国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
hydroxycarbamide
Nova Laboratories Ireland Limited
L01XX05
hydroxycarbamide
Antineoplastic agents
Anemia, Sickle Cell
Prevention of vaso-occlusive complications of sickle cell disease in patients over 2 years of age
Revision: 6
Authorised
2019-07-01
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE USER XROMI 100 MG/ML ORAL SOLUTION hydroxycarbamide 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, pharmacist or nurse. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Xromi is and what it is used for 2. What you need to know before you take Xromi 3. How to take Xromi 4. Possible side effects 5. How to store Xromi 6. Contents of the pack and other information 1. WHAT XROMI IS AND WHAT IT IS USED FOR Xromi contains hydroxycarbamide, a substance which reduces the growth and multiplication of some cells in the bone marrow. These effects lead to a reduction of circulating red, white and coagulation blood cells. In Sickle Cell Disease, hydroxycarbamide also helps to prevent red blood cells from taking the abnormal sickle shape. Sickle Cell disease is an inherited blood disorder that affects the disc shaped red cells of the blood. Some cells become abnormal, rigid and take a crescent or sickle shape which leads to anaemia. The sickle cells also get stuck in blood vessels, blocking blood flow. This can cause acute pain crises and organ damage. Xromi is used to prevent the complications of blocked blood vessels caused by Sickle Cell Disease in patients over 2 years of age. Xromi will decrease the number of painful crises as well as the need for hospitalisation as a result of the disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XROMI _ _ DO NOT TAKE XROMI - if you are allergic to hydroxycarbamide or any of the other ingredients of Xromi (listed in section 6). - if you suffer from severe liver disease - if you suffer 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xromi 100 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 100 mg hydroxycarbamide. Excipients with known effect One ml of solution contains 0.5 mg methyl hydroxybenzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear, colourless to pale yellow viscous liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 2 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hydroxycarbamide treatment should be supervised by a physician or other healthcare professionals experienced in the management of patients with Sickle Cell Disease. Posology The posology should be based on the patient’s body weight (kg). The usual starting dose of hydroxycarbamide is 15 mg/kg/day and usual maintenance dose is between 20-25 mg/kg/day. The maximum dose is 35 mg/kg/day. Full blood cell count with white cell differential and reticulocyte count should be monitored once a month for the first 2 months following treatment initiation. A target absolute neutrophil count 1,500 – 4,000 /μL should be aimed for, whilst maintaining platelet count > 80,000/μL. If neutropenia or thrombocytopenia occurs, hydroxycarbamide dosing should be temporarily withheld and full blood cell count with white cell differential should be monitored weekly. When blood counts have recovered, hydroxycarbamide should be reinstated at a dose 5 mg/kg/day lower than the dose given before onset of cytopenias. If dose escalation is warranted based on clinical and laboratory findings, the following steps should be taken: • Dose to be increased by 5 mg/kg/day increments every 8 weeks • Increases in dose to be continued until mild myelosuppression (absolute neutrophil count 1,500/ μL to 4,000/ μL) is achieved, up to a maximum of 35 mg/kg/day. • Full blood cell count with white cell differe 阅读完整的文件