FrancophonIA/ELRC3.0 huggingface dataset:
English: Three short-term studies compared Latuda with placebo (a dummy treatment) over six weeks in a total of 1,466 patients.
Croatian: Tri kratkoročna ispitivanja usporedila su lijek Latuda sa placebom (lažnim liječenjem) u razdoblju od šest tjedana u ukupno 1.466 bolesnika.
English: Lurasidone acts mainly by blocking the receptors for the neurotransmitters dopamine, 5hydroxytryptamine (also called serotonin) and noradrenaline.
Croatian: Lurasidon djeluje uglavnom blokirajući receptore za neurotransmitere dopamina, 5-hidroksitriptamina (naziva se također i serotonin) i noradrenalina.
English: This is a summary of the European public assessment report (EPAR) for Latuda.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Latuda.
English: Further analyses of the results were carried out by the company, which supported the short-term benefits of treatment with Latuda.
Croatian: Tvrtka je provela daljnju analizu rezultata koji podržavaju kratkoročne koristi liječenja lijekom Latuda.
English: 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.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Latuda nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: 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).
Croatian: Najčešće nuspojave Latuda (kod više od 1 na 10 osoba) su akatizija (kontinuirana potreba za kretanjem) i somnolencija (pospanost).
English: 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.
Croatian: Jedno od kratkoročnih ispitivanja produljeno je na 12 mjeseci (prošireno ispitivanje) kako bi se istražilo održavanje djelovanja lijeka Latuda u 292 bolesnika, u usporedbi s kvetiapinom; dva druga ispitivanja koja su obuhvatila 914 bolesnika istražila su dugoročna djelovanja lijeka Latuda u usporedbi s drugim lijekom za liječenje shizofrenije, risperidonom, odnosno placebom.
English: Why is Latuda approved?
Croatian: Zašto je lijek Latuda odobren?
English: A risk management plan has been developed to ensure that Latuda is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Latuda.
English: Latuda is a medicine that contains the active substance lurasidone.
Croatian: Latuda je lijek koji sadrži djelatnu tvar lurasidon.
English: 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.
Croatian: Iako je kratkoročno i dugoročno djelovanje lijeka Latuda dokazano u dostatnoj mjeri, CHMP je zaključio da su kratkoročna ispitivanja njegove djelotvornosti umjerena.
English: 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.
Croatian: Slabije se doze trebaju koristiti u bolesnika s umjereno ili ozbiljno smanjenom funkcijom bubrega ili jetre i u bolesnika koji uzimaju određene druge lijekove koji mogu utjecati na koncentracije Latuda u krvi.
English: 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.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Latuda uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: Latuda was not shown to be as effective as risperidone in the second study, although the available data supported a long-term benefit.
Croatian: U drugom ispitivanju nije dokazano da je Latuda podjednako djelotvoran kao risperidon, iako dostupni podaci govore u prilog dugoročnim koristima.
English: The active substance in Latuda, lurasidone, is an antipsychotic medicine.
Croatian: Djelatna tvar lijeka Latuda, lurasidon, je antipsihotik.
English: What benefits of Latuda have been shown in studies?
Croatian: Koje su koristi lijeka Latuda dokazane u ispitivanjima?
English: The last study showed that 30% of patients treated with Latuda relapsed within one year, compared with 41% of patients treated with placebo.
Croatian: Posljednje je ispitivanje dokazalo da je 30% bolesnika liječenih lijekom Latuda imalo relaps unutar jedne godine, u usporedbi sa 41% bolesnika liječenih placebom.
English: 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.
Croatian: U proširenom ispitivanju, 21% bolesnika liječeno lijekom Latuda imalo je relaps u roku od godine dana, u usporedbi s 27% bolesnika liječenih kvetiapinom, čime se dokazuje da je lijek Latuda barem u jednakoj mjeri učinkovit kao kvetiapin.
English: 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.
Croatian: U ovim dugoročnim ispitivanjima, djelotvornost lijeka Latuda izmjerena je postotkom bolesnika u relapsu te onima kojima su se simptomi shizofrenije vraćali tijekom liječenja.
English: For more information about treatment with Latuda, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Latuda pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using Latuda, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Latuda pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Latuda used?
Croatian: Kako se Latuda koristi?
English: How does Latuda work?
Croatian: Kako djeluje Latuda?
English: 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.
Croatian: U ovim ispitivanjima, dokazano je da su različite doze lijeka Latuda djelotvornije od placeba.
English: For the full list of all side effects reported with Latuda, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Latuda, potražite u uputi o lijeku.
English: serious infections;
Croatian: ozbiljnim infekcijama;
English: It is available as tablets (10, 20 and 100 mg).
Croatian: Dostupan je u obliku tableta (10, 20 i 100 mg).
English: This summary was last updated in 10-2014.
Croatian: Ovaj sažetak je posljednji put ažuriran: 10.2014.
English: The medicine usually starts to have an effect after four to six weeks.
Croatian: Lijek najčešće počinje djelovati nakon četiri do šest tjedana.
English: Its effect may improve further for up to six months.
Croatian: Djelovanje se može dodatno poboljšati u razdoblju do šest mjeseci.
English: Arava leflunomide
Croatian: Arava leflunomid
English: Two of the studies lasted six months, and two lasted a year.
Croatian: Dva su ispitivanja trajala šest mjeseci, dok su druga dva trajala godinu dana.
English: severe hypoproteinaemia (low blood protein levels).
Croatian: ozbiljnom hipoproteinemijom (niskim razinama proteina u krvi).
English: The two longer studies were then extended, with patients remaining on the medicines for at least one more year.
Croatian: Dulja dva ispitivanja su zatim produljena, pri čemu su bolesnici ostali na lijekovima najmanje još godinu dana.
English: The full EPAR for Arava can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Arava nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
Croatian: ozbiljnim stanjima imunodeficijencije, poput sindroma stečene imunodeficijencije (AIDS);
English: Other information about Arava
Croatian: Ostale informacije o lijeku Arava
English: Arava must not be used in patients with:
Croatian: Arava se ne smije koristiti u bolesnika s:
English: Arava treatment usually starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Croatian: Terapija lijekom Arava najčešće se započinje „dozom punjenja“ od 100 mg jednom na dan tijekom tri dana, nakon čega slijedi doza održavanja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Arava on 2 September 1999.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Arava na snazi u Europskoj uniji od 2. rujna 1999.
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Croatian: Preporučena doza održavanja je 10 do 20 mg jednom na dan u bolesnika s reumatoidnim artritisom, i 20 mg jednom na dan u bolesnika s psorijatičnim artritisom.
English: 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).
Croatian: Najčešće nuspojave lijeka Arava (mogu se javiti u 1 do 10 bolesnika na 100) su leukopenija (mali broj bijelih krvnih stanica), blaga alergijska reakcija, povišene razine kreatin fosfokinaze (marker mišićnog oštećenja), parestezija (abnormalni osjećaj probadanja poput iglica), periferna neuropatija (oštećenje živca u dlanovima i stopalima), glavobolja, omaglica, blago povišeni krvni tlak, proljev, mučnina (osjećaj slabosti), povraćanje, upale usta poput usnih ulcera, abdominalna bol (trbuhobolja), povišeni jetreni enzimi, gubitak kose, ekcemi, osip, pruritus (svrbež), suha koža, tendozinovitis (upala ovojnice oko tetiva), gubitak apetita, gubitak tjelesne mase i astenija (slabost).
English: This is a summary of the European public assessment report (EPAR) for Arava.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Arava.
English: 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.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uvjete uporabe za lijek Arava.
English: Arava must not be used in pregnant women, in women who can become pregnant and who are not using reliable contraception, or during breastfeeding.
Croatian: Arava se ne smije koristiti u trudnica, žena reproduktivne dobi te žena koje ne koriste pouzdanu kontracepciju, niti tijekom dojenja.
English: These results were maintained in the extension studies.
Croatian: Isti su rezultati dobiveni i u produljenim ispitivanjima.
English: 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).
Croatian: Tijekom prve godine liječenja, Arava je bio podjednako djelotvoran kao metotreksat, no samo kada se uzimao s folatom (tipom vitamina B).
English: 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.
Croatian: Između 49 i 55 % bolesnika koji su uzimali lijek Arava odgovorilo je na liječenje, u usporedbi s 26 do 28 % bolesnika koji su uzimali placebo, te 54 % onih koji su uzimali sulfazalazin.
English: moderate to severely impaired kidney function;
Croatian: umjerenim ili ozbiljnim oštećenjem funkcije bubrega;
English: In psoriatic arthritis, Arava has been compared with placebo in 186 patients over six months.
Croatian: U slučaju psorijatičnog artritisa, Arava je uspoređen s placebom u 186 bolesnika tijekom razdoblja od šest mjeseci.
English: 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.
Croatian: Moraju također obratiti posebnu pozornost prilikom prijelaza bolesnika na lijek Arava ili ako bolesnik prelazi na lijek Arava s neke druge terapije.
English: What is Arava?
Croatian: Što je Arava?
English: Why has Arava been approved?
Croatian: Zašto je Arava odobren?
English: 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.
Croatian: U slučaju psorijatičnog artritisa, Arava je bio djelotvorniji od placeba, pri čemu je 59 % bolesnika koji su uzimali lijek Arava odgovorilo na liječenje, u usporedbi sa 30 % onih koji su uzimali placebo.
English: Arava was not as effective as methotrexate in the extension study.
Croatian: Arava nije bio podjednako djelotvoran kao metotreksat u produljenom ispitivanju.
English: For more information about treatment with Arava, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Arava pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku
English: Arava treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Croatian: Liječenje lijekom Arava mora započeti i nadzirati liječnik specijalist s iskustvom u liječenju reumatoidnog i psorijatičnog artritisa.
English: A risk management plan has been developed to ensure that Arava is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Arava.
English: 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).
Croatian: U svim ispitivanjima, glavna mjera djelotvornosti bio je broj bolesnika koji su odgovorili na liječenje kako je definirano kriterijima specifičnima za bolest (vrijednosti odgovora za reumatoidni artritis i kriteriji za odgovor na terapiju psorijatičnog artritisa za psorijatični artritis Američkog instituta za reumatologiju (eng.
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Croatian: Lijek smanjuje upalu smanjujući stvaranje imunosnih stanica naziva „limfociti“, koji su odgovorni za upalu.
English: 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).
Croatian: Arava se koristi za liječenje odraslih osoba s aktivnim reumatoidnim artritisom (bolešću imunosnog sustava koja uzrokuje upalu zglobova) ili aktivnim psorijatičnim artritisom (bolešću koja uzrokuje crvenilo, mjestimično prhutanje kože i upale zglobova).
English: What is the risk associated with Arava?
Croatian: Koji su rizici povezani s lijekom Arava?
English: poor bone marrow function or low blood cell counts (red cells, white cells or platelets) caused by conditions other than rheumatoid or psoriatic arthritis;
Croatian: slabom funkcijom koštane moždine ili malim brojem krvnih stanica (crvenih stanica, bijelih stanica ili tromba) uzrokovane stanjima koja nisu reumatoidni ili psorijatični artritis;
English: Arava is a medicine that contains the active substance leflunomide.
Croatian: Arava je lijek koji sadrži djelatnu tvar leflunomid.
English: 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).
Croatian: U slučaju reumatoidnog artritisa, Arava je ispitan u četiri glavna ispitivanja koja su obuhvatila više od 2000 bolesnika, u kojih je lijek uspoređen s placebom (liječenjem bez djelatne tvari) ili s metotreksatom ili sulfasalazinom (drugim lijekovima koji se koriste za liječenje reumatoidnog artritisa).
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Croatian: Ako je broj limfocita manji, manji je i broj upala u tijelu, što pomaže pri kontroli simptoma artritisa.
English: The CHMP decided that Arava's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP odlučio je da koristi od lijeka Arava nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: 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.
Croatian: Nadalje, tvrtka koja stavlja lijek Arava u promet treba osigurati da liječnici za koje se očekuje da će propisivati lijek prime informativni paket sa svim važnim informacijama o rizicima povezanima s lijekom Arava, te praćenju koje je potrebno provoditi u bolesnika.
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Croatian: Leflunomid djeluje inhibirajući enzim naziva „dihidroorotat dehidrogenaza“, koji je neophodan za diobu limfocita.
English: 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.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Arava nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In rheumatoid arthritis, Arava was more effective than placebo and as effective as sulphasalazine.
Croatian: U slučaju reumatoidnog artritisa, lijek Arava bio je djelotvorniji od placeba te podjednako djelotvoran kao sulfazalazin.
English: What measures are being taken to ensure the safe use of Arava?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Arava?
English: 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.
Croatian: Liječnik treba provesti analizu krvi kako bi provjerio stanje bolesnikove jetre, broj bijelih krvnih stanica i broj trombocita prije propisivanja lijeka Arava.
English: Doctors prescribing Arava need to be aware of the risk of liver problems associated with the medicine.
Croatian: Liječnici koji propisuju lijek Arava moraju biti upoznati s rizikom oštećenja funkcije jetre, koji je povezan s ovim lijekom.
English: The active substance in Arava, leflunomide, is an immunosuppressant.
Croatian: Djelatna tvar lijeka Arava, leflunomid, je imunosupresivan lijek.
English: liver disease;
Croatian: bolešću jetre;
English: 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.
Croatian: Arava se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na leflunomid, na teriflunomid (proizvod razlaganja leflunomid) ili na bilo koju drugu pomoćnu tvar.
English: What is Arava used for?
Croatian: Za što se Arava koristi?
English: What benefit has Arava shown during the studies?
Croatian: Koje su koristi lijeka Arava utvrđene u ispitivanjima?
English: How does Arava work?
Croatian: Kako djeluje Arava?
English: How is Arava used?
Croatian: Kako se Arava koristi?
English: How has Arava been studied?
Croatian: Kako je Arava ispitivan?
English: For the full list of all side effects reported with Arava, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Arava potražite u uputi o lijeku.
English: Infections including opportunistic infections
Croatian: Infekcije, uključujući oportunističke infekcije
English: Talk to your doctor or pharmacist before using <Product name>
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite <naziv lijeka>
English: 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.
Croatian: Te su infekcije često povezane s visokim ukupnim opterećenjem imunosupresivima i mogu dovesti do ozbiljnih ili smrtonosnih stanja, što liječnici moraju uzeti u obzir pri postavljanju diferencijalne dijagnoze u imunosuprimiranih bolesnika s pogoršanjem funkcije jetre ili bubrega ili s neurološkim simptomima.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/758155/2018
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/790408/2018
English: Tacrolimus systemic formulation - Hepatitis E infection (EPITT no 19246)
Croatian: Takrolimus u formulaciji za sistemsku primjenu - infekcija hepatitisom E (EPITT br. 19246)
English: Adopted at the 29-31 October 2018 PRAC
Croatian: Usvojeno na sjednici PRAC-a 29. - 31. listopada 2018.
English: Patients are also at an increased risk of infections with viral hepatitis (for example, hepatitis B and C reactivation and de novo infection, as well as hepatitis E, which may become chronic).
Croatian: Bolesnici su također izloženi povećanom riziku od infekcija virusnim hepatitisom (primjerice, reaktivacija i de novo infekcija virusom hepatitisa B i C, kao i infekcija virusom hepatitisa E, koja može postati kronična).
English: Patients treated with immunosuppressants, including tacrolimus are at increased risk for infections including opportunistic infections (bacterial, fungal, viral and protozoal).
Croatian: Bolesnici koji se liječe imunosupresivima, uključujući takrolimus, izloženi su povećanom riziku od infekcija, uključujući oportunističke infekcije (bakterijske, gljivične, virusne i protozoalne).
English: Among these conditions are such as BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
Croatian: U ta se stanja ubrajaju poput nefropatije povezane s BK virusom i progresivne multifokalne leukoencefalopatije (PML) povezane s JC virusom.