FrancophonIA/ELRC3.0 huggingface dataset:
English: Brexpiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension (including accelerated or malignant).
Croatian: Brekspiprazol treba primjenjivati s oprezom u bolesnika s utvrđenom kardiovaskularnom bolešću (koji u povijesti bolesti imaju infarkt miokarda ili ishemijsku bolest srca, zatajenje srca ili poremećaje provođenja), cerebrovaskularnom bolešću, stanjima koja u bolesnika povećavaju sklonost nastanku hipotenzije (dehidracija, hipovolemija i liječenje antihipertenzivnim lijekovima) ili hipertenzijom (uključujući ubrzanu ili malignu hipertenziju).
English: Following a single oral dose of [14C]-labelled brexpiprazole, approximately 24.6 % and 46 % of the administered radioactivity was recovered in the urine and faeces, respectively.
Croatian: Nakon jedne peroralne doze brekspiprazola označenog izotopom [14C], približno 24,6 % primijenjene radioaktivnosti otkriveno je u mokraći, a 46 % u stolici.
English: In subjects who had a weight gain ≥ 7 % from baseline, weight increased over time, with mean weight gain up to 10.2 kg at week 52.
Croatian: U ispitanika s povećanjem tjelesne težine ≥ 7 % u odnosu na početnu vrijednost, tjelesna težina povećavala se s vremenom, a srednja vrijednost dobivene težine iznosila je do 10,2 kg u 52. tjednu.
English: Switching from other antipsychotics to brexpiprazole When switching from other antipsychotics to brexpiprazole gradual cross-titration should be considered, with gradual discontinuation of the previous treatment while brexpiprazole treatment is initiated.
Croatian: Kod prebacivanja s drugih antipsihotika na brekspiprazol potrebno je razmotriti postupnu ukriženu titraciju, s postupnim ukidanjem prethodnog liječenja dok se započinje liječenje brekspiprazolom.
English: Table 1: Dose adjustments of RXULTI in patients who are CYP2D6 poor metabolisers and for concomitant use with CYP inhibitors
Croatian: Tablica 1: Prilagodbe doze lijeka RXULTI u bolesnika koji su spori metabolizatori CYP2D6 i kod istodobne primjene inhibitora CYP-a
English: Brexpiprazole is an atypical antipsychotic agent.
Croatian: Brekspiprazol je atipični antipsihotik.
English: • antifungal medicines (such as ketoconazole, itraconazole),
Croatian: • lijekove za liječenje gljivičnih infekcija (kao što su ketokonazol, itrakonazol),
English: Following oral administration, brexpiprazole did not affect male fertility in rats but prolonged diestrus and decreased fertility in female rats at similar or even lower exposure levels than those clinically achieved at MRHD.
Croatian: Nakon peroralne primjene, brekspiprazol nije utjecao na plodnost mužjaka štakora, ali je produljio diestrus i smanjio plodnost ženki pri sličnim ili čak nižim razinama izloženosti od kliničkih koje se postižu kod maksimalne preporučene doze u ljudi (MRHD).
English: RXULTI film-coated tablets are supplied in Aluminium/PVC blisters containing 10 or 28 film-coated tablets.
Croatian: RXULTI filmom obložene tablete isporučuju se u aluminij/poli(vinilklorid) (PVC) blisterima koji sadrže 10 ili 28 filmom obloženih tableta.
English: How to take RXULTI
Croatian: Kako uzimati RXULTI
English: Brexpiprazole should be used with caution in patients with a known history of EPS.
Croatian: Brekspiprazol treba primjenjivati s oprezom u bolesnika s potvrđenim EPS-om u anamnezi.
English: If signs and symptoms of tardive dyskinesia appear in a patient on brexpiprazole, dose reduction or discontinuation should be considered.
Croatian: Ako se u bolesnika koji uzima brekspiprazol pojave znakovi i simptomi tardivne diskinezije, potrebno je razmotriti sniženje doze ili prekid primjene.
English: During the stabilisation, brexpiprazole improved clinical symptomology (as assessed by PANSS, CGI-S and CGI-I, [Analysis of Covariance - ANCOVA Last Observation Carried Forward - LOCF]) and functioning (as assessed by Global Assessment of Functioning (GAF) [ANCOVA LOCF]).
Croatian: Tijekom stabilizacije, brekspiprazol je poboljšao kliničke simptome (procijenjene ljestvicom PANSS, CGI-S i CGI-I [analiza kovarijance [ANCOVA] s imputacijom posljednjeg provedenog promatranja [engl.
English: RXULTI 1 mg film-coated tablets 10 or 28 film-coated tablets in Aluminium/PVC blisters.
Croatian: RXULTI 1 mg filmom obložene tablete 10 ili 28 filmom obloženih tableta u aluminij/PVC blisterima.
English: It is unknown whether brexpiprazole/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se brekspiprazol/metaboliti u majčino mlijeko.
English: In trial 1, statistically significant greater improvement on the CGI-S, the key secondary efficacy measure, at week 6 was also shown for the 2 mg/day and 4 mg/day compared to the placebo dose groups.
Croatian: Ispitivanje 1 pokazalo je također statistički značajno veće poboljšanje u CGI-S, ključnoj sekundarnoj mjeri djelotvornosti, u 6. tjednu u skupinama koje su primale doze od 2 mg na dan odnosno 4 mg na dan u usporedbi sa skupinom koja je primala placebo.
English: The primary statistical analysis was performed using an MMRM model with MAR (Missing At Random) imputation.
Croatian: Primarna statistička analiza provedena je pomoću MMRM modela s imputacijom podataka koji slučajno nedostaju (engl.
English: Brexpiprazole is predominantly metabolised by CYP3A4 and CYP2D6.
Croatian: Brekspiprazol pretežno metaboliziraju CYP3A4 i CYP2D6.
English: Subgroup analyses from the thorough QTc trial suggested that the QTc prolongation was larger in female subjects than in males.
Croatian: Analize podskupina u sveobuhvatnom ispitivanju QTc-intervala (engl. thorough QTc trial) nakon primjene brekspiprazola pokazale su da je produljenje QTc-intervala bilo veće u ispitanica nego u muških ispitanika.
English: Based on results of in vitro studies brexpiprazole protein binding is not affected by warfarin, diazepam, and digitoxin.
Croatian: Na temelju rezultata ispitivanja in vitro, varfarin, diazepam i digitoksin ne utječu na vezanje brekspiprazola za proteine.
English: In short-term, controlled trials, the percentage of subjects with clinically significant weight gain (increase of ≥ 7 % from baseline in body weight) was 9.1 % in the brexpiprazole 2 mg/day to 4 mg/day group, compared with 3.8 % in the placebo group.
Croatian: U kratkotrajnim kontroliranim ispitivanjima, postotak ispitanika s klinički značajnim povećanjem tjelesne težine (povećanje za ≥ 7 % od tjelesne težine na početku ispitivanja) iznosio je 9,1 % u skupini liječenoj brekspiprazolom u dozi od 2 mg na dan do 4 mg na dan u usporedbi s 3,8 % u skupini koja je primala placebo.
English: In terms of gender differences, there were higher observed frequencies of nausea (4.8 % versus 2.8 %) and vomiting (4.6 % versus 1.4 %) in females compared to males among brexpiprazole-treated subjects in short-term trials, in subjects receiving placebo: the frequency for nausea was 2.8 % for males versus 3.2 % for females and for vomiting the frequency was 3.0 % for males versus 2.6 % for females (see section 5.2).
Croatian: (4,8 % naspram 2,8 %) i povraćanja (4,6 % naspram 1,4 %) među ispitanicima liječenima brekspiprazolom u kratkotrajnim ispitivanjima, a u ispitanika koji su primali placebo učestalost mučnine bila je 2,8 % u muškaraca naspram 3,2 % u žena, dok je učestalost povraćanja bila 3,0 % u muškaraca naspram 2,6 % u žena (vidjeti dio 5.2).
English: In the long-term, open-label trial, the percentage of subjects with clinically significant weight gain (increase of ≥ 7 % in body weight) at any visit was 20.7 % and 0.4 % of the subjects discontinued due to weight gain.
Croatian: U dugotrajnom otvorenom ispitivanju, postotak ispitanika s klinički značajnim povećanjem tjelesne težine (povećanje tjelesne težine za ≥ 7 %) na bilo kojem kontrolnom pregledu bio je 20,7 %, dok je
English: Patients at increased risk of these adverse reactions (e.g. elderly) or at increased risk of developing complications from hypotension include those with dehydration, hypovolemia, treatment with antihypertensive medicinal products, history of cardiovascular disease (e.g., heart failure, myocardial infarction, ischemia, or conduction abnormalities), history of cerebrovascular disease, as well as patients who are antipsychotic-naive.
Croatian: Bolesnici s povećanim rizikom od ovih nuspojava (npr. starije osobe) ili s povećanim rizikom od razvoja komplikacija zbog hipotenzije uključuju one s dehidracijom, hipovolemijom, bolesnike koji se liječe antihipertenzivnim lijekovima, bolesnike s anamnezom kardiovaskularne bolesti (npr. zatajenje srca, infarkt miokarda, ishemija ili poremećaji provođenja), anamnezom cerebrovaskularne bolesti,
English: Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP2D6 inhibitors (quinidine, paroxetine, and fluoxetine).
Croatian: Na temelju rezultata ispitivanja interakcija, preporučuje se prilagoditi dozu brekspiprazola na pola doze kad se primjenjuje istodobno s jakim inhibitorima CYP2D6 (kinidinom, paroksetinom i fluoksetinom).
English: Neuroleptic Malignant Syndrome (NMS)
Croatian: Maligni neuroleptični sindrom (MNS)
English: Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
Croatian: I obrnuto, nakon prekida primjene može biti potrebno najmanje 2 tjedna da se indukcija CYP3A4 smanji.
English: From fixed-dose trials there appears to be a dose-response relationship for akathisia in patients treated with brexpiprazole, with an increasing frequency with higher doses.
Croatian: Na temelju ispitivanja fiksne doze, čini se da za akatiziju u bolesnika liječenih brekspiprazolom postoji odnos doza-odgovor, s time da se učestalost povećava kod viših doza.
English: If brexpiprazole is used concomitantly with strong CYP3A4 inducers (e.g. rifampicin), the total daily dose requirement of brexpiprazole is increased by approximately a factor of three times the recommended daily dose (see section 4.2).
Croatian: Ako se brekspiprazol primjenuje istodobno s jakim induktorima CYP3A4 (npr. rifampicinom), ukupno potrebnu dnevnu dozu brekspiprazola povisuje se na približno tri puta višu od preporučene dnevne doze (vidjeti dio 4.2).
English: Microcrystalline cellulose Low-substituted hydroxypropylcellulose Hydroxypropylcellulose Magnesium stearate
Croatian: Jezgra tablete laktoza hidrat kukuruzni škrob mikrokristalična celuloza nisko supstituirana hidroksipropilceluloza hidroksipropilceluloza magnezijev stearat pročićena voda
English: Switching to other antipsychotics from brexpiprazole When switching to other antipsychotics from brexpiprazole, no gradual cross-titration is needed, the new antipsychotic should be initiated in its lowest dose while brexpiprazole is discontinued.
Croatian: Kod prebacivanja s brekspiprazola na druge antipsihotike nije potrebna postupna ukrižena titracija i novi se antipsihotik uvodi u najnižoj dozi kad se prestaje s primjenom brekspiprazola.
English: Seizures have been reported during use of brexpiprazole (see section 4.8).
Croatian: Tijekom primjene brekspiprazola zabilježeni su napadaji (vidjeti dio 4.8).
English: Table 2: Primary efficacy results for 6-week trials in schizophrenia Trial
Croatian: Tablica 2: Rezultati primarne mjere djelotvornosti u 6-tjednim ispitivanjima kod shizofrenije Ispitivan je
English: Brexpiprazole does not affect absorption of medicinal products that are substrates of Breast Cancer Resistance Protein transporter (BCRP) and P-glycoprotein (P-gp) transporter.
Croatian: Breast Cancer Resistance Protein, BCRP) i prijenosnika P-glikoprotein (P-gp).
English: Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292
Croatian: Otsuka Pharmaceutical Netherlands B.V.
English: Twice daily divided dosing of brexpiprazole is preferable as once daily dosing results in high peak to trough fluctuation (see section 4.5).
Croatian: Bolje je podijeliti dozu i primijeniti je dvaput dnevno jer doziranje jedanput dnevno rezultira velikim fluktuacijama od vršnih do najnižih vrijednosti (vidjeti dio 4.5).
English: Gambling disorder Impulsive behaviour Binge eating Compulsive shopping
Croatian: Psihijatrijski poremećaji pokušaj samoubojstva suicidalne misli kompulzivno kockanje impulzivno ponašanje kompulzivno prejedanje kompulzivno kupovanje kompulzivno seksualno ponašanje
English: Film-coated tablet 10 film-coated tablets 28 film-coated tablets
Croatian: Filmom obložena tableta 10 filmom obloženih tableta 28 filmom obloženih tableta
English: Brexpiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system effects, such as sedation and dizziness that are common adverse drug reactions (see section 4.8).
Croatian: Brekspiprazol malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog mogućih učinaka na živčani sustav, kao što su sedacija i omaglica koje su česte nuspojave (vidjeti dio 4.8).
English: An electrocardiogram should be obtained in case of overdose and if QT interval prolongation is present, cardiac monitoring should be instituted.
Croatian: U slučaju predoziranja potrebno je napraviti elektrokardiogram te ako je prisutno produljenje QT-intervala,
English: • increased levels of the hormone prolactin, or have a tumour in your pituitary gland.
Croatian: • povišene razine hormona prolaktina ili tumor hipofize.
English: Following oral administration in pregnant rats, foetus and milk transfer of brexpiprazole was demonstrated at concentrations that were generally comparable to levels seen in maternal blood.
Croatian: Dokazan je prijenos brekspiprazola na fetuse nakon peroralne primjene u skotnih ženki štakora te u mlijeko pri koncentracijama koje su uglavnom bile usporedive s razinama opaženima u majčinoj krvi.
English: Film-coated tablet 28 film-coated tablets
Croatian: Filmom obložena tableta 28 filmom obloženih tableta
English: Efficacy was demonstrated in trial 1 for both brexpiprazole 2 mg/day and 4 mg/day and replicated in trial 2 only for brexpiprazole 4 mg/day and in trial 3 only for brexpiprazole 2 mg/day.
Croatian: Djelotvornost brekspiprazola dokazana je u ispitivanju 1 i za dozu od 2 mg na dan i za dozu od 4 mg na dan, što je u ispitivanju 2 ponovljeno samo za brekspiprazol u dozi od 4 mg na dan te u ispitivanju 3 samo za brekspiprazol u dozi od 2 mg na dan.
English: Very common Common Uncommon
Croatian: Manje često Nepoznato
English: Based on in vitro data brexpiprazole showed little to no inhibition of other CYP450 isozymes.
Croatian: Na temelju podataka in vitro pokazalo se da brekspiprazol gotovo uopće ili nimalo ne inhibira druge izoenzime CYP450.
English: In addition, the frequencies of prolactin elevations > 1 × ULN in the 2 mg to 4 mg brexpiprazole group was 13.7 % in females versus 6.4 % in placebo and 11.1 % in males versus 10.3 % in placebo group.
Croatian: Nadalje, učestalost povišenja prolaktina > 1 × GGN u skupini liječenoj brekspiprazolom u dozi od 2 mg do 4 mg bila je 13,7 % u žena naspram 6,4 % u skupini koja je primala placebo te 11,1 % u muškaraca naspram 10,3 % u skupini koja je primala placebo.
English: Patients taking CYP2D6 inhibitors and/or CYP3A4 inhibitors
Croatian: Bolesnici koji uzimaju inhibitore CYP2D6 i/ili inhibitore CYP3A4
English: Akathisia was the most frequently reported EPS related ADR in the brexpiprazole 2 mg/day to 4 mg/day group (5.6 %) compared to 4.5 % in placebo, followed by tremor (2.7 %) compared to 1.2 % in placebo.
Croatian: Ekstrapiramidni simptomi (EPS) Akatizija je bila najčešće prijavljena nuspojava povezana s EPS-om u skupini koja je primala brekspiprazol u dozi od 2 mg na dan do 4 mg na dan (5,6 %) u usporedbi s 4,5 % u skupini koja je primala placebo, a zatim tremor (2,7 %) u usporedbi s 1,2 % u skupini koja je primala placebo.
English: In the three fixed-dose, short-term trials (trials 1, 2 and 3), subjects were randomised to brexpiprazole 2 mg once daily, 4 mg once daily or placebo.
Croatian: U tri kratkotrajna ispitivanja fiksne doze (ispitivanja 1, 2 i 3), ispitanici su bili randomizirani u skupinu koja je primala brekspiprazol u dozi od 2 mg jedanput dnevno, skupinu koja je primala brekspiprazol u dozi od 4 mg jedanput dnevno ili skupinu koja je primala placebo.
English: The key secondary endpoint in trials 1, 2 and 4 was the Clinical Global Impression of Severity (CGI-S) of schizophrenia, a 7-point clinician's assessment of the severity of disease.
Croatian: Ključna sekundarna mjera ishoda u ispitivanjima 1, 2 i 4 bila je opći klinički dojam o težini (engl.
English: • medicines changing the salt concentrations in your body (causing a so-called electrolyte imbalance),
Croatian: • lijekove koji mijenjaju koncentracije soli u tijelu (uzrokujući takozvanu neravnotežu elektrolita), • lijekove koji povisuju razinu enzima pod nazivom kreatin fosfokinaza (CPK),
English: The incidence of akathisia in the brexpiprazole 1 mg/day, 2 mg/day, and 4 mg/day groups was 3.0 %, 4.6 %, and 6.5 %, respectively, compared with 5.2 % of subjects in the placebo group.
Croatian: Incidencija akatizije u skupinama koje su primale brekspiprazol u dozi od 1 mg na dan, 2 mg na dan i 4 mg na dan iznosila je 3,0 %, 4,6 % odnosno 6,5 % u usporedbi s 5,2 % u skupini ispitanika koji su primali placebo.
English: • from day 5 to day 7 take two 1 mg film-coated tablet per day,
Croatian: • tijekom prva 4 dana uzmite jednu filmom obloženu tabletu od 1 mg na dan • od 5. dana do 7. dana uzmite dvije filmom obložene tablete od 1 mg na dan
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotics.
Croatian: Kod primjene antipsihotika prijavljeni su slučajevi venske tromboembolije (VTE).
English: The effects of brexpiprazole at therapeutic (4 mg) and supra-therapeutic (12 mg) doses on QT interval were evaluated in subjects with schizophrenia or schizoaffective disorder in a randomised, double-blind, placebo- and positive-controlled (moxifloxacin), parallel-arm trial.
Croatian: Učinci brekspiprazola u terapijskim (4 mg) i supraterapijskim (12 mg) dozama na QT-interval procijenjeni su u ispitanika sa shizofrenijom ili shizoafektivnim poremećajem u randomiziranom,
English: During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Croatian: Može biti potrebno nekoliko dana do nekoliko tjedana terapije antipsihoticima prije nego što nastupi poboljšanje kliničkog stanja bolesnika.
English: If the CYP3A4 inhibitor/inducers or CYP2D6 inhibitor is withdrawn, the dose may need to be returned to the original dose (see section 4.5).
Croatian: CYP2D6, dozu će možda trebati vratiti na prvobitnu dozu (vidjeti dio 4.5).
English: Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking brexpiprazole.
Croatian: Dok uzimaju brekspiprazol, bolesnici mogu osjećati pojačane porive, osobito za kockanjem, te nemogućnost kontroliranja tih poriva.
English: If you forget to take RXULTI
Croatian: Ako ste zaboravili uzeti lijek RXULTI
English: Spontaneous cases reporting completed suicide and suicide attempt have been reported in the post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet zabilježene su spontane prijave slučajeva izvršenog samoubojstva i pokušaja samoubojstva.
English: Key secondary efficacy measure: CGI-S Mean baseline score (SD)
Croatian: Ključna sekundarna mjera djelotvornosti: CGI-S
English: • a history of seizures (fits) or epilepsy.
Croatian: • napadaje ili epilepsiju u povijesti bolesti.
English: In the short-term trials, the primary efficacy endpoint was defined as the mean change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total scores, a multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement, and anxiety/depression.
Croatian: Positive and Negative Syndrome Scale, PANSS), upitniku s više dijelova koji se sastoji od pet faktora za procjenu pozitivnih simptoma, negativnih simptoma, neorganiziranih misli, nekontroliranog neprijateljskog ponašanja/uzbuđenosti i tjeskobe/depresije.
English: • thoughts or feelings about hurting yourself or to commit suicide or a suicide attempt (uncommon side effect - may affect up to 1 in 100 people).
Croatian: Odmah obavijestite liječnika ako imate: • misli o samoozljeđivanju ili osjećate da biste si mogli nauditi ili počiniti samoubojstvo ili pokušaj samoubojstva (manje česta nuspojava - može se javiti u do 1 na 100 osoba).
English: If you stop taking RXULTI
Croatian: Ako prestanete uzimati lijek RXULTI
English: Co-administration of rifampicin (600 mg twice daily for 12 days), a potent CYP3A4 inducer, with a single 4 mg oral dose of brexpiprazole resulted in an approximate 31 % and 73 % decrease in brexpiprazole Cmax and AUC, respectively.
Croatian: Istodobna primjena rifampicina (600 mg dvaput dnevno tijekom 12 dana), jakog induktora CYP3A4, s jednom peroralnom dozom brekspiprazola od 4 mg rezultirala je sniženjem Cmax brekspiprazola za 31 % i AUC-a za 73 %.
English: Co-administration of ketoconazole (200 mg twice daily for 7 days), a potent inhibitor of CYP3A4, with a 2 mg single oral dose of brexpiprazole increased the AUC of brexpiprazole by 97 % and no change in Cmax.
Croatian: Istodobna primjena ketokonazola (200 mg dvaput dnevno tijekom 7 dana), jakog inhibitora CYP3A4, s jednom peroralnom dozom brekspiprazola od 2 mg povećala je AUC brekspiprazola za 97 %, bez promjene u Cmax.
English: • pain in the upper abdomen,
Croatian: • bol u gornjem dijelu trbuha
English: Diarrhoea Nausea Abdominal pain upper
Croatian: Poremećaji probavnog sustava proljev mučnina bol u gornjem dijelu abdomena zubni karijes vjetrovi
English: In subjects (n = 10) with severe renal impairment (CLcr < 30 mL/min), AUC of oral brexpiprazole (3 mg single dose) compared to matched healthy subjects was increased by 68 % while its Cmax was not changed.
Croatian: AUC peroralnog brekspiprazola (jedne doze od 3 mg) u ispitanika (n = 10) s teškim oštećenjem funkcije bubrega (CLcr < 30 ml/min) u usporedbi s odgovarajućim zdravim ispitanicima bio je povećan za 68 %, dok mu se Cmax nije promijenio.
English: For patients with moderate to severe renal impairment (creatinine clearance CLcr < 60 mL/minute), the maximum recommended dose is reduced to 3 mg once daily (see section 4.2).
Croatian: U bolesnika s umjerenim do teškim oštećenjem funkcije bubrega (klirens kreatnina CLcr < 60 ml/min), maksimalna preporučena doza snižena je na 3 mg jedanput dnevno (vidjeti dio 4.2).
English: EU/1/18/1294/003 (10 film-coated tablets) EU/1/18/1294/004 (28 film-coated tablets)
Croatian: EU/1/18/1294/003 (10 filmom obloženih tableta) EU/1/18/1294/004 (28 filmom obloženih tableta)
English: • parkinsonism - medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity),
Croatian: • parkinsonizam - zdravstveno stanje s mnoštvom različitih simptoma koji uključuju smanjene ili usporene pokrete, usporene misli, iznenadno trzanje prilikom savijanja udova (ukočenost kao kod zupčastog kotača), sitne korake uz povlačenje nogu pri hodu, drhtanje, neznatnu izražajnost lica ili bezizražajno lice, ukočenost mišića, slinjenje
English: In the short-term controlled trials with brexpiprazole, 3 TEAEs related to QT prolongation were reported in the 2 mg to 4 mg group (0.3 %), compared with 3 TEAEs (0.5 %) reported for subjects on placebo.
Croatian: U kratkotrajnim kontroliranim ispitivanjima brekspiprazola zabilježena su 3 štetna događaja nastala tijekom liječenja povezana s produljenjem QT-intervala u skupini koja je primala 2 mg do 4 mg brekspiprazola (0,3 %) u usporedbi s 3 štetna događaja nastala tijekom liječenja (0,5 %) zabilježena u ispitanika koji su primali placebo.