Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
lenalidomide hydrochloride monohydrate
Krka, d.d., Novo mesto
L04AX04
lenalidomide
Immunosuppressants
Multiple Myeloma; Lymphoma, Follicular
Multiple myelomaLenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide krka d.d. Novo mesto 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 krka d.d. Novo mesto 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 krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).Multiple myelomaLenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide krka d.d. Novo mesto 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 krka d.d. Novo mesto 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 krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Revision: 3
Authorised
2021-02-11
79 B. PACKAGE LEAFLET 80 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LENALIDOMIDE KRKA D.D. NOVO MESTO 2.5 MG HARD CAPSULES LENALIDOMIDE KRKA D.D. NOVO MESTO 5 MG HARD CAPSULES LENALIDOMIDE KRKA D.D. NOVO MESTO 7.5 MG HARD CAPSULES LENALIDOMIDE KRKA D.D. NOVO MESTO 10 MG HARD CAPSULES LENALIDOMIDE KRKA D.D. NOVO MESTO 15 MG HARD CAPSULES LENALIDOMIDE KRKA D.D. NOVO MESTO 20 MG HARD CAPSULES LENALIDOMIDE KRKA D.D. NOVO MESTO 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 Krka d.d. Novo mesto is and what it is used for 2. What you need to know before you take Lenalidomide Krka d.d. Novo mesto 3. How to take Lenalidomide Krka d.d. Novo mesto 4. Possible side effects 5. How to store Lenalidomide Krka d.d. Novo mesto 6. Contents of the pack and other information 1. WHAT LENALIDOMIDE KRKA D.D. NOVO MESTO IS AND WHAT IT IS USED FOR WHAT LENALIDOMIDE KRKA D.D. NOVO MESTO IS Lenalidomide Krka d.d. Novo mesto contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. WHAT LENALIDOMIDE KRKA D.D. NOVO MESTO IS USED FOR Lenalidomide Krka d.d. Novo mesto is used in adults for: - Multiple myeloma - 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 c Soma hati kamili
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lenalidomide Krka d.d. Novo mesto 2.5 mg hard capsules Lenalidomide Krka d.d. Novo mesto 5 mg hard capsules Lenalidomide Krka d.d. Novo mesto 7.5 mg hard capsules Lenalidomide Krka d.d. Novo mesto 10 mg hard capsules Lenalidomide Krka d.d. Novo mesto 15 mg hard capsules Lenalidomide Krka d.d. Novo mesto 20 mg hard capsules Lenalidomide Krka d.d. Novo mesto 25 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains lenalidomide hydrochloride monohydrate equivalent to 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg or 25 mg lenalidomide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule) Lenalidomide Krka d.d. Novo mesto 2.5 mg hard capsules Capsule cap is green, capsule body is green with imprinted black mark 2.5. Capsule content is white to yellow white or to brown white powder. Hard capsule size: 4, length 14 ± 1 mm. Lenalidomide Krka d.d. Novo mesto 5 mg hard capsules Capsule cap is blue, capsule body is blue with imprinted black mark 5. Capsule content is white to yellow white or to brown white powder. Hard capsule size: 2, length 18 ± 1 mm. Lenalidomide Krka d.d. Novo mesto 7.5 mg hard capsules Capsule cap is brown, capsule body is brown with imprinted white mark 7.5. Capsule content is white to yellow white or to brown white powder. Hard capsule size: 1, length 19 ± 1 mm. Lenalidomide Krka d.d. Novo mesto 10 mg hard capsules Capsule cap is green, capsule body is brown with imprinted white mark 10. Capsule content is white to yellow white or to brown white powder. Hard capsule size: 0, length 21 ± 1 mm. Lenalidomide Krka d.d. Novo mesto 15 mg hard capsules Capsule cap is brown, capsule body is blue with imprinted black mark 15. Capsule content is white to yellow white or to brown white powder. Hard capsule size: 2, length 18 ± 1 mm. Lenalidomide Krka d.d. Novo mesto 20 mg hard capsules Capsule cap is green, capsule body is blue with imprinted black mark 20 Soma hati kamili