FrancophonIA/ELRC3.0 huggingface dataset:
English: Ritonavir increases the serum levels of indinavir as a result of CYP3A4 inhibition.
Slovenian: Ritonavir zavira CYP3A4 in tako zviša koncentracijo indinavirja v serumu.
English: Co-administration of ritonavir and raltegravir results in a minor reduction in raltegravir levels.
Slovenian: Raltegravir ↓ 16 % ↓ 1 % Sočasna uporaba ritonavirja in raltegravirja nekoliko zmanjša koncentracijo raltegravirja.
English: The full EPAR and risk management plan summary for Dutrebis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Dutrebis sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Dutrebis reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Dutrebis zmanjša količino virusa HIV v krvi in jo ohranja na nizki ravni.
English: It is not intended to provide practical advice on how to use Dutrebis.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Dutrebis' benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Dutrebis večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Dutrebis.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dutrebis.
English: It blocks an enzyme called integrase that is needed for the subsequent stage of virus replication.
Slovenian: Ta zavira encim, imenovan integraza, ki je potreben za naslednjo fazo razmnoževanja virusa.
English: Dutrebis is a medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Slovenian: Zdravilo Dutrebis se uporablja za zdravljenje bolnikov, ki so okuženi z virusom človeške imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: What is Dutrebis and what is it used for?
Slovenian: Kaj je zdravilo Dutrebis in za kaj se uporablja?
English: Dutrebis is available as tablets containing 150 mg of lamivudine and 300 mg of raltegravir, and the recommended dose is one tablet twice a day.
Slovenian: Zdravilo Dutrebis je na voljo v obliki tablet, ki vsebujejo 150 mg lamivudina in 300 mg raltegravirja, priporočeni odmerek pa je ena tableta dvakrat na dan.
English: What benefits of Dutrebis have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Dutrebis izkazalo v študijah?
English: Because lamivudine and raltegravir are already approved individually to treat HIV infection, the company presented data from the studies used to approve these medicines, including a study involving 160 patients given raltegravir with lamivudine (plus another HIV medicine, tenofovir) for a total of 240 weeks.
Slovenian: Ker sta lamivudin in raltegravir posamično že odobrena za zdravljenje okužb z virusom HIV, je družba predložila podatke iz študij, uporabljenih za odobritev teh zdravil, vključno s študijo, v katero je bilo vključenih 160 bolnikov, ki so skupno 240 tednov prejemali raltegravir v kombinaciji z lamivudinom (ter še enim zdravilom proti virusu HIV, tj. tenofovirjem).
English: The active substances in Dutrebis are already available in the European Union (EU) as singlecomponent medicines: lamivudine as Epivir since 1996, and raltegravir as Isentress since 2007.
Slovenian: Zdravilni učinkovini zdravila Dutrebis sta v Evropski uniji (EU) že na voljo kot enokomponentni zdravili: lamivudin kot zdravilo Epivir od leta 1996, raltegravir pa kot zdravilo Isentress od leta 2007.
English: A risk management plan has been developed to ensure that Dutrebis is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Dutrebis je bil pripravljen načrt obvladovanja tveganj.
English: The most common side effects with lamivudine or raltegravir (which may affect up to 1 in 10 people) are headache and nausea (feeling sick).
Slovenian: Najpogostejša neželena učinka lamivudina ali raltegravirja (ki lahko prizadeneta več kot 1 osebo od 10) sta glavobol in navzeja (slabost).
English: The Committee noted that the two active substances in Dutrebis are frequently taken together in clinical practice.
Slovenian: Odbor je opozoril, da se zdravilni učinkovini zdravila Dutrebis v klinični praksi pogosto jemljeta skupaj.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Dutrebis, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What are the risks associated with Dutrebis?
Slovenian: Kakšna tveganja so povezana z zdravilom Dutrebis?
English: The main measure of effectiveness was the proportion of patients with a reduction of the levels of virus in the blood (viral load) to fewer than 50 copies of HIV RNA per ml, which was 68.8%.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih se je raven virusa v krvi (virusno breme) zmanjšala pod 50 kopij HIV RNA na ml,
English: What measures are being taken to ensure the safe and effective use of
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dutrebis?
English: It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Slovenian: Okužbe z virusom HIV ali aidsa ne ozdravi, vendar pa lahko upočasni slabšanje imunskega sistema ter razvoj okužb in
English: Other common side effects with lamivudine are malaise (feeling generally unwell), tiredness, nasal signs and symptoms, diarrhoea and cough.
Slovenian: Drugi pogosti neželeni učinki lamivudina so splošno slabo počutje, utrujenost, znaki in simptomi v nosu, driska in kašelj.
English: For more information about treatment with Dutrebis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Dutrebis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali
English: Dutrebis allows them to be taken as a single tablet, although this will have to be taken twice daily and with other medicines for HIV.
Slovenian: Zdravilo Dutrebis omogoča, da se jemljeta v obliki ene same tablete, čeprav jo je treba jemati dvakrat dnevno in skupaj z drugimi zdravili proti virusu HIV.
English: Dutrebis contains the active substances lamivudine and raltegravir and is only for use in patients whose infection is not resistant to these medicines or certain related antiviral medicines.
Slovenian: Zdravilo Dutrebis vsebuje zdravilni učinkovini lamivudin in raltegravir ter je namenjeno za uporabo le pri bolnikih, katerih okužba ni odporna na ti zdravili ali na določena, z njima povezana protivirusna
English: The effectiveness and safety are taken to be the same as that for the two individual active substances, which are well characterised and do not raise any particular concern.
Slovenian: Za učinkovitost in varnost zdravila Dutrebis se šteje, da sta enaki kot v primeru ločenega jemanja zdravilnih učinkovin, pri čemer sta dobro opredeljeni in ne vzbujata nobenih posebnih pomislekov.
English: The company also looked at the way Dutrebis was absorbed in the body in comparison with two separate tablets containing lamivudine and raltegravir.
Slovenian: Družba je proučila tudi, kako se zdravilo Dutrebis absorbira v telesu v primerjavi z jemanjem ločenih tablet lamivudina in raltegravirja.
English: The other active substance, raltegravir, is an ‘integrase inhibitor'.
Slovenian: Druga zdravilna učinkovina, raltegravir, je zaviralec integraze.
English: One active substance, lamivudine, is a ‘nucleoside reverse transcriptase inhibitor' (NRTI).
Slovenian: Ena od zdravilnih učinkovin, lamivudin, je nukleozidni zaviralec reverzne transkriptaze (NRTI).
English: The results of the studies showed that Dutrebis produced similar levels lamivudine in the body to lamivudine taken separately; although the levels of raltegravir were slightly different, Dutrebis was shown to produce levels of raltegravir that were similarly effective in controlling the virus.
Slovenian: Rezultati študij so pokazali, da zdravilo Dutrebis vzpostavi podobno koncentracijo lamivudina v telesu, kot ga vzpostavi lamivudin, zaužit ločeno; čeprav so bile koncentracije raltegravirja nekoliko drugačne, je bilo dokazano, da zdravilo Dutrebis vzpostavi koncentracije raltegravirja, ki so podobno učinkovite pri obvladovanju okužbe z virusom.
English: For the full list of all side effects and restrictions with Dutrebis, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Dutrebis glejte navodilo za
English: The two active substances in Dutrebis act by blocking different stages of the process by which the HIV virus replicates itself in the body.
Slovenian: Učinkovini v zdravilu Dutrebis delujeta tako, da zavirata različne faze procesa razmnoževanja virusa HIV v telesu.
English: Dutrebis can only be obtained with a prescription and treatment should be prescribed by a doctor who is experienced in managing HIV infections.
Slovenian: Izdaja zdravila Dutrebis je le na recept, predpisati pa ga mora zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
English: Dutrebis must be used in combination with other HIV medicines.
Slovenian: Zdravilo Dutrebis je treba uporabljati v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV.
English: It is used together with other HIV medicines and can be used in patients from 6 years of age and weighing at least 30 kg.
Slovenian: Uporablja se skupaj z drugimi zdravili proti virusu HIV in je namenjeno bolnikom, starejšim od
English: For practical information about using Dutrebis, patients should read the package leaflet or contact their
Slovenian: Za praktične informacije o uporabi zdravila Dutrebis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dutrebis on 26 March 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Dutrebis, veljavno po vsej Evropski uniji, izdala
English: Of these 319 cases, almost all (98%) are from Sweden (67%) and Australia (31%).
Slovenian: Od teh 319 primerov so skoraj vsi (98 %) s Švedske (67 %) in iz Avstralije (31 %).
English: However, this has to be put in perspective of the limited exposure.
Slovenian: Vendar je to treba obravnavati z vidika omejene izpostavljenosti.
English: Diliban retard is not yet placed in the EU market.
Slovenian: Zdravilo Diliban retard še ni bilo dano na trg EU.
English: Seven cases were reported to be unintentional but none of them were fatal.
Slovenian: Po poročilih je bilo sedem primerov nenamernih, nobeden od njih pa ni bil smrten.
English: The PRAC adopted a recommendation on 30 November 2017 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Slovenian: Odbor PRAC je 30. novembra 2017 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
English: Most episodes of hepatotoxicity occur as a result of late presentation to hospital.
Slovenian: Večina epizod hepatotoksičnosti je posledica poznega prihoda v bolnišnico.
English: Conclusions on the benefit-risk balance following the re-examination procedure
Slovenian: Zaključki o razmerju med tveganji in koristmi po postopku ponovne proučitve
English: A second expert group meeting was convened.
Slovenian: Sklicano je bilo drugo srečanje strokovne skupine.
English: There were 5 fatal cases reported out of the 319 cases.
Slovenian: Med 319 primeri, o katerih so poročali, je bilo pet smrtnih.
English: It has to also be taken into account that there could be a subgroup of tramadol abusers in which risk of suicidality is different.
Slovenian: Treba je upoštevati tudi, da lahko obstaja podskupina bolnikov, ki zlorabljajo tramadol, pri katerih je tveganje za samomorilnost drugačno.
English: In addition, due to the presence of opioid component, there is risk of unintentional overdose.
Slovenian: Poleg tega zaradi prisotnosti opioidne sestavine obstaja tudi tveganje za nenamerno preveliko odmerjanje.
English: Dose is an important factor when interpreting poisoning data with paracetamol.
Slovenian: Odmerek je pomemben dejavnik pri razlagi podatkov o zastrupitvi s paracetamolom.
English: The majority of patients recovered or improved while 2 patients needed liver transplants.
Slovenian: Večina bolnikov je okrevala oziroma se je njihovo stanje izboljšalo, dva bolnika pa sta potrebovala presaditev jeter.
English: This includes unexpectedly prolonged paracetamol exposure and double peaks.
Slovenian: To vključuje nepričakovano podaljšano izpostavljenost paracetamolu in dvojne vrhove.
English: Indeed, the product is already under prescription in the EU concerned Member States except in Portugal - this measure would have an effect limited to PT and would not further minimise the risk in other EU Member States.
Slovenian: Zdravilo se že izdaja le na recept v zadevnih državah članicah EU razen Portugalske - učinek tega ukrepa bi bil tako omejen le na Portugalsko, v drugih državah članicah EU pa tveganja ne bi nadalje zmanjšal.
English: It is acknowledged that the rate of overdose is not the same in all EU MSs depending on different factors (e.g. legal status, pattern of use of pain relief medicines).
Slovenian: Priznava se, da stopnja prevelikega odmerjanja ni enaka v vseh državah članicah EU in je odvisna od različnih dejavnikov (npr. pravnega statusa, načina uporabe protibolečinskih zdravil).
English: Available data indicates that patients considered at high risk of hepatotoxicity are those with high initial paracetamol concentrations.
Slovenian: Razpoložljivi podatki kažejo, da so bolniki, ki imajo večje tveganje za hepatotoksičnost, tisti, ki imajo visoke začetne koncentracije paracetamola.
English: Under normal conditions of use, it has an established favourable benefit/risk profile.
Slovenian: V normalnih pogojih uporabe ima ugotovljeno ugodno razmerje med koristmi in tveganji.
English: The overdose treatment guidelines also differ among MSs depending on the healthcare systems.
Slovenian: Tudi smernice zdravljenja prevelikega odmerjanja se med državami članicami razlikujejo glede na zdravstveni sistem.
English: Available data clearly suggest that treatment with NAC should not be discontinued before additional paracetamol concentration and ALT value have been determined.
Slovenian: Razpoložljivi podatki jasno kažejo, da se zdravljenje z NAC ne sme prekiniti, dokler se ne določi dodatna koncentracija paracetamola in vrednost ALT.
English: Overall summary of the scientific evaluation by the PRAC Paracetamol is one of the most commonly utilised compounds worldwide; its use as an anti-pyretic or analgesic drug has been predominant since 1955.
Slovenian: Splošni povzetek znanstvenega vrednotenja odbora PRAC Paracetamol je ena najpogosteje uporabljenih učinkovin na svetu; kot antipiretik in analgetik prevladuje že od leta 1955.
English: In the literature only few studies investigate whether treatment guidelines are followed and these are mostly done with IR formulation and mainly in Australia.
Slovenian: V literaturi je objavljenih le nekaj študij, ki proučujejo upoštevanje smernic zdravljenja, večina med njimi pa je bila opravljena s formulacijo s takojšnjim sproščanjem in večinoma v Avstraliji.
English: It is agreed in the scientific community that massive overdoses are particularly challenging to handle.
Slovenian: Znanstvena skupnost se strinja, da so izrazito preveliki odmerki še poseben izziv, ki ga je treba obravnavati.
English: Following the adoption of the PRAC recommendation in September 2017, two MAHs (GSKCH and KRKA d.d., Novo mesto) have requested the re-examination of the recommendation and submitted detailed grounds for the re-examination.
Slovenian: Po sprejetju priporočila odbora PRAC septembra 2017 sta dva imetnika dovoljenja za promet z zdravilom (GSKCH in KRKA d.d., Novo mesto) zahtevala ponovno proučitev priporočila in predložila podrobno opisane razloge zanjo.
English: Out of these, six patients developed hepatotoxicity (ALT >1000 IU/L).
Slovenian: Od teh se je pri šestih bolnikih pojavila hepatotoksičnost (ALT > 1 000 i.e./l).
English: Having reviewed the PRAC recommendation, the CMDh agree with the PRAC overall conclusions and grounds for recommendation.
Slovenian: Po pregledu priporočila odbora PRAC se je odbor CMDh strinjal s končnimi zaključki odbora PRAC in s podlago za priporočilo.
English: PRAC was in agreement with the experts views.
Slovenian: Odbor PRAC se je strinjal s stališči strokovnjakov.
English: PRAC discussion on the detailed grounds for re-examination
Slovenian: Razprava odbora PRAC v zvezi s podrobno opisanimi razlogi za ponovno proučitev
English: However, it is unclear if such a recommendation is feasible and will result in effective risk minimisation throughout the EU, since the operations of these Centres are different in the EU Member States.
Slovenian: Vendar pa ni jasno, ali je tovrstno priporočilo izvedljivo in ali se bo s tem učinkovito zmanjšalo tveganje po vsej EU, saj se delovanje teh centrov med državami članicami EU razlikuje.
English: The PRAC acknowledged the limitations of the existing studies as they were not designed to compare influence of dose versus formulation on unpredictable PK or outcome.
Slovenian: Priznal je omejitve obstoječih študij, saj niso bile zasnovane za primerjavo vpliva odmerka glede na formulacijo na nepredvidljivo farmakokinetiko ali izid.
English: The CMDh considered the documentation submitted by one MAH (KRKA d.d., Novo mesto) in support of their product and concluded that it did not affect the conclusions of the PRAC.
Slovenian: Skupina CMDh je obravnavala dokumentacijo, ki jo je predložil en imetnik dovoljenja za promet z zdravilom (KRKA d.d., Novo mesto) v podporo svojemu zdravilu, in zaključila, da ne vpliva na zaključke odbora PRAC.
English: The PRAC also considered risk management of overdoses with paracetamol in general, both in the EU and world-wide.
Slovenian: Odbor PRAC je obravnaval tudi obvladovanje tveganja za preveliko odmerjanje paracetamola na splošno v EU in po svetu;
English: In this sense, the second expert group meeting expressed the view that the model currently proposed by the MAH was not sufficient due to sample size limitation and further methodological challenges.
Slovenian: V tem smislu so na drugem srečanju strokovne skupine izrazili mnenje, da model, ki ga je trenutno predlagal imetnik dovoljenja za promet z zdravilom, zaradi omejitev velikosti vzorca in nadaljnjih metodoloških izzivov ne zadošča.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for modified release paracetamol containing medicinal products (see Annex I).
Slovenian: • odbor PRAC je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo paracetamol s prirejenim sproščanjem (glejte Prilogo I);
English: Notwithstanding the feasibility of a revised overdose protocol, it is not acceptable for the PRAC to expose the patients to such revised protocol without sufficient evidence on its effectiveness.
Slovenian: Ne glede na izvedljivost pregledanega protokola za preveliko odmerjanje za odbor PRAC ni sprejemljivo, da bi bolnike tovrstnemu pregledanemu protokolu izpostavljali brez zadostnih dokazov o njegovi učinkovitosti.
English: For the individual patient who has taken an MR overdose this means a longer and more complex encounter with health care services, and an uncertainty if adequate treatment can be provided.
Slovenian: Pri posameznem bolniku, ki je zaužil prevelik odmerek s prirejenim sproščanjem, to pomeni daljšo in zapletenejšo obravnavo pri zdravstvenih delavcih ter negotovost, ali je mogoče zagotoviti ustrezno zdravljenje.
English: The evidence of the efficacy in acute pain is more robust but the clinical need of a mofidied-release formulation is less important and the claimed benefits of the medicinal product are not substantial for this clinical setting.
Slovenian: Dokazi učinkovitosti pri akutni bolečini so tdrnejši, vendar je klinična potreba po formulaciji s prirejenim sproščanjem manj pomembna in navedene koristi zdravila v tem kliničnem primeru niso bistvenega pomena.
English: An ad-hoc expert group meeting was held within this procedure with scientific and clinical experts in the management of poisoning.
Slovenian: V okviru postopka se je sestala priložnostna strokovna skupina znanstvenih in kliničnih strokovnjakov za obravnavo zastrupitev.
English: Data from the study by Chiew and colleagues (2017) indicates that rate of hepatotoxicity declines when either activated charcoal or increased NAC dose are administered to patients.
Slovenian: Podatki študije, ki so jo opravili Chiew in sodelavci (2017), kažejo, da se stopnja hepatotoksičnosti zmanjšuje, kadar bolniki prejmejo aktivno oglje ali večji odmerek NAC.
English: However, study by Carroll and colleagues (2015) that investigated the influence of the change to UK overdose treatment guidelines showed that a proportion of patients is already being treated on a case by case basis, independently of existing UK treatment guidelines.
Slovenian: Študija, ki so jo opravili Carroll in sodelavci (2015), v kateri so proučevali vpliv sprememb smernic zdravljenja prevelikega odmerjanja v Združenem kraljestvu, je pokazala, da se določen del bolnikov že zdravi glede na posamezno presojo in neodvisno od obstoječih smernic zdravljenja v Združenem kraljestvu.
English: Eleven patients (21%) had a serum alanine aminotransferase (ALT), above the reference range (ALT >50 IU/L) at 24 h or later.
Slovenian: Pri enajstih bolnikih (21 %) so bile po 24 urah ali pozneje vrednosti serumske alanin-aminotransferaze (ALT) zunaj referenčnega razpona (ALT > 50 i.e./l).
English: Separate model for the combination, based on appropriate data would be necessary to address uncertainties in the management of a combination overdose.
Slovenian: Za kombinacijo bi bil potreben ločen model, oblikovan na podlagi ustreznih podatkov, ki bi obravnaval negotovosti pri zdravljenju prevelikega odmerjanja kombiniranega zdravila.
English: On the other hand, the experts also considered that there is insufficient evidence in this clinical setting to support the added value of tramadol/paracetamol MR formulation over other therapies in such population or any other patient group.
Slovenian: Po drugi strani so strokovnjaki menili tudi, da je v tem kliničnem primeru premalo dokazov, ki bi podpirali dodano vrednost formulacije s tramadolom/paracetamolom s prirejenim sproščanjem pred drugimi vrstami zdravljenja v tej populaciji ali v kateri koli drugi skupini bolnikov.
English: The measurement of the effectiveness of a modified model or new guidelines for treatment of MR paracetamol overdose was discussed by the second ad-hoc expert group, however the sample size (100 patients) was not considered sufficient.
Slovenian: O merjenju učinkovitosti spremenjenega modela ali novih smernic za zdravljenje prevelikega odmerjanja paracetamola s prirejenim sproščanjem je razpravljala druga priložnostna strokovna skupina, vendar velikost vzorca (100 bolnikov) ni bila ocenjena kot zadostna.
English: Furthermore, there are prolonged-release combination products containing tramadol/paracetamol 75 mg/650 mg.
Slovenian: Obstajajo tudi kombinirana zdravila s podaljšanim sproščanjem, ki vsebujejo tramadol/paracetamol v odmerku 75 mg/650 mg.