KLINICKÁ FARMAKOLOGIE A FARMACIE / Klin Farmakol Farm. 2024;38(3):112-117 / www.klinickafarmakologie.cz 116 HLAVNÍ TÉMA Biologické účinky pomocných látek používaných u intravenózně podávaných léčiv jich extenzivním přívodem v krátkém časovém horizontu, nebo naopak s prodlouženým podáním a rizikem jejich kumulace. V takové situaci může i přes jejich bezpečnost dojít k projevu jejich biologických účinků. Mezi nejčastěji zmiňované účinky patří změny farmakokinetiky léčiv, aktivace imunitního systému, ovlivnění buněčné toxicity a interakce s biologickými membránami. Některé pomocné látky mohou také způsobovat alergické reakce nebo jiné orgánové toxicity, jako hepatotoxicita, dermotoxicita či mohou negativně ovlivňovat kardiovaskulární systém. Vzhledem k těmto potenciálním rizikům je nutné věnovat zvýšenou pozornost výběru a hodnocení pomocných látek při vývoji nových intravenózních formulací, ale i použití stávajících léčivých přípravků. Budoucí výzkum by měl být zaměřen na podrobnější zmapování těchto účinků a na identifikaci bezpečných profilů pomocných látek, aby byla zajištěna co nejvyšší účinnost a bezpečnost intravenózně podávaných léčiv. Vigilance ve smyslu biologických efektů pomocných látek je jednou z klíčových iniciativ pro zajišťování bezpečné farmakoterapie, nikoli jen farmakovigilance zaměřená na farmakologicky účinné látky, jak je tomu doposud například při hodnocení generik a biosimilars. LITERATURA 1. Caballero ML, Krantz MS, Quirce S, et al. Hidden Dangers: Recognizing Excipients as Potential Causes of Drug and Vaccine Hypersensitivity Reactions. J Allergy Clin Immunol Pract. 2021;9(8):2968-2982. 2. Demey HE, Daelemans RA, Verpooten GA, et al. Propylene glycol-induced side effects during intravenous nitroglycerin therapy. Intensive Care Med. 1988;14(3):221-226. 3. Neale BW, Mesler EL, Young M, et al. 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