Land: Jórdanía
Tungumál: enska
Heimild: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)
Rituximab 100 mg/10ml
شركة ام اس فارما - MS Pharma
L01XC02
Rituximab 100 mg/10ml
100 mg/10ml
2 Vial X 10ml
Mabxience S.A.U (الأرجنتين)
TROMAX ® Rituximab 420x300 mm Color: Black TROMAX ® Rituximab 12/2018 DESCRIPTION: _ACTIVE SUBSTANCES: RITUXIMAB _ _EXCIPIENTS:_ Sodium chloride, Sodium Citrate Dihydrate, polysorbate 80, hydrochloric acid, sodium hydroxide and water for injection. TROMAX ® (Rituximab) is a chimeric mouse/human monoclonal antibody that binds specifically to the Transmembrane antigen CD20. This antigen is located on pre-B- and mature B-lymphocytes, But not on hemopoietic stem cells, pro-B-cells, normal plasma cells or other Normal tissue. The antigen is expressed on >95% of all cells of B-cell non-Hodgkin's Lymphomas (NHLs). Following antibody binding, CD20 is not internalized or shed from the cell membrane into the environ- ment. CD20 does not circulate in the plasma as a free Antigen and thus does not compete for antibody binding. Studies conducted to date have shown no connection between the intensity of CD20 expres- sion on malignant cells and Therapeutic response. Rituximab binds to the CD20 antigen on B-Iymphocytes and causes B-cell lysis. Possible Mechanisms of cell lysis include complement-dependent cytotoxicity (CDC) and antibody dependent Cellular cytotox- icity (ADCC) and induction of apoptosis. PROPERTIES: The mean C max following the fourth infusion of 375 mg/m 2 is 486 µg/ml (range 77.5 to 996.6 µg/ml). Following the intravenous administration of 500 and 1,000 mg doses of Rituximab on two occasions two weeks apart, mean C max values were 183 µg/ml (range 81.8 to 279 µg/ml) and 370 µg/ml (range 212 to 637 µg/ml), respectively. Distribution: The mean steady-state distribution volume was 4.6L (range 1.7 to 7.51L). Elimination: Like all proteins, Rituximab is broken down in the liver. The estimated mean Terminal elimination half-life of Rituximab is 20.8 to 24 days (range 6.1 to 52 days). Tumour mass has an influence on specific clearance. INDICATIONS: TROMAX ® INDICATED FOR THE: NON-HODGKIN'S LYMPHOMA Monotherapy in patients with CD20-positive follicular non-Hodgkin's lymphoma (stage III-IV) who have relaps Lestu allt skjalið