Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Deferiprone
Chiesi Farmaceutici S.p.A.
V03AC02
deferiprone
All other therapeutic products
beta-Thalassemia; Iron Overload
Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.Ferriprox in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction.
Revision: 32
Authorised
1999-08-25
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER FERRIPROX 500 MG FILM-COATED TABLETS deferiprone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. − A patient card is attached to the carton. You should detach, complete, read the patient card carefully and carry it with you. Provide this patient card to your doctor if you develop infection symptoms such as a fever, sore throat or flu-like symptoms. WHAT IS IN THIS LEAFLET 1. What Ferriprox is and what it is used for 2. What you need to know before you take Ferriprox 3. How to take Ferriprox 4. Possible side effects 5. How to store Ferriprox 6. Contents of the pack and other information 1. WHAT FERRIPROX IS AND WHAT IT IS USED FOR Ferriprox contains the active substance deferiprone. Ferriprox is an iron chelator, a type of medicine that removes excess iron from the body. Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERRIPROX DO NOT TAKE FERRIPROX − if you are allergic to deferiprone or any of the other ingredients of this medicine (listed in section 6). − if you have a history of repeated episodes of neutropenia (low white blood cell (neutrophil) count). − if you have a history of agranulocytosis (very low white blood cell (neutrophil) count). − if you are currently taking medicines known to cause neutropenia or agranulocytosis (see “Other medicines and Ferriprox”). Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ferriprox 500 mg film-coated tablets Ferriprox 1 000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ferriprox 500 mg film-coated tablets Each tablet contains 500 mg deferiprone. Ferriprox 1 000 mg film-coated tablets Each tablet contains 1 000 mg deferiprone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Ferriprox 500 mg film-coated tablets White to off-white, capsule-shaped, film-coated tablet imprinted “APO” bisect “500” on one side, plain on the other. The tablet is 7.1 mm x 17.5 mm x 6.8 mm and scored. The tablet can be divided into equal halves. Ferriprox 1 000 mg film-coated tablets White to off-white, capsule-shaped, film-coated tablet imprinted “APO” bisect “1000” on one side, plain on the other. The tablet is 7.9 mm x 19.1 mm x 7 mm and scored. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. Ferriprox in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia. 3 Posology Deferiprone is usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight. Dose per kilogram body weight should be calculated to the nearest half tablet. See tables below for recommended doses for body weights at 10 kg increments. To obtain a dose of about 75 mg/kg/day, use the n Læs hele dokumentet