Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
Treosulfan
medac Gesellschaft für klinische Spezialpräparate mbH
L01AB02
treosulfan
Antineoplastic agents
Hematopoietic Stem Cell Transplantation
Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases.
Revision: 4
Authorised
2019-06-20
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER TRECONDI 1 G POWDER FOR SOLUTION FOR INFUSION TRECONDI 5 G POWDER FOR SOLUTION FOR INFUSION treosulfan 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, pharmacist or nurse. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Trecondi is and what it is used for 2. What you need to know before you are given Trecondi 3. How to use Trecondi 4. Possible side effects 5. How to store Trecondi 6. Contents of the pack and other information 1. WHAT TRECONDI IS AND WHAT IT IS USED FOR Trecondi contains the active substance treosulfan, which belongs to a group of medicines called alkylating agents. Treosulfan is used to prepare patients for bone marrow transplant (haematopoietic stem cell transplantation). Treosulfan destroys the bone marrow cells and enables the transplant of new bone marrow cells which leads to the production of healthy blood cells. Trecondi is used as a TREATMENT BEFORE BLOOD STEM CELL TRANSPLANTATION in adults and in adolescents and children older than one month with cancer and non-cancerous disorders. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TRECONDI DO NOT USE TRECONDI if you are allergic to treosulfan, if you suffer from an active uncontrolled infection, if you suffer from severe heart, lung, liver or kidney diseases, if you suffer from hereditary DNA repair disorder, a condition that reduces the ability to repair DNA (which carries your genetic information), if you are pregnant, or think you may be pregnant. WARNINGS AND PRECAUTIONS Trecondi is a cell-killing (cytotoxic) medicine that is used to decrease the number of blood cells. At the recommended dose, this is the desired effect. You will ha Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Trecondi 1 g powder for solution for infusion Trecondi 5 g powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Trecondi 1 g powder for solution for infusion One vial contains 1 g of treosulfan. Trecondi 5 g powder for solution for infusion One vial contains 5 g of treosulfan. When reconstituted according to section 6.6, 1 mL of the solution for infusion contains 50 mg treosulfan. 3. PHARMACEUTICAL FORM Powder for solution for infusion. White crystalline powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients and in paediatric patients older than one month with malignant and non-malignant diseases. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Administration of treosulfan should be supervised by a physician experienced in conditioning treatment followed by alloHSCT. Posology _ _ _Adults with malignant disease _ _ _ Treosulfan is given in combination with fludarabine. The recommended dose and schedule of administration is: • Treosulfan 10 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -4, -3, -2) before stem cell infusion (day 0). The total treosulfan dose is 30 g/m²; • Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0). The total fludarabine dose is 150 mg/m²; • Treosulfan should be administered before fludarabine on days -4, -3, -2 (FT 10 regimen). _Adults with non-malignant disease _ _ _ Treosulfan is given in combination with fludarabine with or without thiotepa. The recommended dose and schedule of administration is: 3 • Treosulfan 14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, Olvassa el a teljes dokumentumot