歐善利"山德士"5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)

资料单张 资料单张 (PIL)
04-06-2021
公众评估报告 公众评估报告 (PAR)
15-06-2020

有效成分:

OXALIPLATIN

可用日期:

台灣諾華股份有限公司 台北市中山區民生東路三段2號8樓 (01516589)

ATC代码:

L01XA03

药物剂型:

注射劑

组成:

OXALIPLATIN (1012001600) MG

每包单位数:

盒裝;;Type I glass vial with chlorobutyl stoppers and flip-off caps

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, A-4866 UNTERACH AM ATTERSEE, AUSTRIA AT

治疗领域:

oxaliplatin

疗效迹象:

和5-fluorouracil (5-FU)及folinic acid (FA)併用,作為-第三期結腸癌(Duke' sC)原發腫瘤完全切除手術後的輔助療法。-治療轉移性結腸直腸癌。和Capecitabine併用可用於局部晚期及復發/轉移性胃癌之治療。

產品總結:

註銷日期: 2021/07/05; 註銷理由: 自請註銷; 有效日期: 2023/06/04; 英文品名: Oxaliplatin Sandoz 5mg/ml concentrate for solution for infusion

授权状态:

已註銷

授权日期:

2013-06-04

资料单张

                                YES
NO
Druckreif / good for printing:
Artikelnr.: / Item no.:
xxxxxxx-xx
Stanznummer / dieCut-No.: ..........................................
6018-01
Format / Size ..............................................
148x889/297 mm
Code
......................................................................................
n.a.
Schriftgröße Text: / font size text:
......................................
n.a.
Schriftgröße Variable Daten: / font size variable data: .......
n.a.
Probedrucknr.: / Proof no.:
1
Farben / colours:
Black
Information:n.a.
Is the supplier allowed to edit
the file for printing adjustments?
Datum / date:
Nochmalige Vorlage /
new proof
Grafik erstellt von / graphic made by:
OXALIPLATIN
/
95%
(
“
”
)
850 MG/M
2 (
10)1020/M
2 (12)10%20%
687%3
3%(2.3%)(0.5%)
(
“
”)
1% 2%
/
(
)()
(
“
”)
LHERMITTE’S
OXALIPLATIN
-
(
85.5%)
12.7%
OXALIPLATIN
1 mlOxaliplatin 5 mg
- Oxaliplatin 5010 ml50 mg oxaliplatin
- Oxaliplatin 10020 ml100 mg oxaliplatin
- Oxaliplatin 15030 ml150 mg oxaliplatin
- Oxaliplatin 20040 ml200 mg oxaliplatin
Water for injection, nitrogen
5-fluorouracil (5-FU)folinic acid (FA)
- (Duke’s C)
-
OxaliplatinCapecitabine
/
Oxaliplatin
85 mg/m
2
2
12
(6
)
Oxaliplatin85 mg/m
2
2
Oxaliplatin
/
3
130 mg/m
2
(
65 mg/m
2
)
(“”)
Oxaliplatin
fluoropyrimidines
fluoropyrimidine (5-fluorouracil)oxaliplatin
Oxaliplatin
250~500 ml
5%
(50 mg/ml)
0.2 mg/ml
0.70 mg/ml
2~6oxaliplatin 85 mg/m
2
0.70 mg/mloxaliplatin
5-flurouracile
5-FUbolus dose
-
Oxaliplatin(“”)
(
“
”
)
-
phase I study
Oxaliplatin
oxaliplatin
-
65
oxaliplatin
5-FU
-
Oxaliplatin
Oxaliplatinoxaliplatin
250~500 ml5%
0.2 mg/ml
oxaliplatin
2~6
Oxaliplatin
5-FU
Oxaliplatin5%(“” )
OXALIPLATIN
- OXALIPLATIN
-
- (MYELOSUPPRESSION)
( < 2 X 10
9
/L < 100 X 10
9
/L)
-
- (CREATININE CLEARANCE < 30 ML/MIN)
OXALIPLATINOXALIPLATIN
PLATINUM
OXALIPLATIN
OXALIPLATIN
OXALIPLATIN
OXALIPLATIN
OXALIPLATIN
2
(
”
”
)
6
(RPLS
PRES
)
(PARESTHESIA, DYSAESTHESIA)OXALIPLATIN
-
7
OXALIPLATIN
85
65 MG/M
2 (
)75 MG/M
2 ()
- OXALIPLATIN85 65 MG/M
                                
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