natgillin/translations-raw huggingface dataset:
In clinical trials of aripiprazole, the incidence of QT prolongation was comparable to placebo.
Prevodne motnje: incidenca podaljšanja intervala QT je bila v kliničnih preskušanjih aripiprazola primerljiva kot pri placebu.
As with other antipsychotics, aripiprazole should be used with caution in patients with a family history of QT prolongation.
Tako kot druge antipsihotike morate tudi aripiprazol uporabljati previdno pri bolnikih z družinsko anamnezo podaljšanja intervala QT.
Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Zapoznela diskinezija: v kliničnih preizkušanjih, 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 ABILIFY, pojavijo znaki in simptomi zapoznele diskinezije, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Takšni simptomi se lahko postopoma poslabšujejo ali se celo pojavijo po prekinitvi zdravljenja.
NMS is a potentially fatal symptom complex associated with antipsychotic medicinal products.
MNS je potencialno usoden splet simptomov, povezan z antipsihotičnimi zdravili.
In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
V kliničnih preizkušanjih so med zdravljenjem z aripiprazolom opisali redke primere MNS.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered
Klinični znaki MNS so hiperpireksija, mišična rigidnost, spremenjeno duševno stanje in znaki avtonomne nestabilnosti (nereden srčni utrip ali krvni tlak, tahikardija, znojenje in motnje srčnega ritma).
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
3 (rabdomioliza) in akutna odpoved ledvic.
However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported.
Opisana sta tudi zvišanje kreatin- fosfokinaze in rabdomioliza, ne nujno v povezavi z MNS.
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 bolniku pojavijo znaki in simptomi MNS ali ima nepojasnjeno zvišanje telesne temperature brez drugih kliničnih znakov MNS, je treba ukiniti vsa antipsihotična zdravila, z zdravilom ABILIFY vred.
Seizure: in clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole.
Konvulzije: v kliničnih preizkušanjih 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.
Aripiprazol je zato treba previdno uporabljati pri bolnikih, ki imajo anamnezo konvulzivnih motenj ali imajo bolezni, povezane s konvulzivnimi napadi.
Elderly patients with dementia-related psychosis:
Starejši bolniki s psihozo zaradi demence:
Increased mortality: in three placebo-controlled trials (n= 938; mean age:
Večja umrljivost: v treh s placebom kontroliranih preizkušanjih (n = 938, povprečna starost:
82.4 years; range:
82, 4 leta, razpon:
56-99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo.
56– 99 let) aripiprazola pri starejših bolnikih s psihozo, povezano z Alzheimerjevo boleznijo, je bilo tveganje smrti večje pri bolnikih, ki so dobivali aripiprazol, kot pri tistih, ki so dobivali placebo.
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% in v skupini s placebom 1, 7%.
Although the causes of deaths were varied, most of the deaths appeared to be either cardiovascular (e. g. heart failure, sudden death) or infectious (e. g. pneumonia) in nature.
Čeprav so se vzroki smrti razlikovali, je bila večina vzrokov kardiovaskularnih (npr. srčno popuščanje, nenadna smrt) ali infekcijskih (npr. pljučnica).
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 učinki: v istih preizkušanjih so poročali o cerebrovaskularnih neželenih učinkih (npr. o možganski kapi, tranzitorni ishemični ataki), vključno s smrtnimi primeri (srednja starost bolnikov:
78-88 years).
84 let, razpon: od 78 do 88 let).
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 preizkušanjih cerebrovaskularne neželene učinke 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 preizkušanj (preizkušanje s fiksnim odmerkom) je pri bolnikih, ki so dobivali aripiprazol, za cerebrovaskularne neželene učinke obstajala značilna povezanost odmerka in odziva.
ABILIFY is not approved for the treatment of dementia-related psychosis.
ABILIFY ni odobren 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.
Pri bolnikih, zdravljenih z atipičnimi antipsihotiki, vključno z zdravilom ABILIFY, je bila opisana hiperglikemija.
Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
V nekaterih primerih je bila zelo izrazita in povezana s ketoacidozo ali hiperosmolarno komo ali smrtjo.
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 preizkušanji aripiprazola v primerjavi s placebom niso ugotovili značilnih razlik v incidenci hiperglikemičnih neželenih učinkov (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.
Ni natančnih ocen tveganja za hiperglikemične neželene dogodke med prejemniki zdravila ABILIFY in drugih atipičnih antipsihotikov, ki bi omogočale neposredno primerjavo.
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.
Bolnike, ki dobivajo kateri koli antipsihotik, vključno z zdravilom ABILIFY, je treba opazovati glede znakov in simptomov hiperglikemije (npr. polidipsije, poliurije, polifagije in šibkosti); bolnike z diabetesom mellitusom ali dejavniki tveganja zanj pa je treba redno nadzirati, da bi odkrili poslabšanje urejenosti glukoze.
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.
Povečanje telesne mase je bilo opisano tudi v pomarketinških študijah bolnikov, ki so dobivali ABILIFY.
In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain (see section 5.1).
V kliničnih preskušanjih niso ugotovili, da bi aripiprazol povzročil klinično pomembno povečanje telesne mase (glejte poglavje 5. 1).
Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Disfagija: z uporabo antipsihotičnih zdravil, tudi zdravila ABILIFY, so bile povezane motnje motilitete požiralnika in aspiracija.
Aripiprazole and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.
Pri bolnikih s tveganjem za aspiracijsko pljučnico morate aripiprazol in druga antipsihotična zdravila uporabljati previdno.
Lactose: patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
Hypersensitivity: as with other medications hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
Preobčutljivost: kot pri ostalih zdravilih, se lahko tudi pri aripiprazolu pojavijo preobčutljivostne reakcije v obliki simptomov alergije (glejte poglavje 4. 8).
4 4.5 Interaction with other medicinal products and other forms of interaction
4 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
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 antihipertenzivnih zdravil.
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 zdravili, ki delujejo na osrednje živčevje in imajo podobne neželene učinke, npr. sedacijo (glejte poglavje 4. 8).
If aripiprazole is administered concomitantly with medicines known to cause QT prolongation or electrolyte imbalance, caution should be used.
Če aripiprazol uporabite sočasno z zdravili, za katera je znano, da podaljšajo interval QT ali povzročajo neravnovesje elektrolitov, morate biti previdni.
Potential for other medicinal products to affect ABILIFY:
Možnost vpliva drugih zdravil na ABILIFY:
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 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 preizkušanju pri zdravih preiskovancih je močan zaviralec CYP2D6 (kinidin) zvečal AUC aripiprazola za 107%, Cmax pa se ni spremenila.
The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32% and 47%.
AUC aktivnega presnovka dehidroaripiprazola se je zmanjšala za 32%, njegova Cmax pa za 47%.
ABILIFY dose should be reduced to approximately one-half of its prescribed dose when concomitant administration of ABILIFY with quinidine occurs.
Če se 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 preizkušanju pri zdravih preiskovancih je močan zaviralec CYP3A4 (ketokonazol) zvečal AUC aripiprazola za 63% in Cmax za 37%.
The AUC and Cmax of dehydro-aripiprazole increased by 77% and 43%, respectively.
AUC dehidroaripiprazola se je zvečala za 77%, njegova Cmax pa za 43%.
In CYP2D6 poor metabolisers, concomitant use of potent inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.
Pri slabih metabolizatorjih s CYP2D6 lahko sočasna uporaba z močnimi zaviralci CYP3A4 povzroči večjo koncentracijo aripiprazola v plazmi kot pri močnih metabolizatorjih s CYP2D6.
When considering concomitant administration of ketoconazole or other potent CYP3A4 inhibitors with ABILIFY, potential benefits should outweigh the potential risks to the patient.
Pri odločanju o sočasni uporabi ketokonazola ali drugih močnih zaviralcev CYP3A4 z zdravilom ABILIFY morajo biti možne koristi za bolnika večje od možnih tveganj.
When concomitant administration of ketoconozole with ABILIFY occurs, ABILIFY dose should be reduced to approximately one-half of its prescribed dose.
Če se ketokonazol uporabi sočasno z zdravilom ABILIFY, je treba odmerek zdravila ABILIFY zmanjšati na približno polovico predpisanega odmerka.
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 sočasne terapije.
When weak inhibitors of CYP3A4 (e. g., diltiazem or escitalopram) or CYP2D6 are used concomitantly with ABILIFY, modest increases in aripiprazole concentrations might be expected.
Med sočasno uporabo zdravila ABILIFY in šibkih zaviralcev CYP3A4 (npr. diltiazema ali escitaloprama) ali CYP2D6 je mogoče pričakovati zmerno zvišanje koncentracije aripiprazola.
Following concomitant administration of carbamazepine, a potent inducer of CYP3A4, the geometric means of Cmax and AUC for aripiprazole were 68% and 73% lower, respectively, compared to when aripiprazole (30 mg) was administered alone.
Po sočasni uporabi karbamazepina, močnega induktorja CYP3A4, je bila geometrična sredina Cmax za 68% nižja, AUC pa za 73% nižja kot po uporabi samega aripiprazola (30 mg).
Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
Podobno je bila po sočasni uporabi karbamazepina geometrična sredina Cmax dehidroaripiprazola za 69% nižja, njegova AUC pa za 71% nižja kot po zdravljenju s samim aripiprazolom.
ABILIFY dose should be doubled when concomitant administration of ABILIFY occurs with carbamazepine.
Med sočasno uporabo zdravila ABILIFY s karbamazepinom je treba odmerek zdravila ABILIFY podvojiti.
Other potent inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St.
Pričakovati je mogoče, da imajo drugi močni induktorji CYP3A4 (npr. rifampicin, rifabutin, fenitoin, fenobarbital, primidon, efavirenz, nevirapin in šentjanževka) podobne učinke, zato je treba odmerjanje podobno zvečati.
John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
Po prenehanju uporabe močnih induktorjev CYP3A4 je treba odmerjanje zdravila ABILIFY zmanjšati na priporočeni odmerek.
Upon discontinuation of potent CYP3A4 inducers, the dosage of ABILIFY should be reduced to the recommended dose.
Med sočasno uporabo aripiprazola z litijem ali valproatom se koncentracija aripiprazola ni klinično pomembno spremenila.
5 When either valproate or lithium were administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations.
5 Možnost vpliva zdravila ABILIFY na druga zdravila:
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 raziskavah 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.
Če so aripiprazol uporabili sočasno z valproatom ali litijem, se koncentracija valproata ali litija ni klinično pomembno spremenila.
4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
There are no adequate and well-controlled trials of aripiprazole in pregnant women.
Ustreznih in dobro kontroliranih preizkušanj aripiprazola pri nosečnicah ni.
Animal studies could not exclude potential developmental toxicity (see section 5.3).
Raziskave 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 raziskave reprodukcije pri živalih, se tega zdravila pri nosečnicah ne sme uporabljati, razen če pričakovane koristi nedvomno upravičujejo možno tveganje za plod.
Aripiprazole was excreted in the milk of treated rats during lactation.
Aripiprazol se je med laktacijo izločal v mleku tretiranih podgan.
It is not known whether aripiprazole is excreted in human milk.
Ni znano, ali se aripiprazol izloča v materinem mleku.
4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
However, as with other antipsychotics, patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that aripiprazole does not affect them adversely.
Toda tako kot velja za druge antipsihotike, je treba bolnike opozoriti, da morajo biti glede upravljanja nevarnih strojev, vključno z motornimi vozili, previdni, dokler niso zares prepričani, da aripiprazol nanje ne vpliva neugodno.
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 (*):
Naslednji neželeni učinki so se pojavili pogosteje (≥ 1/ 100) kot pri placebu, ali pa je bilo ugotovljeno, da pomenijo morebiti medicinsko pomembne neželene reakcije na zdravilo (*):
The frequency listed below is defined using the following convention: common (> 1/ 100 ,< 1/10) and uncommon (> 1/1 ,000, < 1/100).
Pogostnost, navedena spodaj, je definirana glede na sledečo dogovorjeno lestvico: pogosti (> 1/ 100, < 1/ 10) in občasni (> 1/ 1. 000, < 1/ 100).
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, zaprtost, 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 *
6 Extrapyramidal symptoms (EPS):
Ekstrapiramidni simptomi (EPS):
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 kontroliranem preizkušanju je bila celotna incidenca EPS (vključno s parkinsonizmom, akatizijo, distonijo in diskinezijo) manj pogosta (25, 8%) pri bolnikih, ki so dobivali aripiprazol, kot pri tistih, ki so dobivali haloperidol (57, 3%).
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.
6 incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 19% in pri bolnikih, ki so dobivali placebo, 13, 1%.
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 kontroliranem preizkušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 14, 8% in pri bolnikih, zdravljenih z olanzapinom, 15, 1%.
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.
Manične epizode pri bipolarni I motnji – v 12- tedenskem nadzorovanem preskušanju je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 23, 5%, pri bolnikih, ki so se zdravili s haloperidolom pa 53, 3%.
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.
V drugem 12- tedenskem 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%.
In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2% for aripiprazole-treated patients and 15.7% for placebo-treated patients.
V dolgotrajni 26- tedenski vzdrževalni fazi s placebom nadzorovanega preskušanja je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 18, 2%, pri bolnikih, ki so prejemali placebo pa 15, 7%.
In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo.
V s placebom nadzorovanih preskušanjih je bila pojavnost akatizije pri bolnikih z bipolarno motnjo pri uporabi aripiprazola 12, 1%, pri uporabi placeba pa 3, 2%.
In schizophrenia patients the incidence of akathisia was 6.2% with aripiprazole and 3.0% with placebo.
Pri bolnikih s shizofrenijo je bila pojavnost akatizije pri uporabi aripiprazola 6, 2%, pri uporabi placeba pa 3, 0%.
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.
Elevations of CPK (Creatine Phosphokinase), generally transient and asymptomatic, were observed in 3.5% of aripiprazole treated patients as compared to 2.0% of patients who received placebo.
Zvišanje CPK (kreatin- fosfokinaze), ki je praviloma prehodno in asimptomatsko, je bilo zabeleženo pri 3, 5% bolnikov, zdravljenih z aripiprazolom, in pri 2, 0% bolnikov, ki so dobivali placebo.
Other findings:
Druge ugotovitve: