FrancophonIA/ELRC3.0 huggingface dataset:
English: The trials included 2,690 patients with the age of 18 years to 65 years.
Croatian: Ispitivanja su uključila 2690 bolesnika u dobi od 18 godina do 65 godina.
English: If you forget to take a dose, take it as soon as you remember it.
Croatian: Ako ste zaboravili uzeti dozu, uzmite je čim se sjetite.
English: The safety and effectiveness in these patients were not evaluated.
Croatian: Sigurnost i učinkovitost u tih bolesnika nisu procijenjene.
English: • dementia (loss of memory and other mental abilities) especially if you are elderly.
Croatian: • demenciju (gubitak pamćenja i drugih mentalnih sposobnosti), osobito ako ste starije dobi.
English: • or had low or high blood pressure.
Croatian: • ili ste imali nizak ili visok krvni tlak.
English: • pain in arms or legs or both,
Croatian: • bol u rukama ili nogama ili oboje
English: Suicidal thoughts and behaviours are more likely at the beginning of the treatment.
Croatian: Samoubilačke misli i ponašanja vjerojatnija su na početku liječenja.
English: Remember to take the medicine pack with you so that it is clear what you have taken.
Croatian: Ne zaboravite ponijeti pakiranje lijeka sa sobom tako da bude jasno što ste uzeli.
English: Alcohol should be avoided as it can influence how this medicine works.
Croatian: Alkohol je potrebno izbjegavati jer može utjecati na to kako djeluje ovaj lijek.
English: Close medical supervision and monitoring should continue until the patient recovers.
Croatian: Pažljiv medicinski nadzor i praćenje moraju trajati sve do oporavka bolesnika.
English: What RXULTI is and what it is used for
Croatian: Što je RXULTI i za što se koristi
English: Tell your doctor immediately if you
Croatian: Odmah obavijestite liječnika ako
English: • medicines having an effect on the central nervous system.
Croatian: • lijekove koji utječu na središnji živčani sustav.
English: Treatment group n
Croatian: Terapijska skupina n
English: Do not over-exercise and drink plenty of water.
Croatian: Izbjegavajte pretjeranu tjelovježbu i pijte puno vode.
English: • withdrawal symptoms in new-born babies if the mother has taken this medicine during pregnancy.
Croatian: • simptomi ustezanja u novorođenčadi ako je majka uzimala ovaj lijek tijekom trudnoće
English: This leaflet was last revised in MM/YYYY.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: It does not matter whether you take your medicine with or without food.
Croatian: Nije važno uzimate li ovaj lijek s hranom ili bez nje.
English: It is not recommended to take RXULTI during your pregnancy.
Croatian: Ne preporučuje se uzimati RXULTI tijekom trudnoće.
English: Caution should be exercised when prescribing with other medicinal products.
Croatian: Potreban je oprez kad se propisuje s drugim lijekovima.
English: Even if you feel better, do not alter or stop your daily dose of RXULTI unless told to do so by your doctor as your symptoms may return.
Croatian: Čak i ako se osjećate bolje, nemojte mijenjati ili prestati uzimati svoju dnevnu dozu lijeka RXULTI, osim ako Vam liječnik ne kaže da to učinite, jer se simptomi mogu vratiti.
English: Your doctor will consider the benefit of the therapy for you and the benefit of breast-feeding for your baby.
Croatian: Liječnik će razmotriti korist terapije za Vas i korist dojenja za dijete.
English: Your medicine will usually be given to you in increasing doses as follows:
Croatian: Lijek će Vam obično davati u sve višoj dozi na sljedeći način:
English: A risk to the new-borns/infants cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče.
English: • an electrolyte imbalance (problems with the amount of salts in your blood).
Croatian: • neravnotežu elektrolita (probleme s količinom soli u krvi).
English: • have or had a low number of white blood cells in your blood and get a fever or any other sign of infection.
Croatian: • imate ili ste imali nizak broj bijelih krvnih stanica u krvi i dobijete vrućicu ili neki drugi znak infekcije.
English: • if you are allergic to brexpiprazole or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na brekspiprazol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The CGI-S was also assessed in trials 3 and 5 as secondary endpoint.
Croatian: CGI-S je bio procijenjen i u ispitivanjima 3 i 5 kao sekundarna mjera ishoda.
English: Please check that you are not feeling dizzy or sleepy before you start driving or handling machines.
Croatian: Provjerite da ne osjećate omaglicu ili pospanost prije nego što počnete upravljati vozilom ili rukovati strojevima.
English: Thus, DM-3411 is considered not to contribute to the therapeutic effects of brexpiprazole.
Croatian: Stoga se smatra da DM-3411 ne pridonosi terapijskim učincima brekspiprazola.
English: RXULTI can be taken with or without food.
Croatian: RXULTI se može uzimati s hranom ili bez nje.
English: Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.
Croatian: Obavezno obavijestite liječnika ako uzimate lijek koji Vam drži krvni tlak pod kontrolom.
English: Leukopenia, neutropenia and agranulocytosis
Croatian: Leukopenija, neutropenija i agranulocitoza
English: These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Croatian: Ovi se simptomi mogu privremeno pogoršati ili čak pojaviti nakon prekida liječenja.
English: 2500 Valby Denmark
Croatian: 2500 Valby Danska
English: However, your doctor may prescribe a lower or higher dose to a maximum of 4 mg once a day.
Croatian: Međutim, liječnik Vam može propisati nižu ili višu dozu do maksimalno 4 mg jedanput na dan.
English: RXULTI with food and alcohol
Croatian: RXULTI s hranom i alkoholom
English: At the beginning of treatment the lipid profile should be assessed.
Croatian: Na početku liječenja potrebno je procijeniti lipidni profil.
English: Pharmacokinetics in special populations
Croatian: Farmakokinetika u posebnih populacija
English: These symptoms may occur early during treatment.
Croatian: Ti se simptomi mogu pojaviti rano tijekom liječenja.
English: Generally, these risks are greatest at the beginning of treatment with antipsychotics and during dose escalation.
Croatian: Ovi su rizici općenito najveći na početku liječenja antipsihoticima i tijekom povišenja doze.
English: Talk to your doctor or pharmacist before taking RXULTI, or during treatment if you have
Croatian: Obratite se liječniku ili ljekarniku prije nego što uzmete RXULTI ili tijekom liječenja ako imate
English: RXULTI may increase the effect of medicines used to lower the blood pressure.
Croatian: RXULTI može pojačati učinak lijekova koji se primjenjuju za sniženje krvnog tlaka.
English: Elderly patients with dementia-related psychosis
Croatian: Stariji bolesnici s psihozom povezanom s demencijom
English: It is especially important to mention the following medicines to your doctor:
Croatian: Osobito je važno napomenuti liječniku da uzimate sljedeće lijekove:
English: Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.
Croatian: Nemojte upravljati vozilima niti se koristiti alatima ili strojevima dok se ne uvjerite da lijek ne utječe na Vas na negativan način.
English: If you are of childbearing age, you should use effective contraception while taking RXULTI.
Croatian: Ako ste u dobi kada možete zatrudnjeti, morate koristiti učinkovitu kontracepciju dok uzimate RXULTI.
English: If your baby has any of these symptoms you should contact your doctor.
Croatian: Ako Vaše dijete ima bilo koji od ovih simptoma, morate se obratiti liječniku.
English: This medicine may cause significant weight gain which may affect your health.
Croatian: Ovaj lijek može uzrokovati značajno povećanje tjelesne težine, što može ugroziti zdravlje.
English: However, if it is almost time for your next dose, skip the missed dose and continue as usual.
Croatian: Međutim, ako je uskoro vrijeme za sljedeću dozu, preskočite propuštenu dozu i nastavite prema uobičajenom rasporedu.
English: Thereafter, if according to clinical response, further dose adjustments are required, the dose may be increased up to a maximum of three times the recommended daily dose.
Croatian: Ako nakon toga, prema kliničkom odgovoru, budu potrebne daljnje prilagodbe doze, doza se može povećati do najviše trostruke preporučene dnevne doze.
English: • have any difficulty in swallowing.
Croatian: • imate teškoće s gutanjem.
English: • from day 8 onwards take one film-coated tablet of the strength prescribed by your doctor each day.
Croatian: • od 8. dana nadalje, svaki dan uzmite jednu filmom obloženu tabletu one jačine koju Vam propiše liječnik.
English: It should be considered that plasma concentration of brexpiprazole will decline gradually and will be completely washed out in 1 to 2 weeks.
Croatian: Potrebno je uzeti u obzir da će se koncentracija brekspiprazola u plazmi postupno smanjivati i da će brekspiprazol biti potpuno uklonjen iz organizma u roku od 1 do 2 tjedna.
English: Standard error
Croatian: standardna pogreška
English: Your doctor will therefore check your weight and your fats in the blood regularly.
Croatian: Liječnik će Vam stoga redovito kontrolirati tjelesnu težinu i masnoće u krvi.
English: During treatment you may experience these serious side effects that require urgent medical attention.
Croatian: Tijekom liječenja možete razviti sljedeće ozbiljne nuspojave koje zahtijevaju hitnu medicinsku intervenciju.
English: Results for the (key) secondary outcome parameter and additional endpoints were supportive of the primary endpoint.
Croatian: Rezultati za (ključni) parametar sekundarnog ishoda i dodatne mjere ishoda potkrijepili su primarnu mjeru ishoda.
English: Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome.
Croatian: Iako se prevalencija ovog sindroma čini najvišom u starijih osoba, osobito starijih žena, nije moguće oslanjati se na procjene prevalencije kako bi se, na samom početku liječenja antipsihoticima, predvidjelo u kojih će se bolesnika vjerojatno razviti sindrom.
English: If you miss two or more doses, contact your doctor.
Croatian: Ako ste propustili uzeti dvije ili više doza, obratite se svom liječniku.
English: Oral use The film-coated tablets can be taken with or without food.
Croatian: Peroralno Filmom obložene tablete može se uzimati s hranom ili bez nje.
English: • ever experienced or start to experience restlessness and inability to sit still.
Croatian: • ako ste ikada osjećali ili počnete osjećati nemir i nesposobnost da mirno sjedite.
English: If you take more RXULTI than you should
Croatian: Ako uzmete više lijeka RXULTI nego što ste trebali
English: The maximum recommended daily dose is 4 mg.
Croatian: Maksimalna preporučena dnevna doza je 4 mg.
English: • a history of blood clots, or if someone else in your family has a history of blood clots, as medicines for schizophrenia have been associated with formation of blood clots.
Croatian: • krvne ugruške u povijesti bolesti ili ako netko drugi u Vašoj obitelji ima krvne ugruške u povijesti bolesti, jer su lijekovi za shizofreniju povezani sa stvaranjem krvih ugrušaka.
English: While taking RXULTI you should avoid getting over-heated or dehydrated.
Croatian: Dok uzimate RXULTI, morate izbjegavati prekomjerno zagrijavanje tijela ili dehidraciju.
English: Environmental risk assessment (ERA)
Croatian: Procjena rizika za okoliš (ERA)
English: The smaller number of female than male subjects enrolled in the study does not allow to draw definitive conclusions.
Croatian: Budući da je u ispitivanje bio uključen manji broj ispitanica nego muških ispitanika, nije moguće donijeti konačan zaključak.
English: Brexpiprazole has not been studied in elderly patients with dementia and is not recommended to treat elderly patients with dementia due to increased risk of overall mortality.
Croatian: Brekspiprazol nije ispitan u starijih bolesnika s demencijom i ne preporučuje se za liječenje starijih bolesnika s demencijom zbog povećanog rizika od ukupne smrtnosti.
English: Brexpiprazole maintained symptom control and functioning compared to placebo.
Croatian: Brekspiprazol je održao kontrolu simptoma i funkcioniranje u usporedbi s placebom.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code N05AX16
Croatian: Farmakoterapijska skupina: psiholeptici, drugi antipsihotici, ATK oznaka: N05AX16 Mehanizam djelovanja
English: • or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Croatian: • Vi ili Vaša obitelj/njegovatelj(ica) primijetite da razvijate snažnu potrebu ili žudnju za ponašanjem na za Vas neobičan način, te se ne možete oduprijeti nagonu, porivu ili iskušenju da vršite određene aktivnosti koje bi mogle naškoditi Vama ili drugima.
English: It is important that you get your blood checked regularly as this may be fatal.
Croatian: Važno je da redovito obavljate krvne pretrage jer ta stanja mogu imati smrtni ishod.
English: Impulse-control disorders
Croatian: Poremećaji kontrole impulsa
English: • or had heart problems or a history of stroke, especially if you know that you have other risks factors for stroke.
Croatian: • ili ste imali probleme sa srcem ili preboljeli moždani udar, osobito ako znate da imate ostale rizične čimbenike za moždani udar.
English: RXULTI is indicated for the treatment of schizophrenia in adult patients.
Croatian: RXULTI je indiciran za liječenje shizofrenije u odraslih bolesnika.
English: Your doctor will need to check your blood sugar regularly since it may be increased by this medicine.
Croatian: Liječnik će Vam morati redovito provjeravati razinu šećera u krvi jer je ovaj lijek može povisiti.
English: At week 52 brexpiprazole (13.5 %) reduced the risk of impending relapse by 71 % compared with placebo (38.5 %).
Croatian: U 52. tjednu, brekspiprazol (13,5 %) je smanjio rizik od prijetećeg relapsa za 71 % u usporedbi s placebom (38,5 %).
English: Administer a quarter of the recommended dose
Croatian: Primijenite četvrtinu preporučene doze
English: There is a chance that the medicine could affect your ability to drive and use machines.
Croatian: Postoji mogućnost da bi ovaj lijek mogao utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: DK 2500 Valby Denmark
Croatian: DK 2500 Valby Danska
English: The effect of brexpiprazole on blood pressure reduction is attributed to the expected blockade of α1-adrenoceptors in peripheral blood vessels.
Croatian: Učinak brekspiprazola na sniženje krvnog tlaka pripisuje se očekivanoj blokadi α1-adrenergičkih receptora u perifernim krvnim žilama.
English: Please inform your doctor if you take any other medicines that are known to prolong the QT interval.
Croatian: Obavijestite svog liječnika ako uzimate neke druge lijekove za koje se zna da produljuju QT-interval.
English: People with this condition may also feel depressed, guilty, anxious or tense.
Croatian: Bolesnici također mogu osjećati depresiju, krivnju, tjeskobu i napetost.
English: LS mean differencea (95 % CI)
Croatian: (95 % CI)
English: Results of a sensitivity analysis using placebo based multiple imputation (PMI) were consistent with the primary analysis.
Croatian: Rezultati analize osjetljivosti pomoću višestruke imputacije na temelju placeba (engl. placebo based multiple imputation, PMI) bili su u skladu s primarnom analizom.
English: It should be noted that impulse-control symptoms can be associated with the underlying disorder; however, in some cases, urges were reported to have stopped when the dose was reduced or the medication was discontinued.
Croatian: Potrebno je naglasiti da simptomi poremećaja kontrole impulsa mogu biti povezani s osnovnom bolešću, međutim, u nekim je slučajevima prijavljeno da su takvi porivi nestali nakon smanjenja doze ili obustave primjene lijeka.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from brexpiprazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja brekspiprazolom, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: RXULTI can help to keep the symptoms under control and to prevent relapse as you continue treatment.
Croatian: RXULTI može pomoći da se ti simptomi zadrže pod kontrolom i spriječi relaps dok traje liječenje.
English: Gastric lavage and treatment with an emetic may be useful immediately after overdose.
Croatian: Ispiranje želuca i liječenje emetikom može biti korisno neposredno nakon predoziranja.
English: This medicine must not be taken by children and adolescents under 18 years of age.
Croatian: Djeca i adolescenti mlađi od 18 godina ne smiju uzimati ovaj lijek.
English: This may for example be the case if other medicines lowered your white blood cells in the past.
Croatian: To se može dogoditi ako su Vam, primjerice, drugi lijekovi koje ste prije uzimali snizili broj bijelih krvnih stanica.
English: Receiving RXULTI with some medicines may mean the doctor will need to change your dose of RXULTI or the other medicines.
Croatian: Uzimanje lijeka RXULTI s nekim lijekovima može značiti da će Vam liječnik trebati promijeniti dozu lijeka RXULTI ili drugih lijekova.
English: If you stop taking this medicine you will lose the effects of the medicine.
Croatian: Ako prestanete uzimati ovaj lijek, njegovo će djelovanje prestati.
English: All ADRs are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The safety and efficacy of brexpiprazole in the treatment of schizophrenia in patients aged 65 years and older have not been established (see sections 4.4 and 5.2).
Croatian: Sigurnost i djelotvornost brekspiprazola u liječenju shizofrenije u bolesnika u dobi od 65 godina i starijih nisu ustanovljene (vidjeti dijelove 4.4 i 5.2).
English: Other medicines and RXULTI
Croatian: Drugi lijekovi i RXULTI
English: Patients with a prior history of impulse-control disorders may be at increased risk and should be monitored carefully.
Croatian: Bolesnici koji su u povijesti bolesti imali poremećaje kontrole impulsa mogu biti pod povećanim rizikom i mora ih se pažljivo pratiti.
English: Consequently, new-borns should be monitored carefully.
Croatian: Zato je novorođenčad potrebno pažljivo pratiti.
English: On day 8 the dose was increased to 4 mg for some of the treatment arms.
Croatian: Potom je 8. dana doza bila povišena na 4 mg u nekim terapijskim skupinama.
English: Adjusted dose
Croatian: Prilagođena doza
English: The effect of brexpiprazole on human fertility has not been evaluated.
Croatian: Učinak brekspiprazola na ljudsku plodnost nije procijenjen.
English: Short-term trials
Croatian: Kratkotrajna ispitivanja
English: • allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
Croatian: • alergijska reakcija (npr. oticanje usta, jezika, lica i grla, svrbež, koprivnjača)
English: Genotoxicity, carcinogenicity
Croatian: Genotoksičnost, kancerogenost
English: Signs of high blood sugar level are excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak.
Croatian: Znakovi visoke razine šećera u krvi su pretjerana žeđ, obilno mokrenje, pojačan apetit i osjećaj slabosti.
English: Babies of mothers who take this medicine during the last three months of their pregnancy may show the following symptoms: shaking, muscle stiffness and/or muscle weakness, sleepiness, restlessness, breathing problems and difficulty in feeding.
Croatian: Novorođenčad majki koje su uzimale ovaj lijek tijekom zadnja tri mjeseca trudnoće mogu pokazivati sljedeće simptome: drhtanje, ukočenost mišića i/ili slabost mišića, pospanost, nemir, teškoće s disanjem i teškoće s hranjenjem.
English: These can be the signs of the so-called neuroleptic malignant syndrome (it is not known how many people are affected).
Croatian: To mogu biti znakovi takozvanog neuroleptičkog malignog sindroma (nije poznato u koliko se ljudi pojavljuje).
English: The European Medicines Agency has deferred the obligation to submit the results of efficacy and safety studies with brexpiprazole in the paediatric population from 13 years to less than 18 years of age (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja djelotvornosti i sigurnosti brekspiprazola u pedijatrijskoj populaciji u dobi od 13 godina do manje od 18 godina (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine.
Croatian: • mišićna slabost, osjetljivost ili bol, osobito ako se istodobno loše osjećate, imate povišenu tjelesnu temperaturu ili tamnu boju mokraće.
English: Brexpiprazole is very persistent and very bioaccumulative but not toxic, to the environment: possible enrichment of brexpiprazole in terrestrial food chains might pose a concern (see section 6.6).
Croatian: Brekspiprazol je vrlo postojan i jako bioakumulativan, ali nije toksičan za okoliš: moguć ulazak brekspiprazola u kontinentalni hranidbeni lanac mogao biti izvor zabrinutosti (vidjeti dio 6.6).
English: Standard deviation
Croatian: standardna devijacija
English: Body temperature
Croatian: Tjelesna temperatura
English: Brexpiprazole is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Brekspiprazol se ne preporučuje tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Fasting plasma glucose should be assessed before or soon after the initiation of the antipsychotic treatment.
Croatian: Vrijednosti glukoze u plazmi natašte treba procijeniti prije i ubrzo nakon početka liječenja antipsihotikom.
English: • diabetes or risk factors for diabetes (e.g. obesity, or someone else in your family has diabetes).
Croatian: • šećernu bolest ili rizične čimbenike za šećernu bolest (npr. pretilost ili da netko drugi u obitelji ima šećernu bolest).
English: H. Lundbeck A/S Ottiliavej 9
Croatian: Lundbeck A/S Ottiliavej 9
English: Blood pressure increased
Croatian: • povišen krvni tlak
English: During long term treatment the plasma glucose levels should be monitored regularly for worsening of glucose control.
Croatian: Tijekom dugotrajnog liječenja, razine glukoze u plazmi potrebno je redovito pratiti zbog mogućeg pogoršanja kontrole glukoze.
English: In such patients, a lower starting dose and slower titration should be considered, and orthostatic vital signs should be monitored (see section 4.2).
Croatian: U takvih je bolesnika potrebno razmotriti nižu početnu dozu i sporiju titraciju te pratiti ortostatske vitalne znakove (vidjeti dio 4.2).
English: These are called impulse-control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.
Croatian: Oni se nazivaju poremećajima kontrole nagona te mogu uključivati ponašanja kao što je ovisničko kockanje, prekomjerno jedenje ili trošenje, neuobičajeno izražen seksualni poriv ili učestalo razmišljanje s povećanom količinom seksualnih misli ili osjećaja.
English: • tooth decay or cavities (dental caries),
Croatian: • kvarenje zubi ili karijes (zubni karijes)