Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
anagrelide
Shire Pharmaceutical Contracts Limited
L01XX35
anagrelide
Antineoplastic agents
Thrombocythemia, Essential
Xagrid is indicated for the reduction of elevated platelet counts in at-risk essential-thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
Authorised
2004-11-16
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XAGRID 0.5 MG HARD CAPSULES anagrelide 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 TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have 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. WHAT IS IN THIS LEAFLET: 1. What Xagrid is and what it is used for 2. What you need to know before you take Xagrid 3. How to take Xagrid 4. Possible side effects 5. How to store Xagrid 6. Contents of the pack and other information 1. WHAT XAGRID IS AND WHAT IT IS USED FOR Xagrid contains the active substance, anagrelide. Xagrid is a medicine which interferes with the development of platelets. It reduces the number of platelets produced by the bone marrow, which results in a decrease in the platelet count in the blood towards a more normal level. For this reason it is used to treat patients with essential thrombocythaemia. Essential thrombocythaemia is a condition which occurs when the bone marrow produces too many of the blood cells known as platelets. Large numbers of platelets in the blood can cause serious problems with blood circulation and clotting. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XAGRID DO NOT TAKE XAGRID • If you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath; • If you have Lesen Sie das vollständige Dokument
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 Xagrid 0.5 mg hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride). Excipient(s) with known effect Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous lactose (65.8 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. An opaque white hard capsule imprinted with S 063. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xagrid is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy. An at risk patient An at risk essential thrombocythaemia patient is defined by one or more of the following features: • > 60 years of age or • a platelet count > 1000 x 10 9 /l or • a history of thrombo-haemorrhagic events. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Xagrid should be initiated by a clinician with experience in the management of essential thrombocythaemia. Posology The recommended starting dose of anagrelide is 1 mg/day, which should be administered orally in two divided doses (0.5 mg/dose). The starting dose should be maintained for at least one week. After one week the dose may be titrated, on an individual basis, to achieve the lowest effective dose required to reduce and/or maintain a platelet count below 600 x 10 9 /l and ideally at levels between 150 x 10 9 /l and 400 x 10 9 /l. The dose increment must not exceed more than 0.5 mg/day in any one-week and the recommended maximum single dose should not exceed 2.5 mg (see section 4.9). Durin Lesen Sie das vollständige Dokument