国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Lenalidomide
Clonmel Healthcare Ltd
L04AX04
Lenalidomide
10 milligram(s)
Capsule, hard
lenalidomide
Marketed
2021-04-30
Page 1 of 13 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Lenalidomide Clonmel 2.5 mg Hard Capsules Lenalidomide Clonmel 5 mg Hard Capsules Lenalidomide Clonmel 7.5 mg Hard Capsules Lenalidomide Clonmel 10 mg Hard Capsules Lenalidomide Clonmel 15 mg Hard Capsules Lenalidomide Clonmel 20 mg Hard Capsules Lenalidomide Clonmel 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 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 Lenalidomide Clonmel is and what it is used for 2. What you need to know before you take Lenalidomide Clonmel 3. How to take Lenalidomide Clonmel 4. Possible side effects 5. How to store Lenalidomide Clonmel 6. Contents of the pack and other information 1. WHAT LENALIDOMIDE CLONMEL IS AND WHAT IT IS USED FOR WHAT LENALIDOMIDE CLONMEL IS Lenalidomide Clonmel contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. WHAT LENALIDOMIDE CLONMEL IS USED FOR Lenalidomide Clonmel 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 完全なドキュメントを読む
Health Products Regulatory Authority 10 October 2023 CRN00DP5N Page 1 of 52 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lenalidomide Clonmel 10 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of lenalidomide. Excipient with known effect: Each capsule contains 214 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. A yellow opaque cap and grey opaque body, capsule shell size No. 0, 21‑22 mm, imprinted in black ink with "LP" on the cap and "639" on the body and filled with white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Multiple myeloma Lenalidomide Clonmel as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Clonmel 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. Lenalidomide Clonmel in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromes Lenalidomide Clonmel as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anaemia 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 lymphoma Lenalidomide Clonmel as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphoma Lenalidomide Clonmel in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). 4.2 POSOLOGY AND METHO 完全なドキュメントを読む