Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
paclitaxel
Bristol-Myers Squibb Pharma EEIG
L01CD01
paclitaxel
Antineoplastic agents
Breast Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung
Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Revision: 29
Authorised
2008-01-11
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE USER ABRAXANE 5 MG/ML POWDER FOR DISPERSION 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 nurse. - 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Abraxane is and what it is used for 2. What you need to know before you are given Abraxane 3. How to use Abraxane 4. Possible side effects 5. How to store Abraxane 6. Contents of the pack and other information 1. WHAT ABRAXANE IS AND WHAT IT IS USED FOR WHAT ABRAXANE IS Abraxane contains, as its active substance, paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles. Paclitaxel belongs to a group of medicines called “taxanes” used in cancer. • Paclitaxel is the part of the medicine that affects the cancer, it works by stopping cancer cells from dividing – this means that they die. • Albumin is the part of the medicine that helps paclitaxel dissolve in the blood and get across the walls of the blood vessels into the tumour. This means that other chemicals that can cause side effects that can be life threatening are not needed. Such side effects occur far less with Abraxane. WHAT ABRAXANE IS USED FOR Abraxane is used to treat the following types of cancer: Breast Cancer • Breast cancer which has spread to other parts of the body (this is called “metastatic” breast cancer). • Abraxane is used in metastatic breast cancer when at least one other therapy has been tried but has not worked and you are unsuitable for treatments containing a group of medicines called “ant Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Abraxane 5 mg/ml powder for dispersion for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles. Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles. After reconstitution, each ml of dispersion contains 5 mg of paclitaxel formulated as albumin bound nanoparticles. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for dispersion for infusion. The reconstituted dispersion has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg. The powder is white to yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4). Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Abraxane should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents. It should not be substituted for or with other paclitaxel formulations. Posology _Breast cancer _ The recommended dose of Abraxane is 260 mg/m 2 administered intravenously over 30 minutes every 3 weeks. _Dose adjustments during treatment of breast cancer _ Patients who experience severe neutropenia (neutrophil count < 500 cells/mm 3 for a week or longer) or severe sensory neuropathy during Abraxane therapy should have the dose reduced to 220 mg/m 2 for subsequent courses. Following recurrence of severe ne Lesen Sie das vollständige Dokument