FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, in the BaSES study, the hospitalisation time was significantly reduced in patients treated with 6% HES 130/0.4 compared to 0.9% NaCl.
Croatian: Nadalje, u ispitivanju BaSES, vrijeme hospitalizacije bilo je značajno smanjeno u bolesnika liječenih sa 6%-tnim HES 130/0.4 u usporedbi s 0.9%-tnim NaCl.
English: • The PRAC also concluded that there was need for further risk minimisation measures such as information to patients and healthcare professionals.
Croatian: • je PRAC također zaključio da postoji potreba za daljnjim mjerama smanjivanja rizika poput informacija za bolesnike i zdravstvene djelatnike.
English: Some publications also suggest that colloids might help to prevent positive fluid balance and/or overinfusion of fluids (Wills 2005, Naing CM and Win DK 2010).
Croatian: Pojedine publikacije sugeriraju da koloidi mogu pomoći pri sprječavanju pozitivne ravnoteže tekućine i/ili pretjerane infuzije tekućina (Wills 2005., Naing CM i Win DK 2010.).
English: Companies had been encouraged to submit core elements of the risk management plan, but the CMDh considered that this should be a condition.
Croatian: Farmaceutske tvrtke potiče se da dostave ključne elemente planova upravljanja rizikom, no CMDh je smatrao da to treba biti uvjet.
English: Grounds for PRAC recommendation
Croatian: Osnove za preporuku PRAC-a
English: New results from CRYSTAL have also become available.
Croatian: Dostupni su postali i rezultati iz ispitivanja CRYSTAL.
English: Hamaji et al 2013 also showed that significantly fewer red blood cell transfusions were required in the HES group.
Croatian: Hamaji et al 2013. također je utvrdio značajno manji broj transfuzija crvenih krvnih stanica u grupi koje je primala HES.
English: In addition, special warnings in surgery and trauma patients have been included.
Croatian: Nadalje, uključena su posebna upozorenja za kirurške i traumatizirane bolesnike;
English: However, it was noted that short-term haemodynamic improvements have been observed in other patient populations, including surgical and trauma patients.
Croatian: No, napomenuto je da su uočena kratkoročna hemodinamička poboljšanja u drugim populacijama bolesnika, uključujući kirurške i traumatizirane bolesnike.
English: Hydroxyethyl starch (HES) solutions for infusion include products with starch derived from potato or corn with different molecular weights and substitution ratios.
Croatian: Otopine za infuziju koje sadrže hidroksietil škrob (HES) uključuju proizvode koje sadrže škrob dobiven iz krumpira ili kukuruza različitih molekularnih težina i supstitucijskih omjera.
English: The PRAC issued a recommendation on available data for this review in June 2013, concluding that HES solutions should be suspended in all patient populations.
Croatian: PRAC je izdao preporuku u lipnju 2013. godine na temelju podataka dostupnih za ovaj pregled, zaključujući da se otopine koje sadrže HES trebaju suspendirati za cjelokupnu populaciju bolesnika.
English: Consequently the CMDh decided that synopsis were not required in advance of the recommended scientific advice.
Croatian: Nastavno, CMDH je odlučio da kratki pregledi nisu potrebni prije preporučenog znanstvenog savjeta.
English: Some benefit for elective surgical patients has also been shown in short-term surrogate hemodynamic outcomes along with a modest volume sparing effect (Hartog et al. 2011).
Croatian: Određene koristi za elektivne kirurške bolesnike također su utvrđene kratkoročnim surogat hemodinamičkim ishodima zajedno s umjerenim učinkom štednje volumena (Hartog et al.
English: HES containing solutions for infusion were indicated mainly for the treatment and prophylaxis of hypovolaemia and hypovolemic shock.
Croatian: Otopine za infuziju koje sadrže HES indicirane su uglavnom za liječenje i profilaksu hipovolemije i hipovolemijskog šoka.
English: Detailed explanation for the differences from the PRAC recommendation
Croatian: Detaljno pojašnjenje razlika u odnosu na preporuku PRAC-a
English: In hypovolaemic patients with normal pulmonary function, the use of colloids to maintain colloid-osmotic pressure may limit the development of peripheral as well as pulmonary oedema (Vincent JL 2000).
Croatian: Uporaba koloida za održavanje koloidno osmotskog tlaka u hipovolemijskih bolesnika s normalnom pulmonalnom funkcijom može ograničiti razvoj perifernog kao i pulmonalnog endema (Vincent JL 2000.).
English: To this end the MAHs were strongly advised to seek scientific advice with the European Medicines Agency, in time for the submission of the study protocols to the national competent authorities (NCAs) within 6 months of the European Commission Decision.
Croatian: U svrhu toga, nositeljima odobrenja je izričito savjetovano da potraže znanstveni savjet pri Europskoj agenciji za lijekove u trenutku podnošenja protokola ispitivanja nacionalnim nadležnim tijelima u roku od 6 mjeseci nakon odluke Europske komisije.
English: Benefit risk balance
Croatian: Omjer koristi i rizika
English: Results from the RaFTinG registry in intensive care units, an observational, non-randomised study aiming to gather more information in ‘real-life' clinical practice showed no statistically significant differences between patients treated with crystalloids only (n=2482) and those treated with colloids (all HES preparations and gelatin, n=2063) for the endpoints of 90-day mortality.
Croatian: Rezultatima registra RaFTinG u jedinicama intenzivne skrbi i opservacijskim, nerandomiziranim ispitivanjem provedenim sa ciljem prikupljanja više informacija u „stvarnoj” kliničkoj praksi nisu dokazane statistički značajne razlike između bolesnika liječenih samo kristaloidima (n=2482) i onima koji su liječeni koloidima (svi HES pripravci i želatina, n=2063) za krajnje točke 90-dnevne smrtnosti.
English: In view of the above and considering that the study protocols of the drug utilisation study and of the two randomised clinical trials are conditions to the marketing authorisation, the CMDh noted that these elements should be reflected in a risk management plan.
Croatian: U svjetlu prethodno navedenog i uzimajući u obzir da su protokoli ispitivanja iskoristivosti lijeka i dva randomizirana klinička ispitivanja uvjeti za izdavanje odobrenja za stavljanje lijeka u promet, CMDh je napomenuo da se ovi elementi trebaju prikazati u planu upravljanja rizikom.
English: The CMDh amended the due date for the submission of the protocol of the drug utilisation study which is now also due within 6 months of the European Commission Decision in order to harmonise submission dates of all conditions.
Croatian: CMDh je izmijenio datum roka za dostavu protokola ispitivanja o primjeni lijeka, koji je također trebalo dostaviti u roku od 6 mjeseci nakon odluke Europske komisije sa ciljem usklađivanja datuma za podnošenje svih uvjeta.
English: Some of authors argue that a positive net fluid balance is associated with a decrease in organ perfusion and an increased mortality (e.g. Sadaka F et al. 2013, Payen D et al. 2008).
Croatian: Pojedini autori smatraju da je pozitivna neto ravnoteža tekućine povezana sa smanjenjem perfuzije organa i povećanjem smrtnosti (primjerice Sadaka F et al.
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations subject to conditions and detailed explanation for the differences from the PRAC recommendation
Croatian: Znanstveni zaključci i razlozi za promjenu uvjeta odobrenja za stavljanje lijeka u promet i detaljno pojašnjenje razlika u odnosu na preporuku PRAC-a
English: In addition, two phase IV randomised clinical trials with an appropriate control and clinically meaningful endpoints will need to be conducted to provide more evidence on the efficacy and safety, including the risk of 90-day mortality and renal failure, in perioperative and trauma populations.
Croatian: Nadalje, dva radomizirana klinička ispitivanja faze IV s odgovarajućom kontrolom i klinički značajnim krajnjim točkama trebat će provesti kako bi se osiguralo više dokaza o učinkovitosti i sigurnosti, uključujući rizik od 90-dnevne smrtnosti i oštećenja bubrega u perioperativne i traumatizirane populacije.
English: The PRAC also considered that studies should be conducted to provide more evidence on the efficacy and safety of hydroxyethyl starch in the perioperative setting and trauma.
Croatian: PRAC je također zaključio da se ispitivanja trebaju provesti kako bi se osiguralo više dokaza o djelotvornosti i sigurnosti hidroksietil škroba u perioperativnom okruženju i traumi.
English: The experts suggested that benefit of HES may be seen in particular in perioperative bleeding.
Croatian: Stručnjaci su pretpostavili da se koristi HES-a mogu uočiti posebice u slučaju perioperativnog krvarenja.
English: Despite the studies' limitations which were noted, the results from the CRYSTAL study comparing colloids to crystalloids showed that in patients with hypovolaemia, the use of colloids vs crystalloids did not result in a significant difference in 28-day mortality.
Croatian: Usprkos uočenim ograničenjima u ispitivanjima, rezultati ispitivanja CRYSTAL koji uspoređuju koloide i kristaloide dokazuju da u bolesnika s hipovolemijom uporaba koloida u odnosu na kristaloide nije rezultirala značajnom razlikom u 28dnevnoj smrtnosti.
English: • The PRAC noted the conclusions of a review under article 31 of Directive 2001/83/EC.
Croatian: • je PRAC uzeo u obzir zaključke pregleda provedenog u skladu sa člankom 31. Direktive 2001/83/EZ.
English: It is on the basis of the totality of the data available, including the new evidence, that the PRAC issued conclusion on the procedure provided for in Article 107i of Directive 2001/83/EC in October 2013.
Croatian: Na temelju ukupnosti dostupnih podataka, uključujući i novi dokaz, PRAC je izdao zaključak o postupku provedenom prema članku 107.i Direktive 2001/83/EZ u listopadu 2013.
English: The MAHs are also encouraged to submit risk management plans to national competent authorities.
Croatian: Potiče se nositelje odobrenja da dostave i planove upravljanja rizikom nadležnim nacionalnim tijelima.
English: The experts agreed that the benefits may be observed in severe hypovolaemia in short duration only at the beginning i.e. perioperative setting and disappearing faster with patient's stabilisation.
Croatian: Stručnjaci su suglasni da se koristi u slučaju ozbiljne hipovolemije mogu uočiti samo tijekom kratkog razdoblja na početku liječenja, odnosno u perioperativnom okruženju, te da ove koristi brže nestaju nakon što se bolesnik stabilizira.
English: The MAHs should submit within 6 months of the European Commission Decision, the core elements (including protocol of DUS, protocols of the RCTs) of a risk management plan in EU format and this was included in Annex IV.
Croatian: Nositelji odobrenja trebaju dostaviti ključne elemente (uključujući protokol DUS-a, protokole RCT-ova) planova upravljanja rizicima u EU formatu u roku od 6 mjeseci nakon donošenja odluke Europske komisije, te je to uključeno u Dodatak IV.
English: However, with regards to the two phase IV randomised clinical trials (RCTs) requested to provide more evidence on the efficacy and safety in perioperative and trauma populations, including the risk of 90-day mortality and renal failure, , the CMDh encouraged the MAHs to jointly submit common study protocols.
Croatian: No, s obzirom na dva randomizirana klinička ispitivanja faze IV (RCT-ove), koja su zatražena kako bi se osiguralo više dokaza o djelotvornosti i sigurnosti u perioperativnoj populaciji i traumatiziranoj populaciji, uključujući i rizik od 90-dnevne smrtnosti i oštećenja bubrega, CMDh je potaknuo nositelje odobrenja da zajedno dostave zajedničke protokole ispitivanja.
English: Although the mechanisms by which increased renal injury and mortality occur is not well established, it is possible that the degree of inflammatory processes seen in sepsis and critically ill patients is greater and associated with significant capillary leakage compared with other patient populations such as the perioperative setting after elective surgery or un-complicated trauma where the systematic inflammatory process and the extent of capillary leak may be lower.
Croatian: Iako nisu dobro utvrđeni mehanizmi prema kojima nastupa povećani broj oštećenja funkcije bubrega i smrtnosti, moguće je da je stupanj upalnih procesa uočen kod bolesnika sa sepsom i u kritičnom stanju veći i povezan sa značajnim kapilarnim curenjem u usporedbi s drugom populacijom bolesnika, poput perioperativnog okruženja nakon elektivnog kirurškog zahvata ili traume bez komplikacija, u kojima broj sistematskih upalnih procesa i razmjer kapilarnog curenja mogu biti manji.
English: Therefore, the PRAC agreed that the therapeutic indication of hydroxyethyl starch containing products should be restricted to treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Croatian: Stoga je PRAC suglasan da se terapijske indikacije lijekova koji sadrže hidroksietil škrob trebaju ograničiti na liječenje hipovolemije uslijed akutnog gubitka krvi kada se liječenje samim kristaloidima ne smatra dostatnim.
English: Core elements of a direct healthcare professional communication were agreed, together with the timelines for distribution, and that studies should be conducted.
Croatian: Usuglašeni su ključni elementi pisama liječnicima, zajedno s vremenskim okvirima za distribuciju, te potreba za provođenjem ispitivanja.
English: However, it must be noted that new evidence was considered in the procedure under Article 107i of Directive 2001/83/EC.
Croatian: Potrebno je napomenuti da je novi dokaz uzet u obzir postupku provedenom prema članku 107.i Direktive 2001/83/EZ.
English: The PRAC therefore acknowledged the results of this studies which shows no risk of mortality associated with the use of HES but considered that given the limitations of this study its findings could not negate the findings from 6S and VISEP studies that had shown an increased risk of mortality in critically ill patients.
Croatian: Stoga je PRAC potvrdio rezultate ovih ispitivanja čime je dokazano da ne postoji rizik od smrtnosti povezan s uporabom HES-a, no uzeo je u obzir da, s obzirom na ograničenja ovog ispitivanja, otkrića utvrđena ispitivanjem ne mogu negirati otkrića ispitivanja 6S i VISEP, koja su dokazala povećani rizik od smrtnosti u bolesnika u kritičnom stanju.
English: The CMDh also considered that the direct healthcare professional communication (DHPC) should be submitted to the NCAs where HES products are marketed, within one week of the CMDh adopted position as per agreed communication plan.
Croatian: CMDh je također zaključio da se pisma liječnicima trebaju dostaviti nadležnim nacionalnim tijelima u državama gdje su lijekovi koji sadrže HES stavljeni u promet u roku od tjedan dana nakon što ih usvoji CMDh sukladno usuglašenom komunikacijskom planu.
English: The first review was initially started under the framework of Article 31 of Directive 2001/83/EC.
Croatian: Prvi je pregled prvotno pokrenut sukladno članku 31. Direktive 2001/83/EZ.
English: HES products are contraindicated in patients with renal impairment or renal replacement therapy but the contraindications should also be extended to include other patient populations including patients with sepsis, critically ill patients and burns patients.
Croatian: Lijekovi koji sadrže HES kontraindicirani su u bolesnika s oštećenjem funkcije bubrega ili renalnom zamjenskom terapijom, no kontraindikacije se trebaju proširiti tako da uključuju i druge populacije bolesnika, uključujući i bolesnike sa sepsom, bolesnike u kritičnom stanju i s opeklinama.
English: • The PRAC considered, in view of the new evidence which includes data from clinical trials, further expert advice, new proposals for additional risk minimisation measures, including restrictions on use and a commitment from the MAHs to perform additional studies in patients with trauma and in elective surgery, that the benefit of hydroxyethyl starch containing products outweighs the risk in the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Croatian: • je PRAC zaključio na temelju novih dokaza, koji uključuju podatke iz kliničkih ispitivanja, dodatne savjete stručnjaka, nove prijedloge za dodatne mjere smanjivanja rizika, uključujući i ograničenja u uporabi, i obveze koje su preuzeli nositelji odobrenja da će provesti dodatna ispitivanja u traumatiziranih bolesnika i bolesnika podvrgnutih elektivnim kirurškim zahvatima da koristi od lijekova koji sadrže hidroksietil škrob nadmašuju rizike liječenja hipovolemije uslijed akutnog gubitka krvi u slučaju kada se liječenje samo kristaloidima ne smatra dostatnim.
English: On the basis of the available data, in particular results from VISEP, 6S and CHEST studies, the PRAC concluded that HES is associated with an increased risk of mortality and renal failure in patients with sepsis, in critically ill and burn patients and that the benefits of HES do not outweigh the risks in these patient populations.
Croatian: Na temelju dostupnih podataka, posebice rezultata VISEP, 6S i CHEST ispitivanja, PRAC je zaključio da je HES povezan s povećanim rizikom od smrtnosti i oštećenja bubrega u bolesnika sa sepsom, u kritičnom stanju i s opeklinama, te da koristi HES-a ne nadmašuju rizike u populacijama ovih bolesnika.
English: Particular caution should be exercised when treating patients with impaired hepatic function or in patients with blood coagulation disorders.
Croatian: Poseban oprez valja primijeniti prilikom liječenja bolesnika s oštećenjem funkcije jetre ili u bolesnika s poremećajem grušanja krvi.
English: Overall summary of the scientific evaluation of solutions for infusion containing hydroxyethyl starch medicinal products by PRAC
Croatian: Cjelokupni sažetak PRAC-ove znanstvene ocjene otopina za infuziju koje sadrže hidroksietil škrob
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 107i of Directive 2001/83/EC, for hydroxyethyl starch containing products for solutions for infusion.
Croatian: • je Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC) razmotrilo postupak sukladno članku 107.i Direktive 2001/83/EC za otopine za infuziju koje sadrže hidroksietil škrob;
English: HES solutions should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 h. The posology section should identify the maximum daily dose and should recommend that the lowest possible effective dose should be employed.
Croatian: U odjeljku o doziranju treba se identificirati maksimalna dnevna doza i preporučiti najmanja moguća djelotvorna doza koja se treba primjenjivati.
English: Consequently, a second review of HES solutions under Article 107i of Directive 2001/83/EC was initiated, and it ran separately but in parallel with the re-examination of the Article 31, also finalising in October 2013.
Croatian: Stoga je pokrenut drugi pregled otopina koje sadrže HES u skladu sa člankom 107.i Direktive 2001/83/EZ, te je proveden zasebno, no istovremeno s ponovnim pregledom u skladu sa člankom 31., koji je također završen u listopadu 2013.
English: Therefore the conclusions on the Article 107i reflect the most complete and up-to-date evaluation of the available data relating to HES containing medicinal products.
Croatian: Stoga zaključci donijeti sukladno članku 107.i predstavljaju najpotpuniju i aktualnu ocjenu dostupnih podataka povezanih sa lijekovima koji sadrže HES.
English: • The PRAC concluded that hydroxyethyl starch containing products should be contraindicated in patients with sepsis, in critically ill and burn patients.
Croatian: • je PRAC zaključio da lijekovi koji sadrže hidroksietil škrob moraju biti kontraindicirani u bolesnika sa sepsom, u kritičnom stanju i s opeklinama.
English: Therefore the conclusions on the Article 107i of Directive 2001/83/EC reflect the most complete and up-to-date evaluation of the available data relating to the HES containing medicinal products.
Croatian: Stoga zaključci prema članku 107.i Direktive 2001/83/EZ predstavljaju najpotpuniju i najaktualniju ocjenu dostupnih podataka u vezi s lijekovima koji sadrže HES.
English: The CMDh considered the below PRAC recommendations following the procedure under Article 107i of Directive 2001/83/EC dated 10 October 2013 with regards to Hydroxyethyl starch containing medicinal products solutions for infusion:
Croatian: CMDh je razmotrio preporuke PRAC-a nakon postupka iz članka 107.i Direktive 2001/83/EZ od 10. listopada 2013. godine o otopinama za infuziju koje sadrže hidroksietil škrob:
English: The PRAC considered that the use of HES must be discontinued at the first sign of renal injury.
Croatian: PRAC je zaključio da se primjena HES-a mora prekinuti na prvi znak oštećenja funkcije bubrega.
English: The PRAC conclusion in the context of the referral procedure under Article 107i of Directive 2001/83/EC included additional data that was not available when the PRAC issued its recommendation on the referral in accordance with Article 31 of Directive 2001/83/EC in June 2013 and therefore could not be considered in the re-examination of the latter in October 2013.
Croatian: Zaključak PRAC-a u kontekstu postupka upućivanja u skladu sa člankom 107.i Direktive 2001/83/EZ uključio je dodatne podatke koji nisu bili dostupni kada je PRAC izdao svoju preporuku o postupku upućivanja u skladu sa člankom 31. Direktive 2001/83/EZ u lipnju 2013., te stoga nije mogao biti uzet u obzir pri ponovnom pregledu u listopadu 2013. godine.
English: This new evidence was not available when the PRAC recommendation on the procedure under Article 31 of Directive 2001/83/EC was issued in June 2013 and could therefore not be considered in the re-examination of the latter in October 2013.
Croatian: Ovaj novi dokaz nije bio dostupan u lipnju 2013. godine prilikom izdavanja preporuke PRAC-a u postupku prema članku 31. Direktive 2001/83/EZ, te ga se stoga nije moglo uzeti u obzir u ponovnom pregledu potonjeg, provedenom u listopadu 2013. godine.
English: • The PRAC considered that the use of hydroxyethyl starch is associated with an increased risk of mortality and renal replacement therapy or renal impairment in patients with sepsis, critically ill and burn patients.
Croatian: • je PRAC zaključio da je uporaba hidroksietil škroba povezana s povećanim rizikom od smrtnosti i renalnom zamjenskom terapijom ili oštećenjem funkcijom bubrega u bolesnika sa sepsom, u kritičnom stanju i s opeklinama;
English: Therefore, the PRAC noted the available data from studies in surgical and trauma patients and considered that although these studies were limited in size and duration of follow-up they did provide some reassurance that the risks of mortality and renal injury in surgical and trauma patients may be lower than those in the critically ill and sepsis patients.
Croatian: Stoga je PRAC uzeo u obzir dostupne podatke iz ispitivanja provedenih u kirurških bolesnika i traumatiziranih bolesnika, te je zaključio da, iako su ova ispitivanja ograničena u broju ispitanika i trajanju kontrola, ista su pružila određenu potvrdu da rizici od smrtnosti i oštećenja funkcije bubrega u kirurških bolesnika i traumatiziranih bolesnika mogu biti manji od rizika u bolesnika u kritičnom stanju i sa sepsom.