DOCETAXEL ASTRON 80 mg/4 mL docetaxel concentrated injection 80 mg/4 mL glass vial

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
27-11-2017

有效成分:

docetaxel, Quantity: 80 mg

可用日期:

Accord Healthcare Pty Ltd

INN(国际名称):

Docetaxel

药物剂型:

Injection, concentrated

组成:

Excipient Ingredients: polysorbate 80; ethanol absolute; citric acid

给药途径:

Intravenous

每包单位数:

Pack of 1 vial

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Breast cancer Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease Adjuvant treatment of breast cancer Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. Doxorubicin and cyclophosphamide followed by Docetaxel in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. Docetaxel in combination with carboplatin and trastuzumab (TCH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2 Docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of = 1 cm and < 7 cm. Non small cell lung cancer Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, including those who have failed platinum-based chemotherapy. Ovarian cancer Docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. Prostate cancer Docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. Head and neck cancer Docetaxel in combination with cisplatin and fluorouracil, is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

產品總結:

Visual Identification: Supplied in single-dose vials as a sterile, pyrogen-free, non-aqueous,pale yellow to brownish-yellow solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Licence status A

授权日期:

2015-02-17