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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...

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Microwave-assisted Functionalization of Poly(ethylene glycol) and On-resin Peptides for Use in Chain Polymerizations and Hydrogel Formation
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[Limited applications for hydroxyethyl starch : background and alternative concepts].

M Rehm1

  • 1Klinik für Anaesthesiologie, Klinikum der Universität München (LMU), Marchioninistr. 15, 81377, München, Deutschland. markus.rehm@med.uni-muenchen.de

Der Anaesthesist
|August 9, 2013
PubMed
Summary

Hydroxylethyl starch (HES) infusion solutions are no longer recommended due to risks outweighing benefits. Alternative infusion therapies using crystalloids and albumin are discussed, emphasizing the need for scientifically founded practices in critical care.

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Area of Science:

  • Anesthesiology and Critical Care Medicine
  • Pharmacovigilance and Drug Safety

Background:

  • European Medicines Agency's Committee for Risk Assessment of Pharmacovigilance (PRAC) recommended suspending approval of hydroxylethyl starch (HES) infusion solutions due to unfavorable risk-benefit balance.
  • The Federal Institute for Drugs and Medical Products (BfArM) advised against HES use pending finalization of the review process.

Purpose of the Study:

  • To objectively present the data situation regarding HES and alternatives.
  • To provide a foundation for readers to form an informed opinion on HES use.
  • To propose a concept for infusion therapy without HES.

Main Methods:

  • Literature review to establish the background for the HES decision.
  • Assessment of HES relevance in intensive care, emergency, and perioperative medicine.
  • Formulation of an HES-free infusion therapy concept based on current study results.

Main Results:

  • Gelatin solutions pose risks of anaphylaxis and potential kidney injury, and cannot exclude Creutzfeldt-Jacob disease transmission.
  • Balanced crystalloids can substitute for blood loss up to 1-1.5 L.
  • For larger losses, hyperoncotic (20%) or 5% albumin solutions are recommended, with 20% albumin offering a higher volume effect.

Conclusions:

  • Third-generation HES solutions are not fully replaceable by other colloids; crystalloids will form the basis of infusion therapy.
  • Balanced crystalloids are prioritized for acid-base balance.
  • Infusion therapy requires scientifically founded adjustments, necessitating large prospective studies with clinically relevant endpoints.