Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
Imlifidase
Hansa Biopharma AB
L04AA
imlifidase
Immunosuppressants
Desensitization, Immunologic; Kidney Transplantation
Idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.
Revision: 4
Authorised
2020-08-25
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER IDEFIRIX 11 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION imlifidase 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. - If you get any side effects, 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 Idefirix is and what it is used for 2. What you need to know before you are given Idefirix 3. How to use Idefirix 4. Possible side effects 5. How to store Idefirix 6. Contents of the pack and other information 1. WHAT IDEFIRIX IS AND WHAT IT IS USED FOR Idefirix contains the active substance imlifidase, which belongs to a group of medicines called immunosuppressants. It is given before your kidney transplantation to prevent the immune system (your body's defences) from rejecting the donated kidney. Idefirix works by breaking down a type of antibody in the body called immunoglobulin G (IgG), which is involved in destroying 'foreign' or harmful substances. Imlifidase is a protein from a bacterium called _Streptococcus pyogenes._ 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IDEFIRIX _ _ YOU MUST NOT BE GIVEN IDEFIRIX - If you are allergic to imlifidase or any of the other ingredients of this medicine (listed in section 6). - If you have a severe infection. - If you have a blood disorder called thrombotic thrombocytopenic purpura (TTP), that results in blood clots forming in small blood vessels throughout the body. WARNINGS AND PRECAUTIONS Infusion reactions Idefirix contains a protein and it can cause allergic reactions in some people. You will receive medicines t Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 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 Idefirix 11 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 11 mg imlifidase produced in _Escherichia coli_ cells by recombinant DNA technology. After reconstitution and dilution, each mL of concentrate contains 10 mg imlifidase. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). The powder is a white cake. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be prescribed and supervised by specialist physicians experienced in the management of immunosuppressive therapy and of sensitised renal transplant patients. Imlifidase is restricted to hospital use only. Posology The dose is based on patient body weight (kg). The recommended dose is 0.25 mg/kg administered as a single dose preferably within 24 hours before transplantation. One dose is adequate for crossmatch conversion in the majority of patients but, if needed, a second dose can be administered within 24 hours after the first dose. After treatment with imlifidase, crossmatch conversion from positive to negative should be confirmed before transplantation (see section 4.4). Premedication with corticosteroids and antihistamines should be given to reduce the r Perskaitykite visą dokumentą