{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T19:32:39Z","timestamp":1792697559299,"version":"4.5.0"},"reference-count":18,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2017,6,22]],"date-time":"2017-06-22T00:00:00Z","timestamp":1498089600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Ethanol as an excipient is used to enhance the solubility of gemcitabine, but, sometimes, the dose of ethanol a patient may be given is much higher than the dose considered to be toxic. We aimed to assess ethanol-related symptoms and signs in patients receiving two formulations of gemcitabine, with and without ethanol.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A randomized double blind cross-over study was conducted. All patients being treated with gemcitabine received two consecutive doses of the drug, one diluted from a concentrate for solution for infusion (CSI) containing ethanol and the other from a lyophilized powder, without ethanol, which was used as control group. After each administration, patients were surveyed in order to assess the appearance of any alcohol consumption symptoms (dizziness, difficulty speaking, unsteady walking, impaired balance, mood swings and slower reactions). Widmark formula and the amount of alcohol measured on the breath (breathalyzer) were used to estimate blood alcohol concentration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Twenty-four patients received both formulations and were included in the analysis. Mean administered ethanol dose when prepared from CSI was 15.81\u2009\u00b1\u20092.25\u2009g (mean\u2009\u00b1\u2009SD). When using CSI gemcitabine, estimated blood ethanol concentration was 0.033\u2009g\/dl according to Widmark formula and 0.02\u2009g\/dl according to breathalyzer results. Although overall incidence of symptoms was higher in the study group, the difference was not statistically significant (33% vs. 25%; p\u2009=\u20090.53).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These findings prove there is no difference in the onset of ethanol related symptoms when using CSI instead of lyophilized powder on the reconstitution of gemcitabine.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1078155217715790","type":"journal-article","created":{"date-parts":[[2017,6,22]],"date-time":"2017-06-22T06:40:27Z","timestamp":1498113627000},"page":"511-516","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Ethanol-induced symptoms in patients receiving gemcitabine diluted from a concentrate for solution for infusion containing ethanol"],"prefix":"10.1177","volume":"24","author":[{"given":"Ra\u00fal","family":"Diez-Fern\u00e1ndez","sequence":"first","affiliation":[{"name":"Pharmacy Department, Hospital Universitario de Getafe, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roc\u00edo","family":"V\u00e1zquez-S\u00e1nchez","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Hospital Universitario de Getafe, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"L\u00f3pez-Esteban","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Hospital Universitario de Getafe, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Santos","family":"Enrech-Frances","sequence":"additional","affiliation":[{"name":"Oncology Department, Hospital Universitario de Getafe Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana Mar\u00eda","family":"S\u00e1nchez-Pe\u00f1a","sequence":"additional","affiliation":[{"name":"Oncology Department, Hospital Universitario de Getafe Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"D\u00edaz-Paniagua","sequence":"additional","affiliation":[{"name":"Oncology Department, Hospital Universitario de Getafe Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel","family":"Soria-Trist\u00e1n","sequence":"additional","affiliation":[{"name":"Oncology Department, Hospital Universitario de Getafe Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Miguel","family":"Mart\u00edn Mart\u00ednez","sequence":"additional","affiliation":[{"name":"Oncology Department, Hospital Universitario de Getafe Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"Molina-Garc\u00eda","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Hospital Universitario de Getafe, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2017,6,22]]},"reference":[{"key":"bibr1-1078155217715790","doi-asserted-by":"publisher","DOI":"10.1023\/B:PHAM.0000016235.32639.23"},{"key":"bibr2-1078155217715790","unstructured":"Volume 3B. Guidelines: medicinal products for human use. Safety, environment and information Excipients in the label and package leaflet of medicinal products for human use. European Commission, www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500003412.pdf (accessed 19 July 2015)."},{"key":"bibr3-1078155217715790","unstructured":"Guidance for Industry Q3C \u2014 tables and List. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research, www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm073395.pdf (accessed 19 July 2015)."},{"key":"bibr4-1078155217715790","unstructured":"FDA Drug Safety Communication: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment, www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM401754.pdf (accessed 10 March 2016)."},{"key":"bibr5-1078155217715790","unstructured":"Moreno-Garcia M, Gil-Martin A, Diez-Fernandez R, et\u00a0al. Ethanol content in chemotherapy.\n                      Presented at the 18th annual congress EAHP\n                      , Paris, France, 14 March 2013."},{"key":"bibr6-1078155217715790","doi-asserted-by":"publisher","DOI":"10.1111\/j.1360-0443.1990.tb03442.x"},{"key":"bibr7-1078155217715790","doi-asserted-by":"publisher","DOI":"10.1111\/j.1465-3362.2011.00374.x"},{"key":"bibr8-1078155217715790","doi-asserted-by":"publisher","DOI":"10.1016\/j.cld.2012.08.002"},{"key":"bibr9-1078155217715790","unstructured":"Sociedad Espa\u00f1ola de Medicina de Familia y Comunitaria; Grupo de Trabajo de Alcohol de la semFYC. Recomendaciones semFYC: alcohol, www.pnsd.msc.es\/Categoria2\/publica\/pdf\/AlcoholAtencionPrimaria.pdf (accessed 20 June 2015)."},{"key":"bibr10-1078155217715790","doi-asserted-by":"publisher","DOI":"10.1007\/s11065-007-9038-6"},{"key":"bibr11-1078155217715790","doi-asserted-by":"publisher","DOI":"10.3109\/15563650.2015.1059946"},{"key":"bibr12-1078155217715790","doi-asserted-by":"publisher","DOI":"10.1097\/TA.0b013e31815eb12a"},{"key":"bibr13-1078155217715790","doi-asserted-by":"publisher","DOI":"10.1111\/acer.13095"},{"key":"bibr14-1078155217715790","doi-asserted-by":"crossref","unstructured":"Bielefeld L1, Auw\u00e4rter V2, Pollak S2, et\u00a0al. Differences between the measured blood ethanol concentration and the estimated concentration by Widmark's equation in elderly persons.\n                      Forensic Sci Int\n                      2015; 247: 23\u201327.","DOI":"10.1016\/j.forsciint.2014.11.008"},{"key":"bibr15-1078155217715790","unstructured":"Product information Gemcitabina Actavis\u00ae. Electronic version, www.aemps.gob.es\/cima\/fichasTecnicas.doc (accessed 19 July 2015)."},{"key":"bibr16-1078155217715790","first-page":"WMC003291","volume":"3","author":"Kent W","year":"2012","journal-title":"Webmed Central Pharmacol"},{"key":"bibr17-1078155217715790","unstructured":"Medicamentos que contienen etanol y s\u00edntomas de intoxicaci\u00f3n et\u00edlica [Medicines containing ethanol and alcohol poisoning symptoms]. Bolet\u00edn informativo del Centro Farmacovigilancia de la Comunidad de Madrid.\n                      Reacciones Adversas a Medicamentos\n                      2012; 19: 3\u20134."},{"key":"bibr18-1078155217715790","unstructured":"Diez Fern\u00e1ndez R, Mart\u00ednez N\u00fa\u00f1ez M\n                      a\n                      E, Moreno Garc\u00eda M\n                      a\n                      , et\u00a0al. Ethanol as an excipient in chemotherapy drugs.\n                      Eur J Clin Pharm\n                      2014; 16: 182\u2013188."}],"container-title":["Journal of Oncology Pharmacy Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1078155217715790","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1078155217715790","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1078155217715790","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T02:17:26Z","timestamp":1777688246000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1078155217715790"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,6,22]]},"references-count":18,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2018,10]]}},"alternative-id":["10.1177\/1078155217715790"],"URL":"https:\/\/doi.org\/10.1177\/1078155217715790","relation":{},"ISSN":["1078-1552","1477-092X"],"issn-type":[{"value":"1078-1552","type":"print"},{"value":"1477-092X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,6,22]]}}}