国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rituximab
Roche Products Ltd
L01XC02
Rituximab
10mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
VMP not recommended to prescribe - brands not bioequivalent
BNF: 08020300; GTIN: 5000471004977
1 uk-ie-mt-pil-mabthera-clean-180316-100-inf PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MABTHERA 100 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. 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. MabThera can be given alone or with other medicines called “chemotherapy”. In patients where the treatment is working, MabThera may be used as a maintenance treatment for 2 years after completing the initial treatment. 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. Patients with CLL have too many abnormal lymphocytes, which accumulate mainly in the bone marrow and blood. The proliferation of these abnormal B-ly 完全なドキュメントを読む
OBJECT 1 MABTHERA 100MG CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 30-May-2018 | Roche Products Limited 1. Name of the medicinal product MabThera 100 mg concentrate for solution for infusion 2. Qualitative and quantitative composition Each mL contains 10 mg of rituximab. Each vial contains 100 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: This medicinal product contains 2.3 mmol (52.6 mg ) sodium per 10mL vial. 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 MabThera is indicated in adults for the following indications: Non-Hodgkin's lymphoma (NHL) MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. MabThera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. MabThera monotherapy is indicated for treatment of 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 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) 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 effi 完全なドキュメントを読む