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Литература

  1. Иммуносупрессия при трансплантации солидных органов / Под ред. С. В. Готье. – М. – Тверь: ООО «ИздательствоТриада», 2011. – 382 с.
  2. Данович Габриэль М. Трансплантация почки / Пер. с англ. под ред. Я. Г. Мойсюка. – М: ГЭОТАР−Медиа, 2013. – 848 с.
  3. Мойсюк Я. Г., Столяревич Е. C., Томилина Н. А. Болезнь почечного трансплантата / Нефрология: национальное руководство // под ред. Н. А. Мухина. – М.: ГЭОТАР−Медиа, 2009. – 588 с. (Серия «Национальные руководства»).
  4. Столяревич Е.С. «Сандиммун−Неорал и генерические препараты циклоспорина; проблема взаимозаменяемости» // Нефрология и диализ. – 2006. – том. 8, №2. – с. 141−147
  5. Столяревич Е.С, Суханов А.В., ..Багдасарян А.Р., Томилина Н.А. К вопросу об оптимизации мониторинга терапии препаратами циклоспорина в поздние сроки после аллотрансплантации почки. // Нефрология и диализ. – 2004. – том. 6, №2. – с. 145 – 154
  6. Kidney transplantation: principles and practice. 6th ed. / Ed. by Sir Peter J. Morris T. and Stuart J. Knechtle // Philadelphia: Elsevier Saunders, 2008
  7. Kable, A. Alcaraz, K. Budde, U. Humke, G. Karam, M., Lucan, G. Nicita, C. Susal Трансплантация почки: Клинические рекомендации Европейской Ассоциации Урологов, 2010 / Перевод с англ под ред. Д.В. Перлина. – М.: АБВ−Пресс, 2010. 2010. – 100 с.
  8. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant, 2009. 9 Suppl 3: p. S1−155
  9. Belitsky P, Dunn S, Johnston A. et al. Impact of absorbtion profiling on efficacy and safety of cyclosporin therapy in transplant recipients // Clin Pharmacokinet.− 2000.−Vol.39.− p.117−25.
  10. Cantarovich M.,Besner J−G., Barkun J.S. et al. Two−hour cyclosporine level determination is the appropriate tool to monitor Neoral therapy. // Clin Transplant.− 1998.− Vol.12.−pp 243−249
  11. Citterio F., Scata M.C., Borzi M.T. et al. C2 Single−Point sampling to evaluate Cyclosporine exposure in long−term renal transplant recipients // Transplant. Proc.−2001.− Vol.33.−p.3133−3136
  12. Einecke G., Mai I., Diekmann F. et al. Optimizing Neoral therapeutic drug monitoring with cyclosporine trough (Co) and C2 concentrations in stable renal allograft recipients // Transplant. Proc.−2001.− №.33. −Р.3102−3103
  13. Ekberg H, Grinyó J, Nashan B. et al. Cyclosporine sparing with mycophenolate mofetil, daclizumab and corticosteroids in renal allograft recipients: the CAESAR Study // Am J Transplant. −2007. −№3. –Р.560−570
  14. Gaspari F, Anedda MF, Signorini O. et al Prediction of cyclosporine area under the curve using a three−point sampling strategy after Neoral administration. . // J Am Soc Nephrol – 1997.− V8(4)–pp.647−52.
  15. Gaspari F, Perico N, Signorini O et al. Abbreviated kinetic profiles in area−under−the−curve monitoring of cyclosporine therapy. Technical note. // Kidney Int.−1998.V.54(6).−pp.2146−50.
  16. Helderman J. H, Kang N, Legorreta A.P and Chen J.Y. Healthcare Costs in Renal Transplant Recipients Using Branded versus Generic Ciclosporin. Appl Health Econ Health Policy 2010; 8 (1): 61−68
  17. Johnston A, Belitsky P, Frey U. Potential clinical implication of substitution of generic cyclosporine formulations for cyclosporine (Neoral) in transplant recipients. European Journal of clinical pharmacology; 60(6):389−95
  18. Kahan BD,Welsh M, Rutzky l. P Challenges in Cyclosporine therapy: The role of therapeutic monitoring by area under the curve monitoring. Ther Dtug Monit 1995;17:621−624
  19. Kahan BD,Welsh M Urbauer D.L Low Intraindividual Variability of Cyclosporin A Exposure Reduces Chronic Rejection Incidence and Health Care Costs Am Soc Nephrol 11:1122−1131, 2000
  20. Kuypers DR, Ekberg H, Grinyó J. et al. Mycophenolic acid exposure after administration of mycophenolate mofetil in the presence and absence of cyclosporin in renal transplant recipients // Clin Pharmacokinet. −2009. −№5. –Р. 329−341.
  21. Leone J, Vitko S, Whelchel J, et al. Excellent graft function in de novo kidney transplant recipients treated with Certican, Simulect and reduced Neoral exposure: 24 month results // Am. J. Transplant. −2005. −№5(Suppl 11). –Р.1010.
  22. Marsh CL. Abbreviated pharmacokinetic profiles in area−under−the−curve monitoring of cyclosporine therapy in de novo renal transplant patients treated with Sandimmune or Neoral. Neoral study group.// Ther Drug Monit.− 1999.− Vol.21(1).−pp 27−34.
  23. Masri M.A., Barbari A., Stephan A. Pharmacokinetics in stable renal tansplant patients: effect of formulation sandimmun versus consupren versus neural. Transplant Proc 1996;28:1318−1320
  24. Meyer M.M., Munar M., Udeaja J. et al. Efficacy of area under the curve cyclosporine monitoring in renal transplantation. // J Am Soc Nephrol – 1993.− V4–pp.1306−1315.
  25. Morris R.G., Russ G.R., Cervelli M.J. et al. Comparison of trough, 2−hour, and limited AUC blood sampling for monitoring cyclosporin (Neoral) at day 7 post−renal transplantation and incidence of rejection in the first month. // Ther Drug Monit.− 2002.−Vol24.−pp. 479−86.
  26. Noble S.,Markham A. Cyclosporin: а reviеw of its pharmacokinetic properties, clinical efficacy and tolerability of microemulsion−based formulation (Neoral). Drugs,1995;50:924−941
  27. Pascual J, Boletis I, B., Campistol J.M. et al. Everolimus (Certican) in renal transplantation: a review of clinical trial data, current usage, and future directions // Transplantation Reviews. −2006. −№ 20. –Р. 1−18.
  28. Pascual J. Concentration−controlled everolimus (Certican): combination with reduced dose calcineurin inhibitors // Transplantation. −2005. −№9 ( Suppl). –Р.76−79
  29. Pollard S, Nashan B., Johnston A A Pharmacokinetic and clinical review of the potential clinical impact of using different formulations of Cyclosporin A. Clinical Therapeutics (2003)Vol.25; 6: 1654−1664
  30. Qazi YA, Forrest A, Tornatore K, Venuto RC. The clinical impact of 1:1 conversion from Neoral to a generic cyclosporine (Gengraf) in renal transplant recipients with stable graft function. Clin Transplant 2006: 20: 313–317.
  31. Sánchez−Fructuoso AI, de la Higuera MA, Giorgi M et al. Inadequate mycophenolic acid exposure and acute rejection in kidney transplantation // Transplant Proc. −2009. −№41(6). –Р.2104−2105
  32. Vitko S, Tedesco H, Eris J, et al. Everolimus with optimized cyclosporine dosing in renal transplant recipients: 6−month safety and efficacy results of two randomized studies // Am J Transplant. – 2004. −№ 4. –Р. 626−629.
  33. Инструкция по медицинскому применению препаратов циклоспорина и такролимуса
  34. Оценка биоэквивалентности лекарственных средств: Методические указания. Министерство здравоохранения и социального развития РФ, Федеральная служба по надзору в сфере здравоохранения и социального развития, ФГУ «Научный центр экспертизы средств медицинского применения». − М., 2008.
  35. Momper JD, Ridenour TA, Schonder KS, Shapiro R, Humar A, Venkataramanan R. The impact of conversion from prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function. Am J Transplant. 2011 Sep;11(9):1861−7.
  36. McDevitt−Potter LM, Sadaka B, Tichy EM, Roger s CC, Gabardi S. A multicenter experience with generic tacrolimus conversion. Transplantation. 2011 Sep 27;92(6):653−7.
  37. Abdulnour HA, Araya CE, Dharnidharka VR. Comparison of generic tacrolimus and Prograf drug levels in a pediatric kidney transplant program: brief communication. Pediatr Transplant. 2010 Dec;14(8):1007−11. (Abstract)
  38. van Gelder T. et al. European society for organ transplantation advisory committee recommendations on generic substitution of immunosuppressive drugs. Transpl Int. 2011 Dec;24(12):1135−41.
  39. Harrison JJ, Schiff JR, Coursol CJ, Daley CJ, Dipchand AI, Heywood NM, Keough−Ryan TM, Keown PA, Levy GA, Lien DC, Wichart JR, Cantarovich M. Generic immunosuppression in solid organ transplantation: a Canadian perspective. Transplantation. 2012 Apr 15;93(7):657−65.
  40. Immunosoppressori Generici. CONSIDERAZIONI DALLA SIN PIEMONTE E VALLE D'AOSTA. CONSENSUS STATEMENT ON GENERIC SUBSTITUTION FOR IMMUNOSUPPRESSANTS WITH A NARROW THERAPEUTIC INDEX. http://www.nephromeet.com/web/procedure/protocollo.cfm?List=WsIdEven to,WsIdRisposta,WsRelease&c1=SinSpace&c2=13&c3=1
  41. MHRA and CHM. Tacrolimus (Advagraf and Prograf): risk of serious medication errors. Dru Safety. Update. Volume 2, Issue 6 January 2009. Pages 4−5. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON088145 MHRA and CHM. Oral tacrolimus products: measures to reduce risk of medication errors. Drug Safety. Update. Volume 3, Issue 10 May 2010. Pages 5−7. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON085144
  42. MHRA and CHM. Oral tacrolimus products: prescribe and dispense by brand name only, to minimise the risk of inadvertent switching between products, which has been associated with reports of toxicity and graft rejection. Drug Safety. Update. Volume 5, Issue 11 June 2012. A1.http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON155756
  43. Letter to healthcare professionals on updated advice for oral tacrolimus products. https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertI D=101781 http://www.mhra.gov.uk/home/groups/comms−ic/documents/websiteresou rces/con152759.pdf
  44. Ciclosporin: must be prescribed and dispensed by brand name. Drug Safety Update. Volume 3, Issue 5 Dec 2009. Page 2. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON087726
  45. Generic substitution terminated for oral medicines containing cyclosporine or tacrolimus. http://laegemiddelstyrelsen.dk/en/topics/authorisation−and−supervision/lic ensing−of−medicines/news/generic−substitution−terminated−for−oral−−tacr olimus

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