FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Slovenian: Poročali so o agitaciji, hipertoniji, hipotoniji, tremorju, somnolenci, respiratorni stiski in motnjah pri hranjenju.
English: obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
Slovenian: generalizirano anksiozno motnjo, obsesivno-kompulzivno motnjo (OCD) in socialno fobijo, kot tudi za migrene in bolečine,
English: Packsizes:
Slovenian: Velikosti pakiranj:
English: 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.
Slovenian: 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.
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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Quinidine and other CYP2D6 inhibitors
Slovenian: Kinidin in drugi zaviralci CYP2D6
English: 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.
Slovenian: Razdražljivost, povezana z avtistično motnjo: varnost in učinkovitost zdravila Aripiprazol Sandoz pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Če prejemate zdravilo Aripiprazol Sandoz, vam bo zdravnik pomagal pri odločitvi glede dojenja z upoštevanjem prednosti dojenja za otroka in prednosti zdravljenja za vas.
English: 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.
Slovenian: 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.
English: Carbamazepine and other CYP3A4 inducers
Slovenian: Karbamazepin in drugi induktorji CYP3A4
English: 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
Slovenian: 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.
English: 14 x 1 tablets 28 x 1 tablets 49 x 1 tablets 56 x 1 tablets 98 x 1 tablets
Slovenian: 14 x 1 tablet 28 x 1 tablet 49 x 1 tablet 56 x 1 tablet 98 x 1 tablet
English: 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).
Slovenian: 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).
English: Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Slovenian: Zdravilo Aripiprazol Sandoz je indicirano za zdravljenje shizofrenije pri odraslih in mladostnikih, starih 15 let in več.
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 (≥ 1/100, < 1/10).
Slovenian: 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).
English: 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
Slovenian: 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
English: The rate of death in aripiprazole-treated patients was 3.5% compared to 1.7% in the placebo group.
Slovenian: Delež smrti je bil v skupini z aripiprazolom 3,5 % in v skupini s placebom 1,7 %.
English: • muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure,
Slovenian: • okorelost mišic in omotičnost ali zaspanost, upočasnjeno dihanje, dušenje, visok ali nizek krvni tlak, motnje srčnega ritma.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
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.
Slovenian: 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.
English: What you need to know before you take Aripiprazole Sandoz
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Aripiprazol Sandoz
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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: If signs and symptoms of tardive dyskinesia appear in a patient on aripiprazole, dose reduction or discontinuation should be considered (see section 4.8).
Slovenian: 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).
English: Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Aripiprazole Sandoz tablets contain lactose.
Slovenian: Tablete Aripiprazol Sandoz vsebujejo laktozo.
English: 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.
Slovenian: 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.
English: • cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease,
Slovenian: • imate srčnožilne bolezni (bolezni srca in ožilja), srčnožilne bolezni v družini, možgansko kap ali
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.
Slovenian: 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.
English: Warnings and precautions Talk to your doctor before taking Aripiprazole Sandoz.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Aripiprazol Sandoz se posvetujte z zdravnikom.
English: Ketoconazole and other CYP3A4 inhibitors
Slovenian: Ketokonazol in drugi zaviralci CYP3A4
English: •high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine,
Slovenian: • imate visok krvni sladkor (značilni simptomi so prekomerna žeja, izločanje velikih količin urina, povečanje apetita in šibkost) ali sladkorno bolezen v družini,
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 flexibledose (2-15 mg/day) and one fixed-dose (5, 10, or 15 mg/day)] and in one 52-week open-label trial.
Slovenian: 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.
English: Calea Floreasca nr. 169A, Cladirea A, etaj 1, sector 1, Bucure ti e-mail: upit.croatia@sandoz.com
Slovenian: Calea Floreasca nr. 169A, Cladirea A, etaj 1, sector 1, Bucure ti
English: The incidence of hyperprolactinaemia or increased serum prolactin in patients treated with aripiprazole (0.3%) was similar to that of placebo (0.2%).
Slovenian: 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 %).
English: 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.
Slovenian: višjih od 10 mg/dan, večje učinkovitosti niso dokazali, vendar pa posameznim bolnikom lahko koristi tudi zdravljenje z večjim odmerkom.
English: 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%).
Slovenian: 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 %).
English: Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets After first opening of the bottle: 3 months
Slovenian: Aripiprazol Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablete Po prvem odprtju plastenke: 3 mesece
English: 10 tablets 14 tablets 16 tablets 28 tablets 30 tablets 35 tablets 56 tablets 70 tablets
Slovenian: 10 tablet 14 tablet 16 tablet 28 tablet 30 tablet 35 tablet 56 tablet 70 tablet
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sandoz
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sandoz
English: 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).
Slovenian: 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).
English: Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets For storage conditions after first opening of the bottle, see section 6.3.
Slovenian: Aripiprazol Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablete Za pogoje shranjevanja po prvem odprtju plastenke glejte poglavje 6.3.
English: 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.
Slovenian: 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.
English: Manic episodes in Bipolar I Disorder: the recommended starting dose for Aripiprazole Sandoz is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Slovenian: Manične epizode pri bipolarni motnji I: priporočeni začetni odmerek zdravila Aripiprazol Sandoz je 15 mg enkrat na dan ne glede na obroke hrane, in sicer kot samostojno zdravilo ali v sklopu kombiniranega zdravljenja (glejte poglavje 5.1).
English: In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
Slovenian: Med kliničnimi preskušanji aripiprazola v primerjavi s placebom niso ugotovili značilnih razlik v incidenci hiperglikemičnih neželenih učinkov (vključno s sladkorno boleznijo) ali nenormalnih laboratorijskih vrednosti glukoze v krvi.
English: The active substance is aripiprazole.
Slovenian: • Zdravilna učinkovina je aripiprazol.
English: 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.
Slovenian: Aripiprazol Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablete Vsebnik za tablete (plastenka) iz polietilena visoke gostote (HDPE), ki vsebuje silikagelno sušilno sredstvo in poliestrski navoj.
English: How to store Aripiprazole Sandoz tablets Contents of the pack and other information
Slovenian: Shranjevanje zdravila Aripiprazol Sandoz Vsebina pakiranja in dodatne informacije
English: Before treatment with Aripiprazole Sandoz, tell your doctor if you suffer from
Slovenian: Pred začetkom zdravljenja z zdravilom Aripiprazol Sandoz morate obvestiti zdravnika, če:
English: What Aripiprazole Sandoz is and what it is used for
Slovenian: Kaj je zdravilo Aripiprazol Sandoz in za kaj ga uporabljamo
English: 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.
Slovenian: Manične epizode pri bipolarni motnji I: v 12- tedenskem nadzorovanem preskušanju je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 23,5 %, pri bolnikih, ki so se zdravili s haloperidolom pa 53,3 %.
English: The 20 mg tablets are supplied in Aluminium//Aluminium blisters packed in cartons containing 14, 28, 49, 56 or 98 tablets.
Slovenian: Tablete z jakostjo 20 mg so na voljo v škatlah s pretisnimi omoti aluminij/aluminij, ki vsebujejo po 14, 28, 49, 56 ali 98 tablet.
English: • triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder,
Slovenian: • triptane, tramadol in triptofan navadno uporabljamo za bolezni, vključno z depresijo,
English: Aripiprazole Sandoz is not recommended for use in patients with schizophrenia below 15 years of age due to insufficient data on safety and efficacy (see sections 4.8 and 5.1).
Slovenian: Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Aripiprazol Sandoz pri bolnikih s shizofrenijo, mlajših od 15 let, ni priporočljiva (glejte poglavji 4.8 in 5.1).
English: 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).
Slovenian: Dodatni neželeni učinki pri otrocih in mladostnikih Neželeni učinki pri mladostnikih, starih 13 let in starejših, so bili po pogostnosti in vrsti podobni neželenim učinkom pri odraslih, z izjemo naslednjih: zaspanost, nenadzorovani trzaji ali nehotni gibi, nemirnost in utrujenost, ki so bili zelo pogosti (prisotni pri več kot 1 od 10 bolnikov), ter bolečina v zgornjem predelu trebuha, suha usta, hiter srčni utrip, povečanje telesne mase, povečan apetit, trzanje mišic, nenadzorovano gibanje udov in omotica, še posebej pri vstajanju iz ležečega ali sedečega položaja, ki so bili pogosti (prisotni pri več kot 1 od 100 bolnikov).
English: Aripiprazole Sandoz is for oral use.
Slovenian: Zdravilo Aripiprazol Sandoz je namenjeno za peroralno uporabo.
English: Aripiprazole Sandoz 5 mg tablets Aripiprazole Sandoz 10 mg tablets Aripiprazole Sandoz 15 mg tablets Aripiprazole Sandoz 20 mg tablets Aripiprazole Sandoz 30 mg tablets aripiprazole
Slovenian: Aripiprazol Sandoz 5 mg tablete Aripiprazol Sandoz 10 mg tablete Aripiprazol Sandoz 15 mg tablete Aripiprazol Sandoz 20 mg tablete Aripiprazol Sandoz 30 mg tablete aripiprazol
English: Rīga, LV1010
Slovenian: K.Valdemāra iela 33-30 Rīga, LV1010