PACLITAXEL INTAS paclitaxel 100 mg/16.7 mL concentrated injection vial

Active ingredient:

paclitaxel, Quantity: 100 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Paclitaxel

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: ethanol absolute; PEG-35 castor oil

Administration route:

Intravenous Infusion

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

- Primary treatment of ovarian cancer in combination with a platinum agent. - Treatment of metastatic carcinoma of the ovary after failure of standard therapy. - Treatment of metastatic carcinoma of the breast after failure of standard therapy. - Adjuvant treatment of node-positive breast cancer administered sequentially to doxorubicin and cyclophosphamide. - Treatment of metastatic cancer of the breast, in combination with trastuzumab (Herceptin), in patients who have tumours that over-express HER-2 and who have not received previous chemotherapy for their metastatic disease. - in combination with gemcitabine (Gemzar), is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. - for the treatment of non-small cell lung cancer (NSCLC).

Product summary:

Visual Identification: A clear, colorless to slightly yellow solution in a clear glass vial with flip off seal.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-02-02