País: Países Bajos
Idioma: neerlandés
Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LENALIDOMIDE 7,5 mg/stuk
Ohre Pharma 1 rue des Ursulines 37000 TOURS (FRANKRIJK)
L04AX04
LENALIDOMIDE 7,5 mg/stuk
Capsule, hard
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT
Oraal gebruik
Lenalidomide
1900-01-01
11012 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LENALIDOMIDE STRAGEN ® 7.5 MG, HARDE 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1 WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. [Product name] 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 [Product name] is used on its own as a maintenance therapy after patients have recovered enough following a bone marrow transplant. Newly diagnosed multiple myeloma – in patients who cannot have a bone marrow transplant [Product name] is taken with other medicines. These may include: • a chem Leer el documento completo
11012 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lenalidomide Stragen 7.5 mg, harde capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 7.5 mg of lenalidomide. Excipient(s) with known effect: Each capsule contains 99.7 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Harde capsule. Opaque white body and opaque yellow cap, with a length of approximately 18.0 mm, marked “L9NL” and “7.5”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Multiple myeloma Lenalidomide Stragen as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Stragen 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 Stragen in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Follicular lymphoma Lenalidomide Stragen 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 METHOD OF ADMINISTRATION Lenalidomide Stragen treatment should be supervised by a physician experienced in the use of anti-cancer therapies. For all indications described below: • Dose is modified based upon clinical and laboratory findings (see section 4.4). • Dose adjustments, during treatment and restart of treatment, are recommended to manage Grade 3 or 4 thrombocytopenia, neutropenia, or other Grade 3 or 4 toxicity judged to be related to lenalidomide. • In case of neutropenia, the use of growth factors in patient management should be considered. 11012 • If less than 12 hours has elapsed since missing a dose, the patient can Leer el documento completo