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I have been on Epogen for years and it has helped me a lot with my anemia. Now the doctors have stared me on another drug and i feel terrible. I am going to ask for another prescription of Epogen as it is the only medication that allows me to feel ok and live normal life.
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More biosimilars competing with the same reference product will add to pricing pressures, in addition to a discount of 15% or more for a biosimilar compared to the branded drug.
There is however another important difference: the price.
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Immunogenicity can be induced by active-drug substance products, manufacturing impurities from changes in cell lines or media components, structural modifications, protein aggregation, suboptimum storage processes, and patient factors including human leucocyte antigen expression, comorbid conditions, and previous exposures.
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Normalization of haemoglobin concentration with recombinant erythropoietin has minimal effect on blood haemostasis.
Sest pacijenata je imalo pozitivan persantinski test prema ehokardiografskim kriterijumima.
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This was a Phase 3, parallel-group, randomized, multicenter, open-label, active-controlled study of women with epithelial ovarian carcinoma whose disease did not respond to or recurred after treatment with first-line chemotherapy with a platinum-based regimen.
Since nephrotoxicity constitutes the major limiting side effect of CsA, careful and progressive decrease of the dosage to the minimum required for maintenance of remission is appropriate.
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Utilization of darbepoetin alfa and epoetin alfa for chemotherapy-induced anemia.
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Since 1988, millions of patients have received epoetin products intravenously (IV) and subcutaneously.
Traditionally, the most widely used iron tests are serum ferritin and transferrin saturation (TSAT) levels.
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The third case study describes an alternative data visualization tool that involves a more rigorous mathematical treatment of the biophysical data to carry out a statistical comparison for comparability studies (Iyer et al.
Broad understanding of these issues is critical for oncologists preparing for their use in clinical practice.
In this audit of patients with solid tumors and chemotherapy-induced anemia, the hemoglobin response rate was 77% among patients treated with biosimilar epoetin α alone, and 93% among those who received supplemental intravenous iron.
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Hydrea for over a year which did lower the platelets but did not reduce the spleen size.
Spain has not adopted many biosimilars because prescribing decisions are made regionally by local physicians with strong connections to originator manufacturers.
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Anemia of chronic disease (ACD), also called anemia of chronic inflammation (ACI), is a common condition associated with a wide variety of persistent inflammatory diseases.
Many felt that the other restrictions imposed would limit the overall dose.
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Data are submitted of results of treatment of anemia of nephrogenic genesis in 44 patients with diabetes mellitus complicated by diabetic glomerulosclerosis and chronic renal failure (CRF).
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Iron Deficiency, Iron Overload and Therapy.
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US legislation for biosimilars was enacted in 2009.
Red blood cell distribution width and 1-year mortality in acute heart failure.
The hematocrit should return to normal after 2 months of iron therapy.
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Local Medicare contractors may continue to make reasonable and necessary determinations on all uses of ESAs that are not determined by NCD.
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These T cells orchestrate a delayed immune response that most often affects the skin, causing itchy rashes, and occurs days to weeks after exposure to the drug.
Production of endogenous erythropoietin is impaired in patients with chronic renal failure (CRF), and erythropoietin deficiency is the primary cause of their anemia.
In patients with CKD the major cause of resistance towards ESAs is reduced iron availability, due to the action of hepcidin.
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Die AXXO GmbH, ein in Hamburg ansässiges Unternehmen, erwarb unlängst die mexikanische Firma Nedder Farmaceuticos, die als Tochtergesellschaft unter dem Namen Axxo Mexico firmierte und unter anderem ein rekombinantes EPO für den lateinamerikanischen Markt produziert.
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In general, features of clinical studies that improve quality and decrease bias include the selection of a clinically relevant cohort, the consistent use of a single good reference standard, the blinding of readers of the index test and reference test results.
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Enhanced cell production manifested itself as a rise in the plasma iron turnover (PIT) and a decrease in the half-time of iron in the plasma.
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In Study 1 subjects who were not receiving dialysis were randomized to Mircera or darbepoetin alfa, administered for 28 weeks.
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Identification of multiple transferrin species in the spleen and serum from mice with collagen-induced arthritis which may reflect changes in transferrin glycosylation associated with disease activity: The role of CD38.
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Immunogenicity testing of the biosimilar and the reference product should be conducted within the biosimilar comparability exercise by using the same assay format and sampling schedule.
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