מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUDARABINE PHOSPHATE
FRESENIUS KABI MALAYSIA SDN. BHD
FLUDARABINE PHOSPHATE
1vial Vials
Fresenius Kabi Oncology Limited (XI Route)
_ _ _ _ 1 For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory FLUDARABINE KABI 50MG LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION OR INFUSION DESCRIPTION: Fludarabine Kabi 50mg Lyophilized Powder for Solution for Injection or Infusion, is a sterile lyophilized white or almost white powder or cake. The reconstituted solution is clear and colourless. COMPOSITION: Each Vial contains: Fludarabine Phosphate 50 mg Mannitol 50mg Sodium Hydroxide q.s. to adjust pH CHEMICAL STRUCTURE: The chemical name for Fludarabine phosphate is 9 _H_ -Purin-6-amine, 2-fluoro-9-(5- _O_ - phosphono-β-D-arabinofuranosyl)(2-fluoro-ara-AMP). The molecular formula of Fludarabine phosphate is C 10 H 13 FN 5 O 7 P (molecular weight- 365.2) and the structure is: PHARMACOLOGY: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, purine analogues ATC code: L01B B05 Fludarabine is a water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine, 9 ß D arabinofuranosyladenine (ara A) that is relatively resistant to deamination by adenosine deaminase. Fludarabine 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 (deoxyribonucleotide) polymerase α/δ and ε, 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 (ribonucleic acid) 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. _ _ _ _ 2 PHARMACOKINETICS • PLASMA AND URINARY PH קרא את המסמך השלם