Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
DOCETAXEL
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
L01CD02
DOCETAXEL 40 mg/ml
CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
DOCETAXEL 40 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2010-12-21
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER DOCETAXEL ACTAVIS 20 MG/0.5 ML CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION DOCETAXEL ACTAVIS 80 MG/2 ML CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION docetaxel 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Docetaxel Actavis is and what it is used for 2. What you need to know before you use Docetaxel Actavis 3. How to use Docetaxel Actavis 4. Possible side effects 5. How to store Docetaxel Actavis 6. Contents of the pack and other information 1. WHAT DOCETAXEL ACTAVIS IS AND WHAT IT IS USED FOR The name of this medicine is Docetaxel Actavis. Its common name is docetaxel. Docetaxel is a substance derived from the needles of yew trees. Docetaxel belongs to the group of anti-cancer medicines called taxoids. Docetaxel Actavis has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, Docetaxel Actavis could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine. - For the treatment of early breast cancer with or without lymph node involvement, Docetaxel Actavis could be administered in combination with doxorubicin and cyclophosphamide. - For the treatment of lung cancer, Docetaxel Actavis could be administered either alone or in combination with cisplatin. - For the treatment of prostate cancer, Docetaxel Actavis is adminis Citiți documentul complet
Page 1 of 39 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Docetaxel Actavis 20 mg/0.5 ml concentrate and solvent for solution for infusion Docetaxel Actavis 80 mg/2 ml concentrate and solvent for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose vial contains docetaxel 20 mg/0.5 ml or 80 mg/2 ml. Each single dose vial contains 40 mg/ml of docetaxel. Each single dose vial contains 10 mg/ml of docetaxel after reconstitution with the accompanying solvent. Excipients with known effect Each single dose 20 mg/0.5 ml vial of concentrate contains 50 mg ethanol absolute. Each single dose 80 mg/2 ml vial of concentrate contains 200 mg ethanol absolute. Each single dose vial of solvent contains 9.53% (w/w) ethanol absolute. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate and solvent for solution for infusion. The concentrate is a clear, oily, yellow solution. The solvent is a clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer Docetaxel Actavis in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: - operable node- positive breast cancer - operable node- negative breast cancer For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1). Docetaxel Actavis in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Actavis monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Actavis in combination with trastuzumab is indicated fo Citiți documentul complet