What is the difference between fragmin and clexane

Article Navigation. Close mobile search navigation Article Navigation. Volume Article Contents Abstract. Subjects and methods. Comparison of low-molecular-weight heparin enoxaparin sodium and standard unfractionated heparin for haemodialysis anticoagulation.

David Saltissi , David Saltissi. Oxford Academic. Google Scholar. Colleen Morgan. Justin Westhuyzen. Helen Healy. Select Format Select format. Permissions Icon Permissions. Abstract Background.

Table 1. Age, years Open in new tab. Open in new tab Download slide. Table 2. Frequency of adverse events, during and between dialysis sessions. Clexane a. Titrated Clexane b.

Distribution of Clexane doses after dose titration. Table 3. Vascular access clotting times s. Clexane after dose titration. Table 4. J Clin Invest. Clin Nephrol. Scand J Haematol.

N Engl J Med. Aus Prescriber. Eur J Clin Invest. Nephrol Dial Transplant. Kidney Int. Nieren- Hochdruckkr. Thromb Haemost. Blood Purif. Rev Med Chile. Hellen Nephrol. Issue Section:. Download all slides. Comments 0. Add comment Close comment form modal. I agree to the terms and conditions. You must accept the terms and conditions. Add comment Cancel. Submit a comment. Comment title. You have entered an invalid code.

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Why has it taken so long for FDA to approve generic versions of enoxaparin? How did the complex chemical structure of enoxaparin affect generic approval?

Enoxaparin is a complex mixture of oligosaccharides chains of sugar that vary in chemical structure and size. It is made from heparin by chemically breaking up the larger heparin chains into smaller fragments. The complex chemical features of enoxaparin are determined by both the qualities of the heparin and the chemical process used to cleave the heparin into enoxaparin.

Generic enoxaparin sodium must have the same active ingredient as Lovenox. FDA scientists established a scientific approach for demonstrating active ingredient sameness that takes into consideration the complexity of enoxaparin.

These five criteria ensure that a generic enoxaparin drug product will have the same effects as the brand-name drug product when injected into a patient. Why does FDA expect generic manufacturers of enoxaparin to conduct immunogenicity studies? Standard heparin is known to cause adverse reactions called immunogenic responses, such as Heparin Induced Thrombocytopenia HIT. FDA expects sponsors of generic enoxaparin products to demonstrate that their manufactured versions do not have any higher risk of these or other dangerous reactions than Lovenox.

Although conducting immunogenicity testing for this product can be an extensive and time-consuming process for a manufacturer, all manufacturers of generic enoxaparin are expected to do this as part of the application process. These studies evaluated impurities using physiochemical and biological assays. Were the heparin contamination issues in taken into account for FDA approval of enoxaparin? In early , there was a severe medication crisis in the U. There were reported deaths in the United States following administration of heparin between January 1, , and May 31, , of which were reported to the FDA in Because enoxaparin is made from standard heparin, it is important to ensure that the enoxaparin products have not been contaminated, and that the manufacturing processes for heparin and enoxaparin will meet rigorous production standards to avoid future contamination.

We conclude that a daily dose of Clexane led to more bleeding than 5, units of Fragmin did. Abstract In an attempt to reduce medical costs it was decided that four Oslo hospitals should use the same low molecular weight heparin LMWH for thromboprophylaxis. Publication types Comparative Study English Abstract. Head-to-head comparison of two different low-molecular-weight heparins in acute coronary syndrome: a single center experience.

Small numbers of patients studied Wide interquartile range in the parameters measured No short or long term measurement of actual clinical outcomes e. Change in von Willebrand factor a marker that correlates with poor clinical outcome at 4 and 66 hours after initiation of treatment. Small patient group in a single centre No long term follow up of patients end-points after only 5 days.

Plasma levels of Von Willebrand factor vWF increased levels shown to be associated with a worse outcome. Small number of patients despite multicentre trial. No direct comparison of enoxaparin to dalteparin. Patients with non-ST elevation acute coronary syndrome randomized to receive either enoxaparin or fondaparinux a newer type of LMWH.