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DOCETAXEL EBEWE

Package(a):
VIAL: 1 x 20 mg/2 ml.
Dosage(a):
For adults only.
I.V. use only.
Dosage has to be adjusted according to the indication, general condition, concurrent chemotherapy and the blood counts.
Prescribing Restrictions:  None

Package(b):
VIAL: 1 x 80 mg/8 ml.
Dosage(b):
For adults only.
I.V. use only.
Dosage has to be adjusted according to the indication, general condition, concurrent chemotherapy and the blood counts.
Prescribing Restrictions:  None

Package(c):
VIAL: 1 x 160 mg/16 ml.
Dosage(c):
For adults only.
I.V. use only.
Dosage has to be adjusted according to the indication, general condition, concurrent chemotherapy and the blood counts.
Prescribing Restrictions:  None


Indications:
Breast cancer: In combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable node-positive breast cancer. In combination with doxorubicin for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Monotherapy for the treatment of patients with metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. In combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previously have not received chemotherapy for metastatic disease. In combination with capecitabine for the treatment of patients with metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (AC-TH) for the adjuvant treatment of patients with HER2 overexpressing, node-positive or high risk node-negative, breast cancer. In combination with trastuzumab, and carboplatin (TCH) for the adjuvant treatment of patients with HER2 over-expressing, node-positive or high risk node-negative, breast cancer.
Non-small cell lung cancer: Treatment of patients with advanced non-small cell lung carcinoma. 
Ovarian cancer:Treatment of metastatic carcinoma of the ovary after failure of first line or subsequent chemotherapy. 
Prostate cancer:In combination with prednisone or prednisolone for the treatment of patients with hormone refractory metastatic prostate cancer. 
Esophageal cancer: Treatment of esophageal cancer. 
Gastric cancer:Treatment of advanced gastric cancer.
Head and neck (SCCHN): Monotherapy in the treatment of patients with recurrent and/or metastasis squamos cell carcinoma of the head and neck after failure of a previous chemotherapy regimen. In combination with cisplatin and 5 fluorouracil for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Contra-Indications:
Hypersensitivity to docetaxel or to any of the excipients. Should not be used in patients with baseline neutrophil count of < 1,500 cells/mm³. Should not be used in pregnant or breast-feeding women. Should not be used in patients with severe liver impairment since there is no data available.
Special Precautions:
See prescribing information for full list of side effects.
Side Effects:
Neutropenia is the most frequent adverse reactions of docetaxel. See prescribing information for full list of side effects.
Drug Interactions:
See prescribing information for full list of side effects.