FrancophonIA/ELRC3.0 huggingface dataset:
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS brexpiprazole must be discontinued immediately.
Croatian: Ako bolesnik razvije znakove i simptome koji ukazuju na MNS ili u kliničkoj slici ima neobjašnjivu vrućicu bez dodatnih kliničkih manifestacija MNS-a, primjenu brekspiprazola mora se odmah prekinuti.
English: After single and multiple once daily dose administration, brexpiprazole exposure (Cmax and AUC) increase in proportion to the dose administered.
Croatian: Nakon primjene jedne i višestrukih doza jedanput dnevno, izloženost brekspiprazolu (Cmax i AUC) povećava se proporcionalno primijenjenoj dozi.
English: • ever inhaled food, stomach acid, or saliva into your lungs causing a disease called aspiration pneumonia.
Croatian: • ako ste ikad udahnuli hranu, želučanu kiselinu ili slinu u pluća što je uzrokovalo bolest pod nazivom aspiracijska pneumonija.
English: Effects observed in repeated-dose toxicity studies in rats and monkeys were mainly related to the exaggerated pharmacological activity of brexpiprazole.
Croatian: Učinci opaženi u ispitivanjima toksičnosti ponovljenih doza u štakora i majmuna uglavnom su bili povezani s pojačanim farmakološkim djelovanjem brekspiprazola.
English: The incidence of akathisia in the short-term, controlled trials (5.4 %) was similar to the incidence in the long-term, open-label trials (5.7 %).
Croatian: Incidencija akatizije u kratkotrajnim kontroliranim ispitivanjima (5,4 %) bila je slična incidenciji u dugotrajnim otvorenim ispitivanjima (5,7 %).
English: RXULTI contains the active substance brexpiprazole, which belongs to a group of medicines called antipsychotics.
Croatian: RXULTI sadrži djelatnu tvar brekspiprazol koja pripada skupini lijekova pod nazivom antipsihotici.
English: Clinical monitoring of weight and lipid profile is recommended at baseline and during treatment.
Croatian: Preporučuje se kliničko praćenje tjelesne težine i lipidnog profila na početku i tijekom liječenja.
English: This medicinal product may pose a risk to the environment (see section 5.3).
Croatian: Lijek može predstavljati rizik za okoliš (vidjeti dio 5.3).
English: The exposure (AUC) of brexpiprazole in women was estimated to be 25 % higher than in men (see section 4.8).
Croatian: Procijenjeno je da je izloženost (AUC) brekspiprazolu 25 % veća u žena nego u muškaraca (vidjeti dio 4.8).
English: Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur.
Croatian: Bolesnike s neutropenijom potrebno je pažljivo pratiti zbog moguće vrućice ili drugih simptoma i znakova infekcije te ih odmah početi liječiti ako se takvi simptomi ili znakovi pojave.
English: Less than 1 % of unchanged brexpiprazole was excreted in the urine and approximately 14 % of the oral dose was recovered unchanged in the faeces.
Croatian: Manje od 1 % nepromijenjenog brekspiprazola izlučeno je u mokraći, a približno 14 % peroralne doze otkriveno je u nepromijenjenom obliku u stolici.
English: The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with brexpiprazole (see section 4.8).
Croatian: Pojava suicidalnog ponašanja svojstvena je psihičkim bolestima i poremećajima raspoloženja i u nekim je slučajevima zabilježena rano nakon započinjanja ili promjene terapije antipsihoticima, uključujući terapiju brekspiprazolom (vidjeti dio 4.8).
English: The volume of distribution of brexpiprazole following intravenous administration is high (1.56 L/kg ± 0.418 L/kg), indicating extravascular distribution.
Croatian: Brekspiprazol ima veliki volumen distribucije nakon intravenske primjene (1,56 l/kg ± 0,418 l/kg), što ukazuje na ekstravaskularnu distribuciju.
English: Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
Croatian: Inače, zbrinjavanje predoziranja mora biti usmjereno na potpornu terapiju uz održavanje odgovarajuće prohodnosti dišnih putova, oksigenacije i ventilacije te zbrinjavanje simptoma.
English: Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Croatian: Čimbenici rizika zbog kojih bolesnici mogu biti skloni teškim komplikacijama uključuju pretilost i šećernu bolest u obiteljskoj anamnezi.
English: Very common side effects (may affect more than 1 in 10 people): • during blood tests your doctor may find higher amounts of prolactin in your blood.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): • na pretragama krvi, liječnik Vam može pronaći veće količine prolaktina u krvi.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of brexpiprazole/ metabolites in milk of rats (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se brekspiprazol/metaboliti izlučuju u mlijeko štakora (vidjeti dio 5.3).
English: Population PK evaluation identified gender as statistically significant covariate.
Croatian: Spol Populacijska farmakokinetička procjena pokazala je da je spol statistički značajna kovarijata.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder.
Croatian: Zabilježeni su agitacija, hipertonija, hipotonija, tremor, pospanost, respiratorni distres i poremećaj hranjenja.
English: Unstructured variance-covariance matrix structure was used.
Croatian: Upotrijebljena je struktura nestrukturirane matrice varijance-konvarijance.
English: The table is based on adverse reactions reported in short-term placebo-controlled phase 2 and 3 clinical trials with relevant therapeutic doses (2 mg to 4 mg).
Croatian: Tablica se temelji na nuspojavama prijavljenima u kratkotrajnim, placebom kontroliranim kliničkim ispitivanjima faze 2 i 3 s relevantnim terapijskim dozama (2 mg do 4 mg).
English: Patients with liver problems
Croatian: Bolesnici koji imaju probleme s jetrom
English: • or had problems with your movements called extrapyramidal symptoms (EPS) in the past.
Croatian: • ili ste prije imali probleme s kretanjem pod nazivom ekstrapiramidni simptomi.
English: Although there is no information on the effect of haemodialysis in treating an overdose with brexpiprazole, haemodialysis is unlikely to be useful in overdose management since brexpiprazole is highly bound to plasma proteins.
Croatian: Iako nema informacija o učinku hemodijalize u liječenju predoziranja brekspiprazolom, hemodijaliza vjerojatno neće biti korisna u liječenju predoziranja jer se brekspiprazol u visokom postotku veže za proteine plazme.
English: Your doctor will regularly measure the white blood cells in your blood to minimise the risk for diseases called leukopenia, neutropenia and agranulocytosis.
Croatian: Liječnik će Vam redovito određivati broj bijelih krvnih stanica u krvi kako bi se rizik od bolesti pod nazivom leukopenija, neutropenija i agranulocitoza smanjio na najmanju mjeru.
English: Because patients may not recognise these behaviours as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or increased impulse-control disorders or other compulsive behaviours while being treated with brexpiprazole.
Croatian: Budući da bolesnici ne moraju prepoznati ta ponašanja kao abnormalna, važno je da liječnici koji propisuju lijek konkretno pitaju bolesnike ili njihove njegovatelje jesu li im se pojavili novi ili pojačali postojeći poremećaji kontrole impulsa ili javila druga kompulzivna ponašanja tijekom liječenja brekspiprazolom.
English: Contents of the pack and other information What RXULTI film-coated tablets contain
Croatian: Sadržaj pakiranja i druge informacije Što RXULTI filmom obložene tablete sadrže
English: No information on pharmacodynamic interactions of brexpiprazole is available at present.
Croatian: Trenutačno nema dostupnih informacija o farmakodinamičkim interakcijama brekspiprazola.
English: Your doctor will stop the treatment immediately if the white blood cells in your blood are too low.
Croatian: Liječnik će Vam odmah prekinuti liječenje ako broj bijelih krvnih stanica u
English: Brexpiprazole can elevate prolactin levels.
Croatian: Brekspiprazol može povisiti razinu prolaktina.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c (7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Although no specific pharmacokinetic study was conducted, population pharmacokinetic evaluation revealed no evidence of clinically significant race-related differences in the pharmacokinetics of brexpiprazole.
Croatian: Iako nisu provedena specifična farmakokinetička ispitivanja, populacijska farmakokinetička procjena nije pokazala nikakve klinički značajne razlike u farmakokinetici brekspiprazola povezane s etničkom pripadnošću.
English: Brexpiprazole also shows antagonist activity at noradrenergic α1B/2C receptors with affinity in the same sub-nanomolar Ki range (Ki: 0.2 nM to 0.6 nM).
Croatian: Brekspiprazol također ima antagonističko djelovanje na noradrenergičke receptore α1B/2C prema kojima ima afinitet u istom subnanomolarnom rasponu Ki (Ki: 0,2 nM do 0,6 nM).
English: • symptoms related to blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (uncommon side effect - may affect up to 1 in 100 people).
Croatian: • simptome povezane s krvnim ugrušcima u venama, osobito u nogama (simptomi uključuju oticanje, bol i crvenilo noge), koji mogu putovati krvnim žilama do pluća, uzrokujući bol u prsnom košu i poteškoće s disanjem (manje česta nuspojava - može se javiti u do 1 na
English: They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis),
Croatian: To može biti uzrokovano neuobičajenom razgradnjom mišića, što može biti životno opasno stanje i dovesti do problema s bubrezima (stanja pod nazivom rabdomioliza)
English: The recommended starting dose for brexpiprazole is 1 mg once daily on days 1 to 4.
Croatian: Preporučena početna doza brekspiprazola je 1 mg jedanput dnevno od 1. do 4. dana.
English: • medicines known to prolong your QT interval (an important measurement of your heart function in an electrocardiogram [ECG]),
Croatian: • lijekove za koje je poznato da produljuju QT-interval (važna mjera rada srca vidljiva na elektrokardiogramu [EKG]),
English: Administration of a 4 mg brexpiprazole tablet with a standard high fat meal did not significantly affect the Cmax or AUC of brexpiprazole.
Croatian: Primjena tablete brekspiprazola od 4 mg sa standardnim visokomasnim obrokom nije značajno utjecala na Cmax ili AUC brekspiprazola.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with brexpiprazole and preventive measures undertaken.
Croatian: Budući da bolesnici liječeni antipsihoticima često imaju stečene čimbenike rizika za VTE, potrebno je utvrditi sve moguće čimbenike rizika za VTE prije i tijekom liječenja brekspiprazolom te poduzeti preventivne mjere.
English: Administer half of the recommended dose
Croatian: Primijenite pola preporučene doze
English: Other side effects (it is not known how many people are affected):
Croatian: Druge nuspojave (nije poznato u koliko se osoba pojavljuju):
English: After multiple once daily administration of brexpiprazole, the terminal elimination half-life of brexpiprazole and its major metabolite, DM-3411, is 91.4 hours and 85.7 hours, respectively.
Croatian: Nakon višestruke primjene brekspiprazola jedanput dnevno, terminalni poluvijek eliminacije brekspiprazola iznosi 91,4 sati, a njegovog glavnog metabolita DM-3411 85,7 sati.
English: If you have taken more RXULTI than your prescribed dose, contact your doctor or your local hospital immediately.
Croatian: Ako ste uzeli više lijeka RXULTI od propisane doze, odmah se obratite liječniku ili otiđite u najbližu bolnicu.
English: Trial 4 assessed the efficacy, safety, and tolerability of brexpiprazole in a flexible dose range of 2 mg/day to 4 mg/day and 400 mg to 800 mg quetiapine extended release (XR) for assay sensitivity.
Croatian: Ispitivanje 4 procjenjivalo je djelotvornost, sigurnost i podnošljivost brekspiprazola u fleksibilnom rasponu doza od 2 mg na dan do 4 mg na dan te 400 mg do 800 mg kvetiapina s produljenim oslobađanjem (XR) zbog provjere osjetljivosti ispitivanja.
English: Brexpiprazole has not been evaluated in patients with a history of myocardial infarction/ischaemic heart disease or clinically significant cardiovascular disease since such patients were excluded from clinical trials.
Croatian: Brekspiprazol nije procijenjen u bolesnika koji u povijesti bolesti imaju infarkt miokarda / ishemijsku bolest srca ili klinički značajnu kardiovaskularnu bolest jer su takvi bolesnici bili isključeni iz kliničkih ispitivanja.
English: Extrapyramidal symptoms (including acute dystonia) are known class effects for antipsychotics.
Croatian: Ekstrapiramidni simptomi (uključujući akutnu distoniju) poznati su učinci lijekova iz skupine antipsihotika.
English: Significant increased pre-implantation losses were observed at 4.1-fold the clinical exposure at MRHD.
Croatian: Opaženi su značajno povećani predimplantacijski gubici pri razinama 4,1 puta većima od kliničke izloženosti pri MRHD.
English: What RXULTI film-coated tablets look like and contents of the pack
Croatian: Kako RXULTI filmom obložene tablete izgledaju i sadržaj pakiranja
English: Maintenance of efficacy trial
Croatian: Ispitivanje održavanja djelotvornosti
English: • anticonvulsants used to treat epilepsy,
Croatian: • antikonvulzive koji se primjenjuju za liječenje epilepsije,
English: Following oral administration, brexpiprazole decreased blood pressure and prolonged QT interval in safety pharmacology study in conscious male dog, in repeated-dose toxicity studies in male and female monkeys and in juvenile toxicity study in male and female dogs.
Croatian: Nakon peroralne primjene, brekspiprazol je snizio krvni tlak i produljio QT-interval u ispitivanju sigurnosne farmakologije u svjesnog mužjaka psa, u ispitivanjima toksičnosti ponovljene doze u mužjaka i ženki majmuna te u ispitivanjima toksičnosti u muške i ženske mladunčadi psa.
English: • antibiotics to treat bacterial infections (such as clarithromycin),
Croatian: • antibiotike za liječenje bakterijskih infekcija (kao što je klaritromicin),
English: In the same trial the active reference, quetiapine XR added for assay sensitivity only, separated from placebo.
Croatian: U istom je ispitivanju kontrola referentnim lijekom, kvetiapinom XR dodanom samo zbog osjetljivosti ispitivanja, odvojena od placeba.
English: Patients treated with any antipsychotics, including brexpiprazole, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness).
Croatian: Bolesnike liječene bilo kojim antipsihotikom, uključujući brekspiprazol, potrebno je pratiti zbog znakova i simptoma hiperglikemije (kao što su polidipsija, poliurija, polifagija i slabost).
English: It is used to treat schizophrenia in adult patients - a disease with symptoms such as hearing, seeing or sensing things - which are not there, suspiciousness, incoherent speech and behaviour and emotional flatness.
Croatian: Primjenjuje se za liječenje shizofrenije u odraslih bolesnika - bolesti čiji su simptomi kad se čuju, vide ili osjećaju stvari koje ne postoje, sumnjičavost, nepovezani govor i ponašanje te emocionalna tupost.
English: Brexpiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Croatian: Brekspiprazol treba primjenjivati s oprezom u bolesnika s rizikom od aspiracijske pneumonije.
English: Influences of genetic variation on the pharmacodynamic responses to brexpiprazole have not been investigated.
Croatian: Utjecaji genetskih varijacija na farmakodinamički odgovor na brekspiprazol nisu ispitani.
English: The incidence of TEAEs in long-term trials was similar to that of the short-term trials.
Croatian: Incidencija štetnih događaja nastalih tijekom liječenja u dugotrajnim ispitivanjima bila je slična onoj u kratkotrajnim ispitivanjima.
English: In the primary analysis of time to impending relapse patients on brexpiprazole showed a significantly longer time to relapse compared with patients on placebo (p < 0.0001).
Croatian: Primarna analiza vremena do prijetećeg relapsa pokazala je da su bolesnici koji su uzimali brekspiprazol imali značajno dulje vrijeme do relapsa u usporedbi s bolesnicima koji su primali placebo (p < 0,0001).
English: • certain antibiotics used to treat tuberculosis (such as rifampicin),
Croatian: • određene antibiotike koji se primjenjuju za liječenje tuberkuloze (kao što je rifampicin),
English: Patients with severe neutropenia (absolute neutrophil count < 1,000/mm3) should discontinue brexpiprazole and have their WBC followed until recovery.
Croatian: Bolesnicima s teškom neutropenijom (apsolutni broj neutrofila < 1000/mm3) treba prekinuti primjenu brekspiprazola i pratiti broj leukocita do oporavka.
English: Other urges, reported, include: compulsive sexual behaviours, compulsive shopping, binge eating, and other impulsive and compulsive behaviours.
Croatian: kompulzivna seksualna ponašanja, kompulzivno kupovanje, kompulzivno prejedanje i druga impulzivna i kompulzivna ponašanja.
English: These may include jerky movements, spasms, restlessness or slow movements.
Croatian: Oni mogu uključivati nagle pokrete, grčeve, nemir ili usporene kretnje.
English: In vivo, the metabolism of brexpiprazole is mainly mediated by CYP3A4 and CYP2D6 leading to formation of oxidative metabolites with only one metabolite, DM-3411, present in plasma with more than 10 % of plasma exposure.
Croatian: In vivo je metabolizam brekspiprazola uglavnom posredovan CYP3A4 i CYP2D6, što dovodi do stvaranja oksidacijskih metabolita s time da je samo jedan metabolit, DM-3411, prisutan u plazmi s više od 10 % izloženosti plazme.
English: In trials 1, 2 and 3 brexpiprazole was titrated as described in section 4.2 with 1 mg for 4 days, followed by 2 mg on days 5 to 7.
Croatian: U ispitivanjima 1, 2 i 3, brekspiprazol je bio titriran kako je opisano u dijelu 4.2, uz primjenu 1 mg tijekom 4 dana, nakon čega je slijedila primjena 2 mg od 5. do 7. dana.
English: Compulsive behaviours may result in harm to the patient and others if not recognised.
Croatian: Ako se ne prepoznaju, kompulzivna ponašanja mogu rezultirati štetom za bolesnika i druge osobe.
English: • experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness or sleepiness (may be signs of neuroleptic malignant syndrome).
Croatian: • osjetite kombinaciju vrućice, znojenja, ubrzanog disanja, ukočenosti mišića i omamljenosti ili pospanosti (mogu biti znakovi malignog neuroleptičnog sindroma).
English: Based on results of in vitro studies, brexpiprazole is unlikely to cause clinically important pharmacokinetic interactions with medicinal products metabolised by cytochrome P450 enzymes.
Croatian: Na temelju rezultata ispitivanja in vitro, brekspiprazol vjerojatno neće uzrokovati klinički važne farmakokinetičke interakcije s lijekovima koje metaboliziraju enzimi citokroma P450.
English: Adverse reactions related to orthostatic hypotension can include dizziness, light-headedness and tachycardia.
Croatian: Nuspojave povezane s ortostatskom hipotenzijom mogu uključivati omaglicu, ošamućenost i tahikardiju.
English: • certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors e.g. indinavir, ritonavir),
Croatian: • određene lijekove za liječenje HIV-infekcije (kao što su efavirenz, nevirapin, inhibitori proteaze, npr. indinavir, ritonavir),
English: The incidences of other EPS-related ADRs reported in short-term, controlled trials are dyskinesia (0.4 %), extrapyramidal disorder (1.8 %) and Parkinsonism (0.4 %).
Croatian: Incidencija drugih nuspojava povezanih s EPS-om zabilježenih u kratkotrajnim, kontroliranim ispitivanjima su diskinezija (0,4 %), ekstrapiramidni poremećaj (1,8 %) i parkinsonizam (0,4 %).
English: In embryo-foetal developmental toxicity studies, brexpiprazole was not teratogen in orally treated rats up to exposure levels (based on data in non-pregnant rats) clinically achieved at MRHD.
Croatian: U ispitivanjima embriofetalne razvojne toksičnosti, brekspiprazol nije bio teratogen u štakora kojima se davao peroralno do razine izloženosti (na temelju podataka u negravidnih ženki štakora) kakva se klinički postiže pri MRHD.
English: The safety and efficacy of brexpiprazole in children and adolescents aged less than 18 years have not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost brekspiprazola u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: If you have liver problems, your doctor may adjust your dose of this medicine.
Croatian: Ako imate probleme s jetrom, liječnik Vam može prilagoditi dozu ovog lijeka.
English: If you were taking other medicine to treat schizophrenia before starting RXULTI, your doctor will decide whether to stop the other medicine gradually or immediately and how to adjust the dose of RXULTI.
Croatian: Ako ste uzimali drugi lijek za liječenje shizofrenije prije nego što ste počeli uzimati RXULTI, liječnik će odlučiti hoće li se njegova primjena prekinuti postupno ili odjednom te kako prilagoditi dozu lijeka
English: No safety margins based on AUC0-24 h at the Maximum Recommended Human Dose (MRHD) of 4 mg/day could be derived in both female and male rats and monkey.
Croatian: Nisu se mogle izračunati margine sigurnosti na temelju AUC0-24 h pri maksimalnoj preporučenoj dozi za ljude od 4 mg na dan ni u ženki ni u mužjaka štakora i majmuna.
English: Primary efficacy measure: PANSS Mean baseline score (SD)
Croatian: Primarna mjera djelotvornosti: PANSS Srednja vrijednost početnog rezultata (SD)
English: In the overall analysis brexpiprazole did not prolong the QTc interval to clinically relevant extent following therapeutic and supra-therapeutic doses (4 mg/day; n = 62 or 12 mg/day; n = 53) and no correlation has been observed between brexpiprazole concentrations and QTc prolongation.
Croatian: U cjelokupnoj analizi, brekspiprazol nije produljio QTc-interval u klinički značajnoj mjeri nakon terapijskih i supraterapijskih doza (4 mg na dan; n = 62 ili 12 mg na dan; n = 53) te nije bila opažena korelacija između koncentracije brekspiprazola i produljenja
English: The recommended target dose range is 2 mg to 4 mg once daily.
Croatian: Preporučeni ciljani raspon doza je 2 mg do 4 mg jedanput dnevno.
English: In long-term, open-label trials, TEAEs related to suicidality were reported for 23 subjects (1.6 %).
Croatian: dugotrajnim otvorenim ispitivanjima, štetni događaji nastali tijekom liječenja povezani sa suicidalnošću bili su zabilježeni u 23 ispitanika (1,6 %).