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Seminars for education of primary health care doctors in the area of conduction of measures for CVD prevention were prepared.

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In the case of the EMA, various product-specific biosimilar guidelines have been generated (see the EMA website) (for example, for recombinant erythropoietins and recombinant granulocyte colony-stimulating factor) and continue to be generated (for example, for interferon-β and monoclonal antibodies) to help guide applicants of biosimilars to more effectively formulate their comparability studies.

Biosimilar clinical trials may pose distinct challenges for sponsors and patients that should be considered.

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In Vietnam produziert das in ansässige Unternehmen Nanogenpharma ein EPO-α-Präparat unter dem Namen Bioetin.

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Erythropoietin for the treatment of anemia associated with hematological malignancy.

While they are usually a result of malnutrition or defective absorption, they can also be drug-induced.

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SV according to blood pressure, total cholesterol and triglycerides and smoking in 423 employers free of cardiovascular disease during preventive examinations in October and November 2005.

We respond to these below where we separately review each of our proposed determinations.

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Third, what range of structural differences between a proposed biosimilar product and the reference product is consistent with the standard “highly similar” and may be acceptable in a 351(k) application if the applicant can demonstrate the absence of any clinically meaningful differences between the proposed biosimilar product and the reference product?

Patients who receive EPO should have regular blood tests to monitor their hemoglobin so the health care provider can adjust the EPO dose when the level is too high or too low.

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Sa druge strane, ¾ bolesnika smatra da zna koliki treba da bude INR i uglavnom daje tacan odgovor.

Most of these problems are solvable, however; formulation troubles rarely undermine a drug development program to failure.

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Subcutaneous administration of EPREX remains available for the treatment of anemia in patients undergoing cancer chemotherapy, and elective orthopedic surgery.

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Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: position of the World Marrow Donor Association.

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Additional analysis, accounting for dose adjustments within the protocol, also confirmed a statistically significant erythroid response for epoetin alfa (45.

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In keeping up with new biologicals and cutting-edge manufacturing methods, the regulators at NPCB participate in meetings held by WHO and other health-focused initiatives.

This is referred to as defense costs in connection with product liability litigation.

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The app ePrex was born as a personal project to make up for my laziness than having to browse in the Psalter in the morning when it is still a bit sleepy.

Renalzin, which is relatively new but it seems to be effective.

Effect of inflammatory cyokines on hypoxia-induced erythropoietin production.

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Kada se dvije elije priblize jedna drugoj sa stranicama na kojima su poluzljebovi, i to priblizavanje postane dovoljno intimno, formirat e se kanali posebnog znacaja kojim e prema veim kanalima iz elije jetre tei zuc.

They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session.

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In Europe, biosimilars are generally referred to by their trade names, which are different from those of the brand-name reference drug, but the non-proprietary names of European biosimilars are identical to those of their reference drug.

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There are several options for inducing remission of PRCA, but many patients with acquired PRCA require immunosuppressive therapy to maintain remissions.

Im April 2006 wurde bei der Europäischen Arzneimittelagentur der Antrag eingereicht, das Präparat unter dem Handelsnamen Mircera in den Verkehr zu bringen.

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Las drogas genéricas son los mismos productos, como los de Brand, pero ellos están producidos y distribuídos sin defensa del patente.

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The treatment for one type of anemia may be both inappropriate and dangerous for another type of anemia.

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European Medicines Agency Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues.

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In situ hybridization and other techniques can also be used to assess target expression and distribution in tissues to further support species selection.

It is important to note that anemia of chronic disease, if marked, can be a reflection of a more progressive underlying disease.

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Vitamins B12 and folate are important for prevention of megaloblastic anemia and for good health in general.

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This is a decision you and your doctor will make.

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Guidances developed by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and WHO set out principles for showing similarities between biosimilars and reference products ().

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International collaborations in 2004 and 2005 facilitated collaborative reporting of consensus diagnostic criteria, treatment recommendations, and long-term follow-up assessments.

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Your doctor will determine the best treatment plan for you based on your risk for metastasis, or spread of cancer, and hemoglobin levels.

Clinical benefits and risks associated with epoetin and darbepoetin in patients with chemotherapy-induced anemia: a systematic review of the literature.

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Differences in the safety profile will question biosimilarity and will require appropriate in-depth assessment and evaluation.

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The introduction of recombinant human erythropoietin (rHuEpo) in 1989 marked a significant advance in the management of anemia in end stage renal disease (ESRD).

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HX575, recombinant human epoetin alfa, for the treatment of chemotherapy-associated symptomatic anaemia in patients with solid tumours.

Although some of these were studies of ESAs used during radiotherapy or for anemia of cancerboth off-label usesthe data nonetheless raises concerns about the use of ESAs for all cancer indications to include labeled indications.

Accordingly, a poor response to treatment with erythropoietic agents is associated with increased levels of proinflammatory cytokines, on the one hand, and poor iron availability, on the other hand.

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In emergencies, when people need red blood cells but transfusion is not appropriate or available.

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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