Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
Fludarabine phosphate
Actavis Australia Pty Ltd
Medicine Registered
Actavis Australia Pty Ltd FLUDARABINE ACTAVIS 50 fludarabine phosphate 50 mg powder for injection vial CONSUMER MEDICINE INFORMATION MAY 2009 WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Fludarabine Actavis 50. It does not contain all of the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of using Fludarabine Actavis 50 against the benefits it is expected to have for you. Only your doctor is able to weigh up all the relevant facts and you should consult him/her about all aspects of this medication as it relates to you. If you have any concerns about using Fludarabine Actavis 50, ask your doctor. Keep this leaflet. You may want to read it again. WHAT FLUDARABINE ACTAVIS 50 IS USED FOR AND HOW IT WORKS Fludarabine Actavis 50 is used to treat a form of leukaemia known as chronic lymphocytic leukaemia, or CLL. All cells in the body produce new cells like themselves by dividing. For this purpose, the cells' genetic material (DNA) must be copied and reproduced. Fludarabine Actavis 50 works by hindering the production of new DNA. Therefore, when Fludarabine Actavis 50 is taken up by the cancer cells it stops the growth of new cancer cells. It has been discovered that Fludarabine Actavis 50 works especially well against some cancers of the white blood cells. BEFORE YOU ARE GIVEN FLUDARABINE ACTAVIS 50 _WHEN YOU MUST NOT USE _ _IT _ You must not be given Fludarabine Actavis 50 if any of the following apply to you: • Pregnancy or breast- feeding • Allergy (hypersensitivity) to any of the ingredients Прочетете целия документ
Fludarabine Actavis PRODUCT INFORMATION NAME OF THE MEDICINE FLUDARABINE ACTAVIS 50 fludarabine phosphate 50mg powder for injection vial FLUDARABINE PHOSPHATE DESCRIPTION Chemical name: 9-β-D-arabinofuranosyl -2-fluoroadenine 5'-(dihydrogen phosphate). Molecular formula: C 10 H 13 FN 5 O 7 P. MW: 365.2. CAS: 75607-67-9 Fludarabine phosphate is a fluorinated nucleotide analogue of the antiviral agent vidarabine (9- beta-d-arabinofuranosyladenine) that is relatively resistant to deamination by adenosine deaminase. When reconstituted as instructed, the pH range of the final solution is 7.2 to 8.2 (target 7.7). Fludarabine phosphate is a white or almost white, hygroscopic, crystalline powder. It is slightly soluble in water; very slightly soluble in dehydrated alcohol; freely soluble in dimethylformamide. PHARMACOLOGY Fludarabine phosphate is rapidly dephosphorylated to fludarabine (2F-ara-A), which is taken up by cells and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, fludarabine triphosphate (2F-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 fludarabine triphosphate 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 (CLL) lymphocytes to fludarabine (2F-ara-A) triggers extensive DNA fragmentation and cell death characteristic of apoptosis. FLUDARABINE ACTAVIS – Product information Page 2 of 12 Fludarabi Прочетете целия документ