দেশ: ইন্দোনেশিয়া
ভাষা: ইন্দোনেশীয়
সূত্র: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FLUDARABINE PHOSPHATE
AVENTIS PHARMA - Indonesia
FLUDARABINE PHOSPHATE
50.000 MG
SERBUK INJEKSI
DUS, 5 VIAL @ 50 MG
BAXTER ONCOLOGY GMBH - German Democratic Republic
2021-10-25
1 FLUDARA ® FLUDARABINE PHOSPHATE Important information, please read carefully! COMPOSITION Each vial contains 50 mg fludarabine phosphate. 1 ml of reconstituted solution for injection/infusion contains 25 mg fludarabine phosphate. Each vial also contains 50 mg of mannitol and sodium hydroxide which is present to maintain the desired pH. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Antineoplastic agents, purine analogues ATC code: L01B B05 Fludara contains fludarabine phosphate, a fluorinated nucleotide analogue of the antiviral agent vidarabine, 9-ß-D- arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Fludarabine phosphate is rapidly dephosphorylated to 2F-ara-A which is taken up by cells and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2F-ara-ATP. This metabolite has been shown to inhibit ribonucleotide reductase, DNA polymerase , and , DNA primase and DNA ligase thereby inhibiting DNA synthesis. Furthermore, partial inhibition of RNA polymerase II and consequent reduction in protein synthesis occur. While some aspects of the mechanism of action of 2F-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 CLL lymphocytes to 2F-ara-A triggers extensive DNA fragmentation and cell death characteristic of apoptosis. For the indication Lg-NHL a randomised phase III trial in pre-treated Lg-NHL patients compared Fludara with a commonly used combination chemo-therapy cyclophosphamide, vincristine and prednisone (CVP). The overall response rates did not differ statistically significantly, although it was slightly higher in the Fludara- (55%) than in the CVP treatment arm (50%). PHARMACOKINETIC PROPERTIES PLASMA AND URINARY PHARMACOKINETICS OF FLUDARABINE (2F-ARA-A) The pharmacokinetics o সম্পূর্ণ নথি পড়ুন