FrancophonIA/ELRC3.0 huggingface dataset:
English: • With regards to the efficacy, PRAC considered that there is no new significant information related to the approved indication.
Slovenian: • kar zadeva učinkovitost, je odbor PRAC menil, da ni nobene nove pomembne informacije, povezane z odobreno indikacijo.
English: It is expected that the involvement of the learned societies will have an important role in channelling the messages of the training.
Slovenian: Pričakuje se, da bo vključitev strokovnih združenj pomembno vplivala na posredovanje sporočil usposabljanja.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Having reviewed the revised PRAC recommendation7, the CMDh disagreed with the PRAC overall conclusions and grounds for recommendation.
Slovenian: Po pregledu revidiranega priporočila7 odbora PRAC se skupina CMDh ni strinjala s končnimi zaključki odbora PRAC in podlago za priporočilo.
English: 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.
Slovenian: 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.
English: The medication form/checklists would also raise feasibility issues in an emergency setting.
Slovenian: Obrazci/kontrolni seznami za zdravila bi sprožili tudi vprašanje o izvedljivosti v nujnih primerih.
English: 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.
Slovenian: 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.
English: The final training materials, including communication media and distribution modalities should be agreed with the National Competent Authorities.
Slovenian: O končni različici gradiva za usposabljanje, vključno s sredstvi obveščanja in načini razdeljevanja, se je treba dogovoriti z nacionalnimi pristojnimi organi.
English: 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).
Slovenian: 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).
English: 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…).
Slovenian: 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 …).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Izrazitejša hipovolemija zahteva večji volumen (odmerek) raztopin HES za infundiranje in je tudi povezana z večjim tveganjem za ledvično poškodbo in smrt.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: Predlogi za spremembo indikacij in kontraindikacij po oceni ne bi imeli zadostnega vpliva na obnašanje predpisovalcev in niso podprti z ustreznimi znanstvenimi dokazi.
English: The DUS final study report shall be submitted within 24 months from the Commission Decision.
Slovenian: Končno poročilo študije o uporabi zdravil je treba predložiti v 24 mesecih po sklepu Komisije.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • omogočil bo ciljno usmerjenost na zdravstvene delavce, odgovorne za dajanje zdravila, ki imajo pomembno vlogo pri zagotavljanju upoštevanja ustrezne uporabe raztopin HES za infundiranje;
English: With regards to efficacy, PRAC considered that there is no new significant information related to the approved indication.
Slovenian: Kar zadeva učinkovitost, je odbor PRAC menil, da ni nobene nove pomembne informacije, povezane z odobreno indikacijo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The results indicate that the implemented restrictions in use are not sufficiently adhered to.
Slovenian: Rezultati kažejo, da se uvedene omejitve uporabe ne upoštevajo v zadostni meri.
English: The CMDh also agreed on a communication plan for the dissemination of this DHPC.
Slovenian: Skupina CMDh se je dogovorila tudi o načrtu obveščanje za razširjanje tega neposrednega obvestila za zdravstvene delavce.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: A positive benefit-risk balance has been established in elective surgery and trauma patients.
Slovenian: Pozitivno razmerje med tveganji in koristmi so ugotovili pri bolnikih z elektivnim kirurškim posegom in poškodovancih.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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;
English: 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.
Slovenian: Skupina CMDh torej meni, da je program nadzorovanega dostopa izvedljiv in bo v kombinaciji z drugimi ukrepi za zmanjševanje tveganja verjetno učinkovito zmanjšal tveganje.
English: Drug Utilisation Study (DUS)
Slovenian: Študija o uporabi zdravil
English: 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.
Slovenian: 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.
English: It was also considered that HES solutions for infusion are used for the treatment of life-threatening medical conditions.
Slovenian: Upoštevala je tudi, da se raztopine HES za infundiranje uporabljajo za zdravljenje smrtno nevarnih zdravstvenih stanj.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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;
English: • 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.
Slovenian: • 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;
English: 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.
Slovenian: 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.
English: In particular, the CMDh took into consideration the additional details from the MAHs on the proposed controlled access program.
Slovenian: Skupina CMDh je zlasti upoštevala dodatne podrobnosti, ki so jih predložili imetniki dovoljenj za promet z zdravilom, o predlaganem programu nadzorovanega dostopa.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
English: - The MAH should ensure that HES solutions for infusion are only delivered to accredited hospitals/centres.
Slovenian: - Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da se raztopine HES za infundiranje dobavljajo samo akreditiranim bolnišnicam/centrom.
English: 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.
Slovenian: 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.
English: The DUS protocol to be submitted by the MAHs should include clear objectives, focusing on prescribing decisions, especially adherence to indications and contraindications.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Annex II Scientific conclusions and CMDh's detailed explanation on the scientific grounds for differences with the PRAC recommendation
Slovenian: Znanstveni zaključki in podrobna obrazložitev znanstvene podlage skupine CMDh za odstopanja od priporočila odbora PRAC
English: 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.
Slovenian: 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.
English: Med 2008; 358(2):125-39 5 Myburgh J, Finder S, Bellomo R et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care.
Slovenian: 5 Myburgh J, Finder S, Bellomo R et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care.