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Mircera should be 120 mcg and once every two weeks dose should be 60 mcg.
This classic generic paradigm cannot be extrapolated to therapeutic proteins for a number of reasons ().
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This appears to be especially true for therapeutic indications, for which no specific clinical trials with the biosimilar have been performed and that have been licensed based on extrapolation of efficacy and safety data from other indications.
Epoetin Alfa Hexal must not be used in patients who are going to donate their own blood if they have had a heart attack or stroke within the last month, who have angina pectoris (a severe type of chest pain) or who are at risk of deep venous thrombosis (DVT: formation of blood clots in the deep veins of the body, usually in the leg).
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Overview of systematic review and economic evaluation of erythropoiesis stimulating agents for anemia of cancer or of chemotherapy (technology overview number 51) Canadian Agency for Drugs and Technologies in Health; Ottawa: 2009.
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In early February, the FDA accepted Amgen's Biologics License Application, or BLA, for ABP 501, another biosimilar to Humira, based upon clinical trial data from Phase 3 comparative efficacy and safety studies in both moderate-to-severe plaque psoriasis and rheumatoid arthritis, with a final FDA decision expected by September 25.
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Vibration testing and position sense was normal in the great toe bilaterally.
EPREX is used to treat the anaemia associated with kidney disease.
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Effect of covalent attachment of polyethylene glycol on immunogenicity and circulating life of bovine liver catalase.
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Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues.
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Preliminary studies suggest that erythropoietin therapy is beneficial and safe in patients with CHF and anemia.
The body stores only about 100 times its daily requirements for folate and can exhaust this supply within about 3 months if the diet is deficient in folate.
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If an immune response to the reference is rare, two separate studies may be sufficient to evaluate immunogenicity: 1) premarket study to detect major differences in immune responses between biosimilar and reference; 2) postmarket study to detect subtle differences in immunogenicity.
In the present analysis, biosimilar epoetin α remains cost efficient relative to darbepoetin α for both fixed and weight-based dosing even if only continuous standard dosing is considered.
Colorectal Cancer Awareness and Screening Preference: A Survey during the Malaysian World Digestive Day Campaign.
Drug-radiation interactions in tumor blood vessels.
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Indications of the originator product Remicade include autoimmune arthritis of various etiologies, psoriasis, and inflammatory bowel diseases (IBD) (ie, Crohn disease and ulcerative colitis).
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Potentially adverse effects may be due to induction of neoangiogenesis by the hormone, since erythropoietin increases inflammation and ischemia-induced neovascularization by enhancing the mobilization of endothelial progenitor cells.
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Before 1982, the tools available to physicochemically characterize proteins derived from natural sources (the main form of biological product at the time) were Edman degradation, UV and visible spectroscopic methods, protein content, chemical content (e.
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Erythropoietin decreases transfusion requirements during radiochemotherapy.
Obviously, once the diagnosis of epoetin-induced PRCA is suspected or has been proven, epoetin therapy needs to be discontinued.
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