{"?xml":{"@version":"1.0"},"edm:RDF":{"@xmlns:dc":"http://purl.org/dc/elements/1.1/","@xmlns:edm":"http://www.europeana.eu/schemas/edm/","@xmlns:wgs84_pos":"http://www.w3.org/2003/01/geo/wgs84_pos","@xmlns:foaf":"http://xmlns.com/foaf/0.1/","@xmlns:rdaGr2":"http://rdvocab.info/ElementsGr2","@xmlns:oai":"http://www.openarchives.org/OAI/2.0/","@xmlns:owl":"http://www.w3.org/2002/07/owl#","@xmlns:rdf":"http://www.w3.org/1999/02/22-rdf-syntax-ns#","@xmlns:ore":"http://www.openarchives.org/ore/terms/","@xmlns:skos":"http://www.w3.org/2004/02/skos/core#","@xmlns:dcterms":"http://purl.org/dc/terms/","edm:WebResource":[{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-78AEKOAJ/f1665c75-c46c-43d9-b94b-cf53bd29ae97/PDF","dcterms:extent":"2138 KB"},{"@rdf:about":"http://www.dlib.si/stream/URN:NBN:SI:doc-78AEKOAJ/145a0870-872f-4eda-8d3a-f38764ec512c/TEXT","dcterms:extent":"0 KB"}],"edm:TimeSpan":{"@rdf:about":"2005-2025","edm:begin":{"@xml:lang":"en","#text":"2005"},"edm:end":{"@xml:lang":"en","#text":"2025"}},"edm:ProvidedCHO":{"@rdf:about":"URN:NBN:SI:doc-78AEKOAJ","dcterms:isPartOf":[{"@rdf:resource":"https://www.dlib.si/details/URN:NBN:SI:spr-8ER5ZBJN"},{"@xml:lang":"sl","#text":"Farmacevtski vestnik"}],"dcterms:issued":"2021","dc:creator":["Gosenca Matjaž, Mirjam","Zvonar Pobirk, Alenka"],"dc:format":[{"@xml:lang":"sl","#text":"številka:3"},{"@xml:lang":"sl","#text":"letnik:72"},{"@xml:lang":"sl","#text":"str. 147-158"}],"dc:identifier":["ISSN:0014-8229","COBISSID_HOST:69981443","URN:URN:NBN:SI:doc-78AEKOAJ"],"dc:language":"sl","dc:publisher":{"@xml:lang":"sl","#text":"Slovensko farmacevtsko društvo"},"dc:subject":[{"@xml:lang":"sl","#text":"benzalkonijev klorid"},{"@xml:lang":"sl","#text":"benzilalkohol"},{"@xml:lang":"sl","#text":"Farmacevtska industrija"},{"@xml:lang":"sl","#text":"konzervansi"},{"@xml:lang":"sl","#text":"Mikrobiološka analiza"},{"@xml:lang":"sl","#text":"mikrobiološka kakovost"},{"@xml:lang":"sl","#text":"parabeni"}],"dcterms:temporal":{"@rdf:resource":"2005-2025"},"dc:title":{"@xml:lang":"sl","#text":"Mikrobiološka zaščita farmacevtskih izdelkov| Antimicrobial preservation of pharmaceuticals|"},"dc:description":[{"@xml:lang":"sl","#text":"The microbiological quality of pharmaceutical products is one of the key aspects of ensuring quality, safety and efficacy of medicines. Due to strict quality assurance standards in the pharmaceutical industry, it can be considered as self-evident. Yet, as we experienced in the year of the pandemic, nothing really is. This review presents various approaches to microbiological protection of pharmaceutical products with the main emphasis on preservatives posing protection from secondary microbiological contamination of products during their storage, distribution and usage. Finally, case studies of preservatives which safety concerns have been raised up in recent years, are presented. In the case of benzyl alcohol, benzalkonium chloride and benzoic acid/benzoate it resulted in recent revision of medicine labelling by the European Medicines Agency, which highlights the need for continuous careful monitoring and safety risk assessment of preservatives and other excipients, especially for the most vulnerable paediatric group of patients"},{"@xml:lang":"sl","#text":"Mikrobiološka kakovost farmacevtskih izdelkov je eden izmed ključnih aspektov zagotavljanja kakovostnih, varnih in učinkovitih zdravil. Zaradi strogih standardov zagotavljanja kakovosti v farmacevtski industriji jo lahko dojemamo kot samoumevno. Pa vendar, kot smo izkusili v letu pandemije, ni nič samoumevno. V prispevku so predstavljeni različni pristopi mikrobiološke zaščite farmacevtskih izdelkov z glavnim poudarkom na konzervansih, ki ščitijo izdelek pred sekundarno mikrobiološko kontaminacijo med shranjevanjem, distribucijo in uporabo izdelka. Na primeru konzervansov, katerih varnostno vprašanje je bilo izpostavljeno v zadnjih letih in je v primeru benzilalkohola, benzalkonijeva klorida in benzojske kisline oz. benzoatov tudi vodilo v nedavno revizijo označevanja zdravil s strani Evropske agencije za zdravila (EMA), želimo skozi prispevek izpostaviti tudi potrebo po nenehnem skrbnem spremljanju in oceni varnostnega tveganja, zlasti za najranljivejšo pediatrično skupino bolnikov"}],"edm:type":"TEXT","dc:type":[{"@xml:lang":"sl","#text":"znanstveno časopisje"},{"@xml:lang":"en","#text":"journals"},{"@rdf:resource":"http://www.wikidata.org/entity/Q361785"}]},"ore:Aggregation":{"@rdf:about":"http://www.dlib.si/?URN=URN:NBN:SI:doc-78AEKOAJ","edm:aggregatedCHO":{"@rdf:resource":"URN:NBN:SI:doc-78AEKOAJ"},"edm:isShownBy":{"@rdf:resource":"http://www.dlib.si/stream/URN:NBN:SI:doc-78AEKOAJ/f1665c75-c46c-43d9-b94b-cf53bd29ae97/PDF"},"edm:rights":{"@rdf:resource":"http://rightsstatements.org/vocab/InC/1.0/"},"edm:provider":"Slovenian National E-content Aggregator","edm:intermediateProvider":{"@xml:lang":"en","#text":"National and University Library of Slovenia"},"edm:dataProvider":{"@xml:lang":"sl","#text":"Slovensko farmacevtsko društvo"},"edm:object":{"@rdf:resource":"http://www.dlib.si/streamdb/URN:NBN:SI:doc-78AEKOAJ/maxi/edm"},"edm:isShownAt":{"@rdf:resource":"http://www.dlib.si/details/URN:NBN:SI:doc-78AEKOAJ"}}}}