Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
pixantrone dimaleate
Les Laboratoires Servier
L01DB11
pixantrone dimaleate
Antineoplastic agents
Lymphoma, Non-Hodgkin
Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth-line or greater chemotherapy in patients who are refractory to last therapy.
Revision: 23
Authorised
2012-05-10
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ PIXUVRI 29 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION pixantrone 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. - If you get any side effect, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pixuvri is and what it is used for 2. What you need to know before you use Pixuvri 3. How to use Pixuvri 4. Possible side effects 5. How to store Pixuvri 6. Content of the pack and other information 1. WHAT PIXUVRI IS AND WHAT IT IS USED FOR Pixuvri belongs to a pharmacotherapeutic group of medicines known as ‘antineoplastic agents’. These are used to treat cancer. Pixuvri is used for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin Lymphomas. Pixuvri kills cancer cells by binding to DNA, resulting in cell death. It is used for patients whose cancer does not respond or has returned after they have received other chemotherapy treatments. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PIXUVRI _ _ DO NOT USE PIXUVRI - if you are allergic to pixantrone dimaleate or any of the other ingredients of this medicine (listed in section 6). - if you have recently received a vaccine. - if you have been told that you have persistent, long-term low numbers of red blood cells, white blood cells, and platelets. - if you have very severe liver problems. WARNINGS AND PRECAUTIONS Talk to your doctor before using Pixuvri: - if you have been told that your white blood cell count is very low. - if you have heart disease or uncontrolled high blood pressure, especially if you have ever been told you had heart failure or if you have had a heart attack within the last six months. - if you have an infection. - if you have ever been treated for cancer. - if you follow a sp Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pixuvri 29 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains pixantrone dimaleate equivalent to 29 mg pixantrone After reconstitution, each ml of concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone. Excipient with known effect: One vial contains 39 mg sodium. Upon reconstitution and dilution, this medicinal product contains approximately 1g (43 mmol) sodium per dose, equivalent to 50% of the WHO recommended maximum daily intake of 2 g sodium for an adult. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Dark blue lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Pixuvri must be administered by physicians who are familiar with the use of antineoplastic agents and have the facilities for regular monitoring of clinical, haematological, and biochemical parameters during and after treatment (see section 6.6). Posology The recommended dose is 50 mg/m 2 of pixantrone on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. Please note: In the EU recommended dose refers to the base of the active substance (pixantrone). Calculation of the individual dose to be administered to a patient must be based on the strength of the reconstituted solution that contains 5.8mg/ml pixantrone and the dose recommendation of 50 mg/m 2 . In some trials and publications, the recommended dose is based on the salt form (pixantrone dimaleate) However, the dose has to be adjusted before the start of each cycle based on nad Прочетете целия документ