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European PRCA Working Group indicated that immunosuppression or renal transplantation was required to diminish transfusion dependency among hemodialyzed chronic kidney disease patients with PRCA and cautioned against rechallenge with epoetin products.
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Anemia treatment in the pre-ESRD period and associated mortality in elderly patients.
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The matter of expediting competition in the costly and rapidly evolving therapeutic biologics market has great medical and economic significance.
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Exploring the effect of erythropoietin on mortality using USRDS data.
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Evaluation and Determinants of Underprescription of Erythropoiesis Stimulating Agents in Pre-Dialysis Patients with Anaemia.
It also increased the amount of blood that could be taken from patients before surgery for autologous blood transfusion and reduced the need for transfusion in premature babies and in cancer patients receiving chemotherapy.
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Association of inflammation with anaemia in patients with chronic kidney disease not requiring chronic dialysis.
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MEN 11303“ erzielte in In-vitro-Untersuchungen eine im Vergleich zu Dosen der Einzelfaktoren signifikante Verbesserung bei der Expansion von erythroiden Progenitorzellen.
Despite these caveats, data from available studies were sufficient for FDA to reassess the safety of ESAs in patients with cancer and to re-evaluate the net clinical benefit of ESAs in this setting.
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Specifically, the study compared the population-weighted direct costs of managing anemia with originator epoetin α, epoetin β, darbepoetin α, and biosimilar epoetin α in one patient with cancer undergoing a chemotherapy regimen of six cycles at 3-week intervals (18 weeks) and with ESA initiation at week 4 and continued for a total of 15 weeks.
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Recombinant Human Erythropoietin and Overall Survival in Cancer Patients: Results of a Comprehensive Meta-analysis.
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Commenting on the new data Professor François Berthoux of the CHU Saint Etienne, France and scientific committee member of the study said, “Our findings demonstrated that subcutaneous administration of NeoRecormon causes less pain and discomfort and was better tolerated than Aranesp.
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Anemia normalization in patients with type 2 diabetes and chronic kidney disease: results of the NEPHRODIAB2 randomized trial.
In a few patients who do not exhibit adequate response to intravenous ESA administration despite dose adjustment, consideration should be given to switching to the subcutaneous route.
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Extrarenal causes for the anemia were excluded in all patients.
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Anaemia, diabetes and chronic kidney disease: where are we now?
This guideline provides a broad overview of the immunogenic issues that biopharmaceutical companies must adequately address for the approval of a biosimilar product or when a manufacturing change occurs.
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Aranesp on overall mortality in this patient population, and so we conclude that the risk benefit ratio for Aranesp in these extremely ill patients with anemia secondary to malignancy is, at best, neutral and perhaps negative.
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Hepcidin: a new tool in the management of anaemia in patients with chronic kidney disease?
At least 2 RCTs randomized patients with hepatitis C and ribavirin-related anemia to epoetin alfa or usual care.
Administration of ESA may be associated with exacerbation of hypertension in about 5% of patients that will require dose adjustment or switching to a different ESA.
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Anemia and end-stage renal disease in patients with type 2 diabetes and nephropathy.
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Simplify the Treatment of Anemia with Aranesp (STAAR).
Outcomes included the proportion of patients who were able to maintain full-dose treatment with ribavirin, mean Hb level, and QOL as measured by 36-Tiem Short-Form Health Survey.
Bio-Baxy Technologies, a Mumbai-based pharma company, is young and dedicated to developing indigenous resources to produce generic drug formulations.
Patients randomized in treatment group (A) received four injections of EPO-β (30.
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Astor BC, Muntner P, Levin A, Eustace JA, Coresh J: Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (1988-1994).
Vitamin K is excluded in formulations for individuals taking certain anticoagulation medicines.
Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin.
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Epoetin beta provided a slight beneficial effect on tumour progression and did not impact on early survival or thromboembolic-related mortality.
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It is therefore helpful to have contingency plans and guidelines for their management in place in every haematology department and hospital.
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Tungsten-Induced Denaturation and Aggregation of Epoetin Alfa During Primary Packaging as a Cause of Immunogenicity.
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In some embodiments, the compounds, drugs or agents of the present invention may be administered to a cell utilizing liposomes, nanoparticles, nanocapsules, nanovaults, etc.
Safe and Easy Introduction of Darbepoetin-Alpha in Patients Receiving Maintenance Hemodialysis and Epoetin Monotherapy: A “Half-and-Half” Combination Therapy.
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However, TPP can induce unwanted immune responses that can impact both drug efficacy and patient safety.
One example of the product-specific guidelines is the EMEA Annex to the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues; guidance on similar medicinal products containing recombinant erythropoietins.
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It is recommended that haemoglobin is monitored at regular intervals until stabilised and periodically thereafter (see PRECAUTIONS, Cardiovascular and Thrombotic events).
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Although risks of Hb targets greater than needed to avoid transfusions are now well-established, data from adequate, well-controlled studies employing recommended ESA doses and Hb targets are as yet insufficient to assess effects on survival or tumor promotion.
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Anaemia in patients with chronic kidney disease: Management with epoetin beta in primary care setting in New Zealand.
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ESA use increased disease progression.
The evidence for erythropoiesis-stimulating agents (ESAs; eg, epoetin alfa, pegylated epoetin beta, darbepoetin) in individuals who have chronic kidney disease and anemia includes randomized controlled trials (RCTs) and systematic reviews of RCTs.
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ESAs should be administered at the lowest dose possible, and the treatment should increase Hb concentration to the lowest level possible if it aims at avoiding RBC transfusions.
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Although the Mircera product label has not been updated since 2007, “Warnings” for use in CRF are similar to those listed next.
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Thus, the CREATE study adds direct evidence to confirm the current best practice guidelines, which recommend partial correction of anemia and not routine normalization of hemoglobin levels.
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In Study 2, subjects who were receiving dialysis were randomized to Mircera or another ESA (Epoetin alfa or Epoetin beta), administered for 24 weeks.
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Targeted Therapy: The New Frontier of Cancer Treatment.
The present invention also contemplates compositions and formulations comprising agents, compounds, or drugs selected from the group consisting of germacrene, guaiazulene, guaiol, gurjunene, hexahydrohumulene, himachalene, hinesol, humulene, junipene, longifolene, lubiminol, khusimone, khusinol, khusimol, nootkatone, santalene, santalol, santanol, santonene, selinene, solavetivone, spatulenol, sterpurine, sulcatine, thujopsene, valerenol, vetispirene, vetivazulene, vetivene, vetiverol, vetivone, viridiflorine, and viridiflorol as well as their derivatives and analogs.
In these analyses, we used the antimouse EPOR antibody M-20 from Santa Cruz Biotechnology.
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Differences between biological protein products claiming to be similar to approved biopharmaceuticals have been a major concern for the industry and regulatory agencies worldwide.
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It may relate to prolonged exposure (), effects of uremia on erythropoiesis (), and absence of concomitant severe immune suppression.
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Abbreviations: NCI, National Cancer Institute; WHO, World Health Organization.
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ANAEMIA AND MINERAL BONE DISORDER IN CHRONIC KIDNEY DISEASE: A REVIEW OF THE CURRENT LITERATURE AND IMPLICATIONS FOR CLINICAL NURSING PRACTICE.
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