Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
paclitaxel
Accord Healthcare Pty Ltd
Paclitaxel
Registered
Version 4.0 Page 1 of 4 PACLITAXEL ACCORD _Paclitaxel Concentrated Injection 30 mg/5 mL, 100 mg/16.7 mL and 300 mg/50 mL _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Paclitaxel Accord. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT PACLITAXEL ACCORD IS USED FOR Paclitaxel Accord is used to treat cancer of the ovary, the breast, and non small cell cancer of the lung. Paclitaxel Accord may be used alone or in combination with other anticancer agents. Paclitaxel Accord is not recommended for use in children as its safety and effectiveness in patients under 18 years of age has not been established. Ask your doctor if you have any questions about why Paclitaxel Accord was prescribed for you. _HOW PACLITAXEL ACCORD WORKS _ Paclitaxel Accord belongs to a class of anticancer agents known as taxanes. These agents prevent the division of cells, particularly cancer cells. The use of Paclitaxel Accord to treat your cancer can lead to side-effects, which are discussed below. BEFORE RECEIVING PACLITAXEL ACCORD _WHEN PACLITAXEL ACCORD MUST _ _NOT BE GIVEN _ YOU HAVE AN ALLERGY TO: • Any medicine containing paclitaxel or other medicines similar to paclitaxel called taxanes • Any of the ingredients listed at the end of this leaflet • Any medicines containing PEG-35 castor oil such as cyclosporin injection or teniposide injection. • Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE A VERY LOW WHITE B Read the complete document
Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION PACLITAXEL ACCORD (PACLITAXEL) CONCENTRATED INJECTION 1 NAME OF THE MEDICINE Paclitaxel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL contains 6 mg paclitaxel. 1 vial of 5 mL concentrated injection for infusion contains 30 mg paclitaxel. 1 vial of 16.7 mL concentrated injection for infusion contains 100 mg paclitaxel. 1 vial of 50 mL concentrated injection for infusion contains 300 mg paclitaxel. Excipients with known effect: absolute ethanol (49.5% v/v). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Paclitaxel Accord Concentrate for Intravenous Infusion is supplied as a nonaqueous solution intended for dilution with 0.9% Sodium Chloride Injection or 5% Glucose Injection prior to intravenous infusion. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 1. Paclitaxel is indicated for the primary treatment of ovarian cancer in combination with a platinum agent. 2. Paclitaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of standard therapy. 3. Paclitaxel is indicated for the treatment of metastatic carcinoma of the breast after failure of standard therapy. 4. Paclitaxel is indicated for adjuvant treatment of node-positive breast cancer administered sequentially to doxorubicin and cyclophosphamide. 5. Paclitaxel is indicated for the 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. 6. Paclitaxel, 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. 7. Paclitaxel is indicated for the treatment of non-small cell lung cancer (NSCLC). 4.2 D OSE AND METHOD OF ADMINISTRATI Read the complete document