FrancophonIA/ELRC3.0 huggingface dataset:
English: Summary of the safety profile The most frequently observed adverse drug reactions (ADRs) were akathisia (5.6 %) and weight gain
Slovenian: Povzetek varnostnega profila Najpogosteje opažena neželena učinka sta bila akatizija (5,6 %) in povečanje telesne mase (3,9 %).
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.
Slovenian: Kratkoročna preskušanja V treh kratkoročnih preskušanjih s fiksnimi odmerki (preskušanja 1, 2 in 3) so bili bolniki randomizirani v skupino z 2 mg brekspiprazola enkrat na dan, 4 mg enkrat na dan ali v skupino, ki je prejemala placebo.
English: RXULTI 1 mg film-coated tablets 10 or 28 film-coated tablets in Aluminium/PVC blisters.
Slovenian: RXULTI 1 mg filmsko obložene tablete 10 ali 28 filmsko obloženih tablet v pretisnih omotih iz aluminija/PVC.
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).
Slovenian: Če se brekspiprazol sočasno uporablja skupaj s močnimi induktorji CYP3A4 (npr. rifampicinom), je treba odmerek brekspiprazola povečati na približno trikratnik priporočenega dnevnega odmerka (glejte poglavje 4.2).
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.
Slovenian: Na podlagi preskušanj s fiksnimi odmerki kaže, da je akatizija pri bolnikih, zdravljenih z brekspiprazolom, odvisna od odmerka; njena pogostnost se z velikostjo odmerkov povečuje.
English: 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.
Slovenian: Bolnike s shizofrenijo, ki so se odzvali na zdravljenje z brekspiprazolom od 1 do 4 mg/dan, so stabilizirali za od 12 do 36 tednov in jih nato za 52 tednov ali do ponovitve dvojno slepo randomizirali, da so bodisi nadaljevali zdravljenje s stabilizacijskim odmerkom brekspiprazola (n = 96) ali prejemali placebo (n = 104).
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.
Slovenian: Med bolnike z večjim tveganjem za pojav teh neželenih učinkov (npr. starejši bolniki) ali z večjim tveganjem za nastanek zapletov zaradi hipotenzije sodijo bolniki, ki trpijo za dehidracijo, hipovolemijo ali ki se zdravijo z antihipertenzivnimi zdravili, imajo anamnezo bolezni srca in ožilja (npr. srčno popuščanje, miokardni infarkt, ishemija ali motnje prevajanja), anamnezo možganskožilne bolezni, pa tudi bolniki, ki še niso prejemali antipsihotikov.
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.
Slovenian: Pri prehodu na druge antipsihotike z brekspiprazola postopno navzkrižno titriranje ni potrebno, zato je treba začeti z dajanjem najmanjšega odmerka novega antipsihotika, medtem ko se zdravljenje z brekspiprazolom prekine.
English: • increased levels of the hormone prolactin, or have a tumour in your pituitary gland.
Slovenian: • zvišane ravni hormona prolaktina ali tumor na hipofizi.
English: Spontaneous cases reporting completed suicide and suicide attempt have been reported in the post-marketing setting.
Slovenian: obdobju trženja zdravila so iz spontanih poročil poročali o primerih izvedenega samomora in poskusa samomora.
English: If you stop taking RXULTI
Slovenian: Če ste prenehali jemati zdravilo RXULTI
English: In the brexpiprazole 4 mg/day group, the maximum placebo-adjusted mean change from baseline in the QTcl interval was 5.2 ms (90 % Cl: 1.5, 8.9) in males (n = 48) and 15.0 ms (90 % Cl: 7.7., 22.3) in females (n = 14) at 6 hours post-dosing.
Slovenian: V skupini, zdravljeni z brekspiprazolom 4 mg/dan, je po 6 urah po odmerjanju največja sprememba povprečne vrednosti glede na izhodiščno vrednost v intervalu QTcl znašala 5,2 ms (90-% IZ: 1,5, 8,9) pri moških (n = 48) in 15,0 ms (90-% IZ: 7,7; 22,3) pri ženskah (n = 14).
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.
Slovenian: Incidenca akatizije v skupini, ki je prejemala breksipiprazol v odmerku 1 mg/dan, 2 mg/dan oziroma 4 mg/dan, je bila 3,0 %, 4,6 % in 6,5 %, v primerjavi s 5,2 % pri preiskovancih v skupini, ki je prejemala placebo.
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Orthostatic hypotension
Slovenian: (vključno s pljučno embolijo in globoko vensko trombozo)
English: Antipsychotics including brexpiprazole have been associated with metabolic changes, including weight gain and dyslipidaemia.
Slovenian: Povečanje telesne mase in dislipidemija Antipsihotiki, vključno z brekspiprazolom, so bili povezani z metaboličnimi spremembami, vključno s povečanjem telesne mase in dislipidemijo.
English: A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with brexpiprazole (see section 4.4).
Slovenian: V povezavi z zdravljenjem z brekspiprazolom so poročali o potencialno smrtnem kompleksu simptomov, imenovanem nevroleptični maligni sindrom (NMS) (glejte poglavje 4.4).
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).
Slovenian: ali zaviralca CYP2D6, bo morda treba odmerek vrniti na prvotni odmerek (glejte poglavje 4.5).
English: It is unknown whether brexpiprazole/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se brekspiprazol ali njegovi presnovki izločajo v materino mleko.
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).
Slovenian: Pri bolnikih z zmerno do hudo ledvično okvaro (očistek kreatinina CLcr < 60 ml/min) se največji priporočeni odmerek zmanjša na 3 mg enkrat na dan (glejte poglavje 4.2).
English: Twice daily divided dosing of brexpiprazole is preferable as once daily dosing results in high peak to trough fluctuation (see section 4.5).
Slovenian: Priporoča se odmerjanje brekspiprazola dvakrat dnevno, saj enkratno odmerjanje povzroči visoko nihanje med najvišjimi in najnižjimi koncentracijami (glejte poglavje 4.5).
English: Your doctor will also inform you how to act if you switch from RXULTI to other medicine.
Slovenian: Zdravnik vam bo tudi povedal, kako ukrepati, če preidete z zdravila
English: Film-coated tablet 10 film-coated tablets 28 film-coated tablets
Slovenian: Filmsko obložena tableta 10 filmsko obloženih tablet 28 filmsko obloženih tablet
English: Drug withdrawal syndrome neonatal (see section 4.6)
Slovenian: Neonatalni odtegnitveni sindrom (glejte poglavje 4.6)
English: Patients taking strong CYP3A4 inducers
Slovenian: Bolniki, ki jemljejo močne induktorje CYP3A4
English: Placebo Brexpiprazole (2 mg/day) Brexpiprazole (4 mg/day)* 181 94.99
Slovenian: Placebo Brekspiprazol (2 mg/dan) Brekspiprazol (4 mg/dan)* 181 94,99
English: For patients with moderate to severe hepatic impairment (Child-Pugh Classes B and C), the maximum recommended dose is reduced to 3 mg once daily (see section 4.2).
Slovenian: Pri bolnikih z zmerno do hudo jetrno okvaro (skupini B in C po lestvici Child-Pugh), se največji priporočeni odmerek zmanjša na 3 mg enkrat na dan (glejte poglavje 4.2).
English: Please check that you are not feeling dizzy or sleepy before you start driving or handling machines.
Slovenian: Pred začetkom vožnje ali upravljanja strojev se prepričajte, da niste omotični ali zaspani.
English: Oesophageal dysmotility and aspiration have been associated with antipsychotic use.
Slovenian: Z uporabo antipsihotikov sta povezani ezofagealna motnja in aspiracija.
English: For nausea, the incidence in the 2 mg to 4 mg brexpiprazole group was 2.3 % overall in short-term controlled trials, compared to 2.0 % in placebo; for vomiting, these incidences were 1.0 % in the brexpiprazole-treated group compared to 1.2 % in placebo group.
Slovenian: Incidenca navzee je bila v kratkoročno nadzorovanih preskušanjih pri skupini, ki je prejemala od 2 do 4 mg brekspiprazola, v povprečju 2,3 % v primerjavi z 2,0 % v skupini s placebom; pri bruhanju so bile te incidence v skupini, ki je prejemala brekspiprazol, 1,0 % v primerjavi z 1,2 % v skupini s placebom.
English: In clinical trials, only a few, nonserious, QT prolongations have been reported with brexpiprazole.
Slovenian: V kliničnih preskušanjih so pri bolnikih z brekspiprazolom poročali samo o nekaj podaljšanjih intervala QT, ki pa niso bila resna.
English: In trials 1, 2 and 3 brexpiprazole was titrated as described in section 4.2 with 1 mg for 4 days, followed by 2 mg on days 5 to 7.
Slovenian: V preskušanjih 1, 2 in 3 je bil brekspiprazol titriran, kot je opisano v poglavju 4.2, z odmerkom 1 mg
English: Based on estimations from the population pharmacokinetic analysis, CYP2D6 extensive metabolisers receiving both CYP3A4 and CYP2D6 inhibitors or CYP2D6 poor metabolisers receiving strong CYP3A4 inhibitors are expected to have approximately 4-fold to 5-fold increase in brexpiprazole concentrations and dose adjustment to a quarter of the dose is recommended for these subjects (see section 4.2).
Slovenian: CYP2D6, ki prejemajo zaviralce CYP3A4 in CYP2D6, ali slabi presnavljalci CYP2D6, ki prejemajo močne zaviralce CYP3A4, imeli približno 4- do 5-kratno povečane koncentracije brekspiprazola, zato jim je treba prilagoditi odmerke na četrtino priporočenih odmerkov (glejte poglavje 4.2).
English: • cough,
Slovenian: • kašelj,
English: How to take RXULTI
Slovenian: Kako jemati zdravilo RXULTI
English: Strong/moderate CYP2D6 inhibitors with strong/moderate CYP3A4 inhibitors
Slovenian: Močni/zmerni zaviralci CYP2D6 z močnimi/zmernimi zaviralci CYP3A4
English: Patients taking CYP2D6 inhibitors and/or CYP3A4 inhibitors
Slovenian: Bolniki, ki jemljejo zaviralce CYP2D6 in/ali zaviralce CYP3A4
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.
Slovenian: Sočasna uporaba ketokonazola (200 mg dvakrat na dan 7 dni), močnega zaviralca CYP3A4, z enkratnim 2-mg peroralnim odmerkom brekspiprazola je povečala AUC brekspiprazola za 97 % vrednost Cmax pa se ni spremenila.
English: RXULTI 0.25 mg film-coated tablets RXULTI 0.5 mg film-coated tablets RXULTI 1 mg film-coated tablets RXULTI 2 mg film-coated tablets RXULTI 3 mg film-coated tablets RXULTI 4 mg film-coated tablets
Slovenian: RXULTI 0,25 mg filmsko obložene tablete RXULTI 0,5 mg filmsko obložene tablete RXULTI 1 mg filmsko obložene tablete RXULTI 2 mg filmsko obložene tablete RXULTI 3 mg filmsko obložene tablete RXULTI 4 mg filmsko obložene tablete
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotics.
Slovenian: Pri uporabi antipsihotičnih zdravil so poročali o primerih venske trombembolije (VTE).
English: This leaflet was last revised in MM/YYYY.
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL} Drugi viri informacij
English: What RXULTI film-coated tablets look like and contents of the pack
Slovenian: Izgled zdravila filmsko obložene tablete RXULTI in vsebina pakiranja
English: EU/1/18/1294/003 (10 film-coated tablets) EU/1/18/1294/004 (28 film-coated tablets)
Slovenian: EU/1/18/1294/003 (10 filmsko obložene tablete) EU/1/18/1294/004 (28 filmsko obložene tablete)
English: RXULTI 0.25 mg film-coated tablets RXULTI 0.5 mg film-coated tablets RXULTI 1 mg film-coated tablets RXULTI 2 mg film-coated tablets RXULTI 3 mg film-coated tablets RXULTI 4 mg film-coated tablets brexpiprazole This medicine is subject to additional monitoring.
Slovenian: RXULTI 0,25 mg filmsko obložene tablete RXULTI 0,5 mg filmsko obložene tablete RXULTI 1 mg filmsko obložene tablete RXULTI 2 mg filmsko obložene tablete RXULTI 3 mg filmsko obložene tablete RXULTI 4 mg filmsko obložene tablete brekspiprazol Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Higher frequencies of prolactin increased (1.5 % versus 0.60 %) were observed in females compared to males in short-term trials.
Slovenian: V kratkoročnih preskušanjih so pri ženskah opazili višje pogostnosti zvišanja prolaktina v primerjavi z moškimi (1,5 % v primerjavi z 0,60 %).
English: 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.
Slovenian: Farmakokinetika brekspiprazola je po enkratnem odmerku (od 0,2 do 8 mg) in večkratnih odmerkih
English: Film-coated tablet 28 film-coated tablets
Slovenian: filmsko obložena tableta 28 filmsko obloženih tablet
English: Based on studies utilising human liver enzymes in vitro, brexpiprazole is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of brexpiprazole.
Slovenian: Kajenje Na osnovi študij, ki uporabljajo človeške jetrne encime in vitro, brekspiprazol ni substrat za CYP1A2;
English: CI
Slovenian: OS
English: Brexpiprazole (2 mg/day)* Brexpiprazole (4 mg/day)* Placebo Brexpiprazole (2 mg/day) Brexpiprazole (4 mg/day)* Placebo Brexpiprazole (2 mg/day)* Brexpiprazole (4 mg/day) Placebo 4 Brexpiprazole* (2 mg/day to 4 mg/day)b 150 Placebo
Slovenian: Placebo 3 Brekspiprazol (2 mg/dan)* Brekspiprazol (4 mg/dan) Placebo 4 Brekspiprazol* (od 2 do 4 mg/dan)b Placebo SD standardni odklon
English: In rabbit, vertebral malformations were seen in 3 foetuses from 2 litters at maternally toxic brexpiprazole oral doses corresponding to exposure approximately 16.5-fold the clinical exposure at MRHD.
Slovenian: Pri študijah embriofetalne razvojne toksičnosti brekspiprazol ni bil teratogen pri peroralnem dajanju zdravila podganam do klinično doseženih ravni izpostavljenosti pri MRHD (na osnovi podatkov pri nebrejih podganah) Pri kuncih so pri 3 plodih iz 2 legel opazili vertebralne malformacije pri peroralnih odmerkih brekspiprazola, toksičnih za mater, ki so ustrezali izpostavljenosti približno 16,5-kratniku klinične izpostavljenosti pri MRHD.
English: Brexpiprazole is absorbed after administration of the tablet, with peak plasma concentrations occurring within 4.0 hours after single dose administrations; the absolute oral bioavailability of the tablet formulation is 95.1 %.
Slovenian: 4,0 urah po dajanju enkratnega odmerka; absolutna biološka uporabnost po peroralni uporabi tablete je 95,1 %.
English: The incidences of the ADRs associated with brexpiprazole therapy are tabulated below.
Slovenian: Pogostnost neželenih učinkov, povezanih z zdravljenjem z brekspiprazolom, je prikazana spodaj.
English: Blood triglycerides increased
Slovenian: Povišan krvni tlak Zvišane vrednosti trigliceridov v krvi
English: Cardiovascular toxicity
Slovenian: Toksičnost za srčno-žilni sistem
English: Leukopenia, neutropenia and agranulocytosis (including fatal cases) have been reported during treatment with antipsychotics.
Slovenian: Med zdravljenjem z antipsihotiki so poročali o levkopeniji, nevtropeniji in agranulocitozi (vključno s smrtnimi primeri).
English: Angioedema Urticaria
Slovenian: Žilne bolezni
English: Known CYP2D6 poor metabolisers taking strong/moderate CYP3A4 inhibitors
Slovenian: Znani slabi presnavljalci CYP2D6, ki jemljejo močne/zmerne zaviralce CYP3A4
English: 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.
Slovenian: povezanih s samomorilnostjo (0,5 %, 2 resna dogodka, od katerih je pri enem prišlo do prekinitve zdravljenja) in pri 3 preiskovancih (0,4 %, brez resnih dogodkov) v skupini s placebom.
English: Your doctor will stop the treatment immediately if the white blood cells in your blood are too low.
Slovenian: Če bodo vrednosti belih krvnih celic v krvi prenizke, bo zdravnik nemudoma prekinil zdravljenje.
English: Hepatic enzymes increased
Slovenian: Zvišane vrednosti jetrnih encimov
English: Impulse-control disorders including gambling disorder have been reported in patients treated with brexpiprazole.
Slovenian: Pri bolnikih, zdravljenih z brekspiprazolom, so poročali o motnjah nadzora impulzov, vključno z zasvojenostjo od iger na srečo.
English: • irregularities in heart rhythm that may be due to abnormal nerve impulses in the heart, abnormal readings during heart examination (ECG), QT prolongation - it is not known how many people are affected.
Slovenian: nenormalni odčitki s podaljšanjem intervala QT pri preiskavi srca (EKG) - ni znano, pri koliko bolnikih se lahko pojavijo.
English: Following oral administration, brexpiprazole decreased blood pressure and prolonged QT interval in safety pharmacology study in conscious male dog, in repeated-dose toxicity studies in male and female monkeys and in juvenile toxicity study in male and female dogs.
Slovenian: V farmakološki varnostni študiji pri pasjem samcu pri zavesti, pri študijah toksičnosti s ponavljajočimi odmerki pri samcih in samicah opic in študiji toksičnosti pri pasjih mladičih (samcih in samicah) se je po peroralnem jemanju znižal krvni tlak in podaljšal interval QT.
English: Brexpiprazole should be used with caution in patients with a known history of EPS.
Slovenian: Pri bolnikih z znano anamnezo EPS je treba brekspiprazol uporabljati previdno.
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.
Slovenian: Induktorji CYP3A4 Sočasna uporaba rifampicina (600 mg dvakrat na dan 12 dni), močnega induktorja CYP3A4, z enkratnim 4-mg peroralnim odmerkom brekspiprazola je povzročila približno 31-% in 73-% znižanje
English: 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).
Slovenian: Na podlagi rezultatov študij medsebojnega delovanja se pri sočasni uporabi z močnimi zaviralci CYP3A4 (itrakonazol, ketokonazol, ritonavir in klaritromicin) priporoča prilagoditev odmerka brekspiprazola na polovico odmerka.
English: A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic treatment.
Slovenian: V povezavi z zdravljenjem z antipsihotiki so poročali o potencialno smrtem kompleksu simptomov, imenovanem nevroleptični maligni sindrom (NMS).
English: CYP2D6 genotype
Slovenian: Genotip CYP2D6
English: A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotics.
Slovenian: Pri bolnikih, zdravljenih z antipsihotiki, se lahko razvije sindrom potencialno nepovratnih nehotenih diskinetičnih gibov.
English: Cardiovascular disorders
Slovenian: Srčne bolezni
English: Once daily dosing while CYP3A4 inducers are administered results in high peak to trough fluctuation, hence twice daily divided dosing is preferable.
Slovenian: Odmerjanje zdravila enkrat dnevno med uporabo induktorjev CYP3A4 ima za posledico visoko nihanje med najvišjimi in najnižjimi koncentracijami, zato se priporoča dajanje zdravila v razdeljenih odmerkih dvakrat dnevno.
English: Clinical monitoring of weight and lipid profile is recommended at baseline and during treatment.
Slovenian: Ob izhodišču in med zdravljenjem priporočamo klinično spremljanje telesne mase in lipidnega profila.
English: Talk to your doctor or pharmacist before taking RXULTI, or during treatment if you have
Slovenian: Pred jemanjem zdravila RXULTI ali med zdravljenjem se posvetujte z zdravnikom ali farmacevtom,
English: QT prolongation can develop in patients treated with antipsychotics.
Slovenian: Pri bolnikih, zdravljenih z antipsihotiki, se lahko razvije podaljšanje intervala QT.
English: - If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite katerega koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: After multiple once daily administration of brexpiprazole, the terminal elimination half-life of brexpiprazole and its major metabolite, DM-3411, is 91.4 hours and 85.7 hours, respectively.
Slovenian: Po večkratnem dajanju brekspiprazola enkrat dnevno je končni razpolovni čas brekspiprazola 91,4 ure,
English: Brexpiprazole (2 mg/day)* 180 95.85 Brexpiprazole (4 mg/day)* 178 94.70
Slovenian: Brekspiprazol (2 mg/dan)* 180 95,85
English: Brexpiprazole steady-state concentrations are attained within 10 days to 12 days of dosing.
Slovenian: Koncentracije brekspiprazola v stanju dinamičnega ravnovesja so dosežene v od 10 do
English: Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics.
Slovenian: Pri bolnikih, ki so se zdravili z atipičnimi antipsihotiki, so poročali o hiperglikemiji, v nekaterih primerih skrajni in povezani s ketoacidozo ali hiperosmolarno komo ali smrtjo.
English: Consider dose reduction or stopping the medication if a patient develops such urges while taking brexpiprazole (see section 4.8).
Slovenian: Če se pri bolniku med jemanjem brekspiprazola pojavijo take težnje, razmislite o zmanjšanju odmerka ali prekinitvi zdravljenja z zdravilom (glejte poglavje 4.8).
English: • diarrhoea,
Slovenian: • zaspanost,
English: The LS Mean, 95 % CI, and p-values for individual trials were derived from an MMRM (Mixed effect Model Repeat Measurement) analysis as follows: fixed effects of site, treatment, visit, and treatment-by-visit interaction, with baseline and baseline-by-visit interaction as covariates.
Slovenian: * Zdravljenje je statistično značilno boljše od placeba a Razlika (brekspiprazol minus placebo) v srednji vrednosti spremembe od začetka do 6. tedna zdravljenja po metodi najmanjših kvadratov b LS povprečje, 95-% IZ in p-vrednosti za posamezna preskušanja so bili izpeljani iz analize modela MMRM (Mixed-effect Model for Repeated Measures), kot sledi: fiksni učinki mesta, zdravljenja, obiska in interakcije med zdravljenjem in obiskom ter sospremenljivki izhodišče in interakcija med izhodiščem in obiskom.
English: Delayed growth, physical development and impaired viability of the offspring were observed at maternally toxic brexpiprazole doses in a pre-/post-natal developmental toxicity study in orally administered rats.
Slovenian: V študiji toksičnosti pre- in postnatalnega razvoja pri peroralnem dajanju odmerkov brekspiprazola pri podganah, ki so bili toksični za mater, so opazili zaostajanje v rasti, fizičnem razvoju in slabšo sposobnost preživetja potomcev.