Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
defibrotide
Gentium S.r.l.
B01AX01
defibrotide
Antithrombotic agents
Hepatic Veno-Occlusive Disease
Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.It is indicated in adults and in adolescents, children and infants over 1 month of age.
Revision: 15
Authorised
2013-10-18
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER DEFITELIO 80 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION defibrotide 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 Defitelio is and what it is used for 2. What you need to know before you are administered Defitelio 3. How you will be given Defitelio 4. Possible side effects 5. How to store Defitelio 6. Contents of the pack and other information 1. WHAT DEFITELIO IS AND WHAT IT IS USED FOR Defitelio is a medicine that contains the active substance defibrotide. It is used to treat a condition called hepatic veno-occlusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots. This can be caused by medicines that are given prior to a stem cell transplantation. Defibrotide works by protecting the cells of the blood vessels and preventing or breaking down the blood clots. This medicine can be used in adults, and in adolescents, children and infants over one month of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE ADMINISTERED DEFITELIO DO NOT USE DEFITELIO • if you are allergic to defibrotide or any of the other ingredients of this medicine (listed in section 6) • if you are using other medicines to break down blood clots such as tissue plasminogen activator. WARNINGS AND PRECAUTIONS Talk to your doctor before using Defitelio: • if you are taking medicine that increases the risk of bleeding. • if you have heavy bleeding and need a bloo Læs hele dokumentet
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 Defitelio 80 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of concentrate contains defibrotide* 80 mg corresponding to a quantity of 200 mg in 2.5 mL in a vial, and corresponding to a concentration in the range of 4 mg/mL to 20 mg/mL after dilution. * produced from porcine intestinal mucosa. Excipient with known effect Each vial contains 0.89 mmol (equivalent to 20.4 mg) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). The solution is clear light yellow to brown, free from particulate matter or turbidity. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. It is indicated in adults and in adolescents, children and infants over 1 month of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Defitelio must be prescribed and administered to patients by specialised physicians experienced in the diagnosis and treatment of complications of HSCT. Posology The recommended dose is 6.25 mg/kg body weight every 6 hours (25 mg/kg/day). There is limited efficacy and safety data on doses above this level and consequently it is not recommended to increase the dose above 25 mg/kg/day. The treatment should be administered for a minimum of 21 days and continued until the symptoms and signs of severe VOD resolve. 3 _Renal impairment _ Dose adjustment is not required for patients with renal impairment or who are on intermittent haemodialysis (see section 5.2). _Hepatic impair Læs hele dokumentet