natgillin/translations-raw huggingface dataset:
PA/Alu/PVC- Aluminium foil perforated blisters (alu-alu blister) in cartons of 14, 28, 56 and 98 tablets and 28 x 1 tablets (unit dose)
PA/Alu/PVC -Aluminijski folija perforirani blisteri (alu-alu blisteri) djeljivi na jedinične kutijama s 14 28, 56, 98, 28 x 1 tabletom.
In adults it also prevents this condition from returning in patients who have responded to the treatment with Aripiprazole Mylan Pharma.
Aripiprazole Mylan Pharma također sprječava povratak takvog stanja u odraslih bolesnika koji su prethodno imali odgovor na liječenje lijekom Aripiprazole Mylan Pharma.
In CYP2D6 poor metabolisers, concomitant use of strong inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.
U sporih CYP2D6 metabolizatora, istodobna uporaba jakih inhibitora CYP3A4 može rezultirati višim koncentracijama aripiprazola u plazmi u odnosu na one u brzih CYP2D6 metabolizatora.
Aripiprazole dose should be reduced to approximately one-half of its prescribed dose when concomitant administration of aripiprazole with quinidine occurs.
Doza aripiprazola mora se smanjiti na otprilike polovicu propisane doze kad se primjenjuje istodobno s kinidinom.
In paediatric clinical trials of aripiprazole akathisia and Parkinsonism were observed.
U pedijatrijskim kliničkim ispitivanjima aripiprazola primijećeni su akatizija i parkinsonizam.
Population pharmacokinetic evaluation showed no evidence of race-related differences on the pharmacokinetics of aripiprazole.
Populacijska farmakokinetička procjena nije dala nikakve dokaze da postoje razlike povezane s rasom u farmakokinetici aripiprazola.
When aripiprazole was administered concomitantly with either valproate, lithium or lamotrigine, there was no clinically important change in valproate, lithium or lamotrigine concentrations.
Kad se aripiprazol primjenjivao istodobno s valproatom, litijem ili lamotriginom, nije bilo klinički važnih promjena u koncentracijama valproata, litija ni lamotrigina.
There are no differences in the pharmacokinetics of aripiprazole between healthy male and female subjects nor is there any detectable effect of gender in a population pharmacokinetic analysis in schizophrenic patients.
Ne postoje razlike u farmakokinetici aripiprazola između zdravih ispitanika muškog i ženskog spola, niti postoji ikakav prepoznatljiv učinak spola u populacijskoj farmakokinetičkoj analizi u bolesnika sa shizofrenijom.
An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of hydroxy metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 to 125 mg/kg/day (1 to 3 times the mean steady-state AUC at the maximum recommended clinical dose or 16 to 81 times the maximum recommended human dose based on mg/m2).
Dodatni nalaz bio je kolelitijaza kao posljedica precipitacije sulfatnih konjugata hidroksi metabolita aripiprazola u žuči majmuna nakon ponovljenih peroralnih doza od 25 do 125 mg/kg/dan (1 do 3 puta veća od srednje vrijednosti AUC-a u stanju dinamičke ravnoteže pri maksimalnoj preporučenoj kliničkoj dozi ili 16 do 81 puta veća od maksimalne preporučene doze za ljude temeljene na mg/m2).
Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
U bolesnika liječenih aripiprazolom prijavljeni su slučajevi serotoninskog sindroma, a mogući znakovi i simptomi ovog stanja osobito se mogu pojaviti u slučajevima istodobne primjene drugih serotonergičkih lijekova, kao što su selektivni inhibitori ponovne pohrane serotonina (SSRI)/selektivni inhibitori ponovne pohrane serotonina i noradrenalina (SNRI), odnosno lijekova za koje se zna da povećavaju koncentraciju aripiprazola (vidjeti dio 4.8).
Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension
Vaskularni poremećaji ortostatska hipotenzija venska tromboembolija (uključujući plućnu emboliju i duboku vensku trombozu) hipertenzija sinkopa
When concomitant administration of ketoconazole with aripiprazole occurs, aripiprazole dose should be reduced to approximately one-half of its prescribed dose.
Kad se aripiprazol primjenjuje zajedno s ketokonazolom, doza aripiprazola mora se smanjiti na otprilike polovicu propisane doze.
Aripiprazole is excreted in human milk.
Aripiprazol se izlučuje u majčino mlijeko u ljudi.
Greece or
Grčka ili
Aripiprazole was also studied in a placebo-controlled, long-term maintenance trial.
Aripiprazol je ispitivan i u placebom kontroliranom ispitivanju dugotrajnog praćenja.
These included: dose-dependent adrenocortical toxicity (lipofuscin pigment accumulation and/or parenchymal cell loss) in rats after 104 weeks at 20 to 60 mg/kg/day (3 to 10 times the mean steady-state AUC at the maximum recommended human dose) and increased adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats at 60 mg/kg/day (10 times the mean steady-state AUC at the maximum recommended human dose).
Oni su uključivali adrenokortikalnu toksičnost ovisnu o dozi (akumulacija pigmenta lipofuscina i/ili gubitak stanica parenhima) u štakora nakon 104 tjedna primjene doze od 20 do 60 mg/kg/dan (3 do 10 puta veća od srednje vrijednosti AUC-a u stanju dinamičke ravnoteže pri maksimalnoj preporučenoj dozi za ljude) i povišenu učestalost adrenokortikalnih karcinoma te kombinaciju adrenokortikalnih adenoma/karcinoma u ženki štakora koje su primale dozu od 60 mg/kg/dan (10 puta veća od srednje vrijednosti AUC-a u stanju dinamičke ravnoteže pri maksimalnoj preporučenoj dozi za ljude).
Aripiprazole was superior to placebo in change from baseline at week 4 and at week 12 on the Y-MRS total score.
Aripiprazol je bio superioran u odnosu na placebo kada je u pitanju promjena ukupnog Y-MRS rezultata u 4. i 12. tjednu u odnosu na početnu vrijednost.
Concomitant administration of aripiprazole and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
Slični učinci mogu se očekivati i kod istodobne primjene aripiprazola i drugih jakih induktora CYP3A4 (kao što su rifampicin, rifabutin, fenitoin, fenobarbital, primidon, efavirenz, nevirapin i gospina trava) pa se stoga moraju provesti slična povećanja doza.
Stabilized patients were then randomised to continue the same mood stabilizer with double-blind aripiprazole or placebo.
Stabilizirani bolesnici su zatim randomizirani u dvostruko slijepo ispitivanje u kojem su nastavili primati isti stabilizator raspoloženja u kombinaciji s aripiprazolom ili placebom.
If signs and symptoms of other EPS appear in a patient taking aripiprazole, dose reduction and close clinical monitoring should be considered.
Ako se u bolesnika koji uzimaju aripiprazolpojave znakovi i simptomi ekstrapiramidnih simptoma, treba razmotriti smanjenje doze i strog klinički nadzor.
Aripiprazole is the predominant medicinal product moiety in systemic circulation.
Aripiprazol je prevladavajući oblik lijeka u sistemskoj cirkulaciji.
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.
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 nadmoćnim u odnosu na placebo u prevenciji ponavljanja bipolarnog poremećaja, prvenstveno u prevenciji ponavljanja manije, ali nije se pokazao nadmoćnim u odnosu na placebo u prevenciji ponavljanja depresije.
Mean weight gain in the 30 weeks treatment-interval was 2.9 kg as compared to 0.98 kg in patients treated with placebo.
Srednja vrijednost povećanja tjelesne težine tijekom 30-tjednog razdoblja liječenja iznosila je 2,9 kg u usporedbi s 0,98 kg u bolesnika koji su primali placebo.
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
JEDINSTVENA IDENTIFIKACIJSKA OZNAKA - PODACI RAZUMLJIVI ČOVJEKU
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.
U placebom kontroliranom ispitivanju, koje je trajalo 52 tjedna, u bolesnika s trenutno prisutnim maničnim ili miješanim epizodama bipolarnog poremećaja tipa 1, koji su postigli kontinuiranu remisiju (Y-MRS i MADRS ukupni rezultat ≤ 12) s aripiprazolom (10 mg/dan do 30 mg/dan) kao adjuvantnom terapijom uz litij ili valproat tijekom 12 uzastopnih tjedana, adjuvantna terapija aripiprazolom pokazala je nadmoć 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 nadmoć u odnosu na placebo u prevenciji ponavljanja depresije.
Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is administered in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as sedation (see section 4.8).
S obzirom na primarne učinke aripiprazola na središnji živčani sustav (SŽS), nužan je oprez kad se aripiprazol primjenjuje u kombinaciji s alkoholom ili drugim lijekovima koji djeluju na SŽS i čije se nuspojave, kao što je sedacija, preklapaju (vidjeti dio 4.8).
Aripiprazole should be used with caution in patients with a family history of QT prolongation (see section 4.8).
Aripiprazol se mora koristiti s oprezom u bolesnika koji u obiteljskoj anamnezi imaju produljenje QT intervala (vidjeti dio 4.8).
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 (section 5.1).
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 početim vrijednostima (dio 5.1).
When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
Kad se razmatra mogućnost istodobne primjene ketokonazola ili drugih jakih inhibitora enzima CYP3A4 s aripiprazolom, moguća korist od istodobne primjene mora nadmašivati moguće rizike za bolesnika.
In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
U kliničkim ispitivanjima prijavljeni su rijetki slučajevi NMS-a tijekom liječenja aripiprazolom.
Impulse control disorders may result in harm to the patient and others if not recognised.
Ako se ne prepoznaju, poremećaji kontrole nagona mogu naškoditi kako bolesniku, tako i drugima.
BGP Products UAB Tel: +370 5 205 1288
BGP Products UAB Tel: +370 5 205 1288 (Jungtinė Karalystė)
In a clinical trial in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63 % and 37 %, respectively.
U kliničkim ispitivanjima sa zdravim ispitanicima, jaki inhibitor CYP3A4 (ketokonazol) povisio je AUC aripiprazola za 63 %, a Cmax za 37 %.
In the placebo-controlled trials, the mean weight gain was 0.4 kg for placebo and 1.6 kg for aripiprazole.
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.
The total body clearance of aripiprazole is 0.7 ml/min/kg, which is primarily hepatic.
Ukupni klirens aripiprazola iz tijela je 0,7 ml/min/kg i primarno se odvija putem jetre.
In a 60- to 89-week, randomised, double-blind, placebo-controlled trial in adolescent subjects (n = 146; ages 13-17 years) with schizophrenia, there was a statistically significant difference in the rate of relapse of psychotic symptoms between the aripiprazole (19.39 %) and placebo (37.50 %) groups.
U randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 60 do 89 tjedana na adolescentnim bolesnicima (n = 146, u dobi od 13 do 17 godina) sa shizofrenijom, postojala je statistički značajna razlika stope relapsa psihotičnih simptoma između skupine koja je primala aripiprazol (19,39 %) i one koja je primala placebo (37,50 %).
Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures (see section 4.8).
Stoga se aripiprazol mora koristiti s oprezom u bolesnika koji u povijesti bolesti imaju konvulzivni poremećaj ili imaju stanja povezana s napadajima (vidjeti dio 4.8).
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 open-label trial.
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.
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.
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.
What Aripiprazole Mylan Pharma is and what it is used for
Što je Aripiprazole Mylan Pharma i za što se koristi
Dizziness and vision problems may occur during treatment with this medicine (see section 4).
Tijekom liječenja ovim lijekom mogu se javiti omaglica i problemi s vidom (vidjeti dio 4.).
The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively.
AUC dehidro-aripiprazola, djelatnog metabolita, smanjio se za 32 %, a Cmax za 47 %.
In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point was weight gain, significantly less patients had at least 7 % weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of~80.5 kg) on aripiprazole (n = 18, or 13 % of evaluable patients), compared to olanzapine (n = 45, or 33 % of evaluable patients).
U 26-tjednom, olanzapinom kontroliranom, dvostruko slijepom, multinacionalnom ispitivanju shizofrenije koje je uključilo 314 odraslih bolesnika i gdje je primarna mjera ishoda bilo povećanje tjelesne težine, značajno manje bolesnika imalo je povećanje tjelesne težine od najmanje 7 % u odnosu na početnu vrijednost (tj. prirast od najmanje 5,6 kg na prosječnu početnu težinu od ~80,5 kg) u skupini na aripiprazolu (n = 18, ili 13 % bolesnika koji su se mogli procijeniti) u usporedbi sa skupinom koja je uzimala olanzapin (n = 45, ili 33 % bolesnika koji su se mogli procijeniti).
What you need to know before you take Aripiprazole Mylan Pharma
Što morate znati prije nego počnete uzimati Aripiprazole Mylan Pharma
Common side effects (may affect up to 1 in 10 people):
Česte nuspojave (mogu se javiti u do 1 na 10 osoba): šećerna bolest,
Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated although individual patients may benefit from a higher dose.
Nije se pokazalo da dnevne doze veće od 10 mg imaju veću djelotvornost, premda pojedinim bolesnicima može koristiti viša doza.
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 (≥ 1/100,
Sigurnosni profil dugotrajnog, dvostruko slijepog, placebom kontroliranog ispitivanja bio je sličan osim u slučaju sljedećih reakcija koje su prijavljene češće nego u pedijatrijskih bolesnika koji su uzmali placebo: smanjenje tjelesne težine, povećanje razine inzulina u krvi, aritmija i leukopenija vrlo su često prijavljene nuspojave (≥ 1/100, < 1/10).
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).
U tim istim ispitivanjima, u bolesnika (prosječna dob: 84 godine; raspon: 78-88 godina) su bile prijavljene cerebrovaskularne nuspojave (npr. moždani udar, tranzitorna ishemijska ataka), uključujući i smrtne slučajeve.
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.
Kad se je istodobno s aripiprazolom primjenjivao valproat ili litij nije bilo klinički značajne promjene u koncentracijama aripiprazola, stoga nije potrebna prilagodba doze kad se valproat ili litij primjenjuje uz aripiprazol.
The incidence of hyperprolactinaemia or increased serum prolactin in patients treated with aripiprazole (0.3 %) was similar to that of placebo (0.2 %).
Pojava hiperprolaktinemije ili povećanog prolaktina u serumu u bolesnika liječenih aripiprazolom (0,3 %) bila je slična rezultatima placebo ispitivanja (0,2 %).
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 (greater than 1 in 10 patients) 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 (greater than 1 in 100 patients).
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 (više od 1 na 10 bolesnika), 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 (više od 1 na 100 bolesnika).
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.
Kad se slabi inhibitori CYP3A4 (npr., diltiazem) ili CYP2D6 (npr., escitalopram) koriste istodobno s aripiprazolom, mogu se očekivati umjerena povišenja koncentracije aripiprazola u plazmi.
Aripiprazole doses ranging from 0.5 to 30 mg administered once a day to healthy subjects for 2 weeks produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand, to the caudate and putamen detected by positron emission tomography.
Doze aripiprazola u rasponu od 0,5 do 30 mg primijenjene jedanput dnevno u zdravih ispitanika tijekom 2 tjedna proizvele su o dozi ovisno smanjenje vezivanja 11C-rakloprida, liganda D2/D3
Blood glucose increased Glycosylated haemoglobin increased Blood glucose fluctuation Increased creatine phosphokinase
Pretrage povišena razina glukoze u krvi povišeni glikosilizirani hemoglobin oscilacija razina glukoze u krvi povišena razina kreatin fosfokinaze
Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria)
Poremećaji imunološkog sustava alergijske reakcije (npr. anafilaktička reakcija, angioedem i oticanje jezika, edem jezika, edem lica, svrbež ili urtikarija)
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.
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, 34 % u skupini koja je uzimala aripiprazol u odnosu na 57 % u skupini koja je primala placebo.
Enhanced efficacy at doses higher than a daily dose of 15 mg has not been demonstrated although individual patients may benefit from a higher dose.
Nije se pokazalo da doze veće od 15 mg dnevno imaju veću djelotvornost, premda više doze mogu koristiti pojedinim bolesnicima.
In schizophrenia patients the incidence of akathisia was 6.2 % with aripiprazole and 3.0 % with placebo.
U bolesnika sa shizofrenijom, incidencija akatizije bila je 6,2 % uz aripiprazol i 3,0 % uz placebo.
Schizophrenia: the recommended starting dose for aripiprazole 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.
Shizofrenija: preporučena početna doza za Aripiprazole Mylan Pharma je 10 ili 15 mg/dan uz dozu održavanja od 15 mg/dan koja se primjenjuje jedanput dnevno neovisno o obrocima.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Uz primjenu antipsihotika prijavljeni su slučajevi venske tromboembolije (VTE).
Aripiprazole demonstrated statistically superior efficacy compared to placebo on the Aberrant Behaviour Checklist Irritability subscale.
Aripiprazol je bio statistički djelotvorniji u usporedbi s placebom prema rezultatima na podljestvici Razdražljivosti ABC ljestvice (engl.
Aripiprazole Mylan Pharma contains maltose
Aripiprazole Mylan Pharma sadrži maltozu
Manic episodes in Bipolar I Disorder: the recommended starting dose for aripiprazole is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Manične epizode u bipolarnom poremećaju tipa I: preporučena početna doza za Aripiprazole Mylan Pharma je 15 mg i primjenjuje se jedanput dnevno neovisno o obrocima u obliku monoterapije ili kombinirane terapije (vidjeti dio 5.1).
Aripiprazole Mylan Pharma tablets contain maltose.
Aripiprazole Mylan Pharma tablete sadrže maltozu.