natgillin/translations-raw huggingface dataset:
Aripiprazole Sandoz contains the active substance aripiprazole and belong to a group of medicines called antipsychotics. 
Zdravilo Aripiprazol Sandoz vsebuje učinkovino aripiprazol in spada v skupino zdravil, imenovanih antipsihotiki.
In adults it also prevents this condition from returning in patients who have responded to the treatment with Aripiprazole Sandoz. 
Zdravilo tudi preprečuje ponovitve bolezni pri odraslih bolnikih, ki so se odzvali na zdravljenje z zdravilom Aripiprazol Sandoz.
Following any confirmed or suspected overdose with aripiprazole, close medical supervision and monitoring should continue until the patient recovers. 
Po vsakem potrjenem prevelikem odmerjanju ali sumu na preveliko odmerjanje aripiprazola je potreben skrben zdravniški nadzor in spremljanje, dokler si bolnik ne opomore.
Orodispersible tablets or oral solution may be used as an alternative to Aripiprazole Sandoz tablets for patients who have difficulty swallowing Aripiprazole Sandoz tablets (see section 5.2). 
Orodisperzibilne tablete ali peroralna raztopina se lahko uporabijo kot alternativa tabletam Aripiprazol Sandoz pri bolnikih, ki tablete Aripiprazol Sandoz težko pogoltnejo (glejte poglavje 5.2)
Aripiprazol may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls. 
Aripiprazol lahko povzroči somnolenco, posturalno hipotenzijo, motorično in senzorično nestabilnost, ki lahko privedejo do padcev.
It is important that you carry on taking your Aripiprazole Sandoz for as long as your doctor has told you to. 
Pomembno je, da zdravljenje z zdravilom Aripiprazol Sandoz nadaljujete tako dolgo, kot vam je svetoval zdravnik.
• blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots 
• imate krvne strdke ali težave s krvnimi strdki v družini, antipsihotike namreč povezujejo z nastajanjem krvnih strdkov,
Treatment should be initiated at 2 mg (using an appropriate aripiprazole containing medicinal product) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg. 
Zdravljenje je treba uvesti v odmerku 2 mg (z uporabo ustreznega zdravila, ki vsebuje aripiprazol), ki ga bolnik jemlje 2 dni, nato pa se odmerek poveča do odmerka 5 mg, ki ga bolnik jemlje še dodatna 2 dni.
In three placebo-controlled trials (n=938; mean age: 82.4 years; range: 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. 
V treh s placebom nadzorovanih preskušanjih (n = 938, povprečna starost: 82,4 leta, razpon: 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.
Therefore, Aripiprazole Sandoz is not recommended for use in patients below 13 years of age (see sections 4.8 and 5.1). 
Uporabe zdravila Aripiprazol Sandoz se zato pri bolnikih, mlajših od 13 let, ne priporoča (glejte poglavji 4.8 in 5.1).
In contrast the 95% confidence interval for the HR in the older subgroup (aripiprazole, n = 69; placebo, n = 36) was 0.242 to 0.879 and hence a treatment effect could be concluded in the older patients. 
V nasprotju s tem je bil 95% interval zapanja za RO pri starejši podskupini (aripiprazol, n = 69; placebo, n = 36) od 0,242 do 0,879, tako da je pri starejših bolnikih mogoče sprejeti zaključek o učinkovitosti zdravljenja.
To allow the start of the treatment at a low dose you can use an alternative formulation (oral solution - liquid) more suitable than Aripiprazole Sandoz tablets. 
Zdravnik lahko predpiše to zdravilo v majhnem začetnem odmerku v drugi obliki (peroralna raztopina - tekočina), ki je bolj primerna kot Aripiprazol Sandoz.
Taking Aripiprazole Sandoz with some medicines may mean the doctor will need to change your dose of Aripiprazole Sandoz or the other medicines. 
Če jemljete zdravilo Aripiprazol Sandoz z nekaterimi drugimi zdravili, bo morda zdravnik moral spremeniti vaš odmerek zdravila Aripiprazol Sandoz ali drugih zdravil.
Patients treated with any antipsychotic, 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). 
Bolnike, ki dobivajo kateri koli antipsihotik, vključno z aripiprazolom, je treba opazovati glede znakov in simptomov hiperglikemije (npr. polidipsije, poliurije, polifagije in šibkosti); bolnike s sladkorno boleznijoali dejavniki tveganja zanjo pa je treba redno nadzirati, da bi odkrili poslabšanje urejenosti glukoze (glejte poglavje 4.8).
United Kingdom Sandoz Limited Frimley Business Park Camberley, GU16 7SR, UK Tel: + 44 1276 698020 uk.regaffairs@sandoz.com 
Frimley Business Park Camberley, GU16 7SR, UK Tel: + 44 1276 698020 uk.regaffairs@sandoz.com
The total body clearance of aripiprazole is 0.7 ml/min/kg, which is primarily hepatic. 
Celotni telesni očistek aripiprazola je 0,7 ml/min/kg in je v prvi vrsti jetrni.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 
Druga zdravila in zdravilo Aripiprazol Sandoz Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. 
• določena zdravila za zdravljenje okužbe s HIV (kot so efavirenz, nevirapin, zaviralci proteaz,
What Aripiprazole Sandoz tablets are and what they are used for What you need to know before you take Aripiprazole Sandoz tablets How to take Aripiprazole Sandoz tablets Possible side effects 
Kaj je zdravilo Aripiprazol Sandoz in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Aripiprazol Sandoz Kako jemati zdravilo Aripiprazol Sandoz Možni neželeni učinki
There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. 
Poročali so o agitaciji, hipertoniji, hipotoniji, tremorju, somnolenci, respiratorni stiski in motnjah pri hranjenju.
obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain 
generalizirano anksiozno motnjo, obsesivno-kompulzivno motnjo (OCD) in socialno fobijo, kot tudi za migrene in bolečine,
Packsizes: 
Velikosti pakiranj:
87 cases had medical history of confounding risk factors such as balance disorders, loss of consciousness, syncope, somnolence, extrapyramidal disorder, femoral fracture, alcohol abuse, bundle branch block, osteoporosis, knee arthroplasty, spinal fusion surgery, road traffic accident, fall, transient ischemic attack, cerebrovascular accident, head injury and dementia with Lewy bodies and concomitant therapy with risperidone, quetiapine fumarate, clonazepam, Latuda, valium was a confounding factor in 172 cases. 
87 primerov je imelo anamnezo motečih dejavnikov tveganja, kot so motnje ravnovesja, izguba zavesti, sinkopa, somnolenca, ekstrapiramidna motnja, zlom stegnenice, zloraba alkohola, kračni blok, osteoporoza, artroplastika kolena, operacija hrbtenične fuzije, prometna nesreča, padec, prehodni ishemični napad, srčno-žilni dogodek, poškodba glave in demenca z Lewyjevimi telesci, sočasno zdravljenje z risperidonom, kvetiapin fumaratom, klonazepamom, Latudo, valiumom pa je moteče dejavnike izzvalo v 172 primerih.
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. 
Učinkovitost aripiprazola pri shizofreniji in bipolarni motnji I je domnevno posledica kombinacije delnega agonizma na dopaminskih receptorjih D2 in serotoninskih receptorjih 5-HT1a ter antagonizma na serotoninskih receptorjih 5-HT2a.
Recurrence prevention of manic episodes in Bipolar I Disorder: for preventing recurrence of manic episodes in patients who have been receiving aripiprazole as monotherapy or combination therapy, continue therapy at the same dose. 
Preprečevanje ponovitev maničnih epizod pri bipolarni motnji I: za preprečevanje ponovitev maničnih epizod pri bolnikih, ki so se zdravili z aripiprazolom samostojno ali v sklopu kombiniranega zdravljenja, se zdravljenje nadaljuje z istim odmerkom.
Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5-HT1a and 5-HT2a receptors and moderate affinity for dopamine D4, serotonin 5-HT2c and 5-HT7, alpha-1 adrenergic and histamine H1 receptors. 
In vitro je imel aripiprazol veliko vezavno afiniteto za dopaminske receptorje D2 in D3 in za serotoninske receptorje 5-HT1a in 5-HT2a ter zmerno afiniteto za dopaminske receptorje D4, serotoninske receptorje 5-HT2c in 5-HT7, adrenergične receptorje alfa-1 in histaminske receptorje H1.
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. 
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za zdravilo aripiprazol odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) učinkovino aripiprazol, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Quinidine and other CYP2D6 inhibitors 
Kinidin in drugi zaviralci CYP2D6
Irritability associated with autistic disorder: the safety and efficacy of Aripiprazole Sandoz in children and adolescents aged below 18 years have not yet been established. 
Razdražljivost, povezana z avtistično motnjo: varnost in učinkovitost zdravila Aripiprazol Sandoz pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
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. 
Tablete z jakostjo 5 mg, 10 mg, 15 mg in 30 mg so na voljo v naslednjih pakiranjih: Pretisni omot aluminij/aluminij v škatlah, ki vsebujejo po 10, 14, 16, 28, 30, 35, 56 ali 70 tablet.
If you are taking Aripiprazole Sandoz, your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding. 
Če prejemate zdravilo Aripiprazol Sandoz, vam bo zdravnik pomagal pri odločitvi glede dojenja z upoštevanjem prednosti dojenja za otroka in prednosti zdravljenja za vas.
The safety and efficacy of Aripiprazole Sandoz in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established. 
Varnost in učinkovitost zdravila Aripiprazol Sandoz nista bili ugotovljeni pri zdravljenju shizofrenije ali maničnih epizod pri bipolarni motnji I pri bolnikih, starih 65 let in starejših.
Carbamazepine and other CYP3A4 inducers 
Karbamazepin in drugi induktorji CYP3A4
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 
Razvojne toksične učinke, vključno z od odmerka odvisno zapoznelo fetalno osifikacijo in možnimi teratogenimi učinki, so pri podganah opažali v odmerkih, ki so povzročili subterapevtsko izpostavljenost (na podlagi AUC), in pri kuncih v odmerkih, ki so povzročili izpostavljenost 3- in 11kratne srednje AUC v stanju dinamičnega ravnovesja ob največjem priporočenem kliničnem odmerku.
14 x 1 tablets 28 x 1 tablets 49 x 1 tablets 56 x 1 tablets 98 x 1 tablets 
14 x 1 tablet 28 x 1 tablet 49 x 1 tablet 56 x 1 tablet 98 x 1 tablet
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). 
Zdravilo Aripiprazol Sandoz je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I ter za preprečevanje novih maničnih epizod pri odraslih bolnikih, ki so doživljali pretežno manične epizode, ki so bile odzivne na zdravljenje z aripiprazolom (glejte poglavje 5.1).
Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. 
Zdravilo Aripiprazol Sandoz je indicirano za zdravljenje shizofrenije pri odraslih in mladostnikih, starih 15 let in več.
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). 
Profil varnosti v dolgotrajnem dvojnoslepem, s placebom nadzorovanem kliničnem preskušanju je bil prav tako podoben, razen pri naslednjih reakcijah, o katerih so poročali pogosteje pri pediatričnih bolnikih, ki so jemali placebo: pogosto so navajali zmanjšanje telesne mase, zvišano vrednost inzulina v krvi, aritmijo in levkopenijo (≥ 1/100, < 1/10).
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 Pretisni omoti v škatlah: 10, 14, 16, 28, 30, 35, 56, 70 tablet Pretisni omoti (posamezni odmerek) v škatlah: 14 x 1, 28 x 1, 49 x 1, 56 x 1, 98 x 1 tableta Plastenka v škatlah: 100 tablet
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 %.
• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, 
• okorelost mišic in omotičnost ali zaspanost, upočasnjeno dihanje, dušenje, visok ali nizek krvni tlak, motnje srčnega ritma.
Aripiprazole Sandozis used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. 
Zdravilo Aripiprazol Sandoz uporabljamo za zdravljenje odraslih in mladostnikov, starih 13 let in več, ki imajo težave s simptomi, kot so evforično razpoloženje, pretirana energija, zmanjšana potreba po spanju, hitro govorjenje s prehitevajočimi mislimi in občasno huda razdražljivost.
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. 
Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale zdravilo Aripiprazol Sandoz, se lahko pojavijo naslednji simptomi: tresenje, okornost in/ali šibkost mišic, zaspanost, vznemirjenost, težave z dihanjem in motnje pri hranjenju.
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 % manjša kot po zdravljenju s samim aripiprazolom.
What you need to know before you take Aripiprazole Sandoz 
Kaj morate vedeti, preden boste vzeli zdravilo Aripiprazol Sandoz
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). 
Pričakovati je mogoče, da imajo drugi močni zaviralci CYP3A4, npr. itrakonazol in zaviralci proteaz HIV, podobne učinke, zato je treba odmerke podobno zmanjšati (glejte poglavje 4.2).
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. 
Tiki, povezani s Tourettovim sindromom: varnost in učinkovitost zdravila Aripiprazol Sandoz pri otrocih in mladostnikih, starih od 6 do 18 let, še ni bila dokazana.
If signs and symptoms of tardive dyskinesia appear in a patient on aripiprazole, dose reduction or discontinuation should be considered (see section 4.8). 
Če se pri bolniku, ki dobiva aripiprazol, pojavijo znaki in simptomi zapoznele diskinezije, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja (glejtee poglavje 4.8).
Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. 
Učinek zdravil iz te skupine (“Class Effect”) - v prvih nekaj dneh zdravljenja se lahko pri dovzetnih posameznikih pojavijo simptomi distonije, podaljšane nenormalne kontrakcije mišičnih skupin.
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. 
Učinkovitost aripiprazola pri pediatrični populaciji s Tourettovo motnjo (aripiprazol: n = 32, placebo: n = 29) je bila ocenjena tudi s prilagodljivim odmerkom v razponu od 2 mg/dan do 20 mg/dan in začetnim odmerkom 2 mg v 10-tedenski randomizirani, dvojno slepi, s placebom nadzorovani študiji, izvedeni v Južni Koreji.
Aripiprazole Sandoz tablets contain lactose. 
Tablete Aripiprazol Sandoz vsebujejo laktozo.
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. 
Pretisni omot aluminij/aluminij s posameznimi odmerki v škatlah, ki vsebujejo po 14 x 1, 28 x 1, 49 x 1, 56 x 1 ali 98 x 1 tableto.
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, 
• imate srčnožilne bolezni (bolezni srca in ožilja), srčnožilne bolezni v družini, možgansko kap ali
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. 
V 52-tedenskem, s placebom nadzorovanem preskušanju pri bolnikih s trenutno manično ali mešano epizodo bipolarne motnje I, pri katerih je bilo pri dodatnem zdravljenju z aripiprazolom (v odmerku od 10 mg/dan do 30 mg/dan) poleg litija ali valproata doseženo začasno izboljšanje zdravstvenega stanja, ki je trajalo 12 zaporednih tednov (skupna ocena 12 ali manj po lestvicah Y-MRS in MADRS), se je dodatno zdravljenje z aripiprazolom izkazalo za učinkovitejše od dodatka placeba, s 46 % zmanjšanjem tveganja (razmerje ogroženosti (RO) 0,54) za ponovitev bipolarne motnje in 65 % zmanjšanjem tveganja (razmerje ogroženosti (RO) 0,35) za ponovitev manične epizode, pri preprečevanju ponovitve depresivne epizode pa se dodatno zdravljenje z aripiprazolom ni izkazalo za boljše od placeba.
Warnings and precautions Talk to your doctor before taking Aripiprazole Sandoz. 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Aripiprazol Sandoz se posvetujte z zdravnikom.
Ketoconazole and other CYP3A4 inhibitors 
Ketokonazol in drugi zaviralci CYP3A4
•high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, 
• imate visok krvni sladkor (značilni simptomi so prekomerna žeja, izločanje velikih količin urina, povečanje apetita in šibkost) ali sladkorno bolezen v družini,
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 z avtistično motnjo, pri pediatričnih bolnikih (glejte poglavje 4.2) Uporabo aripiprazola so pri bolnikih, starih od 6 do 17 let, raziskovali v dveh 8-tedenskih, s placebom nadzorovanih preskušanjih [v enem z uporabo fleksibilnega odmerka (od 2 do 15 mg/dan), v drugem pa z uporabo fiksnega odmerka (5, 10 ali 15 mg/dan)] in v enem 52-tedenskem odprtem preskušanju.
The incidence of hyperprolactinaemia or increased serum prolactin in patients treated with aripiprazole (0.3%) was similar to that of placebo (0.2%). 
Pojavnost hiperprolaktinemije ali zvišane ravni prolaktina v serumu pri bolnikih, zdravljenih z aripiprazolom (0,3 %), je bila podobna tisti pri skupini s placebom (0,2 %).
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. 
višjih od 10 mg/dan, večje učinkovitosti niso dokazali, vendar pa posameznim bolnikom lahko koristi tudi zdravljenje z večjim odmerkom.
Schizophrenia: in a long term 52-week controlled trial, aripiprazole-treated patients had an overall-lower incidence (25.8%) of EPS including Parkinsonism, akathisia, dystonia and dyskinesia compared with those treated with haloperidol (57.3%). 
Shizofrenija: v dolgoročnem 52-tedenskem nadzorovanem preskušanju je bila celotna incidenca EPS (vključno s parkinsonizmom, akatizijo, distonijo in diskinezijo) manjša (25,8 %) pri bolnikih, ki so dobivali aripiprazol, kot pri tistih, ki so dobivali haloperidol (57,3 %).
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 Po prvem odprtju plastenke: 3 mesece
10 tablets 14 tablets 16 tablets 28 tablets 30 tablets 35 tablets 56 tablets 70 tablets 
10 tablet 14 tablet 16 tablet 28 tablet 30 tablet 35 tablet 56 tablet 70 tablet
NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sandoz
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). 
Znaki in simptomi serotoninskega sindroma se lahko pojavijo še posebej pri sočasni uporabi z drugimi serotoninergičnimi zdravili, kot so selektivni zaviralci privzema serotonina/selektivni zaviralci privzema serotonina in noradrenalina (SSRI/SNRI) ali z zdravili, ki zvišujejo koncentracijo aripiprazola (glejte poglavje 4.8).
Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets For storage conditions after first opening of the bottle, see section 6.3. 
Aripiprazol Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablete Za pogoje shranjevanja po prvem odprtju plastenke glejte poglavje 6.3.
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. 
Shizofrenija: priporočeni začetni odmerek zdravila Aripiprazol Sandoz je 10 ali 15 mg/dan, vzdrževalni odmerek pa 15 mg/dan, uporabljen enkrat na dan ne glede na obroke.