FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a single oral dose of [14C]-labelled aripiprazole, approximately 27% of the administered radioactivity was recovered in the urine and approximately 60% in the faeces.
Croatian: Nakon jednokratne oralne doze aripiprazola obilježenog izotopom [14C], oko 27 % primijenjene radioaktivnosti pojavi se u mokraći, a oko 60 % u stolici.
English: In clinical trials for the approved indications and post-marketing, both increase and decrease in serum prolactin as compared to baseline was observed with aripiprazole (see section 5.1).
Croatian: U kliničkim ispitivanjima u odobrenim indikacijama i nakon stavljanja lijeka u promet, opaženo je i povećanje i smanjenje prolaktina u serumu uz aripiprazol u usporedbi s početnim vrijednostima (vidjeti dio 5.1)
English: Additional side effects in children and adolescents Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (may affect more than 1 in 10 people) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (may affect up to 1 in 10 people).
Croatian: Adolescenti u dobi od 13 ili više godina imali su nuspojave slične učestalosti i vrste kao i odrasli bolesnici, osim što su pospanost, nekontrolirano trzanje mišića ili trzajni pokreti, nemir i umor bili vrlo česti (mogu se javiti u više od 1 na 10 osoba), dok su bol u gornjem dijelu trbuha, suha usta, ubrzani otkucaji srca, povećanje tjelesne težine, pojačan apetit, trzanje mišića, nekontrolirani pokreti udova i osjećaj omaglice, osobito pri ustajanju iz ležećeg ili sjedećeg položaja, bili česti (mogu se javiti u do 1 na 10 osoba).
English: In the placebocontrolled trials, the mean weight gain was 0.4 kg for placebo and 1.6 kg for aripiprazole.
Croatian: U placebom kontroliranim ispitivanjima, srednja vrijednost povećanja tjelesne težine iznosila je 0,4 kg u skupinama koje su primale placebo i 1,6 kg u skupinama koje su primale aripiprazol.
English: Therefore, Aripiprazole Zentiva is not recommended for use in patients below 13 years of age (see sections 4.8 and 5.1).
Croatian: Zentiva ne preporučuje za primjenu u bolesnika mlađih od 13 godina (vidjeti dijelove 4.8 i 5.1).
English: Aripiprazole was also studied in a placebo-controlled, long-term maintenance trial.
Croatian: Aripiprazol je ispitivan i u placebom kontroliranom ispitivanju dugotrajne terapije održavanja.
English: What you need to know before you take Aripiprazole Zentiva
Croatian: Što morate znati prije nego počnete uzimati lijek Aripiprazole Zentiva
English: When either valproate or lithium was administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations and therefore no dose adjustment is necessary when either valproate or lithium is administered with aripiprazole.
Croatian: Kad su se istodobno s aripiprazolom primjenjivali valproat ili litij, nije bilo klinički značajne promjene u koncentracijama aripiprazola pa stoga nije potrebna prilagodba doze kad se valproat ili litij primjenjuju uz aripiprazol.
English: • Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
Croatian: • lijekove za regulaciju srčanog ritma (kao što su kinidin, amiodaron i flekainid)
English: When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Croatian: Kad se slabi inhibitori CYP3A4 (npr. diltiazem) ili CYP2D6 (npr., escitalopram) koriste istodobno s aripiprazolom, mogu se očekivati umjerena povišenja koncentracije aripiprazola u plazmi.
English: Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Zentiva without first consulting your doctor.
Croatian: Čak i ako se osjećate bolje, nemojte mijenjati dozu niti prekidati svakodnevno uzimanje lijeka Apripiprazole
English: • if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati lijek Aripiprazole Zentiva: • ako ste alergični na aripiprazol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax and AUC for aripiprazole were 68% and 73% lower, respectively, compared to when aripiprazole (30 mg) was administered alone.
Croatian: Nakon istodobne primjene karbamazepina, jakog induktora CYP3A4, i peroralnog aripiprazola bolesnicima sa shizofrenijom ili shizoafektivnim poremećajem, geometrijski određena srednja vrijednost Cmax aripiprazola bila je manja za 68 %, a AUC-a za 73 % u usporedbi s onima kad se aripiprazol (30 mg) primjenjivao sam.
English: • excessive sweating,
Croatian: • pojačano znojenje,
English: 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.
Croatian: Slično tome, geometrijski određena srednja vrijednost Cmax dehidro-aripiprazola nakon zajedničke primjene s karbamazepinom bila je manja za 69 %, a AUC-a za 71 % od onih nakon liječenja samo aripiprazolom.
English: • reports of abnormal liver test values,
Croatian: • abnormalne vrijednosti jetrenih pretraga,
English: Irritability associated with autistic disorder in paediatric patients (see section 4.2) Aripiprazole was studied in patients aged 6 to 17 years in two 8-week, placebo-controlled trials [one flexible-dose (2 - 15 mg/day) and one fixed-dose (5, 10, or 15 mg/day)] and in one 52-week openlabel trial.
Croatian: Razdražljivost povezana s autističnim poremećajem u pedijatrijskih bolesnika (vidjeti dio 4.2) Aripiprazol se ispitivao u bolesnika u dobi od 6 do 17 godina u dva placebom kontrolirana ispitivanja u trajanju od 8 tjedana [jedno s fleksibilnom dozom (2 - 15 mg/dan), drugo s fiksnom dozom (5, 10 ili 15 mg/dan)] i jednom otvorenom ispitivanju u trajanju od 52 tjedna.
English: In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who achieved remission on aripiprazole during a stabilization phase prior to randomisation, aripiprazole demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into depression.
Croatian: U placebom kontroliranom ispitivanju u trajanju od 26 tjedana, nakon kojeg je uslijedio produžetak u trajanju od 74 tjedna, u maničnih bolesnika koji su postigli remisiju pomoću aripiprazola tijekom stabilizacijske faze prije randomizacije, aripiprazol se pokazao superiornim u odnosu na placebo u prevenciji ponavljanja bipolarnog poremećaja, prvenstveno u prevenciji ponavljanja manije, ali nije se pokazao superiornim u odnosu na placebo u prevenciji ponavljanja depresije.
English: For patients receiving aripiprazole, the median time to onset was 30 days and median duration was 194 days.
Croatian: Za bolesnike koji su primali aripiprazol, srednje vrijeme do početka hipoprolaktinemije bilo je 30 dana, a srednje vrijeme trajanja terapije bilo je 194 dana.
English: The incidence of hyperprolactinaemia or increased serum prolactin in patients treated with aripiprazole (0.3%) was similar to that of placebo (0.2%).
Croatian: Pojava hiperprolaktinemije ili povećanog prolaktina u serumu u bolesnika liječenih aripiprazolom (0,3 %) bila je slična rezultatima placebo ispitivanja (0,2 %).
English: In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78 - 88 years).
Croatian: U tim istim ispitivanjima, u bolesnika (srednja dob: 84 godine; raspon: 78-88 godina) su bile prijavljene cerebrovaskularne nuspojave (npr. moždani udar, tranzitorna ishemijska ataka), uključujući i smrtne slučajeve.
English: • Tricyclic's (such as clomipramine and amitriptyline) used for depressive illness
Croatian: • triciklički antidepresivi (kao što su klomipramin i amitriptilin) koji se primjenjuju kod depresivne bolesti
English: The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32% and 47%, respectively.
Croatian: AUC dehidro-aripiprazola, djelatnog metabolita, smanjio se za 32 %, a Cmax za 47 %.
English: • Other anti-depressants (such as venlafaxine and tryptophan) used in major depression
Croatian: • drugi antidepresivi (kao što su venlafaksin i triptofan) koji se primjenjuju kod velike depresije
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: Each tablet contains 5 mg/10 mg/15 mg/30 mg of aripiprazole.
Croatian: Jedna tableta sadrži 5 mg/10 mg/15 mg/30 mg aripiprazola.
English: The AUC and Cmax of dehydro-aripiprazole increased by 77% and 43%, respectively.
Croatian: AUC dehidro-aripiprazola povisio se za 77 %, a Cmax za 43 %.
English: If you forget to take Aripiprazole Zentiva
Croatian: Ako ste zaboravili uzeti lijek Aripiprazole Zentiva
English: If you stop taking Aripiprazole Zentiva
Croatian: Ako prestanete uzimati lijek Aripiprazole Zentiva
English: After a 13 - 26 week stabilisation on aripiprazole (2 - 15 mg/day) patients with a stable response were either maintained on aripiprazole or substituted to placebo for further 16 weeks.
Croatian: Nakon stabiliziranja stanja na aripiprazolu (2 - 15 mg/dan) tijekom 13-26 tjedana, bolesnici sa stabilnim odgovorom sljedećih su 16 tjedana održavani na aripiprazolu ili su prebačeni na placebo.
English: These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva, you should see your doctor.
Croatian: Ovi lijekovi mogu povećati rizik od nuspojava; ako dobijete ikakve neobične simptome dok uzimate neki od ovih lijekova zajedno s lijekom Aripiprazole Zentiva, trebate se obratiti liječniku.
English: Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13 - 17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo): Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10).
Croatian: Shizofrenija u adolescenata u dobi od 15 godina i starijih U kratkotrajnom placebom kontroliranom kliničkom ispitivanju u kojem su sudjelovala 302 adolescenta (13-17 godina) sa shizofrenijom, učestalost i vrsta nuspojava bile su slične onima u odraslih, osim što su sljedeće nuspojave bile prijavljene češće u adolescenata koji su primali aripiprazol nego u odraslih koji su primali aripiprazol (i češće nego uz placebo): somnolencija/sedacija i ekstrapiramidni poremećaji bili su prijavljeni vrlo često (≥ 1/10), dok su često bili prijavljeni suha usta, pojačan apetit i ortostatska hipotenzija (≥ 1/100, < 1/10).
English: In schizophrenia patients the incidence of akathisia was 6.2% with aripiprazole and 3.0% with placebo.
Croatian: U bolesnika sa shizofrenijom, incidencija akatizije bila je 6,2 % uz aripiprazol i 3,0 % uz placebo.
English: • in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.
Croatian: • krvne pretrage: fluktuacija šećera u krvi, povišeni glikirani hemoglobin.
English: The recommended starting dose for Aripiprazole Zentiva is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals.
Croatian: Zentiva je 10 ili 15 mg/dan uz dozu održavanja od 15 mg/dan koja se primjenjuje jedanput dnevno neovisno o obrocima.
English: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria)
Croatian: Poremećaji imunološkog sustava alergijska reakcija (npr. anafilaktička reakcija, angioedem uključujući otečen jezik, edem jezika, edem lica, svrbež ili urtikariju)
English: These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Zentiva; if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva, you should see your doctor.
Croatian: Ti lijekovi mogu povećati rizik od nuspojava ili smanjiti učinak lijeka Aripiprazole Zentiva; ako dobijete neki neobični simptom dok uzimate ove lijekove zajedno s lijekom Aripiprazole Zentiva, trebate se obratiti liječniku.
English: • Antifungal medicines (such as ketoconazole, itraconazole)
Croatian: • lijekove za liječenje gljivičnih infekcija (kao što su ketokonazol, itrakonazol)
English: The safety profile of a long-term, double-blind placebo controlled trial was also similar except for the following reactions that were reported more frequently than paediatric patients taking placebo: weight decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly
Croatian: Sigurnosni profil u dugotrajnom, dvostruko slijepom, placebom kontroliranom ispitivanju također je bio sličan, osim što su sljedeće nuspojave bile zabilježene češće nego u pedijatrijskih bolesnika koji su uzimali placebo: često (≥ 1/100, < 1/10) su bili zabilježeni smanjena tjelesna težina, povišen inzulin u krvi, aritmija i leukopenija.
English: The incidence of hypoprolactinaemia or decreased serum prolactin in patients treated with aripiprazole was 0.4%, compared with 0.02% for patients treated with placebo.
Croatian: Pojava hipoprolaktinemije ili smanjenog prolaktina u serumu u bolesnika liječenih aripiprazolom je 0,4 % u usporedbi s 0,02 % za bolesnike liječene placebom.
English: In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo.
Croatian: U placebom kontroliranim ispitivanjima, incidencija akatizije u bipolarnih bolesnika bila je 12,1 % uz aripiprazol i 3,2 % uz placebo.
English: In clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Croatian: U kliničkim ispitivanjima u trajanju od jedne godine ili kraće, diskinezija povezana s liječenjem bila je manje često prijavljena nuspojava tijekom liječenja aripiprazolom.
English: Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors may be expected to have similar effects and similar dose reductions should therefore be applied (see section 4.2).
Croatian: Slični učinci mogu se očekivati i od drugih jakih inhibitora CYP3A4, kao što su itrakonazol i inhibitori HIV proteaze, pa se stoga moraju provesti slična smanjenja doze (vidjeti dio 4.2).
English: Increased Alanine Aminotransferase (ALT) Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Croatian: Poremećaji jetre i žuči zatajenje jetre hepatitis žutica povišene vrijednosti alanin aminotransferaze (ALT) povišene vrijednosti aspartat aminotransferaze (AST) povišene vrijednosti gamaglutamil transferaze (GGT) povišene vrijednosti alkalne fosfataze
English: In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, aripiprazole had significantly greater reduction in relapse rate, 34% in aripiprazole group and 57% in placebo.
Croatian: U placebom kontroliranom ispitivanju u trajanju od 26 tjedana koje je uključilo stabilne odrasle bolesnike s kroničnom shizofrenijom, aripiprazol je imao značajno veće smanjenje stope relapsa, koja je iznosila 34 % u skupini koja je uzimala aripiprazol u odnosu na 57 % u skupini koja je primala placebo.
English: • difficulty in passing urine;
Croatian: • poteškoće pri mokrenju;
English: In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I Disorder who achieved sustained remission (Y-MRS and MADRS total scores ≤ 12) on aripiprazole (10 mg/day to 30 mg/day) adjunctive to lithium or valproate for 12 consecutive weeks, adjunctive aripiprazole demonstrated superiority over placebo with a 46% decreased risk (hazard ratio of 0.54) in preventing bipolar recurrence and a 65% decreased risk (hazard ratio of 0.35) in preventing recurrence into mania over adjunctive placebo but failed to demonstrate superiority over placebo in preventing recurrence into depression.
Croatian: U placebom kontroliranom ispitivanju, koje je trajalo 52 tjedna, u bolesnika s trenutno prisutnom maničnom ili miješanom epizodom bipolarnog poremećaja tipa 1, koji su postigli kontinuiranu remisiju (Y-MRS i MADRS ukupni rezultati ≤ 12) aripiprazolom (10 mg/dan do 30 mg/dan) kao adjuvantnom terapijom uz litij ili valproat tijekom 12 uzastopnih tjedana, adjuvantna terapija aripiprazolom pokazala je superiornost u odnosu na placebo sa 46 %-tnim smanjenjem rizika (omjer hazarda je 0,54) u prevenciji ponavljanja bipolarnog poremećaja i sa 65 %-tnim smanjenjem rizika (omjer hazarda je 0,35) u prevenciji ponavljanja maničnog poremećaja u odnosu na adjuvantnu terapiju placebom, ali nije uspjela pokazati superiornost u odnosu na placebo u prevenciji ponavljanja depresije.
English: • Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
Croatian: • antikonvulzive koji se primjenjuju za liječenje epilepsije (kao što su karbamazepin, fenitoin,
English: The safety and efficacy of aripiprazole in children and adolescents aged below 18 years have not yet been established.
Croatian: Razdražljivost povezana s autističnim poremećajem Sigurnost i djelotvornost aripiprazola u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: In the pooled trials, the incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) in aripiprazole-treated patients was 27/46 (58.7%) and 258/298 (86.6%), respectively.
Croatian: U objedinjenim je ispitivanjima incidencija niske razine prolaktina u serumu u djevojčica (< 3 ng/ml) liječenih aripiprazolom iznosila 27/46 (58,7 %), a u dječaka (< 2 ng/ml) 258/298 (86,6 %).
English: • SSRI s (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
Croatian: • inhibitori ponovne pohrane serotonina (SSRI) (kao što su paroksetin i fluoksetin) koji se primjenjuju kod depresije, opsesivno-kompulzivnog poremećaja, panike i tjeskobe
English: The recommended starting dose for Aripiprazole Zentiva is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Croatian: Zentiva je 15 mg i primjenjuje se jedanput dnevno neovisno o obrocima u obliku monoterapije ili kombinirane terapije (vidjeti dio 5.1).
English: to the caudate and putamen detected by positron emission tomography.
Croatian: D2/D3 receptora, u nucleus caudatusu i putamenu, kako se pokazalo pozitronskom emisijskom tomografijom.
English: Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reductions should therefore be applied.
Croatian: Slični učinci mogu se očekivati i od drugih jakih inhibitora enzima CYP2D6, kao što su fluoksetin i paroksetin, pa se stoga moraju provesti slična smanjenja doze.
English: If you take more Aripiprazole Zentiva than you should If you realise you have taken more Aripiprazole Zentiva than your doctor has recommended (or if someone else has taken some of your Aripiprazole Zentiva), contact your doctor right away.
Croatian: Zentiva nego što Vam je preporučio liječnik (ili ako je neka druga osoba popila dio Vašeg lijeka Aripiprazole Zentiva), odmah o tome obavijestite svog liječnika.
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis)
Croatian: Krvožilni poremećaji ortostatska hipotenzija venska tromboembolija (uključujući plućnu emboliju i duboku vensku trombozu) hipertenzija sinkopa
English: Aripiprazole Zentiva 10 mg, 30 mg tablets: The score line is not intended for breaking the tablet.
Croatian: Zentiva 10 mg, 30 mg tablete: Razdjelna crta nije namijenjena za lomljenje.
English: 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 5-HT1A receptors and antagonism of serotonin 5-HT2A receptors.
Croatian: I jest da je ono posredovano kombinacijom djelomičnog agonizma s dopaminskim D2 i serotoninskim 5-HT1A receptorima i antagonizma sa serotoninskim 5-HT2A receptorima.
English: Overall, 1.3% of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6% of placebo-treated patients in these trials.
Croatian: Cerebrovaskularne nuspojave bile su prijavljene u ukupno 1,3 % bolesnika liječenih aripiprazolom u usporedbi s 0,6 % bolesnika koji su u tim ispitivanjima primali placebo.
English: Aripiprazole Zentiva 10 mg, 30 mg orodispersible tablets: The score line is not intended for breaking the tablet.
Croatian: Aripiprazole Zentiva 10 mg, 30 mg raspadljive tablete za usta: Razdjelna crta nije namijenjena za lomljenje tablete.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Zentiva 5 mg tablets
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Aripiprazole Zentiva 5 mg tablete
English: What Aripiprazole Zentiva is and what it is used for What you need to know before you take Aripiprazole Zentiva How to take Aripiprazole Zentiva Possible side effects
Croatian: Što je Aripiprazole Zentiva i za što se koristi Što morate znati prije nego počnete uzimati Aripiprazole Zentiva
English: Aripiprazole is metabolised by multiple pathways involving the CYP2D6 and CYP3A4 enzymes but not CYP1A enzymes.
Croatian: Aripiprazol se metabolizira kroz više putova, uključujući enzime CYP2D6 i CYP3A4, ali ne i enzime CYP1A, pa stoga nije potrebno prilagoditi dozu u pušača.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva logo
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Zentiva logo
English: Patients treated with any antipsychotics, including aripiprazole, 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 (see section 4.8).
Croatian: Bolesnici liječeni bilo kojim antipsihoticima, uključujući aripiprazol, moraju se motriti zbog moguće pojave znakova i simptoma hiperglikemije (kao što su polidipsija, poliurija, polifagija i slabost), a bolesnike sa šećernom bolešću ili rizičnim čimbenicima za šećernu bolest moraju se redovito kontrolirati zbog mogućeg pogoršanja regulacije glukoze (vidjeti dio 4.8).
English: In a clinical trial in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63% and 37%, respectively.
Croatian: U kliničkim ispitivanjima sa zdravim ispitanicima, jaki inhibitor CYP3A4 (ketokonazol) povisio je AUC aripiprazola za 63 %, a Cmax za 37 %.
English: 49 orodispersible tablets
Croatian: 49 raspadljivih tableta za usta
English: 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.
Croatian: U drugom ispitivanju od 12 tjedana, incidencija EPS-a bila je 26,6 % u bolesnika liječenih aripiprazolom i 17,6 % u onih liječenih litijem.