natgillin/translations-raw huggingface dataset:
The full EPAR and risk management plan summary for Latuda can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Latuda sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The main measure of effectiveness was the change in the patient's symptoms, measured using a standard scale for schizophrenia called ‘positive and negative syndrome scale' (PANSS). 
Glavno merilo učinkovitosti je bila sprememba bolnikovih simptomov, ki so jo izmerili s standardno lestvico za shizofrenijo, imenovano „lestvica pozitivnih in negativnih sindromov“ (positive and negative syndrome scale - PANSS).
Other information about Latuda 
Druge informacije o zdravilu Latuda
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Latuda's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Latuda večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Latuda. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Latuda.
What benefits of Latuda have been shown in studies? 
Kakšne koristi je zdravilo Latuda izkazalo v študijah?
A risk management plan has been developed to ensure that Latuda is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Latuda je bil pripravljen načrt obvladovanja tveganj.
It is used to treat adults with schizophrenia, a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs). 
Uporablja se za zdravljenje odraslih s shizofrenijo, ki je duševna bolezen z vrsto simptomov, med katerimi so nepovezano razmišljanje in govorjenje, halucinacije (bolnik sliši ali vidi stvari, ki jih ni), sumničavost ter blodnje (zmotna prepričanja).
It is not intended to provide practical advice on how to use Latuda. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Further analyses of the results were carried out by the company, which supported the short-term benefits of treatment with Latuda. 
Družba je izvedla dodatne analize rezultatov, ki so potrdile kratkoročne koristi zdravljenja z zdravilom Latuda.
Why is Latuda approved? 
Zakaj je bilo zdravilo Latuda odobreno?
Latuda must not be used together with medicines known as ‘strong CYP3A4 inhibitors' or ‘strong CYP3A4 inducers', which may affect the levels of lurasidone in the blood. 
Zdravilo Latuda se ne sme uporabljati skupaj z drugimi zdravili, imenovanimi „močni zaviralci CYP3A4“ in „močni induktorji CYP3A4“, saj bi lahko vplivali na ravni lurasidona v krvi.
The most common side effects with Latuda (which may affect more than 1 in 10 people) are akathisia (a constant urge to move) and somnolence (sleepiness). 
Najpogostejša neželena učinka zdravila Latuda (ki lahko prizadeneta več kot 1 osebo od 10) sta akatizija (neprestana potreba po gibanju) in somnolenca (zaspanost).
What is Latuda and what is it used for? 
Kaj je zdravilo Latuda in za kaj se uporablja?
In these studies, different doses of Latuda were shown to be more effective than placebo, lowering the PANSS score by up to 16 points more than placebo; however, this effect was not consistently demonstrated for each dose and it was not possible to observe a consistent dose-response relationship. 
Te študije so pokazale, da so bili različni odmerki zdravila Latuda učinkovitejši od placeba, saj so oceno po PANSS znižali za do 16 točk več kot placebo, vendar tega učinka niso dosledno dokazali pri vseh odmerkih, prav tako ni bilo mogoče opaziti dosledne povezave med odmerkom in odzivom.
What are the risks associated with Latuda? 
Kakšna tveganja so povezana z zdravilom Latuda?
For more information about treatment with Latuda, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Latuda preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Lurasidone acts mainly by blocking the receptors for the neurotransmitters dopamine, 5hydroxytryptamine (also called serotonin) and noradrenaline. 
Lurasidon večinoma prepreči delovanje receptorjev za živčne prenašalce dopamin, 5-hidroksitriptamin (imenovan tudi serotonin) in noradrenalin.
Latuda is a medicine that contains the active substance lurasidone. 
Latuda je zdravilo, ki vsebuje zdravilno učinkovino lurasidon.
Regarding safety, the side effects of Latuda were considered similar to those of other medicines of the same type, but it seemed to have fewer effects on body metabolism (such as effects on blood levels of sugar and fat, and body weight) and might have less effect on the activity of the heart than some other available treatments. 
da ima zdravilo Latuda podobne neželene učinke kot druga zdravila iste vrste, vendar ima manj učinkov na presnovo (kot so na primer učinki na ravni sladkorja in maščob v krvi ter telesno maso) in lahko v manjši meri vpliva na aktivnost srca kot nekatera druga razpoložljiva zdravila.
Since dopamine, 5-hydroxytryptamine and noradrenaline play a role in schizophrenia, by blocking their receptors lurasidone helps to normalise the activity of the brain, reducing symptoms. 
Dopamin, 5-hidroksitriptamin in noradrenalin imajo pomembno vlogo pri shizofreniji, zato lurasidon z blokiranjem teh receptorjev pomaga normalizirati aktivnost možganov, s čimer se zmanjšajo simptomi bolezni.
It attaches to and affects several different receptors for neurotransmitters on the surface of nerve cells in the brain. 
Lurasidon se veže na več različnih receptorjev za živčne prenašalce na površini živčnih celic v možganih ter vpliva nanje.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Latuda, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Latuda in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
In these long-term studies, the effectiveness of Latuda was measured by the percentage of patients who relapsed and had symptoms of schizophrenia coming back during treatment. 
V teh dolgoročnih študijah so učinkovitost zdravila Latuda merili na podlagi odstotka bolnikov, pri katerih so se shizofrenija in njeni simptomi med zdravljenjem ponovno pojavili.
For practical information about using Latuda, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Latuda naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Lower doses should be used in patients with moderately or severely reduced kidney or liver function and in patients taking certain other medicines that may affect the levels of Latuda in the blood. 
Pri bolnikih z zmerno ali zelo zmanjšanim delovanjem ledvic ali jeter in pri bolnikih, ki jemljejo nekatera druga zdravila, ki lahko vplivajo na ravni zdravila Latuda v krvi, je treba uporabiti manjše odmerke.
Three short-term studies compared Latuda with placebo (a dummy treatment) over six weeks in a total of 1,466 patients. 
V treh kratkoročnih študijah so 6-tedensko zdravljenje z zdravilom Latuda primerjali s placebom (zdravilom brez zdravilne učinkovine) pri skupno 1 466 bolnikih.
Latuda was not shown to be as effective as risperidone in the second study, although the available data supported a long-term benefit. 
Druga študija je pokazala, da zdravilo Latuda ni bilo tako učinkovito kot risperidon, čeprav so razpoložljivi podatki potrdili dolgoročno korist.
The last study showed that 30% of patients treated with Latuda relapsed within one year, compared with 41% of patients treated with placebo. 
Zadnja študija pa je pokazala, da se je v enem letu bolezen ponovno pojavila pri 30 % bolnikov, zdravljenih z zdravilom Latuda, v primerjavi z 41 % bolnikov, zdravljenih s placebom.
The active substance in Latuda, lurasidone, is an antipsychotic medicine. 
Zdravilna učinkovina v zdravilu Latuda, lurasidon, je antipsihotik.
In the extension study, 21% of patients treated with Latuda had a relapse within one year, compared with 27% of patients treated with quetiapine, showing that Latuda was at least as effective as quetiapine. 
V podaljšani študiji se je v enem letu bolezen ponovno pojavila pri 21 % bolnikov, zdravljenih z zdravilom Latuda, in pri 27 % bolnikov, zdravljenih s kvetiapinom, kar kaže na to, da je bilo zdravilo Latuda vsaj tako učinkovito kot kvetiapin.
How is Latuda used? 
Kako se zdravilo Latuda uporablja?
While both shortand long-term effectiveness of Latuda have been sufficiently demonstrated, the CHMP noted that in the short-term studies its effectiveness was found to be moderate. 
Odbor CHMP je upošteval, da sta bili kratkoročna in dolgoročna učinkovitost zdravila Latuda zadovoljivo dokazani, vendar pa so kratkoročne študije pokazale zmerno učinkovitost zdravila.
How does Latuda work? 
Kako zdravilo Latuda deluje?
For the full list of all side effects reported with Latuda, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Latuda, glejte navodilo za uporabo.
One of the short-term studies was continued to 12 months (extension study) to look at the maintenance of the effect of Latuda in 292 patients, compared with quetiapine; two other studies, involving 914 patients, looked at the long-term effects of Latuda compared with another schizophrenia medicine, risperidone, or placebo, respectively. 
V dveh drugih študijah, v katerih je sodelovalo 914 bolnikov, pa so proučevali dolgoročne učinke zdravila Latuda v primerjavi z drugim zdravilom za shizofrenijo, imenovanim risperidon, oziroma s placebom.
Its effect may improve further for up to six months. 
Njegov učinek se lahko dodatno izboljšuje še do šest mesecev.
It is available as tablets (10, 20 and 100 mg). 
Na voljo je v obliki tablet (10, 20 in 100 mg).
Two of the studies lasted six months, and two lasted a year. 
Dve študiji sta trajali šest mesecev, dve pa eno leto.
These results were maintained in the extension studies. 
V podaljšanih študijah so se ti rezultati ohranili.
The European Commission granted a marketing authorisation valid throughout the European Union for Arava on 2 September 1999. 
Evropska komisija je dovoljenje za promet z zdravilom Arava, veljavno po vsej Evropski uniji, izdala 2. septembra 1999.
The two longer studies were then extended, with patients remaining on the medicines for at least one more year. 
Daljši študiji so nato podaljšali, tako da so bolniki prejemali zdravila vsaj še eno leto.
Other information about Arava 
Druge informacije o zdravilu Arava
The full EPAR for Arava can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Arava je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe use of Arava? 
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Arava?
This is a summary of the European public assessment report (EPAR) for Arava. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Arava.
What benefit has Arava shown during the studies? 
Kakšne koristi je zdravilo Arava izkazalo med študijami?
Arava must not be used in pregnant women, in women who can become pregnant and who are not using reliable contraception, or during breastfeeding. 
Zdravila Arava ne smejo uporabljati nosečnice, ženske, ki bi lahko zanosile in ne uporabljajo zanesljive kontracepcije ali ženske, ki dojijo.
The most common side effects with Arava (seen in between 1 and 10 patients in 100) are leucopenia (low white blood cell counts), mild allergic reactions, increased creatine phosphokinase levels (a marker of muscle damage), paraesthesia (abnormal sensations like pins and needles), peripheral neuropathy (nerve damage in hands and feet), headache, dizziness, mild increases in blood pressure, diarrhoea, nausea (feeling sick), vomiting, inflammation of the mouth such as mouth ulcers, abdominal pain (stomach ache), increased liver enzyme levels, hair loss, eczema, rash, pruritus (itching), dry skin, tenosynovitis (inflammation of the sheath surrounding the tendons), loss of appetite, weight loss and asthenia (weakness). 
Najpogostejši neželeni učinki zdravila Arava (opaženi pri 1 do 10 bolnikih od 100) so levkopenija (zmanjšano število belih krvnih celic), blage alergijske reakcije, povečane ravni kreatin fosfokinaze (znak poškodbe mišic), parestezija (nenormalne kožne zaznave kot zbadanje z iglami), poškodbe živcev v rokah in stopalih), glavobol, omotica, blago zvišanje krvnega tlaka, driska, navzeja (slabost), bruhanje, vnetja v ustih, kot so razjede, bolečine v trebuhu, povišane koncentracije jetrnih encimov, izpadanje las, ekcem, izpuščaji, pruritus (srbenje), suha koža, tendosinovitis (vnetje ovojnice, ki obdaja kite), izguba teka, izguba telesne mase in astenija (šibkost).
For more information about treatment with Arava, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Arava preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A risk management plan has been developed to ensure that Arava is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Arava je bil pripravljen načrt obvladovanja tveganj.
Between 49 and 55% of the patients taking Arava responded to treatment, compared with 26 to 28% of those taking placebo, and 54% of those taking sulphasalazine. 
Med bolniki, ki so jemali zdravilo Arava, se jih je na zdravljenje odzvalo med 49 in 55 % v primerjavi s 26 do 28 % tistih, ki so prejemali placebo, in 54 % tistih, ki so prejemali sulfasalazin.
Over the first year of treatment, Arava was as effective as methotrexate, but only when it was taken with folate (a type of vitamin B). 
V prvem letu zdravljenja je bilo zdravilo Arava prav tako učinkovito kot metotreksat, vendar samo ob hkratnem jemanju folata (vrste vitamina B).
In psoriatic arthritis, Arava has been compared with placebo in 186 patients over six months. 
Pri psoriatičnem artritisu so zdravilo Arava v obdobju šestih mesecev primerjali s placebom pri 186 bolnikih.
In all of the studies, the main measure of effectiveness was the number of patients who responded to treatment, as defined by disease-specific criteria (American College of Rheumatology response rates for rheumatoid arthritis, and the Psoriatic Arthritis treatment Response Criteria for psoriatic arthritis). 
V vseh študijah je bilo glavno merilo učinkovitosti število bolnikov, ki so se odzvali na zdravljenje, kot je določeno v merilih za specifične bolezni (za revmatoidni artritis delež odziva, kot ga določa Ameriški kolidž za revmatologijo (American College of Rheumatology), za psoriatični artritis pa merila odziva na zdravljenje psoriatičnega artiritisa).
Arava treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis. 
Zdravljenje z zdravilom Arava mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem revmatoidnega artritisa in psoriatičnega artritisa.
They also need to take special care when switching a patient to Arava, or when switching a patient who is receiving Arava to another treatment. 
Poleg tega morajo biti posebej pozorni tudi, kadar bolniku predpišejo prehod na zdravljenje z zdravilom Arava ali kadar bolniku, ki že prejema zdravilo Arava, predpišejo prehod na drugo zdravilo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Arava. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Arava, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In psoriatic arthritis, Arava was more effective than placebo, with 59% of the patients taking Arava responding to treatment, compared with 30% of those taking placebo. 
Pri psoriatičnem artritisu je bilo zdravilo Arava učinkovitejše od placeba, saj se je 59 % bolnikov, ki so jemali zdravilo Arava, odzvalo na zdravljenje, v primerjavi s 30 % tistih, ki so jemali placebo.
In addition, the company that markets Arava will ensure that doctors who are expected to prescribe the medicine receive an information pack containing important information on the risks with Arava and the monitoring that should be carried out in patients. 
Poleg tega bo družba, ki izdeluje zdravilo Arava, zdravnikom, ki naj bi predpisovali zdravilo, zagotovila informativno gradivo, ki bo vsebovalo pomembne informacije o tveganjih, povezanih z zdravilom Arava, in spremljanju, ki ga je treba izvajati pri bolnikih.
Arava treatment usually starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose. 
Zdravljenje z zdravilom Arava se začne z udarnim 100-miligramskim dnevnim odmerkom, ki se daje zaporedoma tri dni, čemur sledi jemanje vzdrževalnega odmerka.
Doctors prescribing Arava need to be aware of the risk of liver problems associated with the medicine. 
Zdravniki, ki predpisujejo zdravilo Arava, se morajo zavedati tveganja za pojav ledvičnih težav, ki je povezano s tem zdravilom.
What is the risk associated with Arava? 
Kakšna tveganja so povezana z zdravilom Arava?
In rheumatoid arthritis, Arava was more effective than placebo and as effective as sulphasalazine. 
Pri revmatoidnem artritisu je bilo zdravilo Arava učinkovitejše od placeba in enako učinkovito kot sulfasalazin.
In rheumatoid arthritis, Arava has been studied in four main studies involving over 2,000 patients, in which it was compared with placebo (a dummy treatment), or with methotrexate or sulphasalazine (other medicines used to treat rheumatoid arthritis). 
Pri revmatoidnem artritisu so zdravilo Arava proučevali v štirih glavnih študijah, v katere je bilo vključenih prek 2 000 bolnikov in v katerih so ga primerjali s placebom (zdravilom brez zdravilne učinkovine) ali z metrotreksatom ali sulfasalazinom (drugima zdraviloma, ki se uporabljata za zdravljenje revmatoidnega artritisa).
The CHMP decided that Arava's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Arava večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Why has Arava been approved? 
Zakaj je bilo zdravilo Arava odobreno?
Arava is a medicine that contains the active substance leflunomide. 
Arava je zdravilo, ki vsebuje zdravilno učinkovino leflunomid.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Arava, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Arava must not be used in people who may be hypersensitive (allergic) to leflunomide, to teriflunomide (a breakdown product of leflunomide) or to any of the other ingredients. 
Zdravila Arava ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) leflunomid, teriflunomid (produkt pri razgradnji leflunomida) ali katero koli drugo sestavino zdravila.
Arava is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints). 
Zdravilo Arava se uporablja za zdravljenje odraslih z aktivnim revmatoidnim artritisom (boleznijo imunskega sistema, ki povzroča vnetje sklepov) ali aktivnim psoriatičnim artritisom (boleznijo, ki povzroča rdeče in luskinaste zaplate na koži ter vnetje sklepov).
For the full list of all side effects reported with Arava, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Arava, glejte navodilo za uporabo.
Arava was not as effective as methotrexate in the extension study. 
Zdravilo Arava v podaljšani študiji ni bilo tako učinkovito kot metotreksat.
The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Arava, and regularly during treatment. 
Zdravnik mora preden predpiše zdravilo Arava in nato še redno med zdravljenjem izvesti krvne teste za pregled jeter, števila belih krvnih celic in krvnih ploščic.
How has Arava been studied? 
Kako je bilo zdravilo Arava raziskano?
What is Arava used for? 
Za kaj se zdravilo Arava uporablja?
What is Arava? 
Kaj je zdravilo Arava?
How does Arava work? 
Kako zdravilo Arava deluje?
The active substance in Arava, leflunomide, is an immunosuppressant. 
Zdravilna učinkovina zdravila Arava je leflunomid, ki je zdravilo za zaviranje imunske odzivnosti.
How is Arava used? 
Kako se zdravilo Arava uporablja?
poor bone marrow function or low blood cell counts (red cells, white cells or platelets) caused by conditions other than rheumatoid or psoriatic arthritis; 
Zdravila Arava ne smejo uporabljati: bolniki z obolenji jeter; bolniki s hudo imunsko pomanjkljivostjo, kot je sindrom pridobljene imunske pomanjkljivosti (AIDS); bolniki z okvarjenim delovanjem kostnega mozga ali z nizko ravnjo krvnih celic (eritrocitov, belih krvnih celic ali trombocitov), katerih vzrok ni revmatoidni artritis ali psoriatični artritis; bolniki z resnimi okužbami; bolniki z zmerno do hudo okvarjenim delovanjem ledvic; bolniki s hudo hipoproteinemijo (nizko ravnjo beljakovin v krvi).
Packaging 
14 ablet
Adopted at the 29-31 October 2018 PRAC 
Sprejeto na seji odbora PRAC med 29. in 31. oktobrom 2018
What you need to know before you use <Product name> 
Kaj morate vedeti, preden boste uporabili zdravilo <ime zdravila>
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating hepatic or renal function or neurological symptoms. 
Te okužbe so pogosto povezane z visokim skupnim imunosupresivnim bremenom in lahko vodijo do resnih ali usodnih stanj, kar morajo zdravniki upoštevati pri diferencialni diagnostiki pri bolnikih z oslabljenim imunskim odzivom v primeru pojava znakov slabšega delovanja jeter ali ledvic ali nevroloških simptomov.
Tacrolimus systemic formulation - Hepatitis E infection (EPITT no 19246) 
Takrolimus v sistemski formulaciji - okužba s hepatitisom E (EPITT št. 19246)
New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/758155/2018 
Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih EMA/PRAC/790419/2018
Note: in the package leaflet the text ‘(e.g. long QT syndrome)' should be added to the bullet point mentioning heart disease, taking into account the already existing wording for nationally authorised medicinal products. 
Opomba: v navodilu za uporabo je treba besedilo „(npr. sindrom dolgega intervala QT)“ dodati v alineo, ki govori o bolezni srca, ob upoštevanju že obstoječega besedila za nacionalno odobrena zdravila.