natgillin/translations-raw huggingface dataset:
On the contrary, the Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI) and five Scandinavian learned societies supported the suspension of the marketing authorisations for HES solutions for infusion. 
Skandinavsko združenje za anesteziologijo in intenzivno medicino (SSAI) in pet skandinavskih strokovnih združenj pa je, nasprotno, podprlo začasen umik dovoljenj za promet z zdravilom za raztopine HES za infundiranje.
With regards to the safety data related to these products, the PRAC reviewed all available evidence since the last referral and concluded that the previous conclusions that HES solutions for infusion is associated with an increased risk of mortality and renal failure in patients with sepsis or critical illness were confirmed and that the available information, including more recently submitted clinical data, do not change the established risk in these patient populations. 
Kar zadeva podatke o varnosti, povezane s temi izdelki, je odbor PRAC pregledal vse razpoložljive dokaze od zadnje napotitve in zaključil, da so potrjeni predhodni zaključki, ki so navajali, da so raztopine HES za infundiranje povezane s povečanim tveganjem za umrljivost in ledvično odpoved pri bolnikih s sepso ali kritično boleznijo, in da razpoložljive informacije, vključno s predloženimi novejšimi kliničnimi podatki, ugotovljenega tveganja pri teh populacijah bolnikov ne spreminjajo.
The European Society of Anaesthesiology and some national learned societies, stated that HES solutions for infusion play a role in the therapeutic armamentarium of hypovolemic shock in patients who cannot be stabilised with crystalloids alone. 
Evropsko združenje za anesteziologijo in nekatera nacionalna strokovna združenja so navedla, da imajo raztopine HES za infundiranje svoje mesto v naboru terapevtskih sredstev za zdravljenje hipovolemičnega šoka pri bolnikih, ki jih ni mogoče stabilizirati samo s kristaloidi.
The new data provided does not change the conclusions from the previous 2013 referral that the benefits of HES solutions for infusion do not outweigh the serious risks in patients with sepsis or critical illness. 
Predloženi novi podatki ne spreminjajo zaključkov predhodne napotitve iz leta 2013, ki navajajo, da koristi raztopin HES za infundiranje ne odtehtajo resnih tveganj pri bolnikih s sepso ali kritično boleznijo;
In conclusion, the CMDh is of the position that a controlled access program is feasible and likely to be effective to minimise the risk, in combination with other risk minimization measures. 
Skupina CMDh torej meni, da je program nadzorovanega dostopa izvedljiv in bo v kombinaciji z drugimi ukrepi za zmanjševanje tveganja verjetno učinkovito zmanjšal tveganje.
Drug Utilisation Study (DUS) 
Študija o uporabi zdravil
Eight EU Member States have mentioned that a suspension of the marketing authorisations for HES solutions for infusion would have an impact in the national clinical practice as HES solutions for infusion fulfils currently a medical need in their territory. 
Osem držav članic EU je navedlo, da bi začasni umik dovoljenj za promet z zdravilom za raztopine HES za infundiranje vplival na nacionalno klinično prakso, saj raztopine HES za infundiranje trenutno zadovoljujejo medicinske potrebe na njihovem ozemlju.
It was also considered that HES solutions for infusion are used for the treatment of life-threatening medical conditions. 
Upoštevala je tudi, da se raztopine HES za infundiranje uporabljajo za zdravljenje smrtno nevarnih zdravstvenih stanj.
• The PRAC conclusions of previous reviews under Article 31 of Directive and Article 107i of Directive 2001/83/EC were that HES solutions for infusion are associated with an increased risk of mortality and renal failure in patients with sepsis or critical illness. 
• odbor PRAC je po predhodnih pregledih v skladu s členom 31 in členom 107i Direktive 2001/83/ES zaključil, da so raztopine HES za infundiranje pri bolnikih s sepso ali kritično boleznijo povezane s povečanim tveganjem za umrljivost in ledvično odpoved.
In light of this, the PRAC recommendation and CMDh position were referred back to the Agency by the European Commission for further consideration of any possible unmet medical need that could result from the suspension of the marketing authorisations for the medicinal products concerned by the referral, as well as the feasibility and likely effectiveness of additional risk minimisation measures. 
Zato je Evropska komisija priporočilo odbora PRAC in stališče skupine CMDh napotila nazaj do agencije v nadaljnjo obravnavo morebitnih neizpolnjenih medicinskih potreb, ki bi lahko bile posledica začasnega umika dovoljenj za promet za zdravila, na katera se nanaša napotitev, ter izvedljivosti in verjetne učinkovitosti dodatnih ukrepov za zmanjšanje tveganja.
In view of this exposure and the results from the two DUSs, the PRAC concluded that the estimated level of continued usage in populations where serious harm has been demonstrated raises important public health concerns, including a potentially increased mortality. 
Glede na to izpostavljenost in rezultate dveh študij o uporabi zdravil je odbor PRAC zaključil, da ocenjena stopnja neprekinjene uporabe pri populacijah, pri katerih so dokazali resne škodljive posledice, vzbuja veliko zaskrbljenost za javno zdravje, vključno s potencialno povečano umrljivostjo;
• In particular, the CMDh noted the results of a consultation of Member States where the suspension of the marketing authorisation for HES solutions for infusion would have an impact on the clinical practice and concerns raised by those EU Member States about a potential medical need. 
• skupina CMDh je zlasti upoštevala rezultate posvetovanja držav članic, v katerih bi začasni umik dovoljenj za promet z zdravilom za raztopine HES za infundiranje vplival na klinično prakso, in pomisleke teh držav članic EU o morebitnih medicinskih potrebah;
The PRAC noted that the clinical studies imposed following previous referrals procedures (TETHYS and PHOENICS) to characterise the efficacy and safety in trauma and elective surgery, which is currently the target population for which the product is indicated are ongoing. 
Odbor PRAC je ugotovil, da trenutno potekata klinični študiji, zahtevani po predhodnih napotitvenih postopkih (TETHYS in PHOENICS), ki sta namenjeni opredelitvi učinkovitosti in varnosti pri poškodovancih in bolnikih z elektivnimi kirurškimi posegi, kar je trenutno ciljna populacija, pri kateri je zdravilo indicirano.
In particular, the CMDh took into consideration the additional details from the MAHs on the proposed controlled access program. 
Skupina CMDh je zlasti upoštevala dodatne podrobnosti, ki so jih predložili imetniki dovoljenj za promet z zdravilom, o predlaganem programu nadzorovanega dostopa.
Most of the arguments refer to the use of HES solutions for infusion outside the terms of the MA or to claimed benefits that are not clinically significant or supported by robust data. 
Večina argumentov se nanaša na uporabo raztopin HES za infundiranje zunaj pogojev dovoljenja za promet z zdravilom ali na domnevne koristi, ki niso klinično pomembne oziroma jih ne podpirajo tehtni podatki.
The CMDh discussed whether measures to mitigate the risks associated with HES solutions for infusion, including in particular the risk of increased mortality and renal failure in critically ill patients and patients with sepsis would be effective and feasible, taking into account new elements provided by the MAHs and Member States. 
Skupina CMDh je razpravljala o tem, ali bi bili ukrepi za zmanjšanje tveganj, povezanih z raztopinami HES za infundiranje, vključno zlasti s tveganjem za povečano umrljivost in ledvično odpoved pri kritično bolnih bolnikih in bolnikih s sepso, učinkoviti in izvedljivi, in sicer z upoštevanjem novih elementov, ki so jih predložili imetniki dovoljenj za promet z zdravilom in države članice.
• The emergency setting in which the products are used does not impede the implementation of a controlled access program based on the delivery of appropriate training to the relevant HCPs as the educational program can be organised and delivered well in advance of the use of the products. 
• Nujno zdravljenje, v sklopu katerega se uporabljajo ta zdravila, ne onemogoča izvajanja programa nadzorovanega dostopa, saj se ustrezno usposabljanje za zadevne zdravstvene delavce v obliki izobraževalnega programa lahko organizira in izvede precej pred uporabo zdravil.
- The MAH should ensure that HES solutions for infusion are only delivered to accredited hospitals/centres. 
- Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da se raztopine HES za infundiranje dobavljajo samo akreditiranim bolnišnicam/centrom.
The CMDh noted that eight EU Member States have shared concerns about a medical need created in case of suspension of the marketing authorisation for HES solutions for infusion. 
Skupina CMDh je upoštevala, da je osem držav članic EU izrazilo pomisleke o medicinski potrebi, ki bi nastala v primeru začasnega umika dovoljenj za promet z zdravilom za raztopine HES za infundiranje.
The DUS protocol to be submitted by the MAHs should include clear objectives, focusing on prescribing decisions, especially adherence to indications and contraindications. 
Protokol študije o uporabi zdravil, ki ga morajo predložiti imetniki dovoljenj za promet z zdravilom, mora vključevati jasne cilje, usmerjene na odločitve o predpisovanju, zlasti upoštevanje indikacij in kontraindikacij.
As a consequence, the CMDh is of the position that the benefit-risk balance of HES solutions for infusion remains favourable subject to the agreed amendments to the product information and the conditions to the marketing authorisation. 
Posledično skupina CMDh meni, da je razmerje med tveganji in koristmi raztopin HES za infundiranje še naprej ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu in pogoji dovoljenja za promet z zdravilom.
Annex II Scientific conclusions and CMDh's detailed explanation on the scientific grounds for differences with the PRAC recommendation 
Znanstveni zaključki in podrobna obrazložitev znanstvene podlage skupine CMDh za odstopanja od priporočila odbora PRAC
In 2013, following a review of the risk of kidney injury and mortality related to hydroxyethyl starch (HES) solutions for infusion when administered in patients with sepsis or critical illness, the Pharmacovigilance and Risk Assessment Committee (PRAC) recommended risk minimisation measures such as restrictions in use of these medicinal products. 
Leta 2013 je Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) po pregledu tveganja za poškodbo ledvic in umrljivost, povezanega z raztopinami hidroksietil škroba (HES) za infundiranje pri bolnikih s sepso ali kritično boleznijo, priporočil ukrepe za zmanjševanje tveganja, kot so omejitve uporabe teh zdravil.
However, the CMDh considered that this assumption is not supported by sufficient evidence and might not be representative of a significant portion of the prescribers population and that in any case, the learned societies will have an important role in channelling the messages of the DHPC. 
Vendar je menila, da ta domneva ni podprta z zadostnimi dokazi in morda ni reprezentativna za velik delež populacije predpisovalcev ter da bodo imela strokovna združenja v vsakem primeru pomembno vlogo pri posredovanju sporočil neposrednih obvestil za zdravstvene delavce.
PRAC confirmed that the available information, including more recent submitted clinical data, do not change the established risk of increased mortality and renal failure related to the use of HES solutions for infusion in these patients. 
Odbor PRAC je potrdil, da razpoložljive informacije, vključno z novejšimi predloženimi kliničnimi podatki, ne spreminjajo ugotovljenega tveganja za povečano umrljivost in ledvično odpoved, povezano z uporabo raztopin HES za infundiranje pri teh bolnikih.
The CMDh took into consideration the revised PRAC recommendation to suspend the marketing authorisations for solutions for infusion adopted at May PRAC plenary meeting. 
Skupina CMDh je upoštevala revidirano priporočilo odbora PRAC za začasni umik dovoljenj za promet z zdravilom za raztopine za infundiranje, ki ga je odbor PRAC sprejel na svojem majskem plenarnem zasedanju.
The conduct of this study will be a condition to the marketing authorisations for HES solutions for infusion. 
Izvedba te študije bo pogoj za dovoljenja za promet z zdravilom za raztopine HES za infundiranje.
• With regards to the two separate DUSs conducted to assess the effectiveness of the risk minimisation measures imposed as an outcome of the 2013 referral, PRAC concluded that these studies, despite limitations due to possible misclassification, are representative of the clinical usage in the European Union and that key results are reliable. 
• kar zadeva dve ločeni študiji o uporabi zdravil, v katerih so ocenjevali učinkovitost ukrepov za zmanjšanje tveganja, uvedenih kot izid napotitve iz leta 2013, je odbor PRAC zaključil, da sta ti študiji kljub omejitvi zaradi morebitne napačne razvrstitve reprezentativni za klinično uporabo v Evropski uniji in da so glavni rezultati zanesljivi.
• This controlled access program is a key measure to ensure adherence of HCPs to the terms of the MA by increasing both the awareness of the relevant HCPs to the risks associated to the use of HES solutions for infusions and ensuring that they have received appropriate training before they can use HES solutions for infusion. 
• ta program nadzorovanega dostopa je ključni ukrep za zagotavljanje, da bodo zdravstveni delavci upoštevali pogoje dovoljenj za promet z zdravilom, in sicer s povečevanjem ozaveščenosti zadevnih zdravstvenih delavcev o tveganjih, povezanih z uporabo raztopin HES za infundiranje, in zagotavljanjem, da so ti pred uporabo raztopin HES za infundiranjem deležni ustreznega usposabljanja.
Besides, the CMDh acknowledged the PRAC's concern that non-adherence would not only be due to a lack of awareness by prescribers of the restrictions imposed to HES solutions for infusion. 
Skupina CMDh je tudi sprejela pomislek odbora PRAC, da neupoštevanje ni le posledica dejstva, da predpisovalci ne poznajo omejitev, ki veljajo za raztopine HES za infundiranje.
In 2012 and 2013, PRAC reviewed the benefits and risks of HES solutions for infusion in the treatment and prophylaxis of hypovolaemia, within Article 311 and 107i2 referral procedures. 
Leta 2012 in 2013 je odbor PRAC v okviru napotitvenih postopkov v skladu s členoma 311 in 107i2 pregledal koristi in tveganja raztopin HES za infundiranje pri zdravljenju in profilaksi hipovolemije.
In conclusion, no risk minimisation measures or combination of measures have been identified which would be sufficiently effective or feasible to implement in a reasonable timeframe, when an important number of patients at high risk for serious harm, would continue to be exposed. 
Prepoznali torej niso nobenih ukrepov za zmanjšanje tveganja ali kombinacije ukrepov, ki bi bili dovolj učinkoviti ali izvedljivi za izvedbo v razumnem časovnem okviru, pri čemer bi bili številni bolniki z velikim tveganjem za resne škodljive posledice še naprej izpostavljeni.
Revision of PRAC recommendation 
Revizija priporočila odbora PRAC
In view of the insight that the CMDh has on the national healthcare systems, it agreed that the following additional risk minimisation measures are feasible and likely to be effective to minimise the risk of using HES solutions for infusion in contraindicated populations: the inclusion of an emphasised warning on the SmPC, PL, primary and secondary packaging, the circulation of a targeted DHPC and the implementation of a controlled access program. 
Glede na vpogled, ki ga ima skupina CMDh v nacionalne zdravstvene sisteme, se je strinjala, da so naslednji dodatni ukrepi za zmanjševanja tveganja izvedljivi in verjetno učinkoviti za zmanjšanje tveganja za uporabo raztopin HES za infundiranje pri kontraindiciranih populacijah: vključitev poudarjenega opozorila v povzetek glavnih značilnosti zdravila, navodilo za uporabo, primarno in sekundarno ovojnino, pošiljanje ciljno usmerjenih neposrednih obvestil za zdravstvene delavce in izvedba programa nadzorovanega dostopa;
Controlled access program The objective of such program is to ensure the delivery of HES solutions for infusion to only hospitals/centres where HCPs expected to prescribe or administer (hereinafter ‘relevant HCPs') have been trained adequately on the appropriate use of HES solutions for infusion, irrespective of the department(s) where they operate,. 
Namen tovrstnega programa je zagotoviti dobavo raztopin HES za infundiranje samo tistim bolnišnicam/centrom, v katerih so bili zdravstveni delavci, ki naj bi zdravilo predpisovali ali dajali (v nadaljevanju „zadevni zdravstveni delavci“), ustrezno usposobljeni za primerno uporabo raztopin HES za infundiranje, ne glede na oddelek, kjer delajo.
• Whilst acknowledging the difficulties of continuous training, centralising such organisation and monitoring by the MAH will address the challenges raised. 
• Ob upoštevanju težav s stalnim usposabljanjem pa bi te izzive lahko obravnavali s centralizacijo njihove organizacije in spremljanjem s strani imetnikov dovoljenj za promet z zdravilom.
The PRAC carefully considered all the information provided in relation to a potential unmet medical need at national level should the marketing authorisations for HES solutions for infusion be suspended. 
Odbor PRAC je skrbno preučil vse predložene informacije v povezavi z morebitnimi neizpolnjenimi medicinskimi potrebami na nacionalni ravni v primeru umika dovoljenj za promet z zdravilom za raztopine HES za infundiranje.
Amongst other data related to safety, the PRAC reviewed the results from two separate DUSs conducted to assess the effectiveness of the risk minimisation measures imposed as an outcome of the 2013 referral, and concluded that these studies despite a potential limitation of possible misclassification, are representative of the clinical usage in the European Union and that key results are reliable. 
Med drugimi podatki, povezanimi z varnostjo, je odbor PRAC pregledal rezultate dveh ločenih študij o uporabi zdravil, v katerih so ocenjevali učinkovitost ukrepov za zmanjšanje tveganja, uvedenih kot izid napotitve iz leta 2013, in zaključil, da sta ti študiji kljub potencialni omejitvi zaradi morebitne napačne razvrstitve reprezentativni za klinično uporabo v Evropski uniji in da so glavni rezultati zanesljivi.
The PRAC also contraindicated the use of HES solutions for infusion in patients with sepsis or who are critically ill. 
Odbor PRAC je tudi kontraindiciral uporabo raztopin HES za infundiranje pri bolnikih s sepso in kritično bolnih bolnikih.
A medication form to be filled before administration would also raise feasibility issues in an emergency setting. 
Tudi glede obrazca za zdravilo, ki bi ga bilo treba izpolniti pred dajanjem, bi se porodilo vprašanje o izvedljivosti v nujnih primerih.
These reviews were triggered by the results from large randomised clinical studies3,4,5 which showed an increased risk of mortality in patients with sepsis and an increased risk of kidney injury requiring dialysis in critically ill patients following treatment with HES solutions for infusion. 
Te preglede so sprožili rezultati večjih randomiziranih kliničnih študij3, 4, 5, ki so pokazali, da imajo bolniki s sepso povečano tveganje za umrljivost po zdravljenju z raztopinami HES za infundiranje, kritično bolni bolniki pa povečano tveganje za ledvične poškodbe, zaradi katerih je potrebna dializa.
Furthermore, the PRAC requested that, as conditions to the marketing authorisations of these medicinal products, further studies should be carried out on the use of these medicines in elective surgery and in trauma patients. 
Nadalje je zahteval, da se kot pogoj za pridobitev dovoljenj za promet s temi zdravili opravijo dodatne študije o njihovi uporabi pri elektivnih kirurških posegih in poškodovancih.
The CMDh is of the position that the proposed additional measures described below would be feasible and effective to sufficiently minimise the risks by increasing awareness of HCPs, as well as ensuring that access to HES solutions for infusion is reserved to HCPs that have received adequate training. 
Skupina CMDh meni, da bi bili predlagani spodaj opisani dodatni ukrepi izvedljivi in učinkoviti za zadostno zmanjšanje tveganja s povečanjem ozaveščenosti zdravstvenih delavcev ter zagotavljanjem, da je dostop do raztopin HES za infundiranje omejen na zdravstvene delavce, ki so prestali ustrezno usposabljanje.
Overall, taking into account the divergences amongst the experts on some important issues, the position from the PRAC members on the national situation regarding the clinical use of these products and the stakeholders submissions, PRAC did not consider the clinical utility of these products to outweigh the risk of mortality and renal failure to the proportion of patients with critical illness or sepsis that continue to be exposed to HES solutions for infusion. 
Z upoštevanjem razhajanj med strokovnjaki glede nekaterih pomembnih vprašanj, stališča članov odbora PRAC o nacionalnih razmerah glede klinične uporabe teh zdravil in predložitev deležnikov je odbor PRAC presodil, da klinična uporabnost teh zdravil ne odtehta tveganja za umrljivost in ledvično odpoved pri deležu bolnikov s kritično boleznijo ali sepso, ki so še naprej izpostavljeni raztopinam HES za infundiranje.
In order to optimise the uptake by HCPs and their adherence to the adequate conditions of use of HES solutions for infusion, the learned societies should be involved in the development and distribution of such training materials. 
Da bi zdravstveni delavci bolje sprejemali ustrezne pogoje za uporabo raztopin HES za infundiranje in jih upoštevali, je treba v pripravo in razdeljevanje tovrstnega gradiva za usposabljanje vključiti strokovna združenja.
The focus for the drug utilisation studies (DUSs) has been to evaluate the adherence to the restrictions in use, implemented in the product information, concerning the indication, posology, and contraindication for HES solutions for infusion. 
Študije o uporabi zdravil so se osredotočale na ovrednotenje upoštevanja omejitev uporabe, navedenih v informacijah o zdravilu, kar zadeva indikacijo, odmerjanje in kontraindikacijo za raztopine HES za infundiranje.
In addition, the CMDh is of the view that the MAHs shall perform a Drug Utilisation Study, in order to assess the effectiveness of the new measures recommended. 
Skupina CMDh tudi meni, da morajo imetniki dovoljenj za promet z zdravilom izvesti študijo o uporabi zdravil, s katero bodo ocenili učinkovitost novih priporočenih ukrepov.
Consequently, a direct correlation is to be expected between the indication for treatment with HES solutions for infusion, the dose of HES solutions for infusion required and with the risk for renal injury and death. 
Posledično je mogoče pričakovati neposredno povezavo med indikacijo za zdravljenje z raztopinami HES za infundiranje, potrebnim odmerkom raztopin HES za infundiranje ter tveganjem za ledvično poškodbo in smrt.
The PRAC concluded that the claimed clinical utility for these products does not outweigh the risk of mortality and renal failure to the proportion of patients with critical illness or sepsis that continues to be exposed to HES solutions for infusion. 
Odbor PRAC je zaključil, da domnevna klinična uporabnost teh zdravil ne odtehta tveganja za umrljivost in ledvično odpoved pri deležu bolnikov s kritično boleznijo ali sepso, ki so še vedno izpostavljeni raztopinam HES za infundiranje.
The PRAC concluded that no additional risk minimisation measure or combination of risk minimisation measures, to sufficiently ensure safe and effective use of HES solutions for infusion could be identified. 
Odbor PRAC je zaključil, da ni mogoče določiti nobenih dodatnih ukrepov za zmanjšanje tveganja oziroma kombinacije ukrepov za zmanjšanje tveganja, s katerimi bi lahko zagotovili varno in učinkovito uporabo raztopin HES za infundiranje.
Detailed explanation of the scientific grounds for the differences from the PRAC recommendation 
Podrobna obrazložitev znanstvene podlage za odstopanja od priporočila odbora PRAC