FrancophonIA/ELRC3.0 huggingface dataset:
English: Oral activated charcoal and sorbitol (50 g/240 mL), administered one hour after ingesting 2 mg oral dose of brexpiprazole, decreased brexpiprazole Cmax and AUC by approximately 5 % to 23 % and 31 % to 39 % respectively; however, there is insufficient information available on the therapeutic potential of activated charcoal in treating an overdose with brexpiprazole.
Slovenian: Peroralno zaužito aktivno oglje in sorbitol (50 g/240 ml), ki so ga dajali eno uro po zaužitju peroralnega odmerka brekspiprazola v odmerku 2 mg, je zmanjšalo Cmax za približno 5-23 % in AUC za 31-39 %; vendar pa o terapevtskem potencialu aktivnega oglja pri zdravljenju prevelikega odmerjanja z brekspiprazolom ni na voljo dovolj podatkov.
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).
Slovenian: Brekspiprazol izkazuje tudi antagonistično aktivnost na noradrenergičnih receptorjih α1B/2C, z afiniteto v istem sub-nanomolarnem območju Ki (Ki: od
English: Tablet coat: Hypromellose, talc, titanium dioxide.
Slovenian: Obloga tablete: Hipromeloza, smukec, titanov dioksid.
English: 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.
Slovenian: Pri bolnikih z že obstoječimi nizkimi vrednostmi WBC ali z anamnezo z zdravili povzročene levkopenije/nevtropenije, je treba v prvih nekaj mesecih zdravljenja pogosto spremljati njihovo celotno krvno sliko, pri čemer je treba ob prvem znaku upadanja belih krvnih celic zdravljenje prekiniti, če ni prisotnih drugih vzročnih dejavnikov.
English: 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).
Slovenian: Glede na primarne učinke brekspiprazola v osrednjem živčevju (CNS - central nervous system) je potrebna previdnost, če se uporablja v kombinaciji z alkoholom ali drugimi zdravili za CNS, katerih neželeni učinki se prekrivajo z njegovimi, npr. sedacija (glejte poglavje 4.8).
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.
Slovenian: Učinke brekspiprazola pri terapevtskih (4 mg) in supraterapevtskih odmerkih (12 mg) na interval QT so ovrednotili pri osebah s shizofrenijo ali shizoafektivno motnjo v randomiziranem, dvojno slepem, s placebom in pozitivno kontrolo (moksifloksacin) nadzorovanem preskušanju s paralelnimi kraki.
English: RXULTI film-coated tablets are supplied in Aluminium/PVC blisters containing 10 or 28 film-coated tablets.
Slovenian: RXULTI filmsko obložene tablete so na voljo v pretisnih omotih iz aluminija/PVC, ki vsebuje 10 ali 28 filmsko obloženih tablet.
English: Table 2: Primary efficacy results for 6-week trials in schizophrenia Trial
Slovenian: Preglednica 2: Rezultati primarne učinkovitosti za 6-tedensko preskušanje pri shizofreniji Preskuš anje
English: If you take more RXULTI than you should
Slovenian: Če ste vzeli večji odmerek zdravila RXULTI, kot bi smeli
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.
Slovenian: AUC0-24 ur pri največjem priporočenem odmerku za človeka (MRHD, maximum recommended human dose) 4 mg/dan pri samcih in samicah podgan ter opic ni bilo mogoče določiti.
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.
Slovenian: Ključni sekundarni kriterij v preskušanjih 1, 2 in 4 je bil klinični globalni vtis izrazitosti shizofrenije
English: 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
Slovenian: Za farmakologijo brekspiprazola se smatra, da poteka z modulatorno aktivnostjo na serotoninskem in dopaminskem sistemu, ter obsega delno agonistično delovanje na serotoninergičnih receptorjih 5-HT1A in na dopaminergičnih receptorjih D2 ter antagonistično delovanje na serotoninergičnih receptorjih 5-HT2A, s podobno visokimi afinitetami na vseh teh receptorjih (Ki: od 0,1 do 0,5 nM).
English: Table 1: Dose adjustments of RXULTI in patients who are CYP2D6 poor metabolisers and for concomitant use with CYP inhibitors
Slovenian: Preglednica 1: Prilagoditev odmerka zdravila RXULTI pri bolnikih, ki so znani slabi presnavljalci CYP2D6, in za sočasno uporabo z zaviralci CYP
English: Lactose monohydrate, maize starch, microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, purified water.
Slovenian: Jedro tablete: Laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, malo substituirana hidroksipropilceluloza, hidroksipropilceluloza, magnezijev stearat, prečiščena voda.
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.
Slovenian: V splošni analizi je bilo ugotovljeno, da brekspiprazol ne podaljša intervala QTc do klinično pomembne stopnje po prejemu terapevtskih in supraterapevtskih odmerkov (4 mg/dan, n = 62 ali 12 mg/dan, n = 53), prav tako ni bilo opaziti korelacije med koncentracijo brekspiprazola in podaljšanjem intervala QTc.
English: 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).
Slovenian: Povišanja, povezana z zdravljenjem z brekspiprazolom, so na splošno blaga in se lahko med dajanjem zmanjšajo, vendar pa je lahko v nekaterih redkih primerih učinek med zdravljenjem še vedno prisoten (glejte poglavje 4.8).
English: • during blood tests your doctor may find higher amounts of triglycerides in your blood,
Slovenian: • med krvnimi preiskavami lahko zdravnik odkrije večje količine trigliceridov v krvi,
English: Effects observed in repeated-dose toxicity studies in rats and monkeys were mainly related to the exaggerated pharmacological activity of brexpiprazole.
Slovenian: 5.3 Predklinični podatki o varnosti Učinki, opaženi v študijah toksičnosti pri ponavljajočih odmerkih pri podganah in opicah, so bili v glavnem povezani s prekomerno farmakološko aktivnostjo brekspiprazola.
English: Brexpiprazole is predominantly metabolised by CYP3A4 and CYP2D6.
Slovenian: Brekspiprazol se pretežno presnavlja s CYP3A4 in CYP2D6.
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.
Slovenian: Po peroralnem dajanju brekspiprazol ni vplival na plodnost podganjih samcev, povzročil pa je podaljšan diestrus in zmanjšano plodnost pri podganjih samicah pri podobnih ali celo nižjih ravneh izpostavljenosti kot pri klinično doseženih ravneh pri MRHD.
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.
Slovenian: Presnova brekspiprazola in vivo v glavnem poteka s CYP3A4 in CYP2D6, kar vodi do tvorbe oksidativnih presnovkov z enim samim presnovkom, DM-3411, ki je prisoten v plazmi v več kot 10 % plazemske izpostavljenosti brekspiprazolu.
English: Population pharmacokinetic evaluation shows that CYP2D6 poor metabolisers have 47 % higher exposure to brexpiprazole compared to extensive metabolisers (see section 4.2).
Slovenian: Populacijska farmakokinetična analiza kaže, da imajo slabi presnavljalci CYP2D6 v primerjavi z dobrimi presnavljalci 47 % večjo izpostavljenost brekspiprazolu (glejte poglavje 4.2).
English: Extrapyramidal Symptoms (EPS)
Slovenian: Ekstrapiramidni simptomi (EPS)
English: • pain in the upper abdomen,
Slovenian: • bolečine v zgornjem delu trebuha,
English: • or had dizziness on standing up due to a drop in your blood pressure, which may cause fainting.
Slovenian: • ali ste imeli omotico pri vstajanju zaradi padca krvnega tlaka, kar lahko povzroči omedlevico.
English: Based on in vitro data brexpiprazole showed little to no inhibition of other CYP450 isozymes.
Slovenian: Na osnovi podatkov in vitro je brekspiprazol pokazal malo ali nič inhibicije drugih izocimov CYP450.
English: 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.
Slovenian: primeru neželenih učinkov kljub prilagoditvi odmerka zdravila RXULTI je treba ponovno oceniti nujnost sočasne uporabe zdravila RXULTI in zaviralca CYP2D6 ali CYP3A4.
English: Results of a sensitivity analysis using placebo based multiple imputation (PMI) were consistent with the primary analysis.
Slovenian: Primarna statistična analiza je bila izvedena z uporabo modela MMRM z imputacijo MAR (missing at random) Rezultati analize občutljivosti z večkratno imputacijo na osnovi placeba (PMI, placebo based multiple imputation) so bili v skladu s primarno analizo.
English: paroxetine, St. John's Wort),
Slovenian: paroksetin, šentjanževka),
English: No information on pharmacodynamic interactions of brexpiprazole is available at present.
Slovenian: Farmakodinamične interakcije Trenutno ni na voljo nobenih podatkov o farmakodinamičnih interakcijah brekspiprazola.
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.
Slovenian: V dolgoročnem odprtem preskušanju je bil delež bolnikov s klinično pomembnim povečanjem telesne mase (≥ 7 % povečanje telesne mase) ob katerem koli obisku 20,7 %, zaradi česar je 0,4 % bolnikov prekinilo sodelovanje v študiji.
English: There are no or limited amount of data from the use of brexpiprazole in pregnant women.
Slovenian: Podatkov o uporabi brekspiprazola pri nosečnicah ni ali pa so omejeni.
English: Lactose monohydrate Maize starch
Slovenian: Laktoza monohidrat
English: Caution should be exercised when brexpiprazole is prescribed in patients with known cardiovascular disease, family history of QT prolongation, electrolyte imbalance or in concomitant use with other medicinal products thought to prolong the QT interval (see sections 4.8 and 5.1).
Slovenian: Pri bolnikih z znano srčno-žilno boleznijo, družinsko anamnezo podaljšanja intervala QT, elektrolitskim neravnovesjem ali pri sočasni uporabi z drugimi zdravili, ki naj bi podaljševala interval QT, je potrebna previdnost (glejte poglavji 4.8 in 5.1).
English: 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.
Slovenian: V s placebom kontroliranih preskušanjih z nekaterimi antipsihotiki pri starejših bolnikih z demenco je pri teh bolnikih, v primerjavi z osebami, ki so prejemale placebo, prišlo do večje incidence možganskožilnih neželenih učinkov (cerebrovaskularnih inzultov in prehodnih ishemičnih napadov), vključno s smrtnimi primeri.
English: • muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine.
Slovenian: • mišična oslabelost, občutljivost ali bolečina in še posebej, če se pojavijo sočasno, slabo počutje,
English: 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.
Slovenian: RXULTI 0,25 mg, 0,5 mg, 2 mg, 3 mg in 4 mg filmsko obložene tablete 28 filmsko obloženih tablet v pretisnih omotih iz aluminija/PVC.
English: 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.
Slovenian: Pri predpisovanju brekspiprazola bolnikom, pri katerih se bodo pojavila stanja, ki lahko privedejo k zvišanju telesne temperature, se priporoča primerna oskrba, npr. ekstremna telesna dejavnost, izpostavljenost skrajni toploti, prejemanje sočasnih zdravil z antiholinergično aktivnostjo ali dehidracija.
English: Apparent oral clearance of brexpiprazole tablet after once daily administration is 19.8 (± 11.4) mL/h/kg.
Slovenian: Navidezni peroralni očistek po dajanju tablete brekspiprazola enkrat dnevno je 19,8 (± 11,4) ml/h/kg.
English: Seizures have been reported during use of brexpiprazole (see section 4.8).
Slovenian: Med uporabo brekspiprazola so poročali o epileptičnih napadih (glejte poglavje 4.8).
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.
Slovenian: Učinkovitost so dokazali v 1. preskušanju za brekspiprazol 2 mg/dan in tudi za jakost 4 mg/dan, v 2. preskušanju pa se je rezultat ponovil samo za 4 mg brekspiprazola na dan in v 3. preskušanju samo za 2 mg brekspiprazola na dan.
English: Adverse reactions related to orthostatic hypotension can include dizziness, light-headedness and tachycardia.
Slovenian: Neželeni učinki, povezani z ortostatsko hipotenzijo, lahko vključujejo omotico, omedlevico in tahikardijo.
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).
Slovenian: V preglednici so navedeni neželeni učinki, o katerih so poročali v kratkoročnih, s placebom nadzorovanih kliničnih preskušanjih 2. in 3. faze pri terapevtskih odmerkih od 2 do 4 mg.
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.
Slovenian: Poleg tega so bile frekvence zvišanja prolaktina > 1 × ULN v skupini z od 2 do 4 mg brekspiprazola pri ženskah 13,7 % v primerjavi s 6,4 % v skupini s placebom, in pri moških 11,1 % v primerjavi s 10,3 % v skupini s placebom.
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.
Slovenian: Pri prehodu z drugih antipsihotikov na brekspiprazol je treba razmisliti o postopni navzkrižni titraciji, s postopnim prenehanjem prejšnjega zdravljenja med uvajanjem zdravljenja z brekspiprazolom.
English: Pregnancy, puerperium and perinatal conditions
Slovenian: puerperija in perinatalnem obdobju
English: On day 8 the dose was increased to 4 mg for some of the treatment arms.
Slovenian: 8. dan je bil za nekatere zdravljene skupine odmerek povečan na
English: Brexpiprazole is an atypical antipsychotic agent.
Slovenian: Brekspiprazol je atipični antipsihotik.
English: The smaller number of female than male subjects enrolled in the study does not allow to draw definitive conclusions.
Slovenian: Ker je število žensk, vključenih v študijo, manjše kot je število moških,
English: Microcrystalline cellulose Low-substituted hydroxypropylcellulose Hydroxypropylcellulose Magnesium stearate
Slovenian: Mikrokristalna celuloza Malo substituirana hidroksipropilceluloza Hidroksipropilceluloza Magnezijev stearat
English: • dizziness on standing up due to a drop in your blood pressure, which may cause fainting,
Slovenian: • omotica pri vstajanju zaradi padca krvnega tlaka, kar lahko povzroči omedlevico.
English: RXULTI film-coated tablets contain lactose.
Slovenian: Zdravilo RXULTI filmsko obložene tablete vsebuje laktozo.
English: Studies in animals have shown decreased female fertility (see section 5.3).
Slovenian: Študije na živalih so pokazale zmanjšano plodnost pri samicah (glejte poglavje 5.3).
English: Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
Slovenian: Obratno lahko tudi upadanje indukcije CYP3A4 ob prekinitvi zdravljenja traja najmanj 2 tedna.
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.
Slovenian: Možnost za vpliv brekspiprazola na druga zdravila Na podlagi rezultatov študij in vitro je malo verjetno, da bi brekspiprazol povzročil klinično pomembne farmakokinetične interakcije z zdravili, ki se presnavljajo z encimi citokroma P450.
English: • certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors e.g. indinavir, ritonavir),
Slovenian: • določena zdravila za zdravljenje okužbe s HIV (kot so efavirenz, nevirapin in zaviralci proteaz,
English: Based on results of in vitro studies brexpiprazole protein binding is not affected by warfarin, diazepam, and digitoxin.
Slovenian: Na podlagi rezultatov študij in vitro varfarin, diazepam in digitoksin ne vplivajo na vezavo brekspiprazola na beljakovine.
English: In female mice, an increased incidence of mammary gland adenocarcinoma and adeno-squamous carcinoma, and pars distalis adenoma of the pituitary gland, was observed at similar or even lower clinically relevant exposures: these prolactin-mediated endocrine tumours were also observed in rodents with other antipsychotics and their clinical relevance is unknown.
Slovenian: Pri mišjih samicah so pri izpostavljenostih, podobnih klinično pomembni izpostavljenosti ali celo nižjih, opazili povečano incidenco adenokarcinomov mlečne žleze in adeno-skvamoznega karcinoma ter pars-distalnega adenoma hipofize: ti endokrinski tumorji, ki so odvisni od proaktina, so bili opaženi tudi pri glodavcih, ki so prejemali druge antipsihotike, njihov klinični pomen pa je neznan.
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.
Slovenian: Pri osebah (n = 10) s hudo ledvično okvaro (CLcr < 30 ml/min) se je AUC peroralnega brekspiprazola (3 mg enkratnega odmerka) v primerjavi z zdravimi osebami zvišala za 68 %, medtem ko se njegova
English: Dental caries Flatulence
Slovenian: Zobna gniloba Flatulenca
English: Key secondary efficacy measure: CGI-S Mean baseline score (SD)
Slovenian: Ključni sekundarni parameter učinkovitosti: CGI-S Povprečna vrednost ob izhodišču (SD)
English: Dose adjustments should be made in patients taking concomitant strong CYP3A4 inhibitors/inducers or strong CYP2D6 inhibitors.
Slovenian: Prilagoditve odmerkov so potrebne pri bolnikih, ki sočasno jemljejo močne zaviralce/induktorje CYP3A4 ali močne zaviralce CYP2D6.
English: • medicines to correct heart rhythm (such as quinidine),
Slovenian: • zdravila proti motnjam srčnega ritma (kot je kinidin),
English: Based on in vitro metabolism studies using recombinant human cytochrome P450, the metabolism of brexpiprazole was shown to be mainly mediated by CYP3A4 and CYP2D6 leading to formation of oxidative metabolites.
Slovenian: Presnovne študije in vitro, ki uporabljajo rekombinantni človeški citokrom P450, so pokazale, da pri presnovi brekspiprazola v glavnem delujeta CYP3A4 in CYP2D6, kar vodi k nastanku oksidativnih presnovkov.
English: The categorisation of blood prolactin increased is based on Potentially Clinically Relevant (PCR) criteria of > 1 × upper limit of normal (ULN).
Slovenian: (PCR - Potentially Clinically Relevant) > 1 × zgornja meja normale (ULN, Upper Limit of Normal).
English: These may include jerky movements, spasms, restlessness or slow movements.
Slovenian: Ti lahko vključujejo sunkovite gibe, spazme, nemir ali počasne gibe.
English: Primary efficacy measure: PANSS Mean baseline score (SD)
Slovenian: Primarni kriterij učinkovitosti: PANSS Povprečna vrednost ob izhodišču (SD)
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).
Slovenian: Brekspiprazol ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev zaradi možnih učinkov na živčevje, kot sta sedacija in omotica, ki sta pogosta neželena učinka (glejte poglavje 4.8).
English: An increased frequency of weight gain has been observed with increased duration of brexpiprazole treatment (see section 4.8).
Slovenian: Pri daljšem obdobju zdravljenja z brekspiprazolom so opazili povečano pogostnost povečanja telesne mase (glejte poglavje 4.8).
English: In subjects (n = 22) with varying degrees of hepatic impairment (Child-Pugh Classes A, B, and C), the AUC of oral brexpiprazole (2 mg single dose), compared to matched healthy subjects, increased 24 % in mild hepatic impairment, increased 60 % in moderate hepatic impairment, and did not change in severe hepatic impairment.
Slovenian: Pri osebah (n = 22) z različnimi stopnjami jetrne okvare (skupine A, B in C po lestvici Child-Pugh) se je AUC peroralnega brekspiprazola (2 mg enkratnega odmerka) v primerjavi z zdravimi bolniki povečala za 24 % pri blagi okvari jeter, pri zmerni okvari jeter se je povečala za 60 %, pri hudi okvari jeter pa se vrednosti niso spremenile.
English: • antidepressants or herbal remedies used to treat depression and anxiety (such as fluoxetine,
Slovenian: • antidepresive ali zdravila rastlinskega izvora proti depresiji in tesnobnosti (kot so fluoksetin,
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov proizvajalcev, odgovornih za sproščanje serij
English: If you forget to take RXULTI
Slovenian: Če ste pozabili vzeti zdravilo RXULTI
English: Close supervision of high-risk patients should accompany antipsychotic treatment.
Slovenian: Ob antipsihotičnem zdravljenju je potreben natančen nadzor bolnikov z visokim tveganjem.
English: • during blood tests your doctor may find increases in liver enzymes.
Slovenian: • med krvnimi preiskavami lahko zdravnik odkrije povečanje vrednosti jetrnih encimov.
English: Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292
Slovenian: Otsuka Pharmaceutical Netherlands B.V.
English: • parkinsonism - medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity),
Slovenian: • parkinsonizem - zdravstveno stanje s številnimi različnimi simptomi, ki vključujejo zmanjšane ali počasne gibe, počasnost misli, sunkovite gibe pri upogibanju udov (okorelost po tipu zobatega kolesa), podrsavajočo hojo, tresenje, malo ali nič obrazne mimike, mišično togost,
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.
Slovenian: V kratkoročnem nadzorovanem preskušanju je bil delež bolnikov s klinično pomembnim povečanjem telesne mase (povečanje ≥ 7 % glede na izhodiščno telesno maso) 9,1 % v skupini, ki je prejemala brekspiprazol od 2 do 4 mg/dan, v primerjavi s 3,8 % v skupini, ki je prejemala placebo.