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The use of recombinant human erythropoietin to prevent carboplatin-induced anemia.
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Physician awareness of potential differences between biopharmaceuticals and biosimilars and the impact on safety and efficacy is critical for patient safety.
Investigational New Drug (IND) meetings covering 12 different biological reference products.
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TDAR or other immune function tests.
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Besides this thorough examination of the drugs ingredients and performance, the FDA also conducts periodic inspections of the manufacturing plants to ensure there are no changes in the approved drugs quality.
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Erythropoietin should be used only to treat anemia caused by chemotherapy -- not anemia due to other causes in patients with cancer.
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More recently, the manufacturers have reported estimated product-specific rates of EPO-associated PRCA.
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Cycle 1 - administered weekly for 7 weeks followed by a week of rest.
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For patients on peritoneal dialysis EPREX may be given twice a week.
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Tests to assess the relative risk of mAb candidates for cytokine release syndrome, innate immune system (dendritic cell) activation and immunogenicity in humans are also described.
Inflammation in mice that are hepcidin-deficient did not lead to hypoferremia, a finding that suggests that hepcidin may be centrally involved in the diversion of iron traffic through decreased duodenal absorption of iron and the blocking of iron release from macrophages that occurs in anemia of chronic disease ().
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The metal contaminant may have caused denaturation and aggregation, which in turn could have caused an immune response ().
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Adverse events related to the parenteral mode of administration are often reflected in adverse reactions at the site of administration.
Although a retrospective one, this study, for the first time, answered many of the unknown questions concerning CsA therapy.
Ketosteril Tablets is generally known as Compound Ketosteril Tablets and it is used for preventing and treating renal damages due to protein metabolism disorder in chronic kidney disease (CKD) and the effects are better with low-protein diets.
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All randomized subjects who met enrollment criteria and received at least 2 cycles of study drug were considered evaluable for efficacy.
Current Management of Iron Deficiency Anemia in Inflammatory Bowel Diseases: A Practical Guide.
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Association between the activation of macrophages, changes of iron metabolism and the degree of anaemia in patients with malignant disorders.
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The presence of other medical problems may affect the use of epoetin.
But Eprex is also nonimmunogenic in humans, except in the rare cases of those who develop PRCA.
These types of approaches can result in data interpretation that is not only subjective, but limited in terms of their scope and utility.
This product is used in the treatment of anemia in those with Chronic Renal Failure, Zidovudine treated HIV Infection, and in cancer treatments.
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