PACLITAXEL AN paclitaxel 100mg/16.7mL concentrated injection vial

Active ingredient:

paclitaxel, Quantity: 6 mg/mL

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Paclitaxel

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: PEG-35 castor oil; ethanol absolute; citric acid

Administration route:

Intravenous

Units in package:

1 x 16.7mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PACLITAXEL AN is indicated for the treatment of : Primart treatment of ovarian cancer in combination with a platinum agent; Treatment of metastatic carcinoma of the ovary and 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 metatastic disease; Treatment of non-small cell lung cancer (NSCLC); 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.

Product summary:

Visual Identification: Clear colourless to yellow viscous solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-01-20