格立得植入劑

Land: Taiwan

Sprog: kinesisk

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

Aktiv bestanddel:

CARMUSTINE

Tilgængelig fra:

百博生技有限公司 台北市大安區信義路4段6號15樓之4 (27528131)

ATC-kode:

L01AD01

Lægemiddelform:

植入劑

Sammensætning:

CARMUSTINE (1004000300) MG

Enheder i pakken:

盒裝

Klasse:

製　劑

Recept type:

限由醫師使用

Fremstillet af:

EISAI, INC. 6611 TRIBUTARY STREET, BALTIMORE, MARYLAND 21224, USA US

Terapeutisk område:

carmustine

Terapeutiske indikationer:

作為新診斷之惡性神經膠質瘤(high-grade malignant glioma) 之手術與放射治療輔助; 作為復發性多形性神經膠母細胞瘤病人的手術輔助。

Produkt oversigt:

有效日期: 2028/01/14; 英文品名: Gliadel Wafer

Autorisation dato:

2008-01-14

Indlægsseddel

ਿҳுේΣᏘ
GLIADEL
®
Wafer
(polifeprosan 20 with carmustine implant)
ፏဍ᛾ᒯԅ಑
024777
ဴ
ҏ᛾३ҥᚂৱٺҢ
GLIADEL
®
Wafer (polifeprosan 20 with carmustine implant)
࣏ޢ৷घ
1.45
ϴϷȃࠔघ
1
ϴᵕޟԸҩՍష༁Փฒ຃
ේΣᏘᇧᏘȄؐΙа֤џҡސϷ၌ޟᆹሖ℈ӓᆹӫސ
192.3
యպЅᚖ෩Κஅٳ฼׍શ
(carmustine = 1,3-bis
(2-chloroethyl)-1-nitrosourea or BCNU) 7.7
యպȄ
carmustine
࢐ٳ฼׍શ᜸ޟתඌܒရዴᏘȄԪӓᆹӫސȂ
polifeprosan 20
Ȃҥ
poly [bis (p-carboxyphenoxy) propane: sebacic acid]
оೃՆШٽ
20:80
ಢԙȂ॒೰௡ڙ
carmustine
ޟ׋ഋ༈ଚȂ
carmustine
൷֯ϺϷշܻԪӓᆹӫސஅ፴ϛȄ
Polifeprosan 20
ޟ๖ᄺԒԃήȈ
ńŢųŮŶŴŵŪůŦޟ๖ᄺԒԃήȈ
ᖝח᛾౩Ᏸ
GLIADEL
®
Wafer
ೝ೩ॎ࣏૖ஊޢ௥஠
carmustine
ភܹՍသᕜᄢଶЙ೚ࡣܚഅԙޟ๨ࡉϱȄ࿋᛾ࠢೝညܻЫྙܒ
ޟသ๨ϱȂӓᆹӫސϛޟሖ℈ᗤೝЫ၌Ȃភܹю
carmustine
ȃ
carboxyphenoxypropane
оЅ
sebacic acid
Ȃ
carmustine
ᘗඹՍ໊᜞ޟသಢᙑȂᙤҥᄇў੊ਯᗞਯሖ
(DNA)
Ѕਯᗞਯሖ
(RNA)
ޟ≍அϽհҢՄีථתඌܒရዴ
հҢȄ
Carmustine
џоՌณϷ၌ܖфᗂϷ၌Ȃڏ≍அϽࡣޟ౰ސȂџ૖࢐
chloroethyl carbonium ion
Ȃ૖ٺ
DNA
Һξ
೿๖Ȅ
GLIADEL
®
Wafer
ޟתඌܒရዴ૖ΨؚܻۡೝភܹՍသရዴ๨ޟ
carmustine
ᐨ࡙࢐֏ٗоีථڏಠफࢳܒȄ
຺ႆ
70%
ޟӓᆹӫސܻέ໊ϱϷ၌ȂϷ၌ࡣ൐ᡝޟфᗂЅ௶ݵഊ৷ӨϚࣺӣȇ
carboxyphenoxypropane
ငҥ๫᠚
௶ଶȂ
sebacic acid
ȂΙᆍϱҡܒޟ્޺ሖȂࠌငҥم᠚фᗂԙΠ੊Ͻᆇ௶юᡝѴȄ
ӓᆹӫސӵΡᡝϱޟ֜ԝȃϷշȃфᗂЅ௶ଶ้੫ܒۦϚ఼ཿȄ
GLIADEL
®
Wafer
ភܹՍΡᡝသಢᙑޟ
carmustine
ᐨ࡙ζۦฒก໔፴ȄේΣ
GLIADEL
®
Wafer
ේΣᏘࡣޟՖዎۦҐก໔Ȅоڊυ࣏ၐᡛᄇຫȂේΣ֤
3.85%
carmustine
ޟේΣᏘࡣȂՖశЅသ૗శҐกு
carmustine
Ȅ
ᓗ૕ݧৢ
carmustine 30-170 mg/m
2
Ȃҁ֯ޟശತј૾෈
22
ϷមȂᄐ఼౥
56 mL/min/kg
ȂᛧۡޑᄘϷշᡝᑖ
3.25 L/kg
Ȅᓗ૕ݧৢ
14
C-carmustine 200 mg/m
2
Ȃ
96
ωਢࡣȂघԤ
60%
ငҥ