Country: Kesatuan Eropah
Bahasa: Inggeris
Sumber: EMA (European Medicines Agency)
lenalidomide
Mylan Ireland Limited
L04AX07
lenalidomide
Immunosuppressants
Multiple Myeloma
Multiple myelomaLenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Lenalidomide Mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Follicular lymphomaLenalidomide Mylan in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1-3a).
Revision: 8
Authorised
2020-12-18
99 B. PACKAGE LEAFLET 100 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LENALIDOMIDE MYLAN 2.5 MG HARD CAPSULES LENALIDOMIDE MYLAN 5 MG HARD CAPSULES LENALIDOMIDE MYLAN 7.5 MG HARD CAPSULES LENALIDOMIDE MYLAN 10 MG HARD CAPSULES LENALIDOMIDE MYLAN 15 MG HARD CAPSULES LENALIDOMIDE MYLAN 20 MG HARD CAPSULES LENALIDOMIDE MYLAN 25 MG HARD CAPSULES lenalidomide 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lenalidomide Mylan is and what it is used for 2. What you need to know before you take Lenalidomide Mylan 3. How to take Lenalidomide Mylan 4. Possible side effects 5. How to store Lenalidomide Mylan 6. Contents of the pack and other information 1. WHAT LENALIDOMIDE MYLAN IS AND WHAT IT IS USED FOR Lenalidomide Mylan contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. Lenalidomide Mylan 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 called a ‘response’. Newly diagnosed multiple myeloma – in patients who have had a bone marrow transplant Lenalidomi Baca dokumen lengkap
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lenalidomide Mylan 2.5 mg hard capsules Lenalidomide Mylan 5 mg hard capsules Lenalidomide Mylan 7.5 mg hard capsules Lenalidomide Mylan 10 mg hard capsules Lenalidomide Mylan 15 mg hard capsules Lenalidomide Mylan 20 mg hard capsules Lenalidomide Mylan 25 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Lenalidomide Mylan 2.5 mg hard capsules Each capsule contains 2.5 mg of lenalidomide. Lenalidomide Mylan 5 mg hard capsules Each capsule contains 5 mg of lenalidomide. Lenalidomide Mylan 7.5 mg hard capsules Each capsule contains 7.5 mg of lenalidomide. Lenalidomide Mylan 10 mg hard capsules Each capsule contains 10 mg of lenalidomide. Lenalidomide Mylan 15 mg hard capsules Each capsule contains 15 mg of lenalidomide. Lenalidomide Mylan 20 mg hard capsules Each capsule contains 20 mg of lenalidomide. Lenalidomide Mylan 25 mg hard capsules Each capsule contains 25 mg of lenalidomide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Lenalidomide Mylan 2.5 mg hard capsules Green and white capsules, size 4, 14 mm, marked “MYLAN /LL 2.5”. Lenalidomide Mylan 5 mg hard capsules White capsules, size 2, 18 mm, marked “MYLAN/LL 5”. Lenalidomide Mylan 7.5 mg hard capsules Light grey and white capsules, size 2, 18 mm, marked “MYLAN/LL7.5”. Lenalidomide Mylan 10 mg hard capsules Green and light grey capsules, size 0, 22 mm, marked “MYLAN/LL 10”. Lenalidomide Mylan 15 mg hard capsules White capsules, size 0, 22 mm, marked “MYLAN/LL15”. 3 Lenalidomide Mylan 20 mg hard capsules Green and white capsules, size 0, 22 mm, marked “MYLAN/LL 20”. Lenalidomide Mylan 25 mg hard capsules White capsules, size 0, 22 mm, marked “MYLAN/LL 25”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Multiple myeloma Lenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous st Baca dokumen lengkap