Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)
MolMed SpA
L01
allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)
Antineoplastic agents
Hematopoietic Stem Cell Transplantation; Graft vs Host Disease
Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies.
Revision: 1
Withdrawn
2016-08-18
B. PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZALMOXIS 5-20 X 10 6 CELLS/ML DISPERSION FOR INFUSION Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) 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. 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 a physician experienced in the medical treatment of blood cancer. - If you get any side effects, talk to your doctor, or a physician experienced in the medical treatment of blood cancer. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zalmoxis is and what it is used for 2. What you need to know before you are given Zalmoxis 3. How Zalmoxis is given to you 4. Possible side effects 5. How to store Zalmoxis 6. Contents of the pack and other information 1. WHAT ZALMOXIS IS AND WHAT IT IS USED FOR Zalmoxis consists of white blood cells called T cells that are obtained from the donor. These cells will be genetically modified by introducing a “suicide” gene (HSV-TK Mut2) in their genetic code which can be activated later on in case of graft-versus-host disease. This will ensure that the cells can be eliminated before they can cause damage to the patient’s cells. Zalmoxis is intended for use in adults with certain tumours of the blood known as high-risk haemotological malignancies. It is given after haploidentical bone marrow transplantation (haematopoietic cell transplantation). Haploidentical means that the cells have been obtained from a donor whose tissues part Прочетете целия документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 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 Zalmoxis 5-20 x 10 6 cells/mL dispersion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2). 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each bag of Zalmoxis contains a volume of 10-100 mL of frozen dispersion at the concentration of 5-20 x 10 6 cells/mL. The cells are of human origin and genetically modified with a replication- defective γ-retroviral vector coding for the HSV-TK and ΔLNGFR genes so that these sequences are integrated in the genome of the host cells. The cellular composition and the final cell number will vary according to the weight of the patient. In addition to T cells, NK cells and residual levels of monocytes and of B cells may be present. Excipient with known effect _ _ Each bag contains approximately 13.3 mmol (305.63 mg) of sodium per dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersion for infusion. Opaque, off-white frozen dispersion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies (see section 5.1). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zalmoxis must be administered under the supervision of a physician experienced in HSCT for haematological malignancies. Posology The recommended dose and schedule is 1 ± 0.2 x 10 7 cells/kg given as an intravenous infusion at a time interval of 21-49 days from Прочетете целия документ