FrancophonIA/ELRC3.0 huggingface dataset:
English: The company informed the CHMP that there were no consequences for patients in clinical trials or compassionate use programmes.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička istraživanja ili program milosrdnog davanja lijeka.
English: What was Masiviera expected to be used for?
Croatian: Koja je bila očekivana namjena lijeka Masiviera?
English: These enzymes can be found in some receptors on the surface of cells, including the receptors that are involved in stimulating cancer cells to divide
Croatian: Ovi se enzimi nalaze u nekim receptorima na površini stanica,
English: How is Masiviera expected to work?
Croatian: Koje je bilo očekivano djelovanje lijeka Masiviera?
English: EU number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: Pharmaceutical Form Route of administration Packaging
Croatian: Put primjene Unutarnje pakovanje
English: (Invented) name Strength Pharmaceutical form Route of administration
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik
English: Further information on Rxulti can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Rxulti možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Rxulti (brexpiprazole)
Croatian: Rxulti (brekspiprazol)
English: Schizophrenia is a mental illness with symptoms such as delusions, disorganised thinking and speech, suspiciousness and hallucinations (seeing, hearing or feeling things that are not there).
Croatian: Shizofrenija je mentalna bolest koja se očituje simptomima kao što su deluzije, nesuvislo razmišljanje i govor, sumnjičavost i halucinacije (bolesnici vide, čuju ili osjećaju nešto čega nema).
English: In patients taking certain other medicines the doctor may need to adjust the dose of Rxulti.
Croatian: U bolesnika koji uzimaju određene lijekove liječnik će možda morati prilagoditi dozu lijeka Rxulti.
English: The recommended starting dose is 1 mg once daily for the first 4 days.
Croatian: Preporučena početna doza je 1 mg jedanput na dan tijekom prva četiri dana.
English: In patients with moderately or severely reduced kidney or liver function the dose should be limited to 3 mg once a day.
Croatian: U bolesnika s umjerenim do teškim oštećenjem funkcije bubrega ili jetre dozu treba ograničiti na 3 mg jedanput na dan.
English: These neurotransmitters play a role in schizophrenia, and by acting at their receptors, brexpiprazole helps normalise the activity of the brain and reduce symptoms of schizophrenia.
Croatian: Ti neurotransmiteri imaju ulogu u shizofreniji, a djelovanjem na njihove receptore brekspiprazol pomaže pri normalizaciji moždane aktivnosti i smanjivanju simptoma shizofrenije.
English: What is Rxulti and what is it used for?
Croatian: Što je Rxulti i za što se koristi?
English: The dose is then increased to 2 mg once daily taken on days 5, 6 and 7 and increased again if necessary to 4 mg once daily on day 8.
Croatian: Doza se zatim povećava na 2 mg jedanput na dan tijekom petog, šestog i sedmog dana, te se po potrebi ponovno povećava na 4 mg jedanput na dan osmog dana.
English: What measures are being taken to ensure the safe and effective use of Rxulti?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Rxulti?
English: For more information about using Rxulti, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Rxulti pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Side effects reported with Rxulti are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Rxulti pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The active substance in Rxulti, brexpiprazole, is thought to attach to receptors (targets) in the brain for several neurotransmitters (substances nerve cells use to communicate with neighbouring cells) including dopamine, serotonin and noradrenaline.
Croatian: Smatra se da se djelatna tvar u lijeku Rxulti, brekspiprazol, veže u mozgu na receptore (ciljeve) za nekoliko neurotransmitera (tvari kojima se živčane stanice koriste radi komunikacije sa susjednim stanicama), uključujući dopamin, serotonin i noradrenalin.
English: Rxulti is available as tablets (0.25, 0.5, 1, 2, 3 and 4 mg) to be taken by mouth.
Croatian: Lijek Rxulti dostupan je u obliku tableta (0,25 mg, 0,5 mg, 1 mg, 2 mg, 3 mg i 4 mg) koje se uzimaju kroz usta.
English: The recommended dose is between 2 and 4 mg daily and 4 mg is the maximum recommended daily dose.
Croatian: Preporučena doza iznosi između 2 i 4 mg na dan, a 4 mg je najviša preporučena dnevna doza.
English: Based on available data, it is not possible to say how Rxulti compares with other medicines of the same type.
Croatian: Na temelju dostupnih podataka ne može se usporediti djelovanje lijeka Rxulti s drugim lijekovima istoga tipa.
English: Although the reductions in symptoms were not consistent across the studies, this often occurs in studies with antipsychotic medicines and the European Medicines Agency considered that the effects were sufficient to conclude that Rxulti is beneficial to patients with schizophrenia.
Croatian: Iako u ispitivanjima nije utvrđeno dosljedno smanjenje simptoma, do toga često dolazi u ispitivanjima antipsihotika te je Europska agencija za lijekove smatrala da su učinci lijeka dostatni za donošenje zaključka da je primjena lijeka Rxulti korisna u bolesnika sa shizofrenijom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rxulti have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Rxulti nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: In 4 of the studies, Rxulti was compared with placebo (a dummy treatment) and the main measure of effectiveness was reduction of symptoms on a standard rating scale called PANSS (positive and negative syndrome scale) which ranges from a minimum of 30 (no symptoms) to a maximum of 210 (severest symptoms) after 6 weeks of treatment.
Croatian: U četirima ispitivanjima lijek Rxulti uspoređen je s placebom (prividno liječenje), a glavna mjera djelotvornosti bilo je smanjenje simptoma na standardnoj ljestvici ocjenjivanja naziva PANSS (ocjenska ljestvica pozitivnih i negativnih simptoma shizofrenije) s rasponom rezultata od najmanje 30 (bez simptoma) do najviše 210 (najteži simptomi) nakon šest tjedana liječenja.
English: Rxulti has been shown to be effective at reducing symptoms of schizophrenia in 5 main studies involving 2,404 adults with schizophrenia, although there were some inconsistent results.
Croatian: Lijek Rxulti pokazao se djelotvornim u smanjivanju simptoma shizofrenije u pet glavnih ispitivanja koja su obuhvatila 2 404 odrasle osobe sa shizofrenijom, iako su određeni rezultati bili nedosljedni.
English: The safety profile of Rxulti is similar to other antipsychotic medicines.
Croatian: Sigurnosni profil lijeka Rxulti sličan je sigurnosnom profilu drugih antipsihotika.
English: Why is Rxulti authorised in the EU?
Croatian: Zašto je lijek Rxulti odobren u EU-u?
English: Rxulti is an antipsychotic medicine used to treat schizophrenia in adults.
Croatian: Rxulti je antipsihotik koji se primjenjuje za liječenje shizofrenije u odraslih osoba.
English: Other information about Rxulti
Croatian: Ostale informacije o lijeku Rxulti
English: The most common side effects with Rxulti are akathisia (a constant urge to move, which may affect around 6 in 100 people) and weight gain (which may affect around 4 in 100 people).
Croatian: Najčešće nuspojave lijeka Rxulti su akatizija (neprestana potreba za kretanjem, koja se može javiti u otprilike 6 na 100 osoba) i povećanje tjelesne težine (koje se može javiti u otprilike 4 na 100 osoba).
English: An overview of Rxulti and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Rxulti i zašto je odobren u EU-u
English: What are the risks associated with Rxulti?
Croatian: Koji su rizici povezani s lijekom Rxulti?
English: The fifth study compared Rxulti with placebo over one year, and the main measure of effectiveness was the risk of relapse (worsening of symptoms).
Croatian: U petom ispitivanju jednogodišnje liječenje lijekom Rxulti uspoređeno je s placebom, a glavno mjerilo djelotvornosti bio je rizik od relapsa (pogoršanje simptoma).
English: The Agency decided that Rxulti's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi lijeka Rxulti nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: As for all medicines, data on the use of Rxulti are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Rxulti kontinuirano se prate.
English: Rxulti was effective at reducing symptoms of schizophrenia.
Croatian: Lijek Rxulti pokazao se djelotvornim u smanjenju simptoma shizofrenije.
English: Rxulti can only be obtained with a prescription.
Croatian: Rxulti se izdaje samo na liječnički recept.
English: Results at 2, 3 and 4 weeks showed improvement in symptoms with Rxulti compared with placebo.
Croatian: Rezultati nakon dva, tri i četiri tjedna primjene pokazali su poboljšanje simptoma pri primjeni lijeka Rxulti u usporedbi s placebom.
English: After 6 weeks, there was not considered to be a difference between Rxulti and placebo.
Croatian: Nakon šest tjedana primjene zaključeno je da ne postoji razlika između primjene lijeka Rxulti i placeba.
English: In the fourth study, doses of Rxulti ranging from 2 to 4 mg were compared with placebo and with another antipsychotic medicine, quetiapine.
Croatian: U četvrtom ispitivanju, doze lijeka Rxulti u rasponu od 2 do 4 mg uspoređene su s placebom i s drugim antipsihotikom, kvetiapinom.
English: Quetiapine showed improvement in symptoms at 6 weeks compared with placebo.
Croatian: Zabilježeno je poboljšanje simptoma nakon šest tjedana primjene kvetiapina u usporedbi s placebom.
English: How does Rxulti work?
Croatian: Kako djeluje Rxulti?
English: How is Rxulti used?
Croatian: Kako se Rxulti koristi?
English: However, there was not considered to be a difference between 2 mg Rxulti and placebo.
Croatian: Međutim, zaključeno je da ne postoji razlika između primjene doze lijeka Rxulti od 2 mg i placeba.
English: What benefits of Rxulti have been shown in studies?
Croatian: Koje su koristi lijeka Rxulti dokazane u ispitivanjima?
English: Rxulti contains the active substance brexpiprazole.
Croatian: Rxulti sadrži djelatnu tvar brekspiprazol.
English: For the full list of side effects and restrictions with Rxulti, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Rxulti potražite u uputi o lijeku.
English: In the third study, the PANSS score fell by around 15 points with 2 mg Rxulti compared with 8 points with placebo and there was not considered to be a difference between 4 mg Rxulti and placebo.
Croatian: U trećem ispitivanju, rezultat na ljestvici PANSS smanjio se za otprilike 15 bodova pri primjeni doze lijeka Rxulti od 2 mg, u usporedbi s 8 bodova kod placeba, a zaključeno je da ne postoji razlika između primjene doze lijeka Rxulti od 4 mg i placeba.
English: Rxulti was more effective than placebo in preventing relapse: after a year, 14% of patients taking Rxulti had relapsed compared with 38% of patients taking placebo.
Croatian: Nakon jednogodišnjeg liječenja došlo je do relapsa u 14 % bolesnika koji su uzimali lijek Rxulti, u usporedbi s 38 % u bolesnika koji su uzimali placebo.
English: In the first study, the PANSS score fell by around 21 and 20 points with 2 mg and 4 mg Rxulti respectively compared with 12 points with placebo.
Croatian: U prvom ispitivanju rezultat na ljestvici PANSS smanjio se za otprilike 21 i 20 bodova pri primjeni doze lijeka Rxulti od 2 mg odnosno 4 mg, u usporedbi s 12 bodova kod placeba.
English: In the second study, the PANSS score fell by around 20 points with 4 mg Rxulti compared with 14 points with placebo.
Croatian: U drugom ispitivanju rezultat na ljestvici PANSS smanjio se za otprilike 20 bodova pri primjeni doze lijeka Rxulti od 4 mg, u usporedbi s 14 bodova kod placeba.
English: Annex I List of medicinal products and presentations
Croatian: Popis lijekova
English: For these patients other treatment options should be considered.
Croatian: Za ove bolesnike potrebno je razmotriti druge mogućnosti liječenja.
English: This overview was last updated in 06-2018.
Croatian: Sažetak je posljednji put ažuriran u 06. 2018.
English: Patients who have not been tested or whom results of the test are not clear should also not take this medicine.
Croatian: Bolesnici na kojima nije provedeno ispitivanje ili za koje rezultati ispitivanja nisu jasni također ne bi trebali uzimati ovaj lijek.
English: Patients whose bodies break down this medicine very rapidly (‘ultrarapid metabolisers') should not take Cerdelga.
Croatian: Bolesnici čija tijela razgrađuju ovaj lijek vrlo brzo („ultrabrzi metabolizatori”) ne bi trebali uzimati lijek Cerdelga.
English: The majority of side effects are mild and short-lived.
Croatian: Nuspojave su većinom blage i kratkotrajne.
English: Patients who break down the medicine at normal speed take 1 capsule twice a day, while those who break down the medicine slowly take 1 capsule once a day.
Croatian: Bolesnici koji razgrađuju lijek pri normalnoj brzini uzimaju 1 kapsulu dvaput dnevno, dok bolesnici koji sporo razgrađuju lijek uzimaju 1 kapsulu jedanput dnevno.
English: Cerdelga is available as capsules (84 mg) to be taken by mouth.
Croatian: Lijek Cerdelga dostupan je u obliku kapsula (84 mg) koje se uzimaju kroz usta.
English: Further information on Cerdelga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Cerdelga nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Više informacija o statusu lijeka za rijetku bolesti možete pronaći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Regarding safety, side effects were mostly mild and transient, but it was recommended that the longterm safety of the medicine be further investigated.
Croatian: Što se tiče sigurnosti, nuspojave su najčešće blage i prijelazne, ali preporučeno je daljnje istraživanje dugoročne sigurnosti lijeka.
English: What measures are being taken to ensure the safe and effective use of Cerdelga?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cerdelga?
English: The most common serious side effect is fainting, in 8 out of every 1,000 patients.
Croatian: Najčešća ozbiljna nuspojava jest nesvjestica, koja se pojavljuje u 8 na svakih 1 000 bolesnika.
English: Before starting treatment, the patient is tested to see how rapidly their bodies break down the medicine.
Croatian: Prije početka liječenja ispituje se kako brzo tijelo bolesnika razgrađuje lijek.
English: The disease is caused by the lack of an enzyme for breaking down fat.
Croatian: Bolest je uzrokovana manjkom enzima koji razgrađuje mast.
English: Because the build-up of this fat in organs like the spleen, liver and bones is responsible for the symptoms of type-1 Gaucher disease, reducing its production helps prevent its build-up, and thereby helps the affected organs to function better.
Croatian: Budući da je nakupljanje ove masti u organima kao što su slezena, jetra i kosti odgovorno za simptome Gaucherove bolesti tipa 1, smanjivanjem proizvodnje te tvari pomaže se u sprječavanju njezina nakupljanja, a time i boljem radu zahvaćenih organa.
English: In a study of 40 previously untreated patients with type-1 Gaucher disease, patients taking Cerdelga had a 28% reduction in spleen size, compared with a 2% increase in those taking placebo (a dummy treatment) after 9 months of treatment.
Croatian: U ispitivanju koje je obuhvaćalo 40 prethodno neliječenih bolesnika s Gaucherovom bolesti tipa 1 koji su uzimali lijek Cerdelga doživjelo je 28 %-tno smanjenje veličine slezene u usporedbi s 2 %-tnim povećanjem u bolesnika koji su uzimali placebo (prividno liječenje) nakon 9 mjeseci liječenja.
English: The company will also keep record of patients treated with Cerdelga to look at the long-term safety of the medicine.
Croatian: Tvrtka će također voditi evidenciju o bolesnicima liječenim lijekom Cerdelga radi ispitivanja dugoročne sigurnosti lijeka.
English: However, a minority of patients (about 15%) who were switched from enzyme replacement to Cerdelga, did not respond optimally after treatment for one year.
Croatian: Međutim, manji dio bolesnika (oko 15 %) koji su prebačeni s enzimske nadomjesne terapije na liječenje lijekom Cerdelga nije dobro reagiralo nakon liječenja tijekom jedne godine.
English: For more information about using Cerdelga, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Cerdelga pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Other information about Cerdelga
Croatian: Ostale informacije o lijeku Cerdelga
English: This causes symptoms such as anaemia (low red blood cell counts), tiredness, easy bruising, an enlarged spleen and liver, and bone pain and fractures.
Croatian: To uzrokuje simptome kao što su anemija (niski broj crvenih krvnih stanica), umor, lako stvaranje modrica, povećana slezena i jetra te bol u kostima i lomovi kostiju.
English: Patients who took Cerdelga also showed an improvement of other signs of the disease such as a reduction in liver size and increased levels of haemoglobin (the protein in red blood cells that carries oxygen).
Croatian: U bolesnika koji su uzimali lijek Cerdelga uočeno je poboljšanje ostalih znakova bolesti, kao što su smanjenje veličine jetre i povećane razine hemoglobina (proteina u crvenim krvnim stanicama koji nosi kisik).
English: Cerdelga received a marketing authorisation valid throughout the EU on 19 January 2015.
Croatian: Lijek Cerdelga dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u EU-u od 19. siječnja 2015.
English: Cerdelga must not be taken by some patients with liver problems or those taking certain medicines that can interfere with the ability of the body to break down the medicine.
Croatian: Lijek Cerdelga ne smiju uzimati neki bolesnici s problemima s jetrom ili bolesnici koji uzimaju određene lijekove koji mogu utjecati na sposobnost tijela da razgrađuje lijek.
English: Cerdelga contains the active substance eliglustat.
Croatian: Cerdelga sadrži djelatnu tvar eliglustat.
English: Side effects reported with Cerdelga are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Cerdelga pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The active substance in Cerdelga, eliglustat, works by blocking the action of an enzyme involved in the production of the glucosylceramide fat.
Croatian: Eliglustat, djelatna tvar u lijeku Cerdelga, djeluje na način da blokira djelovanje enzima koji sudjeluje u proizvodnji glukozilceramida.
English: In this study, the disease remained stable in 85% of patients who switched to Cerdelga for a year and in 94% of patients who continued with enzyme replacement therapy.
Croatian: U ovom ispitivanju bolest je ostala stabilna u 85 % bolesnika koji su prebačeni na liječenje lijekom Cerdelga tijekom jedne godine te u 94 % bolesnika koji su nastavili s enzimskom nadomjesnom terapijom.
English: What is Cerdelga and what is it used for?
Croatian: Što je Cerdelga i za što se primjenjuje?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cerdelga have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Cerdelga nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The company that markets Cerdelga will provide doctors and patients with educational materials to ensure that only patients with type-1 Gaucher disease are treated with Cerdelga and that Cerdelga is not used in some patients with liver problems and together with other medicines which can significantly alter its blood levels.
Croatian: Tvrtka koja stavlja lijek Cerdelga u promet dostavit će edukacijske materijale liječnicima i bolesnicima kako bi zajamčila da se samo bolesnici s Gaucherovom bolesti tipa 1 liječe lijekom Cerdelga i da se lijek Cerdelga ne primjenjuje u nekih bolesnika s problemima s jetrom te zajedno s drugim lijekovima koji mogu značajno promijeniti koncentracije u krvi.
English: The European Medicines Agency decided that Cerdelga's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Cerdelga nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Studies show that Cerdelga is effective at treating the disease, including reducing the size of enlarged spleens and livers.
Croatian: Ispitivanja pokazuju da je lijek Cerdelga učinkovit u liječenju bolesti, uključujući smanjenje veličine povećane slezene i jetre.
English: All patients switching from enzyme replacement should be regularly monitored for disease progression.
Croatian: Bolesnike koji su prebačeni s enzimske nadomjesne terapije potrebno je pratiti zbog moguće progresije bolesti.
English: Why is Cerdelga authorised in the EU?
Croatian: Zašto je lijek Cerdelga odobren u EU-u?
English: As for all medicines, data on the use of Cerdelga are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Cerdelga kontinuirano se prate.
English: Another study looked at Cerdelga in 159 patients whose disease was well controlled by enzyme replacement therapy.
Croatian: U okviru drugog ispitivanja promatrano je 159 bolesnika koji su uzimali lijek Cerdelga, a čija je bolest dobro kontrolirana enzimskom nadomjesnom terapijom.
English: An overview of Cerdelga and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Cerdelga i zašto je odobren u EU-u
English: Gaucher disease is a genetic condition, in which a fat called glucosylceramide (or glucocerebroside) builds up in the body, typically in the liver, spleen and bone.
Croatian: Gaucherova bolest tipa 1 nasljedno je stanje kod kojeg se mast koja se zove glukozilceramid (ili glukocerebrozid) nakuplja u tijelu, najčešće u jetri, slezeni i kostima.
English: Studies show that Cerdelga is effective in improving the symptoms of the disease for a majority of previously untreated patients with type-1 Gaucher disease and in keeping the disease stable in most patients previously treated by enzyme replacement.
Croatian: Ispitivanja pokazuju da je lijek Cerdelga učinkovit u poboljšanju simptoma bolesti kod većine prethodno neliječenih bolesnika s Gaucherovom bolesti tipa 1 te u održavanju stabilnosti bolesti u većini bolesnika prethodno liječenih enzimskom nadomjesnom terapijom.
English: Cerdelga is a medicine used for the long-term treatment of type-1 Gaucher disease in adults.
Croatian: Cerdelga je lijek koji se koristi za dugoročno liječenje odraslih bolesnika s Gaucherovom bolesti tipa 1.
English: The most common side effect seen with Cerdelga is dyspepsia (heartburn) in approximately 6 out of 100 patients.
Croatian: Najčešće nuspojave uočene kod uzimanja lijeka Cerdelga jesu dispepsija (žgaravica) u otprilike 6 na 100 bolesnika.