剋癌易注射劑

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:

DOCETAXEL

可用日期:

賽諾菲股份有限公司 台北市信義區松仁路3號7樓 (97168356)

ATC代码:

L01CD02

药物剂型:

注射劑

组成:

DOCETAXEL (1013000200) MG

每包单位数:

小瓶;;盒裝;;小瓶附溶液

类:

製　劑

处方类型:

限由醫師使用

厂商:

AVENTIS PHARMA (DAGENHAM) DAGEHAM,ESSEX RM10 7XS,ENGLAND GB

治疗领域:

docetaxel

疗效迹象:

乳癌、非小細胞肺癌、前列腺癌、胃腺癌、頭頸癌。

產品總結:

註銷日期: 2018/08/08; 註銷理由: 自請註銷; 有效日期: 2018/01/19; 英文品名: TAXOTERE CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

授权状态:

已註銷

授权日期:

1998-01-19

资料单张

1.
NAME OF THE MEDICINAL PRODUCT
TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for
infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose vial of TAXOTERE 20 mg/0.5 ml concentrate contains
docetaxel which is a trihydrate corresponding to 20 mg of docetaxel
(anhydrous). The
viscous solution contains 40 mg/ml docetaxel (anhydrous).
Excipient:
Each single-dose vial of solvent contains 13% (w/w) ethanol 95% in
water for injection.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate and solvent for solution for infusion.
The concentrate is a clear viscous, yellow to brown-yellow solution.
The solvent is a colourless solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Breast cancer
TAXOTERE in combination with doxorubicin and cyclophosphamide is
indicated for the adjuvant treatment of patients with:
 ˙ operable node-positive breast cancer
 ˙ Operable node-negative breast cancer
For patients with operable node-negative breast cancer, adjuvant
treatment should be restricted to patients eligible to receive
chemotherapy according to
internationally established criteria for primary therapy of early
breast cancer (see section 5.1).
TAXOTERE in combination with doxorubicin is indicated for the
treatment of patients with locally advanced or metastatic breast
cancer who have not previously
received cytotoxic therapy for this condition.
TAXOTERE monotherapy is indicated for the treatment of patients with
locally advanced or metastatic breast cancer after failure of
cytotoxic therapy. Previous
chemotherapy should have included an anthracycline or an alkylating
agent.
TAXOTERE in combination with trastuzumab is indicated for the
treatment of patients with metastatic breast cancer whose tumours over
express HER2 and who
previously have not received chemotherapy for metastatic disease.
TAXOTERE in combination with capecitabine is indicated for the
treatment of patients with locally advanced or metastatic breast
cancer after failure of cytotoxic
chemotherapy