Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
rituximab
Celltrion Healthcare Hungary Kft.
L01FA01
rituximab
Antineoplastic agents
Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Blitzima is indicated in adults for the following indications:Non-Hodgkin’s lymphoma (NHL)Blitzima is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.Blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.Blitzima 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.Blitzima 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)Blitzima 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 Blitzima or patients refractory to previous Blitzima plus chemotherapy.
Revision: 19
Authorised
2017-07-13
70 B. PACKAGE LEAFLET 71 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BLITZIMA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION BLITZIMA 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 Blitzima is and what it is used for 2. What you need to know before you use Blitzima 3. How to use Blitzima 4. Possible side effects 5. How to store Blitzima 6. Contents of the pack and other information 1. WHAT BLITZIMA IS AND WHAT IT IS USED FOR WHAT BLITZIMA IS Blitzima 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 BLITZIMA IS USED FOR Blitzima may be used for the treatment of several different conditions in adults and children. Your doctor may prescribe Blitzima 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, Blitzima can be given alone or with other medicines called “chemotherapy”. In adult patients where the treatment is working, Blitzima may be continued for 2 years after completing the initial treatment. In children and adolescents, Blitzima 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. Patients with CLL ha Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Blitzima 100 mg concentrate for solution for infusion Blitzima 500 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Blitzima 100 mg concentrate for solution for infusion Each mL contains 10 mg of rituximab. Each 10 mL vial contains 100 mg of rituximab. Blitzima 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 effect 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 6.3 – 6.8 and osmolality of 329 – 387 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Blitzima is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Blitzima is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. Blitzima maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. Blitzima monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy. Blitzima is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cycl Aqra d-dokument sħiħ