البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
rituximab
Roche Registration GmbH
L01XC02
rituximab
Antineoplastic agents
Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell
MabThera is indicated in adults for the following indications:Non‑Hodgkin’s lymphoma (NHL)MabThera is indicated for the treatment of previously untreated adult patients with stage III‑IV follicular lymphoma in combination with chemotherapy.MabThera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.MabThera monotherapy is indicated for treatment of adult patients with stage III‑IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.MabThera is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non‑Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).Chronic lymphocytic leukaemia (CLL)MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.Rheumatoid arthritisMabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease‑modifying anti‑rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.MabThera has been shown to reduce the rate of progression of joint damage as measured by X‑ray and to improve physical function, when given in combination with methotrexate.Granulomatosis with polyangiitis and microscopic polyangiitisMabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).MabThera, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active GPA (Wegener’s) and MPA.Pemphigus vulgarisMabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Revision: 60
Authorised
1998-06-02
125 B PACKAGE LEAFLET 126 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MABTHERA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION MABTHERA 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION rituximab READ 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. • If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 What MabThera is and what it is used for 2 What you need to know before you use MabThera 3 How to use MabThera 4 Possible side effects 5 How to store MabThera 6 Contents of the pack and other information 1 WHAT MABTHERA IS AND WHAT IT IS USED FOR WHAT MABTHERA IS MabThera contains the active substance “rituximab”. This is a type of protein called a “monoclonal antibody”. It sticks to the surface of a type of white blood cell called “B-Lymphocyte”. When rituximab sticks to the surface of this cell, the cell dies. WHAT MABTHERA IS USED FOR MabThera may be used for the treatment of several different conditions in adults and children. Your doctor may prescribe MabThera for the treatment of: A) NON-HODGKIN’S LYMPHOMA This is a disease of the lymph tissue (part of the immune system) that affects a type of white blood cell called B-Lymphocytes. In adults MabThera can be given alone or with other medicines called “chemotherapy”. In adult patients where the treatment is working, MabThera may be used as a maintenance treatment for 2 years after completing the initial treatment. In children and adolescents, MabThera is given in combination with “chemotherapy”. B) CHRONIC LYMPHOCYTIC LEUKAEMIA Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia. CLL affects a particular lymphocyte, the B cell, which originates from the bone marrow and develops in the lymph nodes. Pati اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1 NAME OF THE MEDICINAL PRODUCT MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MabThera 100 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab. Each 10 mL vial contains 100 mg of rituximab. MabThera 500 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab. Each 50 mL vial contains 500 mg of rituximab. Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures. Excipients with known effects Each 10 mL vial contains 2.3 mmol (52.6 mg) sodium. Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless liquid with pH of 6.2 – 6.8 and osmolality of 324 - 396 mOsmol/kg . 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MabThera is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) MabThera is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. MabThera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. 3 MabThera monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. MabThera is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophospha اقرأ الوثيقة كاملة