Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Dinutuximab
United Therapeutics Europe Ltd
L01FX
dinutuximab
Antineoplastic agents
Neuroblastoma
Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.
Revision: 3
Withdrawn
2015-08-14
24 B. PACKAGE LEAFLET Medicinal product no longer authorised 25 PACKAGE LEAFLET: INFORMATION FOR THE USER UNITUXIN 3.5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION dinutuximab This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. Occasionally a young person who is taking this medicne may be reading the package leaflet, but usually it will be a parent/carer. Nevertheless the leaflet will refer to ‘you’ throughout. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. - 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 Unituxin is and what it is used for 2. What you need to know before you are given Unituxin 3. How Unituxin will be given 4. Possible side effects 5. How to store Unituxin 6. Contents of the pack and other information 1. WHAT UNITUXIN IS AND WHAT IT IS USED FOR WHAT UNITUXIN IS Unituxin is a cancer medicine that contains the active substance dinutuximab. It belongs to a group of medicines called ‘monoclonal antibodies’. These work like the antibodies produced naturally by the body. They help the immune system to target certain cells, such as cancer cells, by ‘sticking’ to them. WHAT UNITUXIN IS USED FOR Unituxin is used to treat ‘high-risk neuroblastoma’ in babies, children and adolescents aged 12 months to 17 years old. Neuroblastoma is a type of cancer that grows from abnormal nerve cells in the body. Some neuroblastomas are classed as ‘high risk’ if the cancer has spread to various parts of the body and contains certain types of cells. High-risk neuroblastomas are more likely to come back again after treat Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Unituxin 3.5 mg/mL concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of concentrate contains 3.5 mg of dinutuximab. Each vial contains 17.5 mg of dinutuximab in 5 mL. Dinutuximab is a chimeric human/mouse monoclonal antibody produced in a murine myeloma cell line (Sp2/0) by recombinant DNA technology. Excipient with known effect: Each 5 mL vial contains 17.2 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Unituxin is restricted to hospital-use only and must be administered under the supervision of a physician experienced in the use of oncological therapies. It must be administered by a healthcare professional prepared to manage severe allergic reactions including anaphylaxis in an environment where full resuscitation services are immediately available. Posology Unituxin is to be administered by intravenous infusion over five courses at a daily dose of 17.5 mg/m 2 . It is administered on Days 4–7 during Courses 1, 3, and 5 (each course lasting approximately 24 days) and on Days 8 Pročitajte cijeli dokument