Solution for  infusion 30mg/5ml, 100mg/16.7ml, 300mg/50ml

Ovarian carcinoma

For first-line treatment of carcinoma of the ovary, paclitaxel is indicated in combination with cisplatin in patients with advanced disease or a residual tumour (> 1 cm) following laparotomy.

For second-line treatment of carcinoma of the ovary, paclitaxel is indicated for treatment of metastatic carcinoma of the ovary after failure of standard therapy with platinum-containing preparations.

Breast carcinoma

As adjuvant treatment paclitaxel is indicated in treatment of node-positive breast carcinoma after anthracycline and cyclophosphamide (AC) treatment. Adjuvant treatment with paclitaxel should be considered as an alternative to prolonged AC treatment.

Paclitaxel is indicated as initial treatment of locally advanced or metastatic breast carcinoma either in combination with anthracycline in patients in whom anthracycline treatment is suitable or in combination with trastuzumab, in patients who over-express HER-2 at a level of 3+ as determined by immunohistochemistry methods and to patients in whom anthracycline treatment is not suitable (see sections 4.4 and 5.1).

Paclitaxel is indicated as a single agent for treatment of metastatic breast carcinoma in patients in whom standard anthracycline therapy has failed or in whom anthracycline therapy is not suitable.

Advanced non-small-cell lung carcinoma

Paclitaxel, in combination with cisplatin, is indicated for treatment of non-small-cell lung carcinoma (NSCLC) in patients who are not candidates for potentially curative surgery and/or radiotherapy.

AIDS-related Kaposi’s sarcoma

Paclitaxel is indicated for the treatment of patients with advanced AIDS-related Kaposi┬┤s sarcoma (KS) who have failed prior liposomal anthracycline therapy.

Limited efficacy data supports this indication, a summary of the relevant studies is shown in section 5.1.