natgillin/translations-raw huggingface dataset:
The PRAC considered that despite arguments raised by some Member States, the potential for unmet medical need is not established. 
Odbor PRAC je kljub argumentom, ki so jih navedle nekatere države članice, ocenil, da potencial za neizpolnjene medicinske potrebe ni opredeljen.
A follow-up questionnaire to be filled after administration would not be effective in minimising the risk. 
Kontrolni vprašalnik, ki bi ga bilo treba izpolniti po dajanju, pri zmanjševanju tveganja ne bi bil učinkovit.
This suggests that the previous communication measures although not sufficient to ensure full compliance, have had some effectiveness. 
To kaže, da so predhodni ukrepi za obveščanje dosegli določeno učinkovitost, čeprav niso zadoščali za zagotavljanje popolnega upoštevanja.
Having considered the specificities of the national systems and the need for agreement with the national competent authorities on the details on the implementation of the controlled access and the time required to complete the adequate training to all HCPs intended to use HES products and the accreditation of the hospitals/ centres, the CMDh requested that the controlled access program should be effectively implemented at the latest 9 months after Commission Decision. 
Z upoštevanjem posebnosti nacionalnih sistemov in potrebe po dogovoru z nacionalnimi pristojnimi organi glede podrobnosti izvajanja programa nadzorovanega dostopa in potrebnega časa za izvedbo ustreznega usposabljanja za vse zdravstvene delavce, ki naj bi uporabljali zdravila s HES, ter glede akreditacije bolnišnic/centrov, je skupina CMDh zahtevala, da mora biti program nadzorovanega dostopa učinkovito uveden najpozneje v devetih mesecih po sklepu Komisije.
See all contraindications in the SmPC.” The CMDh acknowledged that the prescribers would not often administer the solution and therefore could not see this warning label. 
Za vse kontraindikacije glejte povzetek glavnih značilnosti zdravila.“ Skupina CMDh je priznala, da predpisovalci pogosto ne dajejo raztopine in zato te opozorilne oznake ne bi videli.
Treatment of hypovolemia should replace lost blood volume in order to restore tissue perfusion and oxygenation to ultimately prevent renal injury and death. 
Pri zdravljenju hipovolemije je treba nadomestiti izgubljeni volumen krvi, da se obnovita perfuzija in oksigenacija tkiva in se tako v končni fazi preprečita ledvična poškodba in smrt.
Proposals to amend the indications and contraindications were not considered sufficient to have a significant impact on prescriber behaviour. 
Predlogi za spreminjanje indikacij in kontraindikacij niso bili ocenjeni kot zadostni, da bi imeli pomemben vpliv na obnašanje predpisovalcev.
The CMDh also noted that treatment characteristics in some of the previously assessed clinical studies such as strength, dose or length of treatment may differ from current practice. 
Skupina CMDh je upoštevala tudi, da se značilnosti zdravljenja v nekaterih predhodno ocenjenih kliničnih študijah, kot so jakost, odmerek ali dolžina zdravljenja, razlikujejo od trenutne prakse.
• This measure will ensure long term effectiveness through reminders sent to the trained HCPs and training of new ones. 
• ta ukrep bo z opomniki, poslanimi usposobljenim zdravstvenim delavcem, in usposabljanji za nove zdravstvene delavce zagotovil dolgoročno učinkovitost.
The CMDh took also into consideration the responses to the questions raised by the European Commission and the elements collected by the PRAC, as well as the information provided by the MAH during the oral explanations held on 28 May 2018 and 25 June 2018. 
Skupina CMDh je upoštevala tudi odgovore na vprašanja Evropske komisije in elemente, ki jih je zbral odbor PRAC ter informacije, ki so jih predložili imetniki dovoljenj za promet z zdravilom med ustno obrazložitvijo, ki je potekala 28. maja 2018 in 25. junija 2018.
It is proposed to mention explicitly in the new warnings ‘renal impairment' in addition to ‘sepsis' and ‘critically ill patients'; this would add further emphasis on this specific critically ill patients. 
Predloga se, da se v novem opozorilu poleg „sepse“ in „kritično bolnih“ izrecno navede „ledvična okvara“, s čimer bi dodatno poudarili zlasti te kritično bolne bolnike.
The PRAC also reviewed responses from Member States in relation to the potential unmet medical need and proposals for additional risk minimisation measures. 
Odbor PRAC je pregledal tudi odgovore držav članic v zvezi z morebitnimi neizpolnjenimi medicinskimi potrebami in predloge za dodatne ukrepe za zmanjšanje tveganja;
The CMDh acknowledged the complexity of managing patient suffering from hypovolemia due to an acute blood loss, and the fact that these patients require an individual evaluation. 
Skupina CMDh je priznala, da je obravnava bolnikov s hipovolemijo kompleksna, in sicer zaradi akutne izgube krvi in dejstva, da ti bolniki potrebujejo posamično ovrednotenje.
The CMDh considered also the divergence of positions of the learned societies in the EU. 
Skupina CMDh je preučila tudi razhajanja v stališčih strokovnih združenj v EU.
In addition, a significant decrease of the usage of HES solutions for infusion was noted in most EU Member States. 
Poleg tega so v večini držav članic opazili pomembno zmanjšanje uporabe raztopin HES za infundiranje.
There is a direct relation between the degree of hypovolemia and the risk for renal injury and death. 
Obstaja neposredna povezava med stopnjo hipovolemije in tveganjem za ledvično poškodbo in smrt.
The CMDh took into consideration all the new elements available since the previous CMDh position. 
Skupina CMDh je upoštevala vse nove elemente, na voljo od njenega zadnjega stališča.
• The assumption that the non-adherence is not only due to lack of awareness is not supported by sufficient evidence and might not be representative of a significant portion of the prescribers population. 
• domneva, da neupoštevanje ni le posledica nepoznavanja, ni podprta z zadostnimi dokazi in morda ni reprezentativna za velik delež populacije predpisovalcev;
The PRAC have also further considered for the feasibility and likely effectiveness of risk minimisation measures. 
Odbor PRAC je nadalje preučil tudi izvedljivost in verjetno učinkovitost ukrepov za zmanjšanje tveganja.
• In view of the seriousness of the risks related to the use of HES solutions for infusion outside the terms of the MA, the CMDh considered this measure as proportionate. 
• glede na resnost tveganj, povezanih z uporabo raztopin HES za infundiranje zunaj pogojev dovoljenja za promet z zdravilom, je skupina CMDh ta ukrep ocenila za sorazmernega.
The medication form/checklists would also raise feasibility issues in an emergency setting, and implementation of a restricted access/distribution program is unlikely to be feasible and sufficiently effective across EU Member States considering the particular type of distribution and usage of HES solutions for infusion and some national limitations. 
Obrazci/kontrolni seznami za zdravila bi sprožili tudi vprašanje o izvedljivosti v nujnih primerih, uvedba programa omejenega dostopa/distribucije pa je v vseh državah članicah EU verjetno neizvedljiva in ne dovolj učinkovita, glede na poseben način distribucije in uporabe raztopin HES za infundiranje in določenih nacionalnih omejitev.
The PRAC also noted the view of an expert concerning shared clinical experience in handling cases in a EU Member State where HES solutions for infusion are little used and where no medical need is raised. 
Odbor PRAC je upošteval tudi stališče strokovnjaka glede izmenjave kliničnih izkušenj pri obravnavi primerov v državi članici EU, v kateri se raztopine HES za infundiranje uporabljajo le malo in medicinska potreba ne obstaja.
• The CMDh took into consideration the revised PRAC recommendation as well as all the new elements submitted by the MAHs and the Member States regarding potential medical need and the feasibility and likely effectiveness of additional risk minimisation measures and available since the previous CMDh position adopted in January 2018. 
• skupina CMDh je upoštevala revidirano priporočilo odbora PRAC in vse nove elemente, ki so jih predložili imetniki dovoljenj za promet z zdravilom in države članice o morebitnih medicinskih potrebah ter izvedljivosti in verjetni učinkovitosti dodatnih ukrepov za zmanjšanje tveganja in ki so na voljo od zadnjega stališča skupine CMDh, sprejetega januarja 2018;
The CMDh noted the concerns raised by PRAC on some models of controlled access program for HES solutions for infusion, in particular regarding feasibility due to the difficulty to define relevant prescribers / departments / hospitals and their effectiveness. 
Skupina CMDh je upoštevala pomisleke odbora PRAC o določenih modelih programa nadzorovanega dostopa za raztopine HES za infundiranje, zlasti glede izvedljivosti zaradi težavne opredelitve zadevnih predpisovalcev/oddelkov/bolnišnic in njihove učinkovitosti.
• The CMDh, through its representatives of Member States also considered feasibility at national level of some additional risk minimisation measures for which PRAC raised feasibility questions. 
• skupina CMDh je prek svojih predstavnikov iz držav članic preučila tudi izvedljivost določenih dodatnih ukrepov za zmanjšanje tveganja na nacionalni ravni, glede katerih je imel odbor PRAC pomisleke o izvedljivosti.
Having reviewed the PRAC recommendation6, the CMDh agreed by a majority on 24 January 2018 with the PRAC overall conclusions and grounds for recommendation. 
Po pregledu priporočila6 odbora PRAC se je skupina CMDh 24. januarja 2018 večinsko strinjala s končnimi zaključki odbora PRAC in s podlago za priporočilo.
Patients in the approved indication may become critically ill or septic shortly after receiving HES solutions for infusion and these patients cannot be identified prospectively. 
Bolniki z odobreno indikacijo lahko postanejo kritično bolni ali se pri njih pojavi sepsa kmalu po prejemu raztopin HES za infundiranje in teh bolnikov ni mogoče določiti vnaprej.
• The CMDh also considered that the effectiveness of these additional risk minimisation measures must be assessed through the conduct of a drug utilisation study. 
• skupina CMDh je menila tudi, da je treba učinkovitost teh dodatnih ukrepov za zmanjševanje tveganja oceniti z izvedbo študije o uporabi zdravil.
The results indicate that the implemented restrictions in use are not adhered to. 
Rezultati kažejo, da se uvedene omejitve uporabe ne upoštevajo.
Whilst some concerns related to the use of these products in clinical settings not covered by the terms of the MA, the CMDh acknowledged concerns on the medical need related to the authorised use and therefore should be taken into account, even if it might be rare. 
Medtem ko so se nekateri pomisleki nanašali na uporabo teh zdravil v okviru kliničnega zdravljenja, ki ni zajeto v pogoje dovoljenja za promet z zdravilom, je skupina CMDh sprejela pomisleke o medicinski potrebi, povezani z odobreno uporabo, ki jo je treba upoštevati, čeprav je morda redka.
A restricted distribution system to accredited hospitals or physicians would raise serious feasibility concerns and would be unlikely to be effective considering the particular type of distribution and usage of HES solutions for infusion. 
Sistem omejene distribucije akreditiranim bolnišnicam ali zdravnikom bi vzbudil resne pomisleke o izvedljivosti in verjetno ne bi bil učinkovit, glede na poseben način distribucije in uporabe raztopin HES za infundiranje.
(1) Addition of the following warning on the outer packaging and the immediate packaging: “Do not use in sepsis, renal impairment, or critically ill patients. 
(1) Dodatek naslednjega opozorila na zunanjo ovojnino in stično ovojnino: „Ne uporabljajte pri bolnikih s sepso, ledvično okvaro ali kritično bolnih bolnikih.
Acknowledging the need of increasing the compliance to the indication and contraindications, the CMDh is of the position that a targeted communication through DHPC would be effective to this aim. 
S priznavanjem potrebe po izboljšanem upoštevanju indikacije in kontraindikacij skupina CMDh meni, da bi bilo v ta namen učinkovito ciljno obveščanje z neposrednimi obvestili za zdravstvene delavce.
• With regards to the efficacy, PRAC considered that there is no new significant information related to the approved indication. 
• kar zadeva učinkovitost, je odbor PRAC menil, da ni nobene nove pomembne informacije, povezane z odobreno indikacijo.
It is expected that the involvement of the learned societies will have an important role in channelling the messages of the training. 
Pričakuje se, da bo vključitev strokovnih združenj pomembno vplivala na posredovanje sporočil usposabljanja.
For lifting the suspension, the MAHs should provide reliable and convincing evidence on a favourable benefit risk balance in a well-defined population, with feasible and effective measures to adequately minimise exposure of patients at an increased risk of serious harm. 
Za preklic začasnega umika morajo imetniki dovoljenj za promet z zdravilom predložiti zanesljive in prepričljive dokaze o ugodnem razmerju med tveganji in koristmi v dobro opredeljeni populaciji, z izvedljivimi in učinkovitimi ukrepi za ustrezno zmanjšanje izpostavljenosti bolnikov, ki imajo povečano tveganje za resne škodljive posledice.
The CMDh also concluded that the annual PSUR cycle should remain unchanged and would enable periodic review of the benefit-risk balance of these products and the impact of any data that would be generated. 
Skupina CMDh je tudi zaključila, da naj vsakoletni cikel poročil PSUR ostane nespremenjen, kar bo omogočilo reden pregled razmerja med tveganji in koristmi za ta zdravila in vpliva morebitno pridobljenih podatkov.
Having reviewed the revised PRAC recommendation7, the CMDh disagreed with the PRAC overall conclusions and grounds for recommendation. 
Po pregledu revidiranega priporočila7 odbora PRAC se skupina CMDh ni strinjala s končnimi zaključki odbora PRAC in podlago za priporočilo.
The details of the controlled access program, the modalities of its implementation and the final training materials, including communication media and distribution modalities should be agreed with the National Competent Authorities. 
O podrobnostih programa nadzorovanega dostopa, načinih njegove izvedbe in končnih različicah gradiva za usposabljanje, vključno s sredstvi obveščanja in načini razdeljevanja, se je treba dogovoriti z nacionalnimi pristojnimi organi.
The medication form/checklists would also raise feasibility issues in an emergency setting. 
Obrazci/kontrolni seznami za zdravila bi sprožili tudi vprašanje o izvedljivosti v nujnih primerih.
On 17 October 2017, Sweden triggered an urgent Union procedure under Article 107i of Directive 2001/83/EC, and requested the PRAC to assess the impact of the above non-adherence to the product information on the benefit-risk balance of hydroxyethyl starch (HES) solutions for infusion and issue a recommendation on whether the marketing authorisations of these products should be maintained, varied, suspended or revoked. 
Švedska je 17. oktobra 2017 sprožila nujni postopek Unije v skladu s členom 107i Direktive 2001/83/ES in odbor PRAC zaprosila, naj oceni vpliv zgornjega neupoštevanja informacij o zdravilu na razmerje med tveganji in koristmi raztopin hidroksietil škroba (HES) za infundiranje ter izda priporočilo, ali naj se dovoljenja za promet z zdravilom ohranijo, spremenijo, začasno umaknejo ali prekličejo.
The final training materials, including communication media and distribution modalities should be agreed with the National Competent Authorities. 
O končni različici gradiva za usposabljanje, vključno s sredstvi obveščanja in načini razdeljevanja, se je treba dogovoriti z nacionalnimi pristojnimi organi.
Indeed, the CMDh noted the results of the DUSs whereby there was adherence to some of the key restrictions of use recommended following the 2013 referrals (i.e. the maximum daily dose and treatment duration). 
Skupina CMDh je upoštevala rezultate študij o uporabi zdravil, ki so pokazali upoštevanje nekaterih ključnih omejitev uporabe, priporočenih po napotitvah iz leta 2013 (tj. največji dnevni odmerek in trajanje zdravljenja).
The training materials should be distributed to all relevant HCPs intended to prescribe/administer HES solutions for infusion (e.g. anaesthiologists, intensive care physicians, nurses…). 
Gradivo za usposabljanje je treba razdeliti vsem zadevnim zdravstvenim delavcem, ki naj bi predpisovali/dajali raztopine HES za infundiranje (npr. anesteziologom, zdravnikom specialistom intenzivne medicine, medicinskim sestram …).
The CMDh noted the PRAC conclusions that no new safety data was provided that would change the conclusions on the safety profile established in the previous referrals for HES solutions for infusion. 
Skupina CMDh je upoštevala zaključke odbora PRAC, da ni bilo na voljo nobenih novih podatkov o varnosti, ki bi spremenili zaključke o varnostnem profilu, določenem v sklopu predhodnih napotitev za raztopine HES za infundiranje.
A more pronounced hypovolemia requires a greater volume (dose) of HES solutions for infusion and is also associated with a greater risk for renal injury and death. 
Izrazitejša hipovolemija zahteva večji volumen (odmerek) raztopin HES za infundiranje in je tudi povezana z večjim tveganjem za ledvično poškodbo in smrt.
• Whilst patients eligible to treatment with HES solutions for infusion cannot be restricted to specific hospitals or hospital departments, it is possible to identify within a hospital/centre the relevant HCPs who would be prescribing/administrating HES solutions for infusion. 
• Bolnikov, primernih za zdravljenje z raztopinami HES za infundiranje, sicer ni mogoče omejiti na določene bolnišnice ali bolnišnične oddelke, vendar je mogoče znotraj bolnišnice/centra opredeliti zadevne zdravstvene delavce, ki bi predpisovali/dajali raztopine HES za infundiranje.
Proposals to amend the indications and contraindications were not considered have a sufficient impact on prescriber behaviour and were not supported by appropriate scientific evidence. 
Predlogi za spremembo indikacij in kontraindikacij po oceni ne bi imeli zadostnega vpliva na obnašanje predpisovalcev in niso podprti z ustreznimi znanstvenimi dokazi.
The DUS final study report shall be submitted within 24 months from the Commission Decision. 
Končno poročilo študije o uporabi zdravil je treba predložiti v 24 mesecih po sklepu Komisije.
Due to the serious public health impact, Sweden was considering suspending the marketing authorisations for the above mentioned medicinal products, and therefore requested an urgent review of the matter at the European level, and asked the PRAC to assess the impact of the above concerns on the benefit-risk balance of HES solutions for infusion and issue a recommendation on whether the marketing authorisations of these products should be maintained, varied, suspended or revoked. 
Zaradi resnega vpliva na javno zdravje je Švedska razmišljala o začasnem umiku dovoljenj za promet z zgoraj navedenimi zdravili in je zato zahtevala nujni pregled zadeve na evropski ravni ter odbor PRAC zaprosila, naj oceni vpliv zgornjih pomislekov na razmerje med tveganji in koristmi raztopin HES za infundiranje ter izda priporočilo, ali naj se dovoljenja za promet s temi zdravili ohranijo, spremenijo, začasno umaknejo ali prekličejo.
In view of the seriousness of the safety issues and that the proportion of patients who are exposed to these risks in the absence of effective risk minimisation measures could have important public health consequences including a potentially increased mortality, the PRAC concluded that the benefit risk balance of hydroxyethyl starch solutions for infusion is no longer favourable and recommended the suspension of the marketing authorisations. 
Zaradi resnosti vprašanj glede varnosti in dejstva, da bi delež bolnikov, izpostavljenih tem tveganjem, v odsotnosti učinkovitih ukrepov za zmanjševanje tveganja lahko imel pomembne posledice za javno zdravje, vključno s potencialno povečano umrljivostjo, je odbor PRAC zaključil, da razmerje med tveganji in koristmi raztopin hidroksietil škroba za infundiranje ni več ugodno, in priporočil začasni umik dovoljenj za promet z zdravilom.
In the light of the above information, the PRAC confirmed at its May 2018 plenary meeting, its previous scientific conclusions that the benefit risk of HES solutions for infusion is negative and recommended to suspend the marketing authorisations of these medicinal products. 
V luči zgornjih informacij je odbor PRAC na svojem plenarnem sestanku maja 2018 potrdil svoje predhodne znanstvene zaključke, da je razmerje med tveganji in koristmi raztopin HES za infundiranje negativno, in je priporočil začasen umik dovoljenj za promet z zdravilom za ta zdravila.
• It will allow targeting HCPs in charge of the administration of the medicinal product who have an important role in ensuring adherence to the adequate use of HES solutions for infusion. 
• omogočil bo ciljno usmerjenost na zdravstvene delavce, odgovorne za dajanje zdravila, ki imajo pomembno vlogo pri zagotavljanju upoštevanja ustrezne uporabe raztopin HES za infundiranje;
With regards to efficacy, PRAC considered that there is no new significant information related to the approved indication. 
Kar zadeva učinkovitost, je odbor PRAC menil, da ni nobene nove pomembne informacije, povezane z odobreno indikacijo.
As result of the reviews, the PRAC recommended that use of HES solutions for infusion should be restricted to the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. 
Na podlagi pregledov je odbor PRAC priporočil, naj se uporaba raztopin HES za infundiranje omeji na zdravljenje hipovolemije zaradi akutne izgube krvi, kadar samo kristaloidi ne zadoščajo.
With regard to the impact on a suspension of the marketing authorisations for HES solutions for infusion, fifteen EU Member States and Norway mentioned that no unmet medical need is expected in case of suspension of the marketing authorisations for HES solutions for infusion. 
Kar zadeva vpliv začasnega umika dovoljenj za promet z zdravilom za raztopine HES za infundiranje, so petnajst držav članic EU in Norveška navedle, da v primeru umika dovoljenj za promet z zdravilom za raztopine HES za infundiranje ne pričakujejo neizpolnjenih medicinskih potreb.
The results indicate that the implemented restrictions in use are not sufficiently adhered to. 
Rezultati kažejo, da se uvedene omejitve uporabe ne upoštevajo v zadostni meri.
The CMDh also agreed on a communication plan for the dissemination of this DHPC. 
Skupina CMDh se je dogovorila tudi o načrtu obveščanje za razširjanje tega neposrednega obvestila za zdravstvene delavce.
The PRAC also considered views from individual PRAC members on the benefit/risk balance of HES solutions for infusion as well as on the use of these products at the national level. 
Odbor PRAC je preučil tudi stališča posameznih članov odbora PRAC o razmerju med tveganji in koristmi raztopin HES za infundiranje ter o uporabi teh zdravil na nacionalni ravni.
In view of the overall exposure to HES solutions for infusion in the EU, estimated to about 1.5 to 2 million patients per year since 2014 and the reported extent of usage in patients with sepsis from the two DUSs, 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 skupno izpostavljenost raztopinam HES za infundiranje v EU, ki je ocenjena na približno 1,5 do 2 milijona bolnikov na leto od leta 2014, in razširjenost uporabe pri bolnikih s sepso, o kateri so poročali v dveh študijah o uporabi zdravila, ocenjena stopnja neprekinjene uporabe pri populacijah, pri katerih so dokazali resne škodljive učinke, vzbuja pomembne skrbi za javno zdravje, vključno s potencialno povečano umrljivostjo.
A positive benefit-risk balance has been established in elective surgery and trauma patients. 
Pozitivno razmerje med tveganji in koristmi so ugotovili pri bolnikih z elektivnim kirurškim posegom in poškodovancih.