natgillin/translations-raw huggingface dataset:
The effects of brexpiprazole on the QT interval were evaluated in patients with schizophrenia or schizoaffective disorder.
Učinci brekspiprazola na QT-interval bili su procijenjeni u bolesnika sa shizofenijom ili shizoafektivnim poremećajem.
Additional signs may include increased creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Dodatni znakovi mogu uključivati povišene vrijednost kreatin fosfokinaze, mioglobinuriju (rabdomiolizu) i akutno zatajenje bubrega.
In trial 5, a long-term trial designed to assess the maintenance of effect of brexpiprazole by assessing the delay in time to impending relapse of schizophrenia, patients with schizophrenia, who responded to treatment with brexpiprazole 1 mg/day to 4 mg/day, were stabilised over 12 weeks to 36 weeks, and then randomised in a double-blind manner to either continue treatment with the stabilisation dose of brexpiprazole (n = 96) or to receive placebo (n = 104) for 52 weeks or until relapse occurred.
U ispitivanju 5, dugotrajnom ispitivanju provedenom radi procjene održanja učinka brekspiprazola procjenom produljenja razdoblja do prijetećeg relapsa shizofrenije, bolesnici sa shizofrenijom, koji su odgovorili na liječenje brekspiprazolom u dozi od 1 mg na dan do 4 mg na dan, bili su stabilizirani tijekom 12 tjedana do 36 tjedana te potom randomizirani na dvostruko slijep način da nastave liječenje stabilizirajućom dozom brekspiprazola (n = 96) ili da primaju placebo (n = 104) tijekom 52 tjedna ili do pojave relapsa.
Lactose monohydrate, maize starch, microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, purified water.
Laktoza hidrat, kukuruzni škrob, mikrokristalična celuloza, nisko supstituirana hidroksipropilceluloza, hidroksipropilceluloza, magnezijev stearat, pročićena voda.
Studies in animals have shown decreased female fertility (see section 5.3).
Ispitivanja na životinjama pokazala su smanjenu plodnost ženki (vidjeti dio 5.3).
Neuroleptic malignant syndrome
Maligni neuroleptični sindrom
Potential for other medicinal products to affect brexpiprazole
Mogućnost utjecaja drugih lijekova na brekspiprazol
Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotics.
Antipsihoticima se pripisuje narušavanje sposobnosti tijela da snizi unutarnju tjelesnu temperaturu.
CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction.
Učinak induktora CYP3A4 ovisan je o vremenu te nakon njihova uvođenja može biti potrebno najmanje 2 tjedna da bi postigli maksimalni učinak.
Appropriate care is advised when prescribing brexpiprazole for patients who will be experiencing conditions that may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medicinal products with anticholinergic activity, or being subject to dehydration.
Savjetuje se odgovarajući oprez kad se brekspiprazol propisuje bolesnicima u kojih će nastati stanja koja mogu pridonijeti povišenju unutarnje tjelesne temperature, npr. naporna tjelovježba, izloženost velikoj vrućini, istodobno uzimanje lijekova s antikolinergičkim djelovanjem ili podložnost dehidraciji.
Patients with a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and brexpiprazole should be discontinued at the first sign of decline in WBC, in the absence of other causative factors.
U bolesnika s već niskim brojem bijelih krvnih stanica (leukocita) i leukopenijom/neutropenijom izazvanom lijekovima u povijesti bolesti treba često provjeravati kompletnu krvnu sliku (KKS) tijekom prvih nekoliko mjeseci terapije i primjenu brekspiprazola treba prekinuti na prvi znak sniženja broja leukocita u odsutnosti drugih uzročnih čimbenika.
The mean change in body weight overall for the brexpiprazole group in the long term, open label trial was 2.1 kg at week 52.
Srednja vrijednost promjene tjelesne težine sveukupno u skupini liječenoj brekspiprazolom u dugotrajnom otvorenom ispitivanju iznosila je 2,1 kg u 52. tjednu.
An increased frequency of weight gain has been observed with increased duration of brexpiprazole treatment (see section 4.8).
Opažena je povećana učestalost povećanja tjelesne težine s duljim trajanjem liječenja brekspiprazolom (vidjeti dio 4.8).
Effects on QT
Učinci na QT-interval
Due to the testing hierarchy the greater improvement shown for both 2 mg/day and 4 mg/day on the CGI-S can only be considered supportive for trials 2, 3 and 4 (see table 3).
Zbog hijerarhije testova, može se smatrati da veće poboljšanje u CGI-S i pri dozi od 2 mg na dan i pri dozi od 4 mg na dan samo potkrepljuje ispitivanja 2, 3 i 4 (vidjeti tablicu 3).
RXULTI film-coated tablets contain lactose.
RXULTI filmom obložene tablete sadrže laktozu.
The categorisation of blood prolactin increased is based on Potentially Clinically Relevant (PCR) criteria of > 1 × upper limit of normal (ULN).
Clinically Relevant, PCR) kriterijima od > 1 × gornja granica normale (GGN).
In case of adverse reactions despite dose adjustments of RXULTI, the necessity of concomitant use of RXULTI and CYP2D6 or CYP3A4 inhibitor should be reassessed.
U slučaju nuspojava unatoč prilagodbama doze lijeka RXULTI, potrebno je ponovno procijeniti potrebu za istodobnom primjenom lijeka RXULTI i inhibitora CYP2D6 ili CYP3A4.
• combination of fever, sweating, muscle stiffness, and drowsiness or sleepiness.
• kombinaciju vrućice, znojenja, ukočenosti mišića i omamljenosti ili pospanosti.
Tablet coat: Hypromellose, talc, titanium dioxide.
Hipromeloza, talk, titanijev dioksid.
Higher frequencies of prolactin increased (1.5 % versus 0.60 %) were observed in females compared to males in short-term trials.
Opažena učestalost povišenog prolaktina bila je veća u žena nego u muškaraca (1,5 % naspram 0,60 %) u kratkotrajnim ispitivanjima.
H. Lundbeck A/S Tel: +45 36301311
Lundbeck A/S Tel: +45 36301311
Potential for brexpiprazole to affect other medicinal products
Mogućnost utjecaja brekspiprazola na druge lijekove
• dizziness on standing up due to a drop in your blood pressure, which may cause fainting,
• omaglica pri ustajanju zbog pada krvnog tlaka, što može uzrokovati nesvjesticu
At steady-state, DM-3411 represents 23.1 % to 47.7 % of brexpiprazole exposure (AUC) in plasma.
U stanju dinamičke ravnoteže, DM-3411 predstavlja 23,1 % do 47,7 % izloženosti brekspiprazolu
Keep this medicine out of the sight and reach of children.
Kako čuvati RXULTI Lijek čuvajte izvan pogleda i dohvata djece.
In short-term, controlled trials, Treatment Emergent Adverse Events (TEAEs) related to suicidality were reported for 8 subjects (0.5 %, 2 serious events, 1 leading to discontinuation) in the all brexpiprazole treatment group and 3 subjects (0.4 %, none serious) in the placebo group.
Treatment Emergent Adverse Events, TEAEs) povezani sa suicidalnošću zabilježeni su u 8 ispitanika (0,5 %, 2 ozbiljna događaja, 1 koji je doveo do prekida uzimanja lijeka) u svim skupinama liječenima brekspiprazolom i 3 ispitanika (0,4 %, nijedan ozbiljan) u skupini koja je primala placebo.
The pharmacology of brexpiprazole is believed to be mediated by a modulatory activity at the serotonin and dopamine systems that combines partial agonist activity at serotonergic 5-HT1A and at dopaminergic D2 receptors with antagonist activity at serotonergic 5-HT2A receptors, with similar high affinities at all of these receptors
Smatra se da je farmakologija brekspiprazola posredovana modulacijskim djelovanjem na serotoninski i dopaminski sustav, pri čemu se djelomično agonističko djelovanje na serotoninergičke receptore 5-HT1A i dopaminergičke receptore D2 kombinira s antagonističkim djelovanjem na serotoninergičke receptore 5-HT2A, uz slično jak afinitet za sve ove receptore (Ki: 0,1 nM do 0,5 nM).
There are no or limited amount of data from the use of brexpiprazole in pregnant women.
Nema podataka ili su podaci o primjeni brekspiprazola u trudnica ograničeni.
RXULTI 0.25 mg, 0.5 mg, 2 mg, 3 mg and 4 mg film-coated tablets 28 film-coated tablets in Aluminium/PVC blisters.
RXULTI 0,25 mg, 0,5 mg, 2 mg, 3 mg i 4 mg filmom obložene tablete 28 filmom obloženih tableta u aluminij/PVC blisterima.
Given the primary Central Nervous System (CNS) effects of brexpiprazole, caution should be used when brexpiprazole is taken in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as sedation (see section 4.8).
S obzirom na to da brekspiprazol primarno djeluje na središnji živčani sustav (SŽS), potreban je oprez kad se brekspiprazol uzima u kombinaciji s alkoholom ili drugim lijekovima koji djeluju na SŽS a imaju podudarne nuspojave poput sedacije (vidjeti dio 4.8).
Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia.
Mogući čimbenici rizika za leukopeniju/neutropeniju uključuju već prisutan nizak broj bijelih krvnih stanica i leukopeniju/neutropeniju izazvanu lijekovima u povijesti bolesti.
If you have kidney problems, your doctor may adjust your dose of this medicine.
Ako imate probleme s bubrezima, liječnik Vam može prilagoditi dozu ovog lijeka.
In placebo-controlled trials with some antipsychotics in elderly patients with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks), including fatalities, compared to placebo-treated subjects.
U placebom kontroliranim ispitivanjima nekih antipsihotika u starijih bolesnika s demencijom, incidencija cerebrovaskularnih nuspojava (cerebrovaskularnih incidenata i tranzitornih ishemijskih ataka), uključujući smrtne slučajeve, bila je viša nego u ispitanika koji su primali placebo.
The incidences of the ADRs associated with brexpiprazole therapy are tabulated below.
Incidencije nuspojava povezanih s terapijom brekspiprazolom prikazane su u tablici niže.
Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir, and clarithromycin).
Na temelju rezultata ispitivanja interakcija preporučuje se prilagodba doze brekspiprazola na pola doze kad se primjenjuje istodobno s jakim inhibitorima CYP3A4 (itrakonazolom, ketokonazolom, ritonavirom i klaritromicinom).
Weight gain and dyslipidaemia
Povećanje tjelesne težine i dislipidemija
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
ukočenost mišića, promijenjen mentalni status i znakovi autonomne nestabilnosti (nepravilan rad srca ili krvni tlak, tahikardija, dijaforeza i poremećaj srčanog ritma).
The pharmacokinetic of brexpiprazole is dose proportional and time-invariant after single-dose (0.2 mg to 8 mg) and multiple-dose (0.5 mg to 4 mg) using once-daily administration.
Farmakokinetika brekspiprazola proporcionalna je dozi i ne mijenja se tijekom vremena nakon primjene jedne doze (od 0,2 mg do 8 mg) ili višestrukih doza (od 0,5 mg do 4 mg) jedanput dnevno.
If brexpiprazole is used concomitantly with strong CYP3A4 inducers (e.g. rifampicin), in a patient stabilised on brexpiprazole it is necessary to titrate the daily dose of brexpiprazole stepwise up to double the recommended dose over the course of 1 to 2 weeks.
Ako se brekspiprazol primjenjuje istodobno s jakim induktorima CYP3A4 (npr. rifampicinom), u bolesnika stabiliziranog na brekspiprazolu potrebno je postepeno povisivati dnevnu dozu brekspiprazola do dvostruke preporučene doze tijekom 1 do 2 tjedna.
Elevations associated with brexpiprazole treatment are generally mild and may decline during administration, however, in some infrequent cases the effect may persist during administration (see section 4.8).
Povišenje povezano s liječenjem brekspiprazolom općenito je blago i može opasti tijekom primjene; međutim, u nekim ne tako čestim slučajevima taj učinak može biti prisutan tijekom cijelog trajanja primjene (vidjeti dio 4.8).
As with other antipsychotics, brexpiprazole should be used with caution in patients who have a history of seizure disorder or other conditions that potentially lower the seizure threshold.
Napadaji Kao i druge antipsihotike, brekspiprazol treba primjenjivati s oprezom u bolesnika koji u anamnezi imaju epileptički poremećaj ili druga stanja koja mogu sniziti konvulzivni prag.
Placebo Brexpiprazole (2 mg/day)* 113 96.55 Brexpiprazole (4 mg/day) Placebo Brexpiprazole (2 mg/day to 4 mg/day
Placebo (2 mg na dan)* 113 96,55 Brekspiprazol (4 mg na dan) Placebo Brekspiprazol (2 mg na dan do 4 mg na dan)
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).
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).
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.
Nakon jedne peroralne doze brekspiprazola označenog izotopom [14C], približno 24,6 % primijenjene radioaktivnosti otkriveno je u mokraći, a 46 % u stolici.
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.
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.
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.
Kod prebacivanja s drugih antipsihotika na brekspiprazol potrebno je razmotriti postupnu ukriženu titraciju, s postupnim ukidanjem prethodnog liječenja dok se započinje liječenje brekspiprazolom.
Table 1: Dose adjustments of RXULTI in patients who are CYP2D6 poor metabolisers and for concomitant use with CYP inhibitors
Tablica 1: Prilagodbe doze lijeka RXULTI u bolesnika koji su spori metabolizatori CYP2D6 i kod istodobne primjene inhibitora CYP-a
Brexpiprazole is an atypical antipsychotic agent.
Brekspiprazol je atipični antipsihotik.
• antifungal medicines (such as ketoconazole, itraconazole),
• lijekove za liječenje gljivičnih infekcija (kao što su ketokonazol, itrakonazol),
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.
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).
RXULTI film-coated tablets are supplied in Aluminium/PVC blisters containing 10 or 28 film-coated tablets.
RXULTI filmom obložene tablete isporučuju se u aluminij/poli(vinilklorid) (PVC) blisterima koji sadrže 10 ili 28 filmom obloženih tableta.
How to take RXULTI
Kako uzimati RXULTI
Brexpiprazole should be used with caution in patients with a known history of EPS.
Brekspiprazol treba primjenjivati s oprezom u bolesnika s potvrđenim EPS-om u anamnezi.
If signs and symptoms of tardive dyskinesia appear in a patient on brexpiprazole, dose reduction or discontinuation should be considered.
Ako se u bolesnika koji uzima brekspiprazol pojave znakovi i simptomi tardivne diskinezije, potrebno je razmotriti sniženje doze ili prekid primjene.
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]).
Tijekom stabilizacije, brekspiprazol je poboljšao kliničke simptome (procijenjene ljestvicom PANSS, CGI-S i CGI-I [analiza kovarijance [ANCOVA] s imputacijom posljednjeg provedenog promatranja [engl.
RXULTI 1 mg film-coated tablets 10 or 28 film-coated tablets in Aluminium/PVC blisters.
RXULTI 1 mg filmom obložene tablete 10 ili 28 filmom obloženih tableta u aluminij/PVC blisterima.
It is unknown whether brexpiprazole/metabolites are excreted in human milk.
Nije poznato izlučuju li se brekspiprazol/metaboliti u majčino mlijeko.
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.
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.
The primary statistical analysis was performed using an MMRM model with MAR (Missing At Random) imputation.
Primarna statistička analiza provedena je pomoću MMRM modela s imputacijom podataka koji slučajno nedostaju (engl.
Brexpiprazole is predominantly metabolised by CYP3A4 and CYP2D6.
Brekspiprazol pretežno metaboliziraju CYP3A4 i CYP2D6.
Subgroup analyses from the thorough QTc trial suggested that the QTc prolongation was larger in female subjects than in males.
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.
Based on results of in vitro studies brexpiprazole protein binding is not affected by warfarin, diazepam, and digitoxin.
Na temelju rezultata ispitivanja in vitro, varfarin, diazepam i digitoksin ne utječu na vezanje brekspiprazola za proteine.
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.
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.
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).
(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).
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.
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
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.
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,
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).
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).
Neuroleptic Malignant Syndrome (NMS)
Maligni neuroleptični sindrom (MNS)
Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
I obrnuto, nakon prekida primjene može biti potrebno najmanje 2 tjedna da se indukcija CYP3A4 smanji.
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.
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.
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).
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).
Microcrystalline cellulose Low-substituted hydroxypropylcellulose Hydroxypropylcellulose Magnesium stearate
Jezgra tablete laktoza hidrat kukuruzni škrob mikrokristalična celuloza nisko supstituirana hidroksipropilceluloza hidroksipropilceluloza magnezijev stearat pročićena voda
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.
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.
Seizures have been reported during use of brexpiprazole (see section 4.8).
Tijekom primjene brekspiprazola zabilježeni su napadaji (vidjeti dio 4.8).
Table 2: Primary efficacy results for 6-week trials in schizophrenia Trial
Tablica 2: Rezultati primarne mjere djelotvornosti u 6-tjednim ispitivanjima kod shizofrenije Ispitivan je
Brexpiprazole does not affect absorption of medicinal products that are substrates of Breast Cancer Resistance Protein transporter (BCRP) and P-glycoprotein (P-gp) transporter.
Breast Cancer Resistance Protein, BCRP) i prijenosnika P-glikoprotein (P-gp).