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

Active ingredient:

docetaxel, Quantity: 80 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Docetaxel

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: polysorbate 80; ethanol absolute; citric acid

Administration route:

Intravenous

Units in package:

Pack of 1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2015-02-17