Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
lenalidomide hydrochloride monohydrate
Krka, d.d., Novo mesto
L04AX04
lenalidomide
Immunosuppressants
Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell
Multiple myelomaLenalidomide Krka 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 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 in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesLenalidomide Krka 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 lymphomaLenalidomide Krka 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 lymphomaLenalidomide Krka 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 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 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 in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesLenalidomide Krka 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 lymphomaLenalidomide Krka 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 lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Revision: 4
Authorised
2021-02-11
90 B. PACKAGE LEAFLET 91 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LENALIDOMIDE KRKA 2.5 MG HARD CAPSULES LENALIDOMIDE KRKA 5 MG HARD CAPSULES LENALIDOMIDE KRKA 7.5 MG HARD CAPSULES LENALIDOMIDE KRKA 10 MG HARD CAPSULES LENALIDOMIDE KRKA 15 MG HARD CAPSULES LENALIDOMIDE KRKA 20 MG HARD CAPSULES LENALIDOMIDE KRKA 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 is and what it is used for 2. What you need to know before you take Lenalidomide Krka 3. How to take Lenalidomide Krka 4. Possible side effects 5. How to store Lenalidomide Krka 6. Contents of the pack and other information 1. WHAT LENALIDOMIDE KRKA IS AND WHAT IT IS USED FOR WHAT LENALIDOMIDE KRKA IS Lenalidomide Krka contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. WHAT LENALIDOMIDE KRKA IS USED FOR Lenalidomide Krka 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 bo Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lenalidomide Krka 2.5 mg hard capsules Lenalidomide Krka 5 mg hard capsules Lenalidomide Krka 7.5 mg hard capsules Lenalidomide Krka 10 mg hard capsules Lenalidomide Krka 15 mg hard capsules Lenalidomide Krka 20 mg hard capsules Lenalidomide Krka 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 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 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 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 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 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 20 mg hard capsules Capsule cap is green, capsule body is blue with imprinted black mark 20. Capsule content is white to yellow white or to brown white powder. Hard capsule size: 1, length 19 ± 1 mm. Lenalidomide Krka 25 mg hard capsules Capsule cap is brown, capsule body is brown with imprinted w Aqra d-dokument sħiħ