Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
lenalidomide
Bristol-Myers Squibb Pharma EEIG
L04AX04
lenalidomide
Immunosuppressants
Multiple Myeloma; Lymphoma, Mantle-Cell; Myelodysplastic Syndromes
Multiple myelomaRevlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesRevlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaRevlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.Follicular lymphomaRevlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Revision: 51
Authorised
2007-06-14
88 B. PACKAGE LEAFLET 89 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT REVLIMID 2.5 MG HARD CAPSULES REVLIMID 5 MG HARD CAPSULES REVLIMID 7.5 MG HARD CAPSULES REVLIMID 10 MG HARD CAPSULES REVLIMID 15 MG HARD CAPSULES REVLIMID 20 MG HARD CAPSULES REVLIMID 25 MG HARD CAPSULES lenalidomide 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 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. WHAT IS IN THIS LEAFLET 1. What Revlimid is and what it is used for 2. What you need to know before you take Revlimid 3. How to take Revlimid 4. Possible side effects 5. How to store Revlimid 6. Contents of the pack and other information 1. WHAT REVLIMID IS AND WHAT IT IS USED FOR WHAT REVLIMID IS Revlimid contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. WHAT REVLIMID IS USED FOR Revlimid is used in adults for: • Multiple myeloma • Myelodysplastic syndromes • Mantle cell lymphoma • Follicular lymphoma MULTIPLE MYELOMA Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell. These cells collect in the bone marrow and divide, becoming out of control. This can damage the bones and kidneys. Multiple myeloma generally cannot be cured. However, the signs and symptoms can be greatly reduced or disappear for a period of time. This is Przeczytaj cały 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 Revlimid 2.5 mg hard capsules Revlimid 5 mg hard capsules Revlimid 7.5 mg hard capsules Revlimid 10 mg hard capsules Revlimid 15 mg hard capsules Revlimid 20 mg hard capsules Revlimid 25 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ U Revlimid 2.5 mg hard capsules Each capsule contains 2.5 mg of lenalidomide. U Excipient(s) with known effect Each capsule contains 73.5 mg of lactose (as anhydrous lactose). U Revlimid 5 mg hard capsules Each capsule contains 5 mg of lenalidomide. U Excipient(s) with known effect Each capsule contains 147 mg of lactose (as anhydrous lactose). U Revlimid 7.5 mg hard capsules Each capsule contains 7.5 mg of lenalidomide. U Excipient(s) with known effect Each capsule contains 144.5 mg of lactose (as anhydrous lactose). U Revlimid 10 mg hard capsules Each capsule contains 10 mg of lenalidomide. U Excipient(s) with known effect Each capsule contains 294 mg of lactose (as anhydrous lactose). U Revlimid 15 mg hard capsules Each capsule contains 15 mg of lenalidomide. U Excipient(s) with known effect Each capsule contains 289 mg of lactose (as anhydrous lactose). U Revlimid 20 mg hard capsules Each capsule contains 20 mg of lenalidomide. U Excipient(s) with known effect Each capsule contains 244.5 mg of lactose (as anhydrous lactose). U Revlimid 25 mg hard capsules Each capsule contains 25 mg of lenalidomide. U Excipient(s) with known effect Each capsule contains 200 mg of lactose (as anhydrous lactose). For the full list of excipients, see section 6.1. 3 3. PHARMACEUTICAL FORM Hard capsule. U Revlimid 2.5 mg hard capsules Blue-green/white capsules, size 4, 14.3 mm, marked “REV 2.5 mg”. U Revlimid 5 mg hard capsules White capsules, size 2, Przeczytaj cały dokument