FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Uporablja se za zdravljenje shizofrenije pri odraslih bolnikih - bolezen s simptomi, kot so, da bolnik vidi ali zaznava stvari, ki jih ni, sumničavost, nepovezan govor in neorganizirano vedenje ter čustvena otopelost.
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.
Slovenian: Čeprav ni podatkov o učinku hemodialize pri zdravljenju prevelikega odmerjanja z brekspiprazolom, hemodializa verjetno ne bi bila koristna pri prevelikem odmerjanju, ker se brekspiprazol v veliki meri veže na beljakovine v plazmi.
English: Patients with liver problems
Slovenian: Bolniki z ledvičnimi težavami
English: • certain antibiotics used to treat tuberculosis (such as rifampicin),
Slovenian: • določene antibiotike, ki se uporabljajo za zdravljenje tuberkoloze (kot je rifampicin),
English: • anticonvulsants used to treat epilepsy,
Slovenian: • antikonvulzive, ki se uporabljajo za zdravljenje epilepsije,
English: LS mean differencea (95 % CI)
Slovenian: LS povprečna razlikaa (95-% IZ)
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.
Slovenian: Bolniki, ki prejemajo antipsihotike, imajo pogosto pridobljene dejavnike tveganja za VTE, zato je treba pred in med zdravljenjem s brekspiprazolom ugotoviti vse možne dejavnike tveganja in ukrepati preventivno.
English: Daily dose must not exceed 12 mg when brexpiprazole is used concomitantly with strong CYP3A4 inducers.
Slovenian: Dnevni odmerek ne sme preseči 12 mg, kadar se brekspiprazol uporablja sočasno z močnimi induktorji CYP3A4.
English: The safety and efficacy of brexpiprazole in children and adolescents aged less than 18 years have not been established.
Slovenian: Varnosti in učinkovitosti brekspiprazola pri otrocih in mladostnikih, mlajših od 18 let, niso ugotovili.
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.
Slovenian: Če ste pred jemanjem zdravila RXULTI uporabljali druga zdravila za zdravljenje shizofrenije, se bo zdravnik odločil, ali naj jemanje drugega zdravila prekinete postopoma ali takoj, in kako prilagoditi odmerek zdravila RXULTI.
English: • from day 5 to day 7 take two 1 mg film-coated tablet per day,
Slovenian: • od 5. do 7. dne vzemite dve 1-mg filmsko obloženi tableti na dan,
English: • irregular heart beat or if someone else in your family has a history of irregular heart beat (including so called QT prolongation seen with ECG monitoring).
Slovenian: • nereden srčni utrip ali če ima nekdo drug v vaši družini zdravstveno zgodovino nerednega srčnega utripa (vključno s podaljšanjem intervala QT, ki ga opazimo pri spremljanju EKG).
English: Potential for other medicinal products to affect brexpiprazole
Slovenian: Možnost, da druga zdravila vplivajo na brekspiprazol
English: The recommended target dose range is 2 mg to 4 mg once daily.
Slovenian: Priporočeni ciljni odmerek je od 2 mg do 4 mg enkrat na dan.
English: • antibiotics to treat bacterial infections (such as clarithromycin),
Slovenian: • antibiotike za zdravljenje bakterijskih okužb (kot je klaritromicin),
English: This may for example be the case if other medicines lowered your white blood cells in the past.
Slovenian: To se lahko na primer zgodi, če se je vrednost belih krvnih celic znižala zaradi jemanja drugih zdravil.
English: Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
Slovenian: Sicer je treba pri prevelikem odmerku izvesti podporno zdravljenje, z vzdrževanjem ustrezne dihalne poti, preskrbe s kisikom in predihavanja, ter obvladovati simptome.
English: Adjusted dose
Slovenian: Prilagojeni odmerek
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.
Slovenian: Brekspiprazol ni bil raziskan pri starejših bolnikih z demenco in zato zaradi povečanega tveganja splošne umrljivosti ni priporočljiv za zdravljenje teh bolnikov.
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]).
Slovenian: Med stabilizacijo je brekspiprazol izboljšal klinične simptome (po lestvicah PANSS, CGI-S in CGI-I [analiza kovariance - ANCOVA (Analysis of Covariance) zadnje naprej preneseno opazovanje LOCF (Last Observation Carried Forward)]) in funkcioniranje (po lestvici za splošno oceno bolnikovega funkcioniranja (Global Assessment of Functioning (GAF) [ANCOVA LOCF]).
English: CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction.
Slovenian: Induktorji CYP3A4 učinkujejo na časovno odvisen način in vsaj 2 tedna po njihovi uvedbi lahko traja,
English: Based on the patient's clinical response and tolerability the brexpiprazole dose can be titrated to 2 mg once daily on day 5 through day 7 and then to 4 mg on day 8.
Slovenian: Na podlagi bolnikovega kliničnega odziva in prenašanja lahko odmerek brekspiprazola od 5. do 7. dne titriramo na 2 mg enkrat na dan ter nato 8. dan na 4 mg.
English: • a history of seizures (fits) or epilepsy.
Slovenian: • zdravstveno zgodovino epileptičnih napadov ali epilepsije.
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.
Slovenian: Uporaba brekspiprazola ni bila ovrednotena pri bolnikih z anamnezo miokardnega infarkta/ishemične srčne bolezni ali klinično pomembne bolezni srca in ožilja, saj so bili ti bolniki izključeni iz kliničnih preskušanj.
English: If you stop taking this medicine you will lose the effects of the medicine.
Slovenian: Če boste prekinili z jemanjem zdravila, bo prenehalo učinkovati.
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).
Slovenian: Psihotične bolezni in težave z nihanjem razpoloženja so neločljivo povezane s pojavnostjo samomorilnega vedenja in v nekaterih primerih so o tem poročali kmalu po uvedbi ali zamenjavi antipsihotičnega zdravljenja, vključno z zdravljenjem z brekspiprazolom (glejte poglavje 4.8).
English: Significant increased pre-implantation losses were observed at 4.1-fold the clinical exposure at MRHD.
Slovenian: Opazili so pomembno povečane predimplantacijske izgube pri 4,1-kratniku klinične izpostavljenosti pri MRHD.
English: Neonates exposed to antipsychotics, including brexpiprazole, during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Slovenian: Pri novorojenčkih, izpostavljenih antipsihotikom, vključno z brekspiprazolom, v tretjem trimesečju nosečnosti, obstaja nevarnost za pojav neželenih učinkov, vključno z ekstrapiramidnimi motnjami in/ali odtegnitvenimi simptomi, ki se lahko po porodu razlikujejo po resnosti in trajanju.
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.
Slovenian: To so imenuje motnja nadzora impulzov, kamor štejemo vedenja, kot so odvisnost od hazardiranja, čezmerno uživanje hrane ali trošenje denarja, nenormalno povečan libido ali preokupacija z mislimi na spolnost ali spolnimi občutki.
English: If brexpiprazole is administered concomitantly with medicinal products known to increase creatine phosphokinase (CPK) the possible additive effect with CPK increase induced by brexpiprazole should be considered.
Slovenian: Če se brekspiprazol sočasno uporablja z zdravili, za katera je znano, da zvišujejo vrednosti kreatin-fosfokinaze (CPK), je treba upoštevati možen sinergijski učinek s povečanjem CPK, ki ga povzroča brekspiprazol.
English: • have any difficulty in swallowing.
Slovenian: • imate težave pri požiranju.
English: • tooth decay or cavities (dental caries),
Slovenian: • zobna gniloba v ustni votlini (zobni karies),
English: Additional signs may include increased creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Slovenian: Dodatni znaki lahko vključujejo zvišanje kreatinfosfokinaze, mioglobinurijo (rabdomiolizo) in akutno ledvično odpoved.
English: Gambling disorder Impulsive behaviour Binge eating Compulsive shopping
Slovenian: Impulzivno vedenje Prenajedanje Kompulzivno nakupovanje Kompulzivno spolno vedenje
English: The efficacy and safety of brexpiprazole in the treatment of adults with schizophrenia was studied in two multi-national and one regional (Japan), 6-week, randomised, double-blind, placebo-controlled, fixed-dose clinical trials (trials 1 to 3), a multi-national, 6-week, randomised, double-blind, placebo-controlled, active reference (quetiapine), flexible-dose clinical trial (trial 4), and, one multi-national, placebo-controlled, 52-week maintenance trial (trial 5).
Slovenian: Učinkovitost in varnost brekspiprazola pri zdravljenju odraslih bolnikov s shizofrenijo so preučevali v dveh večnacionalnih in enem regionalnem (Japonska) 6-tedenskem, randomiziranem, dvojno slepem, s placebom nadzorovanem kliničnem preskušanju (preskušanja od 1 do 3), večnacionalnem 6tedenskem randomiziranem, dvojnoslepem, s placebom nadzorovanem kliničnem preskušanju z aktivno referenco (kvetiapin) in prilagodljivim odmerkom (preskušanje 4), in enim večnacionalnim, s placebom nadzorovanim 52-tedenskim vzdrževalnim preskušanjem (preskušanje 5).
English: If signs and symptoms of tardive dyskinesia appear in a patient on brexpiprazole, dose reduction or discontinuation should be considered.
Slovenian: Če se pri bolniku na brekspiprazolu pojavijo znaki in simptomi tardivne diskinezije, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
English: In the same trial the active reference, quetiapine XR added for assay sensitivity only, separated from placebo.
Slovenian: V istem preskušanju je bila dodana aktivna referenca kvetiapin s podaljšanim sproščanjem samo za občutljivost testa, ločeno od placeba.
English: Other medicines and RXULTI
Slovenian: Druga zdravila in zdravilo RXULTI
English: 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.
Slovenian: Povprečna sprememba telesne mase na splošno v skupini bolnikov, ki je prejemala brekspiprazol v dolgoročnem odprtem preskušanju, je bila v 52. tednu 2,1 kg.
English: The effect of brexpiprazole on human fertility has not been evaluated.
Slovenian: Učinek brekspiprazola na plodnost pri človeku ni bil ovrednoten.
English: The effects of brexpiprazole were also evaluated across a number of pre-specified secondary endpoints; the specific aspects of symptoms of schizophrenia (PANSS Positive Subscale score, PANSS Negative Subscale score, PANSS Excited Component [PEC] score, PANSS Marder factors positive, negative, disorganised thoughts, uncontrolled hostility/excitement and anxiety/depression), and analyses of response (defined as 30 % improvement in PANSS total score compared to baseline or a CGI-I score of 1 [very much improved] or 2 [much improved]).
Slovenian: Učinki brekspiprazola so bili ovrednoteni tudi po številnih vnaprej določenih sekundarnih kriterijih; specifičnih vidikih simptomov shizofrenije (ocena po pozitivni lestvici PANSS, ocena po negativni lestvici PANSS, ocena živahnosti po lestvici PANSS [PANSS Excited Component, PEC], lestvica PANSS Marder za oceno pozitivnih simptomov, negativnih simptomov, neorganiziranih misli, nenadzorovane sovražnosti/vznemirjenosti ter anksioznosti/depresije) ter z analizami odziva (opredeljen kot 30-odstotno izboljšanje skupnega rezultata PANSS v primerjavi z izhodiščem ali rezultat po lestvici CGI-I z oceno 1 [zelo močno izboljšan] ali 2 [zelo izboljšan]).
English: Subgroup analyses from the thorough QTc trial suggested that the QTc prolongation was larger in female subjects than in males.
Slovenian: Analize podskupin iz natančnega preskušanja QTc so pokazale, da je bilo podaljšanje intervala QTc pri ženskah večje kot pri moških.
English: Akathisia Dizziness Tremor Sedation
Slovenian: Akatizija Omotica Tremor Sedacija
English: • experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness or sleepiness (may be signs of neuroleptic malignant syndrome).
Slovenian: • se je pri vas pojavila kombinacija vročine, znojenja, hitrejšega dihanja, togosti mišic in dremavosti ali zaspanosti (to so lahko znaki nevroleptičnega malignega sindroma).
English: The recommended starting dose for brexpiprazole is 1 mg once daily on days 1 to 4.
Slovenian: Priporočeni začetni odmerek brekspiprazola je 1 mg enkrat na dan od 1. do 4. dne.
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.
Slovenian: V kratkoročnih preskušanjih je bil primarni kriterij učinkovitosti opredeljen kot povprečna sprememba vrednosti od izhodišča do 6. tedna v skupnih rezultatih lestvice pozitivnega in negativnega sindroma (Positive and Negative Syndrome Scale, PANSS), večtočkovnega popisa bolezni, sestavljenega iz petih dejavnikov za oceno pozitivnih simptomov, negativnih simptomov, neorganiziranih misli, nenadzorovane sovražnosti/vznemirjenosti ter anksioznosti/depresije.
English: Blood creatine phosphokinase increased
Slovenian: Zvišanje kreatin fosfokinaze v krvi
English: Receiving RXULTI with some medicines may mean the doctor will need to change your dose of RXULTI or the other medicines.
Slovenian: Če jemljete zdravilo RXULTI z nekaterimi drugimi zdravili, bo morda moral zdravnik spremeniti vaš odmerek zdravila RXULTI ali drugih zdravil.
English: Tell your doctor if this happens.
Slovenian: Povejte zdravniku, če se pojavijo.
English: • or had problems with your movements called extrapyramidal symptoms (EPS) in the past.
Slovenian: • ali ste kdaj imeli težave z gibi, ki se imenujejo ekstrapiramidni simptomi (EPS).
English: Brexpiprazole can elevate prolactin levels.
Slovenian: Brekspiprazol lahko zviša ravni prolaktina.
English: Contents of the pack and other information What RXULTI film-coated tablets contain
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo filmsko obložene tablete RXULTI
English: Brexpiprazole is highly protein bound in plasma (greater than 99 %) to serum albumin and α1-acid glycoprotein, and its protein binding is not affected by renal or hepatic impairment.
Slovenian: Brekspiprazol se v veliki meri veže na beljakovine v plazmi (več kot 99 %), na serumski albumin in α1-kisli glikoprotein, na vezavo zdravila na beljakovine pa ne vplivata ledvična ali jetrna okvara.
English: Influences of genetic variation on the pharmacodynamic responses to brexpiprazole have not been investigated.
Slovenian: Vplivov genetskih različic na farmakodinamične odzive na brekspiprazol še niso raziskali.
English: It is not recommended to take RXULTI during your pregnancy.
Slovenian: Jemanje zdravila RXULTI med nosečnostjo ni priporočljivo.
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.
Slovenian: Po peroralnem dajanju so pri brejih podganah, podganjem plodu in prehajanju v mleko dokazali koncentracije brekspiprazola, ki so bile na splošno primerljive z ravnjo, ki jo opazimo v materini krvi.
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 %).
Slovenian: Incidence drugih neželenih učinkov, povezanih z EPS, o katerih so poročali v kratkoročnih nadzorovanih preskušanjih, vključujejo diskinezijo (0,4 %), ekstrapiramidno motnjo (1,8 %) in parkinsonizem (0,4 %).
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.
Slovenian: S preskusom 4 so ocenjevali učinkovitost, varnost in prenašanje brekspiprazola v prilagodljivem naboru odmerkov od 2 do 4 mg/dan in od 400 do 800 mg kvetiapina s podaljšanim sproščanjem za občutljivost testa.
English: If brexpiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.
Slovenian: Če se brekspiprazol sočasno uporablja z zdravili, za katera je znano, da povzročajo podaljšanje intervala QT ali elektrolitsko neravnovesje, je potrebna previdnost.
English: It should be noted that in vivo preclinical studies have shown that at clinically relevant plasma exposures of brexpiprazole, DM-3411 brain exposures were below the detection limit.
Slovenian: Opozoriti je treba, da so v predkliničnih študijah in vivo ugotovili, da je bila pri klinično pomembnih izpostavljenostih brekspiprazolu v plazmi izpostavljenost presnovku DM-3411 v možganih pod zaznavno mejo.
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.
Slovenian: Po enkratnem peroralnem odmerku s [14C] označenega brekspiprazola se je približno 24,6 % aplicirane radioaktivnosti izločilo z urinom in 46 % blatom.
English: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotics.
Slovenian: Antipsihotikom se pripisujejo motnje sposobnosti telesa za znižanje telesne temperature.
English: Back pain Pain in extremity
Slovenian: Bolečine v hrbtu Bolečine v okončinah
English: Based on in vivo studies, brexpiprazole is neither a substrate nor an inhibitor of efflux transporters, such as Multi Drug Resistance (MDR) 1 (P-gp) and BCRP.
Slovenian: Na osnovi študij in vivo brekspiprazol ni niti substrat niti zaviralec izločevalnih prenašalcev, kot sta MDR 1 (Multi Drug Resistance protein 1) (P-gp) in BCRP.
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.
Slovenian: Manj kot 1 % peroralnega odmerka brekspiprazola se je nespremenjenega izločilo z urinom in približno 14 % z blatom.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: The effects of brexpiprazole on the QT interval were evaluated in patients with schizophrenia or schizoaffective disorder.
Slovenian: Učinke brekspiprazola na interval QT so ovrednotili pri bolnikih s shizofrenijo ali shizoafektivno motnjo.
English: 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).
Slovenian: rigidnost mišic, spremenjen mentalni status in dokazi avtonomne nestabilnosti (nepravilen pulz ali krvni tlak, tahikardija, diaforeza in srčna aritmija).
English: • antifungal medicines (such as ketoconazole, itraconazole),
Slovenian: • zdravila proti glivicam (kot sta ketokonazol, itrakonazol),
English: Orthostatic hypotension and syncope
Slovenian: Ortostatska hipotenzija in sinkopa
English: Table 3: Key secondary efficacy results for 6-week trials in schizophrenia Trial
Slovenian: Preglednica 3: Ključni rezultati sekundarnega parametra učinkovitosti za 6-tedensko preskušanje pri shizofreniji
English: Subgroup analyses from this trial suggested that the QTc prolongation was larger in female subjects than in males (see section 5.1).
Slovenian: Analize podskupin iz tega preskušanja so pokazale, da je bilo podaljšanje intervala QT pri ženskah večje kot pri moških (glejte poglavje 5.1).
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).
Slovenian: Pri takih bolnikih je treba razmisliti o manjšem začetnem odmerku in počasnejši titraciji ter nadzirati ortostatske vitalne znake
English: 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.
Slovenian: Kot pri drugih antipsihotikih je treba brekspiprazol pri bolnikih, ki imajo v anamnezi epileptični napad ali druge težave, ki potencialno nižajo prag pojava epileptičnih napadov, uporabljati previdno.
English: In the flexible-dose trial 4, at week 6, subjects in the brexpiprazole treatment group had numerically greater improvements on PANSS total score than the subjects in the placebo group, although, the difference at week 6 did not reach statistical significance for the primary efficacy analysis (p = 0.0560; see table 2).
Slovenian: Pri preskušanju 4 s prilagodljivim odmerkom v 6. tednu so pri bolnikih v skupini, ki je prejemala brekspiprazol, opazili številčno večje izboljšanje v skupnem rezultatu PANSS kot pri osebah v skupini, ki je prejemala placebo, vendar pa razlika v 6. tednu pri primarni analizi učinkovitosti ni bila statistično značilna (p = 0,0560; glejte preglednico 2).
English: Brexpiprazole did not show any genotoxic potential in both in vitro and in vivo studies using clinically relevant exposures.
Slovenian: Brekspiprazol ni pokazal nobenega genotoksičnega potenciala ob klinično relevantni izpostavljenosti v študijah in vitro in in vivo.
English: Brexpiprazole administered orally did not increase in the incidence of tumours in 2-year carcinogenicity study in both male and female rats and in male mice at exposures up to 4.4-fold and 3.1-fold the MRHD.
Slovenian: Brekspiprazol, ki se je uporabljal peroralno, ni povečal pojavnosti tumorjev v 2-letni študiji kancerogenosti pri samcih in samicah podgan in pri mišjih samcih ob izpostavljenosti do 4,4- in 3,1-kratniku pri MRHD.
English: What you need to know before you take RXULTI Do not take RXULTI
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo RXULTI Ne jemljite zdravila RXULTI
English: • combination of fever, sweating, muscle stiffness, and drowsiness or sleepiness.
Slovenian: • kombinacija zvišane telesne temperature, znojenja, mišične togosti in dremavost ali zaspanost.
English: If you have liver problems, your doctor may adjust your dose of this medicine.
Slovenian: Če imate težave z ledvicami, vam bo zdravnik morda prilagodil odmerek tega zdravila.
English: Brexpiprazole is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Brekspiprazola ne uporabljajte med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Brexpiprazole maintained symptom control and functioning compared to placebo.
Slovenian: Brekspiprazol je v primerjavi s placebom ohranil nadzor nad simptomi in funkcioniranje bolnikov.