A Prospective Study on the Pharmacokinetics of Monoclonal-antibody-purified Factor VIII Concentrate (GreenMono (R)) in Previously Treated Subjects with Hemophilia A / 대한혈액학회지
Korean Journal of Hematology
;
: 148-153, 2001.
Artículo
en Coreano
| WPRIM
| ID: wpr-720540
ABSTRACT
BACKGROUND:
GreenMono (R) is a plasma-derived factor VIII concentrate produced by Greencross PD based on a license of Baxters monoclonal antibody technology. The purpose of this prospective study was to document the pharmacokinetics and the acute safety of the drug.METHODS:
Pharmacokinetic analysis was performed in 13 previously treated patients with hemophilia A after administration of GreenMono (R) with dose of 50units/kg. The adverse effects were observed, and changes of laboratory tests, including complete blood counts, liver and kidney function tests, urinalysis, were assessed 48 hours after the drug administration. Bethesda assay for inhibitors to factor VIII were performed on 3-7 days.RESULTS:
The recovery rate of GreenMono (R) was 99+-22% (range, 71~136%), and plasma beta half life analysed by 2-compartment model was 15.7+-6.6 hours (range, 9.7~35.9 hours). No clinically significant immediate adverse effects were observed after administration of GreenMono (R). No significant change in laboratory tests were observed after administration of GreenMono (R). Inhibitors to factor VIII were maintained below 0.6 BU.CONCLUSION:
GreenMono (R) is effective in pharmacokinetic analysis, and is safe without any immediate adverse effect.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Plasma
/
Recuento de Células Sanguíneas
/
Factor VIII
/
Farmacocinética
/
Estudios Prospectivos
/
Urinálisis
/
Semivida
/
Hemofilia A
/
Pruebas de Función Renal
/
Concesión de Licencias
Tipo de estudio:
Estudio observacional
/
Estudio pronóstico
Límite:
Humanos
Idioma:
Coreano
Revista:
Korean Journal of Hematology
Año:
2001
Tipo del documento:
Artículo
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