FrancophonIA/ELRC3.0 huggingface dataset:
English: • This measure will act as a reminder at time of administration, which is important in an emergency setting.
Slovenian: • ta ukrep bo deloval kot opomnik ob času dajanja, kar je pomembno pri nujnih primerih.
English: Revised CMDh position
Slovenian: Revidirano stališče skupine CMDh
English: Overall, the evidence for this indication is based on studies for which the sample size and the duration of follow-up are limited.
Slovenian: Dokazi pri tej indikaciji na splošno temeljijo na študijah, v katerih sta bila velikost vzorca in trajanje spremljanja omejena.
English: The CMDh emphasised the importance of having meaningful results from these studies as soon as possible.
Slovenian: Skupina CMDh je poudarila, da je zelo pomembno čim prej pridobiti tehtne rezultate teh študij.
English: These views, along with all substantial data and information crucial for the full understanding of these views have been either shared with all the parties involved or otherwise made available in the course of the procedure.
Slovenian: Ta stališča so bila skupaj z vsemi bistvenimi podatki in informacijami, ki so ključnega pomena za celovito razumevanje teh stališč, posredovana vsem vključenim osebam ali so bila kako drugače na voljo v teku postopka.
English: The PRAC also consulted an ad-hoc expert group and considered carefully views expressed during the meeting that took place on 18 December 2017.
Slovenian: Odbor PRAC se je posvetoval tudi z ad-hoc skupino strokovnjakov in skrbno upošteval stališča, izražena med sestankom, ki je potekal 18. decembra 2017.
English: Communication measures
Slovenian: Ukrepi za obveščanje
English: • The continued presence of this warning on the packaging will also contribute to long-term awareness of HPCs.
Slovenian: • stalna prisotnost tega opozorila na ovojnini bo prispevala tudi k dolgoročni ozaveščenosti zdravstvenih delavcev;
English: This controlled access program should be described in a Risk Management Plan which shall be submitted to the National Competent Authorities for assessment within 3 months from the Commission Decision.
Slovenian: Ta program nadzorovanega dostopa je treba opisati v načrtu za obvladovanje tveganja, ki ga je treba predložiti nacionalnim pristojnim organom v oceno v treh mesecih od sklepa Komisije.
English: This reflects a long-standing controversy among health-care professionals and echoes the range of stakeholder responses received in the current review.
Slovenian: To odraža dolgoletno polemiko med zdravstvenimi delavci in razpon odzivov deležnikov, prejetih med trenutnim pregledom.
English: In terms of readability, the warning should be strongly emphasised (e.g. capitalized, bold letters or use of colours).
Slovenian: V smislu berljivosti mora biti opozorilo močno poudarjeno (npr. s krepkimi, velikimi tiskanimi črkami ali z uporabo barv).
English: In light of the well-established risk for serious harm when HES solutions for infusion are used in patients with critical illness, including sepsis, together with the above-mentioned newly available data, Sweden triggered, on 17th October 2017, an urgent Union procedure under Article 107i of Directive 2001/83/EC.
Slovenian: V luči dobro znanega tveganja za resne škodljive posledice uporabe raztopin HES za infundiranje pri bolnikih s kritično boleznijo, vključno s sepso, skupaj z zgoraj omenjenimi novimi podatki, je Švedska 17. oktobra 2017 sprožila nujni postopek Unije v skladu s členom 107i Direktive 2001/83/ES.
English: These views are based on PRAC members' routine review processes and preparation.
Slovenian: Ta stališča temeljijo na rutinskih pregledih in pripravi članov odbora PRAC.
English: Progress on the ongoing DUS shall be reported within the upcoming PSUR.
Slovenian: O napredku trenutne študije o uporabi zdravil je treba poročati v naslednjem poročilu PSUR.
English: The PRAC adopted a recommendation on 11 January 2018 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Slovenian: Odbor PRAC je 11. januarja 2018 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
English: This complicates effective risk minimisation in these patients.
Slovenian: Tako se učinkovito zmanjšanje tveganja pri teh bolnikih zaplete.
English: It will complement other measures such as training to HCPs.
Slovenian: Dopolnjeval bo druge ukrepe, kot je usposabljanje zdravstvenih delavcev;
English: The PRAC duly considered the view of the majority of the experts in the meeting that HES is used in clinical practice.
Slovenian: Odbor PRAC je ustrezno upošteval stališče večine strokovnjakov na sestanku, da se HES uporablja v klinični praksi.
English: The position was afterwards forwarded to the European Commission, the Member States, to Iceland and Norway and to the marketing authorisation holders for the above mentioned medicinal products, together with its annexes and appendices.
Slovenian: Svoje stališče je nato posredovala Evropski komisiji, državam članicam, Islandiji in Norveški ter imetnikom dovoljenj za promet z zdravilom za zgoraj navedena zdravila, skupaj s prilogami in dodatki.
English: During the decision-making process, at a meeting of the Standing Committee on Medicinal Products for Human Use, some EU Member States raised new questions of technical nature which they considered had not been sufficiently addressed in the PRAC recommendation and CMDh position.
Slovenian: Med odločanjem na sestanku Stalnega odbora za zdravila za uporabo v humani medicini so nekatere države članice EU sprožile nova vprašanja tehnične narave, za katera so menile, da v priporočilu odbora PRAC in stališču skupine CMDh niso bila obravnavana v zadostni meri.
English: They should also allow adequate description of national contexts to guarantee the adequate analysis and extrapolation of the outcome and justify potential adjustments (i.e. successful/unsuccessful distribution of safety communications, adherence to the controlled access program, qualitative feedback from prescribers, etc).
Slovenian: Omogočati morajo tudi ustrezen opis nacionalnih okvirov, kar zagotavlja ustrezno analizo in ekstrapolacijo izida ter utemeljitev morebitnih prilagoditev (tj. uspešno/neuspešno razdeljevanje obvestil o varnosti, upoštevanje programa nadzorovanega dostopa, kvalitativne povratne informacije od predpisovalcev itd.).
English: The training materials should be based on interactive learning tools in order to ensure the active involvement of the HCPs.
Slovenian: Gradivo za usposabljanje mora temeljiti na interaktivnih učnih orodjih, ki zagotavljajo aktivno vključenost zdravstvenih delavcev.
English: Hydroxyethyl starch (HES) solutions for infusion contain starch with different molecular weights (mainly 130kD; 200kD) and substitution ratio (the number of hydroxyethyl groups per glucose molecule).
Slovenian: Raztopine hidroksietil škroba (HES) za infundiranje vsebujejo škrob različnih molekulskih mas (večinoma 130 kD; 200 kD) in substitucijskih vzorcev (število hidroksietilnih skupin na molekulo glukoze).
English: HES solutions for infusion are authorised worldwide for the treatment of hypovolaemia associated with various conditions.
Slovenian: Raztopine HES za infundiranje so odobrene po vsem svetu za zdravljenje hipovolemije, povezane z različnimi stanji.
English: • A reference to section 4.3 of the SmPC will avoid undermining the importance of other contraindications, and ensure these continue to be adhered to.
Slovenian: • sklic na poglavje 4.3 povzetka glavnih značilnosti zdravila bo preprečil slabitev pomena drugih kontraindikacij in zagotovil njihovo nadaljnje upoštevanje.
English: The benefits in the approved indication therefore remain modest.
Slovenian: Koristi pri odobreni indikaciji torej ostajajo skromne.
English: • The PRAC also noted the overall exposure to HES solutions for infusion in the EU, estimated to about 1.5 to 2 million patients per year since 2014.
Slovenian: • odbor PRAC je opozoril tudi, da je skupna izpostavljenost raztopinam HES za infundiranje v EU od leta 2014 ocenjena na približno 1,5 do 2 milijona bolnikov na leto.
English: The safety concerns of primary importance in this referral are increased mortality and a higher incidence of renal failure - the opposite of the benefit expected.
Slovenian: Najpomembnejši varnostni pomisleki v tej napotitvi so povečana umrljivost in večja pojavnost ledvične odpovedi, kar je ravno nasprotno od pričakovane koristi.
English: In view of the above and whilst noting the PRAC's reservations on the expected effectiveness of this measure, notably in view of the non-adherence by prescribers not only due to a lack of awareness, the CMDh considered that:
Slovenian: Glede na zgoraj navedeno in z upoštevanjem zadržkov odbora PRAC glede pričakovane učinkovitosti tega ukrepa, predvsem v smislu neupoštevanja s strani predpisovalcev, ki ni le posledica nepoznavanja, je skupina CMDh menila naslednje:
English: The CMDh finally encouraged the integration of the training activities abovementioned in the continuing medical education at national level.
Slovenian: Skupina CMDh je tudi spodbudila vključevanje zgoraj navedenih aktivnosti usposabljanja v stalno medicinsko izobraževanje na nacionalni ravni.
English: The CMDh through its representatives of NCAs have further discussed the national specificities of the healthcare systems and was of the view that the proposed controlled access program is likely to be feasible for the following reasons:
Slovenian: Skupina CMDh je prek svojih predstavnikov iz nacionalnih pristojnih organov nadalje razpravljala o nacionalnih posebnostih zdravstvenih sistemov in menila, da bi bil predlagani program nadzorovanega dostopa izvedljiv, in sicer zaradi naslednjih razlogov:
English: Therefore, the PRAC recommends the suspension of the marketing authorisations for all medicinal products referred to in Annex I.
Slovenian: Zato priporoča začasni umik dovoljenj za promet z vsemi zdravili, navedenimi v Prilogi I.
English: It should also be noted that the ultimate benefit expected from HES solutions for infusion (and treatment of hypovolemia in general) is a reduction of mortality and lower incidence of renal failure.
Slovenian: Opozoriti je treba tudi, da je končna korist, pričakovana od raztopin HES za infundiranje (in od zdravljenja hipovolemije na splošno), zmanjšanje umrljivosti in manjša pojavnost ledvične odpovedi.
English: The protocol should also include a measure of the primary outcomes at baseline.
Slovenian: Protokol mora vključevati tudi merilo primarnih izidov ob izhodišču.
English: Results from two drug utilisation studies, submitted by the concerned Marketing Authorisation Holders (‘MAHs') in 2017, have shown that the recommended restrictions in use are not being sufficiently adhered to.
Slovenian: Rezultati dveh študij o uporabi zdravil, ki so ju predložili zadevni imetniki dovoljenj za promet z zdravilom leta 2017, kažejo, da se priporočene omejitve uporabe ne upoštevajo v zadostni meri.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 107i of Directive 2001/83/EC, for hydroxyethyl starch (HES) solution for infusion (see Annex I).
Slovenian: • Odbor za oceno tveganja na področju farmakovigilance (PRAC) je obravnaval postopek v skladu s členom 107i Direktive 2001/83/ES za raztopino hidroksietil škroba (HES) za infundiranje (glejte Prilogo I);
English: The PRAC considered that despite arguments raised by some Member States, the potential for unmet medical need is not established.
Slovenian: Odbor PRAC je kljub argumentom, ki so jih navedle nekatere države članice, ocenil, da potencial za neizpolnjene medicinske potrebe ni opredeljen.
English: A follow-up questionnaire to be filled after administration would not be effective in minimising the risk.
Slovenian: Kontrolni vprašalnik, ki bi ga bilo treba izpolniti po dajanju, pri zmanjševanju tveganja ne bi bil učinkovit.
English: This suggests that the previous communication measures although not sufficient to ensure full compliance, have had some effectiveness.
Slovenian: To kaže, da so predhodni ukrepi za obveščanje dosegli določeno učinkovitost, čeprav niso zadoščali za zagotavljanje popolnega upoštevanja.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Treatment of hypovolemia should replace lost blood volume in order to restore tissue perfusion and oxygenation to ultimately prevent renal injury and death.
Slovenian: 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.
English: Proposals to amend the indications and contraindications were not considered sufficient to have a significant impact on prescriber behaviour.
Slovenian: Predlogi za spreminjanje indikacij in kontraindikacij niso bili ocenjeni kot zadostni, da bi imeli pomemben vpliv na obnašanje predpisovalcev.
English: 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.
Slovenian: 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.
English: • This measure will ensure long term effectiveness through reminders sent to the trained HCPs and training of new ones.
Slovenian: • ta ukrep bo z opomniki, poslanimi usposobljenim zdravstvenim delavcem, in usposabljanji za nove zdravstvene delavce zagotovil dolgoročno učinkovitost.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The PRAC also reviewed responses from Member States in relation to the potential unmet medical need and proposals for additional risk minimisation measures.
Slovenian: Odbor PRAC je pregledal tudi odgovore držav članic v zvezi z morebitnimi neizpolnjenimi medicinskimi potrebami in predloge za dodatne ukrepe za zmanjšanje tveganja;
English: 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.
Slovenian: 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.
English: The CMDh considered also the divergence of positions of the learned societies in the EU.
Slovenian: Skupina CMDh je preučila tudi razhajanja v stališčih strokovnih združenj v EU.
English: In addition, a significant decrease of the usage of HES solutions for infusion was noted in most EU Member States.
Slovenian: Poleg tega so v večini držav članic opazili pomembno zmanjšanje uporabe raztopin HES za infundiranje.
English: There is a direct relation between the degree of hypovolemia and the risk for renal injury and death.
Slovenian: Obstaja neposredna povezava med stopnjo hipovolemije in tveganjem za ledvično poškodbo in smrt.
English: The CMDh took into consideration all the new elements available since the previous CMDh position.
Slovenian: Skupina CMDh je upoštevala vse nove elemente, na voljo od njenega zadnjega stališča.
English: • 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.
Slovenian: • domneva, da neupoštevanje ni le posledica nepoznavanja, ni podprta z zadostnimi dokazi in morda ni reprezentativna za velik delež populacije predpisovalcev;
English: The PRAC have also further considered for the feasibility and likely effectiveness of risk minimisation measures.
Slovenian: Odbor PRAC je nadalje preučil tudi izvedljivost in verjetno učinkovitost ukrepov za zmanjšanje tveganja.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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;
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
English: Having reviewed the PRAC recommendation6, the CMDh agreed by a majority on 24 January 2018 with the PRAC overall conclusions and grounds for recommendation.
Slovenian: Po pregledu priporočila6 odbora PRAC se je skupina CMDh 24. januarja 2018 večinsko strinjala s končnimi zaključki odbora PRAC in s podlago za priporočilo.
English: 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.
Slovenian: 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.
English: • The CMDh also considered that the effectiveness of these additional risk minimisation measures must be assessed through the conduct of a drug utilisation study.
Slovenian: • skupina CMDh je menila tudi, da je treba učinkovitost teh dodatnih ukrepov za zmanjševanje tveganja oceniti z izvedbo študije o uporabi zdravil.
English: The results indicate that the implemented restrictions in use are not adhered to.
Slovenian: Rezultati kažejo, da se uvedene omejitve uporabe ne upoštevajo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: (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.
Slovenian: (1) Dodatek naslednjega opozorila na zunanjo ovojnino in stično ovojnino: „Ne uporabljajte pri bolnikih s sepso, ledvično okvaro ali kritično bolnih bolnikih.
English: 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.
Slovenian: 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.