natgillin/translations-raw huggingface dataset:
Patients receiving aripiprazole solution for injection should be observed for orthostatic hypotension.
Bolnike, ki prejemajo aripiprazol v obliki raztopine za injiciranje, je treba nadzirati glede ortostatske hipotenzije.
The safety and efficacy of aripiprazole solution for injection has not been evaluated in patients with alcohol or medicinal product intoxication (either with prescribed or illicit medicinal products).
Pri bolnikih, ki so se zastrupili z alkoholom ali zdravili (bodisi predpisanimi bodisi nedovoljenimi), varnost in učinkovitost aripiprazola v obliki raztopine za injiciranje nista bili ovrednoteni.
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 therapy, including treatment with aripiprazole (see section 4.8).
V nekaterih primerih so o njegovem pojavu poročali zgodaj po uvedbi ali zamenjavi antipsihotičnega zdravljenja, tudi pri zdravljenju z aripiprazolom (glejte poglavje 4. 8).
Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or
100 Srčnožilne bolezni: aripiprazol morate uporabljati previdno pri bolnikih z znano srčnožilno boleznijo (anamnezo miokardnega infarkta ali ishemično boleznijo srca, srčnim popuščanjem ali prevodnimi motnjami), cerebrovaskularno boleznijo ali stanji, ki ustvarjajo nagnjenost k hipotenziji (dehidracija, hipovolemija, zdravljenje z antihipertenzivi) ali hipertenziji, vključno s pospešeno in maligno hipertenzijo.
Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Tardivna diskinezija: v kliničnih preskušanjih, ki so trajala eno leto ali manj, so med zdravljenjem z aripiprazolom občasno poročali o diskineziji, nastali med zdravljenjem.
If signs and symptoms of tardive dyskinesia appear in a patient on ABILIFY, dose reduction or discontinuation should be considered.
Če se pri bolniku, ki dobiva zdravilo ABILIFY, pojavijo znaki in simptomi tardivne diskinezije, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
V kliničnih preskušanjih so med zdravljenjem z aripiprazolom poročali o redkih primerih MNS- a.
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).
Klinični znaki MNS- a so hiperpireksija, mišična rigidnost, spremenjeno duševno stanje in znaki avtonomne nestabilnosti (nereden srčni utrip ali krvni tlak, tahikardija, čezmerno znojenje in motnje srčnega ritma).
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Med dodatnimi znaki so lahko zvišana kreatin - fosfokinaza, mioglobinurija (rabdomioliza) in akutna odpoved ledvic.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicinal products, including ABILIFY, must be discontinued.
Če se pri bolniku pojavijo znaki in simptomi MNS- a ali ima nepojasnjeno zvišano telesno temperaturo brez drugih kliničnih znakov MNS- a, je treba ukiniti vsa antipsihotična zdravila, tudi zdravilo ABILIFY.
Seizure: in clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole.
Konvulzije: v kliničnih preskušanjih so poročali o občasnih primerih konvulzij med zdravljenjem z aripiprazolom.
Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.
Pri bolnikih, ki imajo anamnezo konvulzivnih motenj ali bolezni, povezane s konvulzivnimi napadi, je potrebna previdnost pri uporabi aripiprazola.
Elderly patients with dementia-related psychosis:
Starejši bolniki s psihozo, povezano z demenco:
Increased mortality: in three placebo-controlled trials (n= 938; mean age:
Večja umrljivost: v treh s placebom nadzorovanih preskušanjih (n = 938, povprečna starost:
82.4 years; range:
82, 4 let, razpon:
The rate of death in aripiprazole-treated patients was 3.5% compared to 1.7% in the placebo group.
Delež smrti je bil v skupini z aripiprazolom 3, 5%, v skupini s placebom pa 1, 7%.
Cerebrovascular adverse events: in the same trials, cerebrovascular adverse events (e. g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age:
Cerebrovaskularni neželeni dogodki: v istih preskušanjih so poročali o cerebrovaskularnih neželenih dogodkih (npr. možganski kapi, tranzitorni ishemični ataki), vključno s smrtnimi primeri (srednja starost bolnikov:
Overall, 1.3% of aripiprazole-treated patients reported cerebrovascular adverse events compared with 0.6% of placebo-treated patients in these trials.
V celoti so v teh preskušanjih cerebrovaskularne neželene dogodke zabeležili pri 1, 3% bolnikov, zdravljenih z aripiprazolom, in pri 0, 6% bolnikov, ki so dobivali placebo.
However, in one of these trials, a fixed-dose trial, there was a significant dose response relationship for cerebrovascular adverse events in patients treated with aripiprazole.
Toda v enem od teh preskušanj (preskušanje s fiksnim odmerkom) je pri bolnikih, ki so dobivali aripiprazol, za cerebrovaskularne neželene dogodke obstajala značilna povezanost odmerka in odziva.
ABILIFY is not approved for the treatment of dementia-related psychosis.
Zdravilo ABILIFY ni odobreno za zdravljenje psihoze, povezane z demenco.
Hyperglycaemia and Diabetes Mellitus: hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotic agents, including ABILIFY.
Hiperglikemija in diabetes mellitus: pri bolnikih, ki so se zdravili z atipičnimi antipsihotiki, vključno z zdravilom ABILIFY, so poročali o hiperglikemiji, ki je bila v nekaterih primerih zelo izrazita in povezana s ketoacidozo, hiperosmolarno komo ali smrtjo.
Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Med dejavniki tveganja, ki lahko povečajo bolnikovo nagnjenost k hudim zapletom, so debelost in družinska anamneza diabetesa.
In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse events (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
Med kliničnimi preskušanji aripiprazola v primerjavi s placebom niso ugotovili značilnih razlik v incidenci hiperglikemičnih neželenih dogodkov (vključno z diabetesom) ali nenormalnih laboratorijskih vrednosti glukoze v krvi.
Precise risk estimates for hyperglycaemia-related adverse events in patients treated with ABILIFY and with other atypical antipsychotic agents are not available to allow direct comparisons.
Bolnike, ki dobivajo kateri koli antipsihotik, vključno z zdravilom ABILIFY, je treba opazovati glede znakov in simptomov hiperglikemije (kot so polidipsija, poliurija, polifagija in
Patients treated with any antipsychotic agents, including ABILIFY, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
101 šibkost); bolnike z diabetesom mellitusom ali dejavniki tveganja zanj pa je treba redno nadzirati, da bi odkrili poslabšanje urejenosti glukoze.
96 Weight gain: weight gain is commonly seen in schizophrenic and bipolar mania patients due to co- morbidities, use of antipsychotics known to cause weight gain, poorly managed life-style, and might lead to severe complications.
Povečanje telesne mase lahko povzroči hude zaplete.
Weight gain has been reported post-marketing among patients prescribed ABILIFY.
V pomarketinških študijah bolnikov, ki so dobivali ABILIFY, je bilo opisano povečanje telesne mase.
Due to its α 1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents.
Aripiprazol deluje antagonistično na adrenergične receptorje α1, zato lahko stopnjuje učinek nekaterih antihipertenzivov.
Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is taken in combination with alcohol or other CNS medicinal products with overlapping undesirable effects such as sedation (see section 4.8).
Glede na primarne učinke aripiprazola na osrednji živčni sistem je potrebna previdnost pri uporabi aripiprazola v kombinaciji z alkoholom ali drugimi zdravili, ki delujejo na osrednje živčevje in imajo podobne neželene učinke, npr. sedacijo (glejte poglavje 4. 8).
Potential for other medicinal products to affect ABILIFY:
Možnost vpliva drugih zdravil na zdravilo ABILIFY:
The administration of lorazepam solution for injection had no effect on the pharmacokinetics of aripiprazole solution for injection when administered concomitantly.
Pri sočasni uporabi lorazepama v obliki raztopine za injiciranje ne vpliva na farmakokinetiko aripiprazola v obliki raztopine za injiciranje.
A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Zaviralec želodčne kisline, antagonist histaminskih receptorjev H2 famotidin, zmanjša hitrost absorpcije aripiprazola, vendar ta učinek ne velja za klinično pomembnega.
In a clinical trial in healthy subjects, a potent inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107%, while Cmax was unchanged.
V kliničnem preskušanju pri zdravih preiskovancih je močan zaviralec CYP2D6 (kinidin) zvečal AUC aripiprazola za 107%, Cmax pa se ni spremenila.
ABILIFY dose should be reduced to approximately one-half of its prescribed dose when concomitant administration of ABILIFY with quinidine occurs.
Če se zdravilo ABILIFY uporablja sočasno s kinidinom, je treba odmerek zdravila ABILIFY zmanjšati na približno polovico predpisanega odmerka.
In a clinical trial in healthy subjects, a potent inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63% and 37%, respectively.
V kliničnem preskušanju pri zdravih preiskovancih je močan zaviralec CYP3A4 (ketokonazol) zvečal AUC aripiprazola za 63%, Cmax pa za 37%.
When considering concomitant administration of ketoconazole or other potent CYP3A4 inhibitors with ABILIFY, potential benefits should outweigh the potential risks to the patient.
Če se ketokonazol
When concomitant administration of ketoconozole with ABILIFY occurs, ABILIFY dose should be reduced to approximately one-half of its prescribed dose.
102 uporabi sočasno z zdravilom ABILIFY, je treba odmerek zdravila ABILIFY zmanjšati na približno polovico predpisanega odmerka.
97 Upon discontinuation of the CYP2D6 or 3A4 inhibitor, the dosage of ABILIFY should be increased to the level prior to the initiation of the concomitant therapy.
Po koncu uporabe zaviralca CYP2D6 ali 3A4 je treba odmerjanje zdravila ABILIFY zvečati na raven, kakršna je bila pred uvedbo sočasnega zdravljenja.
The administration of aripiprazole solution for injection had no effect on the pharmacokinetics of lorazepam solution for injection when administered concomitantly.
Pri sočasni uporabi aripiprazol v obliki raztopine za injiciranje ne vpliva na farmakokinetiko lorazepama v obliki raztopine za injiciranje.
In clinical studies, 10-30 mg/ day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/ 3-methoxymorphinan ratio), 2C9 (warfarin), 2C19 (omeprazole), and 3A4 (dextromethorphan).
V kliničnih študijah odmerki od 10 do 30 mg aripiprazola na dan niso pomembno vplivali na presnovo substratov CYP2D6 (razmerje dekstrometorfan/ 3- metoksimorfinan), 2C9 (varfarin), 2C19 (omeprazol) ali 3A4 (dekstrometorfan).
When aripiprazole was administered concomitantly with either valproate or lithium, there was no clinically important change in valproate or lithium concentrations.
Pri sočasnem dajanju aripiprazola in valproata ali litija niso opazili klinično pomembnih sprememb koncentracij valproata ali litija.
Animal studies could not exclude potential developmental toxicity (see section 5.3).
Študije na živalih niso mogle izključiti možnosti toksičnih učinkov na razvoj (glejte poglavje 5. 3).
Due to insufficient safety information in humans and concerns raised by animal reproductive studies, this medicinal product should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the foetus.
Zaradi nezadostnih podatkov o varnosti pri človeku in zaradi pomislekov, ki jih porajajo študije razmnoževanja pri živalih, se tega zdravila pri nosečnicah ne sme uporabljati, če pričakovana korist nedvomno ne prevlada nad možnim tveganjem za plod.
Patients should be advised not to breast feed if they are taking aripiprazole.
Bolnicam je treba svetovati, naj ne dojijo, če uporabljajo aripiprazol.
4.7 Effects on ability to drive and use machines
103 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
98 4.8 Undesirable effects
4. 8 Neželeni učinki
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*) in clinical trials with aripiprazole solution for injection (see section 5.1):
Pri kliničnih preskušanjih aripiprazola v obliki raztopine za injiciranje so se naslednji neželeni učinki pojavili pogosteje (≥ 1/ 100) kot pri placebu, ali pa so jih identificirali kot neželene učinke, ki bi lahko imeli zdravstveni pomen (*) (glejte poglavje 5. 1):
The frequency listed below is defined using the following convention: common (≥ 1/ 100, < 1/ 10) and uncommon (≥ 1/ 1,000, < 1/ 100).
Pogostnost, navedena v nadaljevanju, je definirana glede na sledeči dogovor: pogosti (≥ 1/ 100, < 1/ 10) in občasni (≥ 1/ 1. 000, < 1/ 100).
Cardiac disorders Uncommon: tachycardia* Nervous system disorders Common: somnolence, dizziness, headache, akathisia Gastrointestinal disorders Common: nausea, vomiting Uncommon: dry mouth* Vascular disorders Uncommon: orthostatic hypotension*, increased diastolic blood pressure* General disorders and administration site conditions Uncommon: fatigue*
Srčne bolezni Občasni: tahikardija * Bolezni živčevja Pogosti: somnolenca, omotica, glavobol, akatizija Bolezni prebavil Pogosti: navzea, bruhanje Občasni: suha usta * Žilne bolezni Občasni: ortostatska hipotenzija *, zvišanje diastoličnega krvnega tlaka * Splošne težave in spremembe na mestu aplikacije Občasni: utrujenost *
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*) in clinical trials with oral formulations of aripiprazole (see section 5.1):
Pri kliničnih preskušanjih peroralnih farmacevtskih oblik aripiprazola so se naslednji neželeni učinki pojavili pogosteje kot pri placebo (≥ 1/ 100) ali pa so jih identificirali kot neželene učinke, ki bi lahko imeli zdravstveni pomen (*) (glejte poglavje 5. 1):
Cardiac disorders Uncommon: tachycardia* Nervous system disorders Common: extrapyramidal disorder, akathisia, tremor, dizziness, somnolence, sedation, headache Eye disorders Common: blurred vision Gastrointestinal disorders Common: dyspepsia, vomiting, nausea, constipation, salivary hypersecretion Vascular disorders Uncommon: orthostatic hypotension* General disorders and administration site conditions Common: fatigue Psychiatric disorders Common: restlessness, insomnia, anxiety Uncommon: depression*
Srčne bolezni Občasni: tahikardija * Bolezni živčevja Pogosti: ekstrapiramidne motnje, akatizija, tremor, omotica, somnolenca, sedacija, glavobol Očesne bolezni Pogosti: zamegljen vid Bolezni prebavil Pogosti: dispepsija, bruhanje, navzea, obstipacija, močnejše izločanje sline Žilne bolezni Občasni: ortostatska hipotenzija * Splošne težave in spremembe na mestu aplikacije Pogosti: utrujenost Psihiatrične motnje Pogosti: nemir, nespečnost, anksioznost Občasni: depresija *
Schizophrenia - in a long term 52-week controlled trial, aripiprazole-treated patients had an overall-lower incidence (25.8%) of EPS including parkinsonism, akathisia, dystonia and dyskinesia compared with those treated with haloperidol (57.3%).
Shizofrenija - v dolgoročnem 52- tedenskem nadzorovanem preskušanju je bila celotna incidenca EPS (vključno s parkinsonizmom, akatizijo, distonijo in diskinezijo) manjša (25, 8- odstotna) pri bolnikih, ki so dobivali aripiprazol, kot pri tistih, ki so dobivali haloperidol (57, 3- odstotna).
In a long term 26-week placebo-controlled trial, the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients.
V dolgoročnem 26- tedenskem s placebom nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 19- odstotna, pri bolnikih, ki so dobivali placebo, pa 13, 1- odstotna.
In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapine-treated patients.
V drugem dolgoročnem 26- tedenskem nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 14, 8- odstotna, pri bolnikih, zdravljenih z olanzapinom, pa 15, 1- odstotna.
Manic episodes in Bipolar I Disorder - in a 12-week controlled trial, the incidence of EPS was 23.5% for aripiprazole-treated patients and 53.3% for haloperidol-treated patients.
V drugem 12- tedenskem
In another 12-week trial, the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for those treated with lithium.
104 preskušanju je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 26, 6%, pri bolnikih, ki so se zdravili z litijem pa 17, 6%.
99 Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially clinically significant changes in routine laboratory parameters revealed no medically important differences.
Primerjava deležev bolnikov, ki so doživeli potencialno klinično značilne spremembe rutinskih laboratorijskih vrednosti, ni pokazala medicinsko pomembnih razlik med aripiprazolom in placebom.
Undesirable effects known to be associated with antipsychotic therapy and also reported during treatment with aripiprazole include neuroleptic malignant syndrome, tardive dyskinesia, seizure, cerebrovascular adverse events and increased mortality in elderly demented patients, hyperglycaemia and diabetes mellitus (see section 4.4).
Med neželenimi učinki, za katere je znano, da so povezani z antipsihotičnim zdravljenjem in so opisani tudi med zdravljenjem z aripiprazolom, so maligni nevroleptični sindrom, tardivna diskinezija, konvulzije, cerebrovaskularni neželeni dogodki, večja umrljivost pri starejših bolnikih z demenco, hiperglikemija in diabetes mellitus (glejte poglavje 4. 4).
Post-Marketing:
105 Izkušnje po pridobitvi dovoljenja za promet:
The following adverse events have been reported during post-marketing surveillance.
Med obdobjem nadzora zdravila na tržišču so bili opisani naslednji neželeni učinki.
The frequency of these events is considered not known (cannot be estimated from the available data).
Pogostnost teh učinkov ni znana (ni je mogoče oceniti iz razpoložljivih podatkov):
In clinical trials and post-marketing experience, accidental or intentional acute overdosage of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg with no fatalities.
Med kliničnimi preskušanji in obdobju pomarketinških izkušenj so ugotovili naključno ali namerno preveliko odmerjanje peroralnega aripiprazola samega pri odraslih bolnikih z ocenjenimi odmerki do 1. 260 mg brez smrtnih primerov.
In addition, reports of accidental overdose with aripiprazole alone (up to 195 mg) in children have been received with no fatalities.
Opisani so tudi primeri naključnega prevelikega odmerjanja peroralnega aripiprazola samega (do 195 mg) pri otrocih, brez smrtnih primerov.
Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment of overdose.
Aktivno oglje (50 g), uporabljeno eno uro po aripiprazolu, je zmanjšalo Cmax aripiprazola za približno 41%, AUC pa za približno 51%, kar kaže, da bi bilo oglje lahko učinkovito pri zdravljenju prevelikega odmerjanja.
It has been proposed that aripiprazole’ s efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Učinkovitost aripiprazola pri shizofreniji in bipolarni motnji I je domnevno posledica kombinacije delnega agonizma na dopaminskih receptorjih D2 in serotoninskih receptorjih 5- HT1a ter antagonizma na serotoninskih receptorjih 5- HT2a.
Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic hypoactivity.
V živalskih modelih dopaminergične hiperaktivnosti je
Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.
In vitro je imel aripiprazol veliko vezavno afiniteto za dopaminske receptorje D2 in D3 in za serotoninske receptorje 5- HT1a in 5- HT2a ter zmerno afiniteto za dopaminske receptorje D4, serotoninske receptorje 5- HT2c in 5- HT7, adrenergične receptorje alfa- 1 in histaminske receptorje H1.
101 Further information on clinical trials:
Dodatne informacije o kliničnih preskušanjih:
In two short- term (24-hour) placebo-controlled trials involving 554 schizophrenic patients presenting with agitation and disturbed behaviours, aripiprazole solution for injection was associated with statistically significant greater improvements in agitation/ behavioural symptoms compared to placebo and was similar to haloperidol.
Uporaba aripiprazola v obliki raztopine za injiciranje v primeru agitacije pri shizofreniji ali bipolarni motnji I: v dveh kratkotrajnih (24- urnih) s placebom nadzorovanih preskušanjih, ki sta vključevali 554 bolnikov s shizofrenijo, pri katerih je bila prisotna agitacija in vedenjske motnje, je bil aripiprazol v obliki raztopine za injiciranje povezan s statistično pomembnim izboljšanjem agitacije/ vedenjskih simptomov v primerjavi s placebom in primerljiv s haloperidolom.
In one short-term (24-hour) placebo-controlled trial involving 291 patients with bipolar disorder presenting with agitation and disturbed behaviours, aripiprazole solution for injection was associated with statistically significant greater improvements in agitation/ behavioural symptoms compared to placebo and was similar to the reference arm lorazepam.
V enem kratkotrajnem (24- urnem) s placebom nadzorovanem preskušanju, ki je vključevalo 291 bolnikov z bipolarno motnjo, pri katerih je bila prisotna agitacija in vedenjske motnje, je bil aripiprazol v obliki raztopine za injiciranje povezan s statistično pomembnim izboljšanjem agitacije/ vedenjskih simptomov v primerjavi s placebom in primerljiv z lorazepamom.
The observed mean improvement from baseline on the PANSS Excitement Component score at the primary 2-hour endpoint was 5.8 for placebo, 9.6 for lorazepam, and 8.7 for aripiprazole.
Ugotovljeno povprečno izboljšanje od izhodišča po ocenjevalni lestvici PANSS za komponento razburjenja je bilo po dveh urah (primarna končna točka) pri bolnikih, ki so jemali placebo 5, 8, pri bolnikih, ki so jemali lorazepam 9, 6 in pri bolnikih, ki so jemali aripiprazol 8, 7.