国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
rituximab
Celltrion Healthcare Hungary Kft.
L01XC02
rituximab
Antineoplastic agents
Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis
Rituzena is indicated in adults for the following indications:Non-Hodgkin’s lymphoma (NHL)Rituzena is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy.Rituzena monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.Rituzena is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.Chronic lymphocytic leukaemia (CLL)Rituzena 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 Rituzenaor patients refractory to previous Rituzena plus chemotherapy.Granulomatosis with polyangiitis and microscopic polyangiitisRituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
Revision: 7
Withdrawn
2017-07-13
78 B. PACKAGE LEAFLET 79 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RITUZENA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION rituximab This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Rituzena is and what it is used for 2. What you need to know before you use Rituzena 3. How to use Rituzena 4. Possible side effects 5. How to store Rituzena 6. Contents of the pack and other information 1. WHAT RITUZENA IS AND WHAT IT IS USED FOR WHAT RITUZENA IS Rituzena contains the active substance “rituximab”. This is a type of protein called a “monoclonal antibody”. It is designed to stick to a type of white blood cell called “B-Lymphocyte”. When sticking to the surface of this cell, rituximab causes the cell to die. WHAT RITUZENA IS USED FOR Rituzena may be used for the treatment of several different conditions in adults. Your doctor may prescribe Rituzena for the treatment of: A) NON-HODGKIN’S LYMPHOMA This is a disease of the lymph tissue (part of the immune system) that affects B-Lymphocytes. Rituzena can be given alone or with other medicines called “chemotherapy”. B) CHRONIC LYMPHOCYTIC LEUKAEMIA Chronic lymphocytic leukaemia (CLL) is the most common form of adult leukaemia. CLL affects B-lymphocytes, which originate in the bone marrow and develop in the lymph nodes. Patients with CLL have too many abnormal lymphocytes, which accumulate mainly in the bone marrow and blood. The spread of these abnorm 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Rituzena 100 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of rituximab. Each mL of concentrate contains 10mg 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. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rituzena is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Rituzena is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. Rituzena monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy. Rituzena is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Chronic lymphocytic leukaemia (CLL) Rituzena 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 完全なドキュメントを読む