Maa: Jordania
Kieli: englanti
Lähde: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)
Rituximab 100 mg/10ml
مستودع ادوية شاوي و رشيدات و مسنات - Shawi & Rushedat Drug Store
L01XC02
Rituximab 100 mg/10ml
100 mg/10ml
2 vials
Roche Diagnostics GmbH , Mannheim (المانيا)
Aug 2021 Product Information GCC Ro 45-2294 MabThera Aug 2021 1 Product Information GCC MABTHERA ® Rituximab COMPOSITION _Active substances:_ Rituximab (produced by recombinant DNA technology using CHO [Chinese hamster ovary] cells). _Excipients:_ Polysorbate 80 (produced from genetically modified maize), sodium chloride, sodium citrate, sodium hydroxide, hydrochloric acid, water for injection. Each 10 ml vial of concentrate contains 52.6 mg of sodium; each 50 ml vial of concentrate contains 263 mg of sodium. PHARMACEUTICAL FORM AND ACTIVE SUBSTANCE QUANTITY PER UNIT 1 rubber-stoppered vial with 10 ml concentrate for solution for infusion contains 100 mg rituximab. 1 rubber-stoppered vial with 50 ml concentrate for solution for infusion contains 500 mg rituximab. INDICATIONS/USES NON- HODGKIN’S LYMPHOMA (NHL) Monotherapy in patients with CD20-positive follicular non-Hodgkin’s lymphoma (stage III–IV) who have relapsed after, or failed to respond to, chemotherapy. Treatment of previously untreated patients with CD20-positive follicular non-Hodgkin’s lymphoma (stage III–IV) with high tumour burden in combination with CVP or CHOP. Responders may be administered maintenance therapy with rituximab monotherapy for 2 years. Maintenance therapy of patients with relapsed or refractory CD20-positive follicular non- Hodgkin’s lymphoma (stage III–IV) who have responded to induction therapy with CHOP with or without rituximab. Treatment of patients with CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL) in combination with standard CHOP (8 cycles of cyclophosphamide, doxorubicin, vincristine and prednisone). Use in combination with fludarabine and cyclophosphamide (R-FC) for patients requiring treatment for chronic lymphocytic leukaemia (CLL). Patients previously treated with fludarabine should have responded for a period of at least 6 months. RHEUMATOID ARTHRITIS (RA) MabThera in combination with methotrexate (MTX) is indicated for the treatment of adult patients with moderately severe to sever Lue koko asiakirja