克癌平 凍晶注射劑150毫克

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:

TRASTUZUMAB

可用日期:

台灣羅氏醫療診斷設備股份有限公司 台北市中山區民權東路3段2號10樓 (23932173)

ATC代码:

L01XC03

药物剂型:

凍晶注射劑

组成:

TRASTUZUMAB (1013000500) MG

每包单位数:

玻璃小瓶裝;;盒裝

类:

菌　疫

处方类型:

限由醫師使用

厂商:

ROCHE DIAGNOSTICS GMBH NONNENWALD 2, D-82377 PENZBERG, GERMANY DE

治疗领域:

trastuzumab

疗效迹象:

Herclon應使用於下列HER2過度表現或HER2基因amplification之早期乳癌、轉移性乳癌患者說明：1.早期乳癌(EBC)：(1)經外科手術、化學療法(術前或術後)之輔助療法。(2)以doxorubicin與cyclophosphamide治療，再合併pactlitaxel或docetaxel之輔助療法。(3)與docetaxel及carboplatin併用之輔助療法。(4)術前與化學療法並用和術後之輔助療法使用於治療局部晚期(包括炎症)乳癌或腫瘤(直徑>2 厘米)2.轉移性乳癌(MBC)：(1)單獨使用於曾接受過一次(含)以上化學療法之轉移性乳癌；除非患者不適合使用anthracyclin或taxane，否則先前之化學治療應至少包括anthracyclin或taxane。使用於荷爾蒙療法失敗之荷爾蒙受體陽性之患者，除非患者不適用荷爾蒙療法。(2)與pactlitaxel或docetaxel併用於未曾接受過化學療法之轉移性乳癌。(3)與芳香環酶抑制劑併用於荷爾蒙受體陽性之轉移性乳癌。3.轉移性胃癌(MGC)：Herceptin合併capecitabine(或5-f1uorouracil)及cisplatin適用於未曾接受過化學治療之HER2過度表現轉移性胃腺癌(或胃食道接合處腺癌)的治療。

產品總結:

註銷日期: 2020/04/13; 註銷理由: 未展延而逾期者; 有效日期: 2018/10/21; 英文品名: Herclon vial 150mg

授权状态:

已註銷

授权日期:

2013-10-21

资料单张

1
HERCEPTIN
®
Vial 150 mg
Vial 440 mg
Trastuzumab
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, AND PULMONARY TOXICITY
CARDIOMYOPATHY
Herceptin can result in sub-clinical and clinical cardiac failure
manifesting as CHF and decreased
LVEF. The incidence and severity of left ventricular cardiac
dysfunction was highest in patients
who received Herceptin concurrently with anthracycline-containing
chemotherapy regimens.
Evaluate left ventricular function in all patients prior to and during
treatment with Herceptin.
Discontinue Herceptin treatment in patients receiving adjuvant therapy
and strongly consider
discontinuation of Herceptin treatment in patients with metastatic
breast cancer for clinically
significant decrease in left ventricular function.
INFUSION REACTIONS; PULMONARY TOXICITY
Herceptin administration can result in serious infusion reactions and
pulmonary toxicity. Fatal
infusion reactions have been reported. In most cases, symptoms
occurred during or within 24
hours of administration of Herceptin. Herceptin infusion should be
interrupted for patients
experiencing dyspnea or clinically significant hypotension. Patients
should be monitored until
signs
and
symptoms
completely
resolve.
Discontinue
Herceptin
for
infusion
reactions
manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or
acute respiratory distress
syndrome.
1 INDICATIONS AND USAGE
_Metastatic Breast Cancer (MBC) _
Herceptin is indicated for the treatment of patients with metastatic
breast cancer who have tumors
that overexpress HER2:
a)
as
monotherapy
for
the
treatment
of
those
patients
who
have
received
one
or
more
chemotherapy regimens for their metastatic disease
b)
in combination with paclitaxel or docetaxel for the treatment of those
patients who have not
received chemotherapy for their metastatic disease
c)
in combination with an aromatase inhibitor for the treatment of
patients with hormone-
receptor positive metastatic breast cancer
_Early Breast Cancer (EBC) _
Herceptin is indicated for the treatment of patients with HER2
p