Inhixa (enoxaparin biosimilar) / Techdow 
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 0 Diseases   4 Trials   4 Trials   15 News 
  • ||||||||||  Zarzio (filgrastim biosimilar) / Novartis, Inhixa (enoxaparin biosimilar) / Techdow
    [VIRTUAL] EXPERIENCE IN THE USE OF BIOSIMILAR ENOXAPARIN SODIUM FOR PROPHYLAXIS AND TREATMENT OF VENOUS THROMBOEMBOLIC DISEASE IN OUR HOSPITAL () -  May 13, 2021 - Abstract #EHA2021EHA_2118;    
    Bridging therapy consisted of suspending VKA from 4 (acenocoumarol) to 6 days (warfarin) before the procedure and substitution with biosimilar enoxaparin sodium: 1.5 mg / kg / 24 h, and administration of a prophylactic dose 4,000 IU, 12 hours before of the procedure, and another dose 6-12 hours after it, depending on the risk of bleeding from the intervention and the thrombotic risk of the patient's underlying disease...Further studies will provide more confirmatory data. Biosimilar drugs have the potential to offer the National Health System cost savings and expand access to therapeutic innovations.
  • ||||||||||  enoxaparin sodium / Generic mfg.
    Clinical, Journal:  Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol. (Pubmed Central) -  Jul 8, 2020   
    P3
    To assess whether high doses of Low Molecular Weight Heparin (LMWH) (i.e. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (i.e., Enoxaparin 4000 IU once day), in hospitalized patients with COVID19 not requiring Invasive Mechanical Ventilation [IMV], are: a)more effective in preventing clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first: 1.Death2.Acute Myocardial Infarction [AMI]3.Objectively confirmed, symptomatic arterial or venous thromboembolism [TE]4.Need of either: a.Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) orb.IMV in patients who at randomisation were receiving standard oxygen therapy5.IMV in patients who at randomisation were receiving non-invasive mechanical ventilationb)Similar in terms of major bleeding risk TRIAL DESIGN: Multicentre, randomised controlled, superiority, open label, parallel group, two arms (1:1 ratio), in-hospital study...Administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization; prophylactic doses are allowed 12...Recruitment start (expected): 08/06/2020 Recruitment finish (expected): 30/04/2021 Trial registration EudraCT 2020-001972-13, registered on April 17th, 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
  • ||||||||||  Thorinane (enoxaparin biosimilar) / Pharmathen, Inhixa (enoxaparin biosimilar) / Techdow
    [VIRTUAL] Biosimilar Enoxaparin Sodium Inhixa® Compared with Clexane®: An in vitro Study (Virtual Meeting Room 6) -  May 14, 2020 - Abstract #ISTH2020ISTH_563;    
    Limits are represented by the “in vitro” evaluation that cannot give any information respect “in vivo” pharmacokinetic, pharmakodynamic, clinical efficacy, safety and collateral effect as immunogenic reactivity. A strict pharmacovigilance should be recommended and anti-FXa monitoring, at least in particular clinical settings, should be advised.