Integrilin
2.65 μg/mL
eptifibatide
PCI
10
175 μmol/l
2.0 mcg/kg/min
175
350 μmol/l
1.0
mcg/kg/min0.5 mcg/kg/min
12
Integrilin (
)
Integrilin
Integrilin
aspirin (99.7%)
97.1%
thienopyridine (95.4%
clopidogel
2.7%
ticlopidine)
PCI
53.1%
thienopyridine (52.7%
clopidogel
0.5%ticlopidine)(loading dose) (30 mg)
(aspirin99.
                                
                                阅读完整的文件