怡瑞納"山德士"20毫克/毫升注射液

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)

有效成分:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE

可用日期:

台灣諾華股份有限公司 台北市中正區仁愛路二段99號11、12、13樓 (01516589)

ATC代码:

L01CE02

药物剂型:

注射劑

组成:

IRINOTECAN HYDROCHLORIDE TRIHYDRATE (9200037710) (corr. To 18.4mg irinotecan hydrochloridMG

每包单位数:

盒裝;;玻璃小瓶裝

类:

製　劑

处方类型:

限由醫師使用

厂商:

EBEWE PHARMA GES.M.B.H.NFG. KG MONDSEESTRABE 11,AT-4866 UNTERACH AM ATTERSEE, AUSTRIA AT

治疗领域:

irinotecan

疗效迹象:

晚期性大腸直腸癌之第一線治療藥物：與5-FU及folinic acid合併，使用於未曾接受過化學治療之患者。單獨使用於曾接受5-FU療程治療無效之患者。與cetuximab併用，治療曾接受含irinotecan之細胞毒性療法治療失敗且具有上皮生長因子接受體(EGFR)表現型KRAS野生型轉移性大腸直腸癌患者。與5-fluorouracol、folinic acid及bevacizumab合併治療，作為轉移性大腸癌或直腸癌患者的第一線治療藥物。與capecitabine合併治療，作為轉移性大腸直腸癌患者的第一線治療藥物。

產品總結:

註銷日期: 2018/12/27; 註銷理由: 自請註銷; 有效日期: 2022/07/20; 英文品名: Irinotecan Sandoz 20mg/ml concentrate for solution for infusion

授权状态:

已註銷

授权日期:

2012-07-20

资料单张

1.
“” 20/
Irinotecan Sandoz 20mg/mL concentrate for solution for infusion
2.
20 mg/ml
irinotecan hydrochloride, trihydrate (
17.33 mg/mlirinotecan)
Irinotecan
40 mg
100 mg
150 mg
300 mg
500 mg
irinotecan hydrochloride, trihydrate
3.
4.
4.1
●
5-FU
folinic acid
● 5-FU
●
cetuximab
irinotecan
(EGFR)
KRAS
(
5.1
)
●
5-fluorouracil
folinic acid
bevacizumab
●
capecitabine
4.2
Irinotecan
()
Irinotecan
350 mg/m
2
30
90
(
)
()
Irinotecan
5-fluorouracil (5FU)
folinic
acid (FA)()
● Irinotecan5FU/FA
Irinotecan
180 mg/m
2
30-90folinic acid5-fluorouracil
cetuximab
Irinotecan
irinotecan
Irinotecan
cetuximab
1
bevacizumab
bevacizumab
capecitabine
5.1
capecitabine
NCI-CTC (
)01
Irinotecan
Irinotecan
5FU
(
)
1
2
Irinotecan
/
5FU (
)
15-20%
●
(
4
(
3-4
2-4
)
(4))
● (3-4 )
irinotecan
cetuximab
bevacizumab
Irinotecan/5FU/FA
bevacizumab
c a p e c i t a b i n e
6 5
(
)
capecitabine
capecitabine
800 mg/m
2
capecitabine
Irinotecan
2
Irinotecan
(
(ULN)
3
)
50%
irinotecan
(
“
”
)
●
(ULN)
1 . 5
Irinotecan350 mg/m
2
●
1.5-3
Irinotecan
200 mg/m
2
●
3
Irinotecan
(
)
Irinotecan
Irinotecan
(
)
()
“”
Irinotecan Sandoz 20mg/mL concentrate
for solution for infusion
4.3 -()
●
/
(
)
●
irinotecan hydrochloride trihydrate
Irinotecan
● (
)
●
>3
(
)
●
● WHO>2
● (St. John’s Wort)(
)
cetuximab
bevacizumab
capecitabine
4.4 -()
Irinotecan
Irinotecan
● WHO=2
●
(
)
Irinotecan
(
)
Irinotecan
24
Irinotecan
®
5
/
2
Irinotecan
Irinotecan
loperamide (
4 mg22 mg)
12
loperamide
4812
(
<500
/mm
3
)
●
● ()
●
loperamide
48
loperamide
()
Irinotecan
(
>38°C
1,000/mm
3
)
()
Irinotecan
(
)
1.5
3
irinotecan
(
“
”
)
3
Irinotecan
Irinotecan
(
)
atropine sulphate (0.25 mg
)
Irinotecan
atropine sulphate
irinotecan
(colony stimulating factors)
irinotecan
Irinotecan
Irinotecan()
Irinotecan
(
)
(
)
irinotecan
()
(
)
(
irinotecan)
irinotecan
/
Irinotecan
CYP3A4
(
ketoconazole)
(
rifampicin
carbamazepine
phenobarbital
phenytoin
)
irinotecan
(
)
4.5 -()
irinotecan
Irinotecan
(suxamethonium)
C Y P 3 A
(
c a r b a m a z e p