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āĻāĻžāĻˇāĻž: āĻāĻāĻ°ā§āĻāĻŋ
āĻ¸ā§āĻ¤ā§āĻ°: JFDA (Jordan Food & Drug Administration - اŲŲ ؤØŗØŗØŠ اŲؚاŲ ØŠ ŲŲØēØ°Ø§ØĄ ŲاŲدŲØ§ØĄ)
Rituximab 100 mg/10ml
Ų ØŗØĒŲدؚ ادŲŲØŠ شاŲŲ Ų ØąØ´ŲداØĒ Ų Ų ØŗŲاØĒ - Shawi & Rushedat Drug Store
L01XC02
Rituximab 100 mg/10ml
100 mg/10ml
2 vials
Roche Diagnostics GmbH , Mannheim (اŲŲ اŲŲا)
Aug 2021 Product Information GCC Ro 45-2294 MabThera Aug 2021 1 Product Information GCC MABTHERA ÂŽ 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- HODGKINâS LYMPHOMA (NHL) Monotherapy in patients with CD20-positive follicular non-Hodgkinâs lymphoma (stage IIIâIV) who have relapsed after, or failed to respond to, chemotherapy. Treatment of previously untreated patients with CD20-positive follicular non-Hodgkinâs lymphoma (stage IIIâIV) 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- Hodgkinâs lymphoma (stage IIIâIV) who have responded to induction therapy with CHOP with or without rituximab. Treatment of patients with CD20-positive diffuse large B-cell non-Hodgkinâs 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 āĻ¸āĻŽā§āĻĒā§āĻ°ā§āĻŖ āĻ¨āĻĨāĻŋ āĻĒāĻĄāĻŧā§āĻ¨