البلد: جنوب أفريقيا
اللغة: الإنجليزية
المصدر: South African Health Products Regulatory Authority (SAHPRA)
Schering
INDICATIONS [/za_1085.html#1] [/za_1085.html#1] [/za_1085.html#1] CONTRA-INDICATIONS [/za_1085.html#1] [/za_1085.html#1] DOSAGE [/za_1085.html#1] [/za_1085.html#1] SIDE-EFFECTS [/za_1085.html#1] [/za_1085.html#1] [/za_1085.html#1] PREGNANCY [/za_1085.html#1] [/za_1085.html#1] OVERDOSE [/za_1085.html#1] IDENTIFICATION [/za_1085.html#1] [/za_1085.html#1] PATIENT INFORMATION FLUDARA SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): FLUDARA STERILE LYOPHILISED SOLID CAKE FOR SOLUTION COMPOSITION Each vial contains 50 mg FLUDARABINE phosphate as a lyophilised solid cake (equivalent to 39,05 mg fludarabine per vial). PHARMACOLOGICAL CLASSIFICATION A. 26 Cytostatic agents. PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Fludara contains fludarabine phosphate, a fluorinated nucleotide analogue of the antiviral agent vidarabine, 9-beta-D- arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A which is taken up by cells and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite has been shown to inhibit ribonucleotide reductase, DNA polymerase alpha/delta and epsilon, DNA primase and DNA ligase thereby inhibiting DNA synthesis. Furthermore, partial inhibition of RNA polymerase II and consequent reduction in protein synthesis occurs. While some aspects of the mechanism of action of 2-fluoro-ara-ATP are as yet unclear, it is assumed that effects on DNA, RNA and protein synthesis all contribute to inhibition of cell growth with inhibition of DNA synthesis being the dominant factor. In addition, in vitro studies have shown that exposure of chronic lymphocytic leukaemia lymphocytes to 2F-ara-A triggers اقرأ الوثيقة كاملة