Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
rituximab
Celltrion Healthcare Hungary Kft.
L01XC02
rituximab
Antineoplastic agents
Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Wegener Granulomatosis
Ritemvia is indicated in adults for the following indications:Non-Hodgkin’s lymphoma (NHL) Ritemvia is indicated for the treatment of previously untreated patients with stage III, IV follicular lymphoma in combination with chemotherapy.Ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.Ritemvia 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.Ritemvia 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.Granulomatosis with polyangiitis and microscopic polyangiitis.Ritemvia, 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: 8
Withdrawn
2017-07-13
68 B. PACKAGE LEAFLET Medicinal product no longer authorised 69 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RITEMVIA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION RITEMVIA 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 Ritemvia is and what it is used for 2. What you need to know before you use Ritemvia 3. How to use Ritemvia 4. Possible side effects 5. How to store Ritemvia 6. Contents of the pack and other information 1. WHAT RITEMVIA IS AND WHAT IT IS USED FOR WHAT RITEMVIA IS Ritemvia 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 RITEMVIA IS USED FOR Ritemvia may be used for the treatment of several different conditions in adults and children. Your doctor may prescribe Ritemvia 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, Ritemvia can be given alone or with other medicines called “chemotherapy”. In adult patients where the treatment is working, Ritemvia may be continued for 2 years after completing the initial treatment. In children and adolescents, Ritemvia is given in combination with “ch Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 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 Ritemvia 100 mg concentrate for solution for infusion Ritemvia 500 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ritemvia 100mg concentrate for solution for infusion Each mL contains 10 mg of rituximab. Each 10 mL vial contains 100 mg of rituximab. Ritemvia 500mg 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. 6mg) 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 Ritemvia is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Ritemvia is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. Ritemvia maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. Ritemvia monotherapy is indicated for treatment of adul Lue koko asiakirja