natgillin/translations-raw huggingface dataset:
10 tablets 14 tablets 16 tablets 28 tablets 30 tablets 35 tablets 56 tablets 70 tablets 
10 tableta 14 tableta 16 tableta 28 tableta 30 tableta 35 tableta 56 tableta 70 tableta
CZ-140 00 Praha 4 - Nusle 
Na Pankráci 1724/129 CZ-140 00 Praha 4 - Nusle
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.
Increased Alanine Aminotransferase (ALT) Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase 
Poremećaji jetre i žuči zatajenje jetre hepatitis žutica povišene vrijednosti alanin aminotransferaze (ALT) povišene vrijednosti aspartat aminotransferaze (AST) povišene vrijednosti gama-glutamil transferaze (GGT) povišene vrijednosti alkalne fosfataze
Blood pressure-lowering medicines: Aripiprazole Sandoz may increase the effect of medicines used to lower the blood pressure. 
Sandoz može pojačati učinak lijekova koji se koriste za snižavanje krvnog tlaka.
Serotonin syndrome 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).
Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets Blister packs in cartons: 10, 14, 16, 28, 30, 35, 56, 70 tablets Blister packs (unit dose) in cartons: 14 x 1, 28 x 1, 49 x 1, 56 x 1, 98 x 1 tablet Bottle packs in cartons: 100 tablets 
Aripiprazol Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablete Blisteri u kartonskoj kutiji: 10, 14, 16, 28, 30, 35, 56 i 70 tableta Blisteri (djeljivi na jedinične doze) u kartonskoj kutiji: 14 x 1, 28 x 1, 49 x 1, 56 x 1, 98 x 1 tableta Boca u kartonskoj kutiji: 100 tableta
Aripiprazole dose should be doubled when concomitant administration of aripiprazole occurs with carbamazepine. 
Doza lijeka aripiprazol mora se udvostručiti kad se uz aripiprazol istodobno primjenjuje karbamazepin.
Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Sandoz without first consulting your doctor. 
Čak i ako se osjećate bolje, nemojte mijenjati dozu niti prekidati svakodnevno uzimanje lijeka Aripiprazol
LIST OF EXCIPIENTS Also contains: lactose monohydrate. 
Također sadrži: laktozu hidrat.
Aripiprazole group showed animprovement of 14.97 on TTS-YGTSS change from baseline to week 10 as compared with an improvement of 9.62 in the placebo group. 
Skupina koja je primala aripiprazol pokazala je poboljšanje od 14,97 na ljestvici TTS-YGTSS od početne vrijednosti do one u 10. tjednu u usporedbi s poboljšanjem od 9,62 u skupini koja je primala placebo.
Aluminium//Aluminium unit dose blisters packed in cartons containing 14 x 1, 28 x 1, 49 x 1, 56 x 1 or 98 x 1 tablet. 
Aluminij/aluminij blisteri djeljivi na jedinične doze pakirani su u kutije koje sadrže 14 x 1, 28 x 1, 49 x 1, 56 x 1 ili 98 x 1 tableta.
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. 
• određene lijekove za liječenje HIV-infekcije (kao što su efavirenz, nevirapin, inhibitori proteaze, npr. indinavir, ritonavir)
The 5 mg, 10 mg, 15 mg and 30 mg tablets are supplied in the following presentations: Aluminium//Aluminium blisters packed in cartons containing 10, 14, 16, 28, 30, 35, 56 or 70 tablets. 
5 mg, 10 mg, 15 mg i 30 mg tablete su dostupne u sljedećim oblicima pakiranja: Aluminij/aluminij blisteri pakirani u kutije koje sadrže 10, 14, 16, 28, 30, 35, 56 ili 70 tableta.
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital) 
• antikonvulzive koji se primjenjuju za liječenje epilepsije (kao što su karbamazepin, fenitoin, fenobarbital)
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).
Other medicines and Aripiprazole Sandoz 
Drugi lijekovi i Aripiprazol Sandoz
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 lijeka aripiprazol mora se smanjiti na otprilike polovicu propisane doze.
What you need to know before you take Aripiprazole Sandoz 
Što morate znati prije nego počnete uzimati Aripiprazol
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, < 1/10). 
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.
These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole Sandoz, you should see your doctor. 
Ovi lijekovi mogu povećati rizik od nuspojava; ako dobijete ikakve neobične simptome dok uzimate neki od ovih lijekova zajedno s lijekom Aripiprazol
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 lijekom aripiprazol, moguća korist od istodobne primjene mora nadmašivati moguće rizike za bolesnika.
Aripiprazole Sandoz tablets contain lactose. 
Sandoz tablete sadrže laktozu.
Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria) 
Poremećaji imunološkog sustava alergijska reakcija (npr. anafilaktička reakcija, angioedem uključujući otečen jezik, edem jezika, edem lica, svrbež i urtikariju)
What Aripiprazole Sandoz is and what it is used for 
Sandoz i za što se koristi
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 flexibledose (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.
Therefore, Aripiprazole Sandoz is not recommended for use in patients below 13 years of age (see sections 4.8 and 5.1). 
Sandoz ne preporučuje za primjenu u bolesnika mlađih od 13 godina (vidjeti dijelove 4.8 i
If you stop taking Aripiprazole Sandoz 
Ako prestanete uzimati Aripiprazol
Developmental toxicity, including dosedependent delayed foetal ossification and possible teratogenic effects, were observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures 3 and 11 
Razvojna toksičnost, uključujući odgođenu fetalnu osifikaciju ovisnu o dozi i moguće teratogene učinke, bila je primijećena u štakora pri dozama koje su izazvale subterapijsku izloženost (na temelju AUC-a) i u kunića pri dozama koje su izazvale izloženost 3 i 11 puta veću od srednje vrijednosti AUC-a u stanju dinamičke ravnoteže uz maksimalnu preporučenu kliničku dozu.
If you have the impression that the effect of Aripiprazole Sandozis too strong or too weak, talk to your doctor or pharmacist. 
Sandoz prejak ili preslab, obratite se svom liječniku ili ljekarniku.
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.
• difficulty sleeping, 
• šećerna bolest, • poteškoće sa spavanjem,
Population pharmacokinetic evaluation has revealed no evidence of clinically significant effects from smoking on the pharmacokinetics of aripiprazole. 
Pušenje Procjenom populacijske farmakokinetike nije se otkrio dokaz klinički učinaka pušenja na farmakokinetiku aripiprazola.
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): 
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):
Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n=99, placebo: n=44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weightbased treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg. 
Tikovi povezani s Touretteovim poremećajem u pedijatrijskih bolesnika (vidjeti dio 4.2) Djelotvornost aripiprazola bila je ispitana u pedijatrijskih ispitanika s Touretteovim sindromom (aripiprazol: n = 99, placebo: n = 44) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 8 tjedana u kojem su terapijske skupine primale fiksne doze na temelju tjelesne težine u rasponu od 5 mg na dan do 20 mg na dan, uz početnu dozu od 2 mg.
• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, 
• ukočenosti mišića i omamljenosti ili pospanosti, usporeno disanje, gušenje, visok ili nizak krvni tlak, abnormalni srčani ritam.
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. 
I jest da je ono posredovano kombinacijom djelomičnog agonizma s dopaminskim D2 i serotoninskim 5HT1a receptorima i antagonizma sa serotoninskim 5HT2a receptorima.
Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets High density polyethylene (HDPE) tablet container (bottle) containing a silica gel desiccant and a polyester coil. 
Aripiprazol Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablete Spremnik (boca) od polietilena visoke gustoće (HDPE) za tablete, koji sadrži silika gel kao sredstvo za sušenje i poliestersku vaticu.
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 lijekom aripiprazol, mogu se očekivati mala povišenja koncentracije aripiprazola u plazmi.
It may harm them, even iftheirsignsof illnessarethesameasyours. 
Može im štetiti, čak i ako su njihovi znakovi bolesti jednaki Vašima.
Despite the high comorbidity frequency of Bipolar I Disorder and ADHD, very limited safety data are available on concomitant use of aripiprazole and stimulants; therefore, extreme caution should be taken when these medicinal products are co-administered. 
I i ADHD-a, dostupno je vrlo malo podataka o sigurnosti istodobne primjene lijeka aripiprazol i stimulansa; stoga je potreban izniman oprez kod istodobne primjene tih dvaju lijekova.
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 početnim vrijednostima (dio
The 20 mg tablets are supplied in Aluminium//Aluminium blisters packed in cartons containing 14, 28, 49, 56 or 98 tablets. 
20 mg tablete dostupne su u aluminij/aluminij blisterima pakiranima u kutije koje sadrže 14, 28, 49, 56 ili 98 tableta.
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 u bipolarnom poremećaju tipa I: u kontroliranom ispitivanju u trajanju od 12 tjedana, incidencija EPS-a bila je 23,5 % u bolesnika liječenih aripiprazolom i 53,3 % u bolesnika liječenih haloperidolom.
It is important that you carry on taking your Aripiprazole Sandoz for as long as your doctor has told you to. 
Sandoz onoliko dugo koliko Vam je to rekao Vaš liječnik.
• triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, 
• triptani, tramadol i triptofan koji se primjenjuju u stanjima koja uključuju depresiju,
• antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, 
• antidepresive ili biljne lijekove koji se primjenjuju za liječenje depresije i tjeskobe (kao što su fluoksetin, paroksetin, venlafaksin, gospina trava)
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, 
• serotoninski sindrom (reakcija koje može dovesti do osjećaja velike sreće, omamljenosti, nespretnosti, nemira, osjećaja pijanstva, vrućice, znojenja ili ukočenih mišića),
Overall, 1.3% of aripiprazoletreated patients reported cerebrovascular adverse reactions compared with 0.6% of placebo-treated patients in these trials. 
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.
55 Nikola Vaptzarov blvd. 
Regulatory Affairs Department Representative Office Sandoz d.d. 55 Nikola Vaptzarov blvd.
Upon discontinuation of the CYP2D6 or CYP3A4 inhibitor, the dosage of aripiprazole should be increased to the level prior to the initiation of the concomitant therapy. 
Nakon prekida primjene inhibitora CYP2D6 ili CYP3A4, dozu lijeka aripiprazol mora se povisiti na razinu kakva je bila prije započinjanja istodobne terapije tim lijekovima.
The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole Sandoz in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. 
Sandoz u posljednjem tromjesečju (posljednja tri mjeseca trudnoće): tresavica, ukočenost i/ili slabost mišića, pospanost, uznemirenost, tegobe s disanjem i poteškoće s hranjenjem.
The efficacy of aripiprazole in paediatric subjects with Tourette's syndrome (aripiprazole: n=32, placebo: n=29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in South-Korea. 
Djelotvornost aripiprazola također je bila procijenjena u fleksibilnom rasponu doza od 2 mg na dan do 20 mg na dan uz početnu dozu od 2 mg u pedijatrijskih ispitanika s Touretteovim sindromom (aripiprazol: n = 32, placebo: n = 29) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 10 tjedana provedenom u Južnoj Koreji.
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0%), extrapyramidal disorder (18.4%), akathisia (16.0%), and fatigue (11.8%); and commonly (≥ 1/100, < 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia. 
I bile su slične onima u odraslih bolesnika, osim sljedećih nuspojava: vrlo često (≥ 1/10) somnolencija (23,0 %), ekstrapiramidni poremećaj (18,4 %), akatizija (16,0 %) i umor (11,8 %); te često (≥ 1/100, < 1/10) bol u gornjem dijelu abdomena, ubrzan srčani ritam, povećanje tjelesne težine, pojačan tek, trzanje mišića i diskinezija.
which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately), 
• krvni ugrušci u venama osobito nogu (simptomi uključuju oticanje, bol i crvenilo noge), koji mogu putovati kroz krvne žile do pluća i tamo prouzročiti bol u prsištu i otežano disanje (ako primijetite neki od navedenih simptoma, odmah potražite liječničku pomoć);
If you take more Aripiprazole Sandoz than you should If you realise you have taken more Aripiprazole Sandoz than your doctor has recommended (or if someone else has taken some of your Aripiprazole Sandoz), contact your doctor right away. 
Sandoz tableta nego što Vam je preporučio liječnik (ili ako je neka druga osoba popila dio Vašeg lijeka Aripiprazol
Schizophrenia: the recommended starting dose for Aripiprazole Sandoz 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. 
Sandoz je 10 ili 15 mg/dan uz dozu održavanja od 15 mg/dan koja se primjenjuje jedanput dnevno neovisno o obrocima.
Aripiprazole Sandoz with food, drink and alcohol This medicine can be taken regardless of meals. 
Sandoz tablete s hranom, pićem i alkoholom
Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1). 
I te za prevenciju nove manične epizode u odraslih osoba s pretežno maničnim epizodama u kojih su prethodne manične epizode odgovorile na liječenje aripiprazolom (vidjeti dio 5.1).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTERS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE ZA BLISTER
Aripiprazole Sandoz is for oral use. 
Sandoz namijenjen je za peroralnu primjenu.
On the basis of the scientific conclusions for aripiprazole the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aripiprazole is unchanged subject to the proposed changes to the product information. 
Na temelju znanstvenih zaključaka za aripiprazol, CHMP smatra da je omjer koristi i rizika lijeka(ova)
Manic episodes in Bipolar I Disorder in children and adolescents Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents (1017 years), who met DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS score ≥ 20 at baseline. 
I u djece i adolescenata Aripiprazol se ispitivao u 30-tjednom placebom kontroliranom ispitivanju u kojem je sudjelovalo 296 djece i adolescenata (10-17 godina) koji su zadovoljavali DSM-IV kriterije za bipolarni poremećaj tipa
In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapinetreated patients. 
U drugom dugotrajnom kontroliranom ispitivanju od 26 tjedana, incidencija EPS-a bila je 14,8 % u bolesnika liječenih aripiprazolom i 15,1 % u bolesnika liječenih olanzapinom.
Excipient(s) with known effect 132.33 mg lactose monohydrate per tablet. 
Pomoćna(e) tvar(i) s poznatim učinkom 132,33 mg laktoze hidrata po tableti.
Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension 
Krvožilni poremećaji ortostatska hipotenzija venska tromboembolija (uključujući plućnu emboliju i
18 years and presented an average score of 29 on TTS-YGTSS at baseline. 
Bolesnici su bili u dobi od 6 do 18 godina i imali su prosječno 29 bodova na ljestvici TTS-YGTSS na početku ispitivanja.
Tics associated with Tourette's disorder: the safety and efficacy of Aripiprazole Sandoz in children and adolescents 6 to 18 years of age have not yet been established. 
Sandoz u djece i adolescenata u dobi od 6 do 18 godina nisu još ustanovljene.
: + 359 2 970 47 47 regaffairs.bg@sandoz.com 
1407 Sofia, Bulgaria Teл.: + 359 2 970 47 47 regaffairs.bg@sandoz.com
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE ZA BLISTERE
Excipient(s) with known effect 71.02 mg lactose monohydrate per tablet. 
Pomoćna(e) tvar(i) s poznatim učinkom 71,02 mg laktoze hidrata po tableti.
Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets After first opening of the bottle: 3 months 
Aripiprazol Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablete