ERYSAA®

• ERYSAA® PREFILLED SYRINGE 2,000 IU / 0.5 ml is a sterile, clear, colorless liquid in phosphate-buffered solution for intravenous administration that is available in single-use, graduated pre-filled syringes containing 2,000 IU / 0.5 ml. Each pre-filled syringe contains Epoetin alfa 2,000 international units (IU) corresponding to 16.8 micrograms Epoetin alfa. • ERYSAA® PREFILLED SYRINGE 4,000 IU / 0.4 ml is a sterile, clear, colorless liquid in phosphate-buffered solution for intravenous administration that is available in single-use, graduated pre-filled syringes containing 4,000 IU / 0.4 ml. Each pre-filled syringe contains Epoetin alfa 4,000 international units (IU) corresponding to 33.6 micrograms Epoetin alfa. • Epoetin alfa is a glycoprotein that is produced by recombinant DNA technology. ERYSAA® stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. ERYSAA® (Epoetin alfa) obtained by gene technology is glycosylated and is identical in its amino acid and carbohydrate composition to endogenous human erythropoietin that has been isolated from the urine of anaemic patients. • ERYSAA® has the highest possible purity according to the latest state of the art technology. In particular, no residue of the cell line used for the production is detectable at the concentrations of the active ingredient that are used in humans. • ERYSAA® is an erythropoiesis-stimulating agent (ESA) indicated for treatment of anaemia associated with chronic renal failure in adult haemodialysis and predialysis patients and paediatric patients on haemodialysis. ERYSAA® also use to facilitate autologous blood collection within a predeposit program and decrease the risk of receiving allogeneic blood transfusions in patients with hematocrits of 33 - 39%, who are scheduled for major elective surgery and are expected to require more blood than that which can be obtained through autologous blood collection techniques in the absence of Epoetin alfa.