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Conversion to generic cyclosporine A in stable chronic patients after heart transplantation.
Drug Des Devel Ther
August 2014
Department of Cardiology, University of Heidelberg, Heidelberg, Germany.
Background: Cyclosporine A (CSA) is a narrow therapeutic index drug. Available CSA products differ in the constitution of their emulsion. To compare intra-individual differences after a conversion to a generic CSA, a retrospective single-center study was initiated.
View Article and Find Full Text PDFGeneric formulation of Cyclosporine A, Equoral®, in de novo kidney transplant recipients: five-year follow-up.
Ann Transplant
October 2011
Department of Immunology, Transplant Medicine, and Internal Diseases, Medical University of Warsaw, Poland.
Background: Equoral(®) is a generic formulation of Cyclosporine A (CsA), which is significantly cheaper than the original medicine. Our center participated in the clinical trial designed to evaluate the efficacy and safety of Equoral(®) in kidney transplant recipients in the first 9 months after a transplant procedure. The aim of our paper is to present the 5-year follow-up of patients who participated in the study and were monitored in our center.
View Article and Find Full Text PDFIntroduction: Bioequivalence of Equoral has been suggested by measurements of pharmacokinetic parameters in healthy volunteers and in stable renal transplant recipients, but not study in allogeneic stem cell transplant (ASCT) recipients. The aim of our study was to compare the pharmacokinetics and safety of Equoral to Neoral solution among ASCT recipients.
Patients And Methods: Our open-label, two-way crossover, randomized controlled trial compared Equoral versus Neoral solutions in ASCT recipients.
The efficacy and safety of ciclosporin (Equoral®) capsules after renal transplantation: A multicentre, open-label, phase IV clinical trial.
Ann Transplant
March 2011
Department of Transplantation Medicine and Nephrology, Medical University of Warsaw, Poland.
Background: The use of bioequivalent generic ciclosporin is a cost-effective alternative to non-generic ciclosporin in renal transplant patients. This study aims to explore the efficacy, safety and tolerability of Equoral®, a generic ciclosporin, in adult de novo renal transplant patients.
Material/methods: This was a multicentre, open label, phase IV clinical study consisting of a 6-month treatment and 3-month follow-up periods.
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