Land: Malta
Språk: engelsk
Kilde: Malta Medicines Authority
PACLITAXEL
Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom
L01CD01
PACLITAXEL 6 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
PACLITAXEL 6 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2015-07-03
PACKAGE LEAFLET: INFORMATION FOR THE USER PACLITAXEL 6 MG/ ML CONCENTRATE FOR SOLUTION FOR INFUSION paclitaxel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What PACLITAXEL IS and what it is used for 2. What you need to know before you use PACLITAXEL 3. How to use PACLITAXEL 4. Possible side effects 5. How to store PACLITAXEL 6. Contents of the pack and other information 1. WHAT PACLITAXEL IS AND WHAT IT IS USED FOR The name of your medicine is ‘Paclitaxel 6 mg/ ml concentrate for solution for infusion’ but in the rest of leaflet it will be called ‘Paclitaxel’. Paclitaxel is available as vials containing 30 mg, 100 mg, or 300 mg paclitaxel in a 6 mg/ml solution which has to be diluted before being given to you. This medicine belongs to a group of anti-cancer medicines called taxanes. These agents inhibit the growth of cancer cells. Paclitaxel is used to treat_: _ OVARIAN CANCER: • as first therapy (after initial surgery in combination with the platinum-containing medicine cisplatin) • after standard platinum-containing medicines have been tried but did not work. BREAST CANCER: • as first therapy for advanced disease or disease which has spred to other parts of the body (metastatic disease). Paclitaxel is either in combination with an anthracyclines (e.g. doxorubicin) or with a medicine called trastuzumab (for patients for whom anthracycline is not suitable and whose cancer cells have a protein on their surface called HER2, see package of trastuzumab). • after initial surgery following treatment with anthracycline and cyclophosphamide (AC) as an additional treatment. • As second-line treatment for patients who have not res Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paclitaxel 6 mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 6 mg paclitaxel. Each vial of 5 ml contains 30 mg of paclitaxel. Each vial of 16.7 ml contains 100 mg of paclitaxel. Each vial of 50 ml contains 300 mg of paclitaxel. Excipients with known effect: Ethanol, 392.133 mg per ml (49.7%v/v) Macrogolglycerol Ricinoleate (polyoxyl castor oil), 527.33 mg per ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear colourless to slightly yellow viscous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ovarian carcinoma: in the first-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of patients with advanced carcinoma of the ovary or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin. In the second-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of standard, platinum containing therapy. Breast carcinoma: In the adjuvant setting, paclitaxel is indicated for the treatment of patients with node-positive breast carcinoma following anthracycline and cyclophosphamide (AC) therapy. Adjuvant treatment with paclitaxel should be regarded as an alternative to extended AC therapy. Paclitaxel is indicated for the initial treatment of locally advanced or metastatic breast cancer either in combination with an anthracycline in patients for whom anthracycline therapy is suitable, or in combination with trastuzumab, in patients who over-express HER-2 (human epidermal growth factor receptor 2) at a 3+ level as determined by immunohistochemistry and for whom an anthracycline is not suitable (see section 4.4 and 5.1). As a single agent, paclitaxel is indicated for the treatment of metastatic carcinoma of the breast in patients who have failed, or are not Les hele dokumentet