FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking into account the clinical utility of Esmya in the intermittent treatment indication, where no other long-term pharmacological alternative is authorised, this indication should be limited to adult women of reproductive age who are not eligible for surgery.
Slovenian: Ob upoštevanju klinične uporabnosti zdravila Esmya pri indikaciji za intermitentno zdravljenje, pri kateri ni odobrena nobena druga dolgoročna farmakološka alternativa, je treba to indikacijo omejiti na odrasle ženske v rodni dobi, ki niso primerne za operacijo.
English: In addition, the PRAC considers that warnings regarding monitoring and stopping criteria should be implemented, in order to identify a hepatic injury of any origin before the patient experiences symptoms, which could reduce the risk of developing serious injury.
Slovenian: Poleg tega je odbor PRAC presodil, da je treba uvesti opozorila o spremljanju in ustavitvi, da bi lahko prepoznali poškodbo jeter kakršnega koli izvora pred pojavom simptomov pri bolnicah, s čimer bi lahko zmanjšali tveganje za nastanek resne poškodbe.
English: Based on the safety findings and possible mechanism of action, the experts of the ad hoc experts group were of the view that a causal association between Esmya and severe liver injury is plausible.
Slovenian: Na podlagi izsledkov o varnosti in mogočega mehanizma delovanja so strokovnjaki iz ad hoc skupine strokovnjakov menili, da je vzročno razmerje med zdravilom Esmya in hudo poškodbo jeter verjetno.
English: PRAC considered all the data submitted by the MAH, as well as data provided by the National Competent Authorities including follow-up information on cases of liver transplantation.
Slovenian: Odbor PRAC je proučil vse podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, ter podatke, ki so jih predložili pristojni nacionalni organi, vključno z nadaljnjimi informacijami o primerih presaditve jeter.
English: Since a possible causal relationship between Esmya and acute liver failure could not be ruled out, these cases prompted an in-depth investigation of this risk and its impact on the benefit risk balance of Esmya.
Slovenian: Ker ni bilo mogoče izključiti vzročne zveze med zdravilom Esmya in akutno odpovedjo jeter, so ti primeri sprožili poglobljeno raziskavo tega tveganja in njegovega vpliva na razmerje med tveganji in koristmi zdravila Esmya.
English: It was noted that no signal of hepatic toxicity was identified from non-clinical or clinical studies on Esmya.
Slovenian: Ugotovljeno je bilo, da iz nekliničnih ali kliničnih študij zdravila Esmya ni bilo mogoče prepoznati nobenega signala hepatotoksičnosti.
English: Usually, DILI events occur within the first 6 months after starting a new medication2.
Slovenian: Običajno se z zdravili povzročene poškodbe jeter pojavijo v prvih šestih mesecih po uvedbi novega zdravila2.
English: While uncertainties around causality remain, PRAC recognised the very serious outcome of the reported cases of liver injury.
Slovenian: Čeprav nejasnosti o vzročni zvezi ostajajo, je odbor PRAC prepoznal zelo resen izid prijavljenih primerov poškodbe jeter.
English: Of note, the development of drug induced liver injury generally tends to be a gradual phenomenon, developing over 1-4 weeks.
Slovenian: Omeniti je treba, da je z zdravili povzročena poškodba jeter na splošno postopen pojav, ki nastane v enem do štirih tednih.
English: Uterine fibroids are the most common female pelvic tumour.
Slovenian: Maternični fibroidi so najpogostejši ženski medenični tumor.
English: Patients should be informed of potential adverse reactions related to liver that could be caused by the use of Esmya, as well as on the need to warn their physicians on any liver problems they may have.
Slovenian: Bolnice je treba poučiti o mogočih neželenih učinkih, povezanih z jetri, ki bi jih lahko povzročila uporaba zdravila Esmya, ter o potrebi po tem, da zdravnike opozorijo na težave z jetri, ki jih morda imajo.
English: In the view of the remaining uncertainties, the PRAC is of the view that further data on Esmya and liver injury should be collected.
Slovenian: Glede na preostale nejasnosti odbor PRAC meni, da je treba zbrati nadaljnje podatke o zdravilu Esmya in poškodbi jeter.
English: • The PRAC also found it necessary to introduce a patient card to be provided in each package of Esmya, to ensure that patients are adequately informed on the possible risks of liver injury and the implemented risk minimisation measures.
Slovenian: • odbor PRAC je tudi presodil, da je treba k vsakemu pakiranju zdravila Esmya dodati kartico bolnika, da bi zagotovili, da so bolnice ustrezno poučene o mogočih tveganjih poškodbe jeter in uvedenih ukrepih za zmanjševanje tveganja.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Esmya (ulipristal acetate).
Slovenian: Odbor zato priporoča spremembo pogojev dovoljenja za promet z zdravilom Esmya (ulipristalacetat).
English: In particular, there was a consensus among hepatologists that in at least 2 cases reported, a relation with the use of Esmya could be observed.
Slovenian: Hepatologi so se zlasti strinjali, da je bilo v vsaj dveh prijavljenih primerih mogoče ugotoviti povezavo z uporabo zdravila Esmya.
English: Therefore, liver function tests should be performed before starting treatment with Esmya, monthly during the first two courses of treatment as well as two to four weeks after the discontinuation of the treatment.
Slovenian: Preiskave jetrne funkcije je zato treba opraviti pred začetkom zdravljenja z zdravilom Esmya, vsak mesec pri prvih dveh ciklusih zdravljenja in v dveh do štirih tednih po prenehanju zdravljenja.
English: Also, due to hormonal differences between rodents and humans, the toxicological liver safety findings obtained in rodents were assessed as less relevant for humans.
Slovenian: Poleg tega so bili toksikološki izsledki o varnosti za jetra pri glodavcih zaradi hormonskih razlik med glodavci in ljudmi ocenjeni kot manj ustrezni za ljudi.
English: and assuming that all such cases are due to Esmya, regardless of causality, the peak time to onset of liver injury is around 140 days and the vast majority of the reported potential drug induced liver injuries occurring between 1 and 8 months (2 treatment cycles including 2 months pause).
Slovenian: Na podlagi prijavljenih primerov morebitne poškodbe jeter pri zdravilu Esmya iz obdobja trženja in ob predpostavki, da je vse take primere povzročilo zdravilo Esmya, ne glede na vzročno zvezo, se poškodba jeter najpogosteje pojavi po približno 140 dneh, velika večina prijavljenih primerov morebitne z zdravili povzročene poškodbe jeter pa po enem do osmih mesecih (dveh ciklusih zdravljenja, vključno z dvema mesecema premora).
English: In post marketing settings, all of the reported cases lack information hampering causality assessment, and causal relationship with Esmya and serious hepatic injury is therefore not firmly established.
Slovenian: Informacije so pri vseh primerih, ki so bili prijavljeni v obdobju trženja, pomanjkljive, kar ovira oceno vzročne zveze, zato vzročna zveza med zdravilom Esmya in resno poškodbo jeter ni trdno dokazana.
English: In addition, observational studies should be performed to further characterise the hepatic risk and to evaluate the effectiveness of implemented risk minimisation measures.
Slovenian: Poleg tega je treba opraviti opazovalne študije za nadaljnjo opredelitev tveganja poškodbe jeter ter oceno učinkovitosti uvedenih ukrepov za zmanjševanje tveganja.
English: In view of the above, the Committee considers that the benefit-risk balance of Esmya (ulipristal acetate) remains favourable subject to the agreed amendments to the product information and the additional risk minimisation measures.
Slovenian: Ob upoštevanju zgoraj navedenega je odbor zaključil, da je razmerje med tveganji in koristmi zdravila Esmya (ulipristalacetat) še naprej ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu in dodatni ukrepi za zmanjševanje tveganja.
English: In order to ensure that decisions on the initiation and continuation of the treatment are made by physicians who are familiar with diagnosis of uterine fibrosis, the PRAC also recommends that the initiation and supervision of treatment with Esmya should be restricted to physicians experienced in the diagnosis and treatment of uterine fibroids.
Slovenian: Da bi zagotovili, da odločitve o uvedbi in nadaljevanju zdravljenja sprejmejo zdravniki, ki so seznanjeni z diagnozo maternične fibroze, je odbor PRAC priporočil tudi, da se uvedba in nadzor zdravljenja z zdravilom Esmya omejita na zdravnike, ki imajo izkušnje z diagnostiko in zdravljenjem materničnih fibroidov.
English: As assessed in the initial marketing authorisation of Esmya, the clinical efficacy of ulipristal acetate in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on short-term studies demonstrating the ability of the active substance to reduce fibroid-related bleeding, anaemia and fibroid size if administered in a daily dose of 5 mg for up to three months.
Slovenian: Kot je bilo ugotovljeno pri izdaji prvotnega dovoljenja za promet z zdravilom Esmya, klinična učinkovitost ulipristalacetata pri predoperacijskem zdravljenju zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v rodni dobi temelji na kratkotrajnih študijah, ki so pokazale zmožnost učinkovine za zmanjševanje s fibroidi povezanih krvavitev, anemije in velikosti fibroidov ob največ trimesečnem vsakodnevnem dajanju 5miligramskega odmerka.
English: Furthermore, measures to minimise a risk for liver injury should be implemented.
Slovenian: Poleg tega je treba uvesti ukrepe za zmanjševanje tveganja za poškodbo jeter;
English: • The PRAC reviewed the totality of the data regarding the risk for liver injury with Esmya provided by the marketing authorisation holder and National Competent Authorities on cases of liver injury and liver transplantation reported since the initial marketing authorisation of the product.
Slovenian: • odbor PRAC je pregledal vse podatke o tveganju za poškodbo jeter pri uporabi zdravila Esmya, ki so mu jih v povezavi s primeri poškodbe in presaditve jeter, o katerih so poročali od izdaje prvotnega dovoljenja za promet z zdravilom, predložili imetnik dovoljenja za promet z zdravilom in pristojni nacionalni organi.
English: • The PRAC concluded that Esmya (ulipristal acetate) may carry a risk for serious liver injury.
Slovenian: • odbor PRAC je zaključil, da je lahko zdravilo Esmya (ulipristalacetat) povezano s tveganjem za resno poškodbo jeter.
English: • The PRAC recommended that intermittent treatment of moderate to severe symptoms of uterine fibroids with Esmya should be restricted to adult women of reproductive age who are not eligible for surgery.
Slovenian: • odbor PRAC je priporočil, da je treba intermitentno zdravljenje zmernih do hudih simptomov materničnih fibroidov z zdravilom Esmya omejiti na odrasle ženske v rodni dobi, ki niso primerne za operacijo.
English: Although the general characteristics of Esmya do not support it to be a typical DILI causing agent, based on the current review, and taking experts views into consideration, the PRAC concluded that Esmya (ulipristal acetate) may carry a risk for serious liver injury.
Slovenian: Čeprav na podlagi splošnih značilnosti zdravila Esmya ni mogoče skleniti, da gre za tipično učinkovino, ki povzroča z zdravili povzročeno poškodbo jeter, je odbor PRAC na podlagi trenutnega pregleda in ob upoštevanju pogledov strokovnjakov zaključil, da je lahko zdravilo Esmya (ulipristalacetat) povezano s tveganjem za resno poškodbo jeter.
English: In addition, patients who develop transaminase levels (ALT or AST) > 3 x ULN during treatment should stop treatment and be closely monitored.
Slovenian: bolnicah, pri katerih se med zdravljenjem pojavijo koncetracije transaminaz (ALT in AST), več kot 3krat višje od zgornje meje normalnih vrednosti, prenehati z zdravljenjem in jih pozorno spremljati.
English: In addition, the PRAC recommended the performance of liver function tests before starting each treatment course with Esmya, during treatment as well as two to four weeks after the discontinuation of treatment.
Slovenian: Poleg tega je odbor PRAC priporočil, da se preiskave delovanja jeter opravijo pred začetkom vsakega ciklusa zdravljenja z zdravilom Esmya, med zdravljenjem in po dveh do štirih tednih po prenehanju zdravljenja.
English: Balancing this to the benefits of Esmya treatment of moderate to severe symptoms of uterine fibroids, the PRAC concluded that the indicated population should be restricted for safety reasons.
Slovenian: Ob primerjavi tega s koristmi zdravljenja zmernih do hudih simptomov materničnih fibroidov z zdravilom Esmya je odbor PRAC zaključil, da je treba indicirano populacijo iz varnostnih razlogov omejiti.
English: The temporary measure recommended by the PRAC in February 2018, to not treat any new patients is superseded by these new recommendations.
Slovenian: Ta nova priporočila nadomeščajo začasni ukrep prepovedi zdravljenja novih bolnic, ki ga je odbor PRAC priporočil februarja 2018.
English: PRAC considered that it should be clarified in in the wording of the indication that in line with the current posology Esmya is to be used for a single treatment course in pre-operative setting.
Slovenian: Odbor PRAC je presodil, da je treba v besedilu indikacije pojasniti, da se sme zdravilo Esmya skladno s trenutno veljavnim odmerjanjem zdravila v predoperacijskih okoliščinah uporabiti samo enkrat.
English: In addition, in order to analyse data on risk of liver injury related with Esmya and on effectiveness of risk minimisation measures, observational studies should be performed.
Slovenian: Poleg tega je treba za analizo podatkov o tveganju za poškodbo jeter, povezano z zdravilom Esmya, in učinkovitosti ukrepov za zmanjševanje tveganja opraviti opazovalne študije.
English: In line with the exclusion criteria in the clinical studies of Esmya, patients with ALT or AST> 2 x ULN (isolated or in combination with bilirubin >2 x ULN) should not initiate treatment.
Slovenian: Skladno z izključitvenimi merili v kliničnih študijah zdravila Esmya se zdravljenje ne sme uvesti pri bolnicah, pri katerih so vrednosti transaminaz ALT ali AST več kot 2-krat višje od zgornje meje normalne vrednosti (ULN) (izolirano ali v kombinaciji z bilirubinom v 2-krat višji vrednosti od ULN).
English: No information on hepatic events was at that time included in the Product Information of Esmya.
Slovenian: V informacije o zdravilu Esmya takrat niso bile vključene nobene informacije o dogodkih, povezanih z jetri.
English: The PRAC also recommended that the initiation and supervision of treatment with Esmya should be restricted to physicians experienced in the diagnosis and treatment of uterine fibroids.
Slovenian: Odbor PRAC je priporočil tudi, da se uvedba in nadzor zdravljenja z zdravilom Esmya omejita na zdravnike, ki imajo izkušnje z diagnostiko in zdravljenjem materničnih fibroidov;
English: In conclusion, the PRAC considered that the benefit-risk balance of Esmya remained favourable subject to the amendments of the terms of the marketing authorisations.
Slovenian: Odbor PRAC je sklenil, da je razmerje med tveganji in koristmi zdravila Esmya še naprej ugodno, če se upoštevajo spremembe pogojev dovoljenj za promet z zdravilom.
English: In order to exclude patients that would be potentially more susceptible to hepatic insult from the treatment with Esmya, the product should be contraindicated in patients with underlying hepatic disorder.
Slovenian: Da bi izključili bolnice, ki bi bile ob zdravljenju z zdravilom Esmya morda dovzetnejše za poškodbo jeter, mora biti zdravilo pri bolnicah z osnovno boleznijo jeter kontraindicirano.
English: In addition, other cases of hepatic injury were also reported post marketing for Esmya.
Slovenian: Poleg tega so v obdobju trženja zdravila Esmya poročali tudi o drugih primerih poškodbe jeter.
English: The PRAC considers that in vitro studies should be performed by the MAH, in order to better characterize the mechanistic profile of DILI as associated with Esmya.
Slovenian: Odbor PRAC meni, da mora imetnik dovoljenja za promet z zdravilom opraviti študije in vitro, da bi bolje opredelil mehanistični profil z zdravili povzročene poškodbe jeter v povezavi z zdravilom Esmya.
English: • The PRAC further concluded that Esmya should be contraindicated in patients with underlying hepatic disorder.
Slovenian: • odbor PRAC je sklenil tudi, da je treba zdravilo Esmya kontraindicirati pri bolnicah z drugimi boleznimi jeter.
English: The marketing authorisation of Esmya was extended to include the therapeutic indication for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Slovenian: Dovoljenje za promet z zdravilom Esmya je bilo razširjeno z vključitvijo terapevtske indikacije za intermitentno zdravljenje zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v rodni dobi.
English: Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment, as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Slovenian: Zdravilo Esmya (ulipristalacetat, 5 mg) je odobreno po centraliziranem postopku in je indicirano za predoperacijsko in intermitentno zdravljenje zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v rodni dobi.
English: It is also clarified that Esmya can be used as one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Slovenian: Poleg tega je pojasnil, da se lahko zdravilo Esmya uporabi v enem ciklusu predoperacijskega zdravljenja zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v rodni dobi.
English: Three cases of serious liver injury leading to a hepatic transplantation were reported between the marketing authorisation of Esmya (ulipristal acetate) and November 2017.
Slovenian: Od izdaje dovoljenja za promet z zdravilom Esmya (ulipristalacetat) do novembra 2017 so poročali o treh primerih resne poškodbe jeter, ki je privedla do presaditve jeter.
English: Patients should inform physicians on any liver problems they may have, and be also aware of the liver function monitoring tests to be performed before the treatment, during the treatment and after its discontinuation.
Slovenian: Prav tako morajo vedeti, da je treba preiskave delovanja jeter opraviti pred zdravljenjem, med zdravljenjem in po prenehanju zdravljenja.
English: The results from three main studies are as follows:
Slovenian: Izsledki treh glavnih študij so naslednji:
English: Emtriva emtricitabine
Slovenian: Emtriva emtricitabin
English: The Committee recommended that it be given marketing authorisation.
Slovenian: Odbor je priporočil, da se zanj izda dovoljenje za promet.
English: This difference was maintained after 48 weeks of treatment (73% and 56%).
Slovenian: Ta razlika se je ohranila tudi po 48 tednih zdravljenja (73 % in 56 %);
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emtriva on 24 October 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Emtriva, veljavno po vsej Evropski uniji, izdala 24. oktobra 2003.
English: What measures are being taken to ensure the safe and effective use of Emtriva?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Emtriva?
English: The full EPAR for Emtriva 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) za zdravilo Emtriva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Emtriva:
Slovenian: Druge informacije o zdravilu Emtriva:
English: The usual dose of oral solution is 6 mg per kilogram body weight once a day, up to a maximum of 240 mg (24 ml).
Slovenian: Običajni odmerek peroralne raztopine znaša od 6 mg na kilogram telesne mase do največ 240 mg (24 ml) enkrat na dan.
English: This is a summary of the European public assessment report (EPAR) for Emtriva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Emtriva.
English: It blocks the activity of reverse transcriptase, an enzyme made by the virus that allows it to reproduce itself in the cells it has infected.
Slovenian: Zavira delovanje reverzne transkriptaze, tj. encima, ki ga tvori virus in ki mu omogoča, da se razmnožuje v celicah, ki jih je okužil.
English: What benefits of Emtriva have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Emtriva izkazalo v študijah?
English: It is not intended to provide practical advice on how to use Emtriva.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Similar results on effectiveness were seen in two studies involving 120 children and adolescents taking Emtriva in combination with other antiviral medicines.
Slovenian: Podobne rezultate glede učinkovitosti so opazili tudi v dveh študijah, v kateri je bilo vključenih 120 otrok in mladostnikov, ki so zdravilo Emtriva jemali v kombinaciji z drugimi protivirusnimi zdravili.
English: Emtriva is available as capsules (200 mg) and as a solution (10 mg/ml) to be taken by mouth.
Slovenian: Zdravilo Emtriva je na voljo v obliki kapsul (200 mg) in raztopine (10 mg/ml) za peroralno uporabo.
English: What is Emtriva and what is it used for?
Slovenian: Kaj je zdravilo Emtriva in za kaj se uporablja?
English: Skin discoloration was very common in children.
Slovenian: Pri otrocih je bilo pogosto opaziti razbarvanje kože.
English: For more information about treatment with Emtriva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Emtriva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtriva have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Emtriva upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What is the risk associated with Emtriva?
Slovenian: Kakšna tveganja so povezana z zdravilom Emtriva?
English: Emtriva is an antiviral medicine for treating adults and children infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Emtriva je protivirusno zdravilo za zdravljenje odraslih in otrok, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: Why is Emtriva approved?
Slovenian: Zakaj je bilo zdravilo Emtriva odobreno?
English: In this study after 48 weeks, around two thirds of the patients had viral loads below 400 copies/ml, and slightly fewer had viral loads below 50 copies/ml.
Slovenian: Po 48 tednih je bilo v tej študiji pri okoli dveh tretjinah bolnikov virusno breme pod 400 kopij/ml, pri nekoliko manjšem številu pa pod 50 kopij/ml;
English: Emtriva does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Emtriva ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.