Indications : התוויות

4.1 Therapeutic indications

Breast Cancer
• Docetaxel Seacross 20 mg/ml in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
• Docetaxel Seacross 20 mg/ml 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.
• Docetaxel Seacross 20 mg/ml monotherapy is indicated 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.
• Docetaxel Seacross 20 mg/ml in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors over-express HER2 and who previously have not received chemotherapy for metastatic disease.
• Docetaxel Seacross 20 mg/ml in combination with capecitabine is indicated 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 Seacross 20 mg/ml in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with HER2 over- expressing, node-positive or high risk node-negative, breast cancer.
• Docetaxel Seacross 20 mg/ml in combination with trastuzumab, and carboplatin (TCH) is indicated for the adjuvant treatment of patients with HER2 over-expressing, node-positive or high risk node- negative, breast cancer.
Non-small cell lung cancer: Docetaxel Seacross 20 mg/ml is indicated for the treatment of patients with advanced non-small cell lung carcinoma.

Ovarian cancer: Docetaxel Seacross 20 mg/ml is indicated for treatment of metastatic carcinoma of the ovary after failure of first line or subsequent chemotherapy.

Prostate cancer: Docetaxel Seacross 20 mg/ml in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Esophageal cancer: Docetaxel Seacross 20 mg/ml for the treatment of esophageal cancer.

Gastric cancer: Docetaxel Seacross 20 mg/ml for the treatment of advanced gastric cancer.
Head and neck (SCCHN):
• Docetaxel Seacross 20 mg/ml as monotherapy in the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck after failure of a previous chemotherapy regimen.
• Docetaxel Seacross 20 mg/ml in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.