Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Deferoxamine mesilate
Novartis Ireland Limited
V03AC; V03AC01
Deferoxamine mesilate
500 milligram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Iron chelating agents; deferoxamine
Marketed
1980-02-07
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DESFERAL ® 500MG VIALS POWDER FOR SOLUTION FOR INJECTION OR POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION. Desferoxamine mesilate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, nurse or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Desferal is and what it is used for 2. What you need to know before you are given Desferal 3. How you are given Desferal 4. Possible side effects 5. How to store Desferal 6. Contents of the pack and further information 1. WHAT DESFERAL IS AND WHAT IT IS USED FOR The full name of your medicine is desferoxamine mesilate. In this leaflet the shorter name Desferal will be used. Desferal is an injection used when you have too much iron or aluminium in your blood (iron or aluminium overload). It is a “chelating” agent. This means that it sticks to the unwanted iron or aluminium in the blood to form a compound which the body can get rid of safely. You may have too much iron or aluminium in your blood after iron poisoning or as a side effect of blood transfusions or kidney dialysis. Certain illnesses can also have the same effect. The aim here is to balance out your levels and avoid an overload occurring. In older people, iron may be removed from the blood in order to encourage a slow release of iron from body stores that have already reached a toxic level. Desferal can also be used to test whether you have too much or too little iron or aluminium in your body. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DESFERAL DO NOT HAVE DESFERAL IF: - You are allergic to Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Desferal 500mg Vials Powder for Solution for Injection or Powder for Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500mg deferoxamine mesilate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or powder for concentrate for solution for infusion. White to practically white lyophilised powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IRON OVERLOAD _MONOTHERAPY IRON CHELATION TREATMENT OF CHRONIC IRON OVERLOAD_ primary and secondary haemochromatosis including thalassaemia transfusional haemosiderosis; in patients in whom concomitant disorders (eg severe anaemia, hypoproteinaemia, renal failure) preclude phlebotomy. Treatment of acute iron poisoning For the diagnosis of iron storage disease and certain anaemias. ALUMINIUM OVERLOAD - in patients under maintenance dialysis for end stage renal failure with aluminium-related bone disease and/or anaemia, dialysis encephalopathy; and for diagnosis of aluminium overload. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TREATMENT FOR CHRONIC IRON OVERLOAD The main aim of chelation therapy in iron overload in young patients is to achieve an iron balance and to prevent haemosiderosis, while in the older patient a negative iron balance is desirable in order to reduce slowly the increased iron stores and to prevent the toxic effects of iron. _ADULTS AND CHILDREN:_ Desferal therapy should be commenced after the first 10-20 blood transfusions, or when serum ferritin levels reach 1,000 ng/mL. Growth retardation may result from iron overload or excessive Desferal doses. If chelation is begun before 3 years of age, growth must be monitored carefully and the mean daily dose should not exceed 40mg/kg. The dosage and mode of administration may be individually adapted according to the degree of iron overload. The lowest effective dosage should be used. To assess the response to chelation therapy, 24 hour urina Lees het volledige document