Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rituximab
Napp Pharmaceuticals Ltd
L01XC02
Rituximab
10mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
VMP not recommended to prescribe - brands not bioequivalent
BNF: 08020300
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRUXIMA 500 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 Truxima is and what it is used for 2. What you need to know before you use Truxima 3. How to use Truxima 4. Possible side effects 5. How to store Truxima 6. Contents of the pack and other information 1. WHAT TRUXIMA IS AND WHAT IT IS USED FOR WHAT TRUXIMA IS Truxima 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 TRUXIMA IS USED FOR Truxima may be used for the treatment of several different conditions in adults. Your doctor may prescribe Truxima 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. Truxima can be given alone or with other medicines called “chemotherapy”. If the treatment is working, Truxima may be continued 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 B- lymphocytes, which originate in the bone marrow and develop in the lymph nodes. Patients with CLL have too many abnormal lymphocytes, which accu Les hele dokumentet
OBJECT 1 TRUXIMA 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 27-Feb-2018 | Napp Pharmaceuticals Limited 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 Truxima 500 mg concentrate for solution for infusion 2. Qualitative and quantitative composition Each vial contains 500 mg of rituximab. Each mL of concentrate contains 10 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. 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 Truxima is indicated in adults for the following indications: Non-Hodgkin's lymphoma (NHL) Truxima is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Truxima 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. Truxima 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) Truxima in co Les hele dokumentet