natgillin/translations-raw huggingface dataset:
OPA/Alu/PVC/Alu foil blisters (Alu-Alu blister), carton box. 
6.5 Vrsta ovojnine in vsebina OPA/Alu/PVC/Alu pretisni omoti (Alu-Alu pretisni omot), škatla.
Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria) 
Bolezni imunskega sistema alergijska reakcija (npr. anafilaksijska reakcija, angioedem, vključno z oteklino jezika, edem jezika, edem obraza, srbenje ali urtikarija)
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, 
S pozitronsko emisijsko tomografijo so pokazali, da je 2-tedenska uporaba odmerkov od 0,5 do 30 mg aripiprazola enkrat na dan pri zdravih preiskovancih povzročila od odmerka odvisno zmanjšanje vezave 11C-rakloprida, liganda receptorjev D2/D3, v nucleusu caudatusu in putamnu.
• Tricyclic's (such as clomipramine and amitriptyline) used for depressive illness 
• triciklične antidepresive (kot sta klomipramin in amitriptilin) uporabljamo za depresijo,
The incidence of hypoprolactinaemia or decreased serum prolactin in patients treated with aripiprazole was 0.4%, compared with 0.02% for patients treated with placebo. 
Pojavnost hipoprolaktinemije ali znižane ravni prolaktina v serumu pri bolnikih, zdravljenih z aripiprazolom, je bila 0,4 % v primerjavi s skupino s placebom (0,02 %).
When appropriate, subsequent dose increases should be administered in 5 mg increments without exceeding the maximum daily dose of 30 mg (see section 
Bolnik nato začne jemati priporočeni dnevni odmerek 10 mg. Odmerek se po potrebi lahko nato še nadalje povečuje po 5 mg, vendar pa ne sme preseči največjega dnevnega odmerka 30 mg (glejte poglavje 5.1).
Suicide attempt, suicidal ideation and completed suicide (see section 4.4) Pathological gambling Impulse-control disorders Binge eating 
Psihiatrične motnje nespečnost anksioznost nemir depresija hiperseksualnost poskus samomora, misli na samomor in samomor (glejte poglavje 4.4) patološko hazardiranje motnje nadzora impulzov kompulzivno prenajedanje kompulzivno nakupovanje poriomanija agresija agitacija živčnost
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The recommended dose for Aripiprazole Zentiva is 10 mg/day administered on a once-a-day schedule without regard to meals. 
Manične epizode pri bipolarni motnji I pri mladostnikih, starih 13 let in več Priporočeni odmerek zdravila Aripiprazol Zentiva je 10 mg enkrat na dan ne glede na obrok hrane.
In schizophrenia patients the incidence of akathisia was 6.2% with aripiprazole and 3.0% with placebo. 
Pri bolnikih s shizofrenijo je bila pojavnost akatizije pri uporabi aripiprazola 6,2 %, pri uporabi placeba pa 3,0 %.
Additional side effects in children and adolescents Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (may affect more than 1 in 10 people) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (may affect up to 1 in 10 people). 
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 (pojavijo se lahko 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 (pojavijo se lahko pri največ 1 od 10 bolnikov).
Pack size: 14, 28, 49, 56, or 98 tablets 
Velikost pakiranja: 14, 28, 49, 56 ali 98 tablet.
Neuroleptic Malignant Syndrome (NMS) Grand mal convulsion Serotonin syndrome Speech disorder 
generalizirana konvulzija serotoninski sindrom motnje govora
The AUC and Cmax of dehydro-aripiprazole increased by 77% and 43%, respectively. 
AUC dehidroaripiprazola se je zvečala za 77 %, njegova Cmax pa za 43 %.
Aripiprazole Zentiva orodispersible tablets contain lactose. 
Orodisperzibilne tablete Aripiprazol Zentiva vsebujejo laktozo.
Aripiprazole Zentiva 10 mg, 30 mg tablets: The score line is not intended for breaking the tablet. 
Aripiprazol Zentiva 10 mg, 30 mg tablete: Zareza ni namenjena delitvi tablete.
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 (10 - 17 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. 
Manične epizode pri bipolarni motnji I pri otrocih in mladostnikih Uporabo aripiprazola so raziskovali v 30-tedenskem s placebom nadzorovanem preskušanju, ki je vključevalo 296 otrok in mladostnikov (10-17 let), ki so ustrezali kriterijem DSM-IV za bipolarno motnjo I z maničnimi ali mešanimi epizodami s psihotičnimi lastnostmi ali brez njih, in so imeli v izhodišču oceno ≥ 20 po lestvici Y-MRS. Izmed bolnikov, ki so bili vključeni v primarno analizo učinkovitosti, je imelo 139 bolnikov sočasno tudi diagnozo motnje pomanjkanja pozornosti (ADHD
Method of administration Aripiprazole Zentiva is for oral use. 
Zdravilo Aripiprazol Zentiva je namenjeno za peroralno uporabo.
Increased Alanine Aminotransferase (ALT) 
zvišana aktivnost aspartat aminotransferaze (AST)
The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32% and 47%, respectively. 
AUC aktivnega presnovka dehidroaripiprazola se je zmanjšala za 32 %, njegova Cmax pa za 47 %.
In another 12-week trial, the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for those treated with lithium. 
V drugem 12-tedenskem preskušanju je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 26,6 %, pri bolnikih, ki so se zdravili z litijem pa 17,6 %.
Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13 - 17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo): Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10). 
V kratkotrajnem, s placebom nadzorovanem kliničnem preskušanju, ki je vključevalo 302 mladostnika (13-17 let) s shizofrenijo, so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih neželenih učinkov, ki so bili pri mladostnikih, ki so prejemali aripiprazol, pogostejši kot pri odraslih, ki so prejemali aripiprazol (in pogostejši kot pri placebu): Somnolenca/sedacija in ekstrapiramidne motnje so bili zelo pogosti (≥ 1/10), suha usta, povečan apetit in ortostatska hipotenzija pa pogosti (≥ 1/100, < 1/10) neželeni učinki.
Aripiprazole Zentiva 10 mg, 30 mg orodispersible tablets: The score line is not intended for breaking the tablet. 
Aripiprazol Zentiva 10 mg, 30 mg orodisperzibilne tablete: Zareza ni namenjena delitvi tablete.
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 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 %.
Schizophrenia - in a long term 52-week controlled trial, aripiprazole-treated patients had an overalllower 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 %).
The active substance is aripiprazole. 
Učinkovina je aripiprazol.
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, acesulfame potassium, mango flavour, magnesium stearate. 
Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza, krospovidon, hidroksipropilceluloza, brezvodni koloidni silicijev dioksid, premrežen natrijev karmelozat, kalcijev acesulfamat, aroma manga, magnezijev stearat.
How to take Aripiprazole Zentiva 
Kako jemati zdravilo Aripiprazol Zentiva
Overall, 1.3% of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6% of placebo-treated patients in these trials. 
V celoti so v teh preskušanjih cerebrovaskularne neželene učinke zabeležili pri 1,3 % bolnikov, zdravljenih z aripiprazolom, in pri 0,6 % bolnikov, ki so dobivali placebo.
Excipient with known effect: each orodispersible tablet contains 55.5 mg of lactose (as monohydrate) and 1.97 mg of sodium. 
Pomožna snov z znanim učinkom: ena orodisperzibilna tableta vsebuje 55,5 mg laktoze (v obliki monohidrata) in 1,97 mg natrija.
In the pooled trials, the incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) in aripiprazole-treated patients was 27/46 (58.7%) and 258/298 (86.6%), respectively. 
Podatki združenih preskušanj kažejo, da je bila pri zdravljenju z aripiprazolom pogostnost nizkih vrednosti prolaktina v serumu pri deklicah (< 3 ng/ml) 58,7 % (27/46), pri dečkih (< 2 ng/ml) pa 86,6 % (258/298).
Pack size: 14, 28 or 49 orodispersible tablets 
Velikost pakiranja: 14, 28 ali 49 orodisperzibilnih tablet.
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. 
Kljub pogosti sočasni obolevnosti za bipolarno motnjo I in motnjo pomanjkanja pozornosti je na voljo zelo malo podatkov o sočasni uporabi aripiprazola in stimulansov.
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 odmerjanje podobno zmanjšati
In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo. 
Akatizija V s placebom nadzorovanih preskušanjih je bila pojavnost akatizije pri bolnikih z bipolarno motnjo pri uporabi aripiprazola 12,1 %, pri uporabi placeba pa 3,2 %.
In a long term 26-week placebo-controlled trial, the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients. 
V dolgoročnem 26-tedenskem s placebom nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 19 % in pri bolnikih, ki so dobivali placebo, 13,1 %.
LIST OF EXCIPIENTS Contains lactose and sodium. 
SEZNAM POMOŽNIH SNOVI Vsebuje laktozo monohidrat in natrij.
Each orodispersible tablet contains 10 mg/15 mg/30 mg of aripiprazole. 
Ena orodisperzibilna tableta vsebuje 10 mg/15 mg/30 mg aripiprazola.
Before treatment with Aripiprazole Zentiva, tell your doctor if you suffer from 
Pred začetkom zdravljenja z zdravilom Aripiprazol Zentiva morate obvestiti zdravnika, če:
In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapine-treated patients. 
V drugem dolgoročnem 26-tedenskem nadzorovanem preskušanju je bila incidenca EPS pri bolnikih, zdravljenih z aripiprazolom, 14,8 % in pri bolnikih, zdravljenih z olanzapinom, 15,1 %.
Excipient with known effect: each orodispersible tablet contains 111 mg of lactose (as monohydrate) and 3.93 mg of sodium. 
Pomožna snov z znanim učinkom: ena orodisperzibilna tableta vsebuje 111 mg laktoze (v obliki monohidrata) in 3,93 mg natrija.
Sudden unexplained death Torsades de pointes QT prolongation Ventricular arrhythmias Cardiac arrest Bradycardia 
Srčne bolezni tahikardija nenadna nepojasnjena smrt torsades de pointes podaljšanje intervala QT
Always take the tablet with water and swallow it whole. 
Ni pomembno, ali ga vzamete s hrano ali brez nje, vedno pa jo vzemite z vodo in jo pogoltnite celo.
In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2% for aripiprazole-treated patients and 15.7% for placebo-treated patients. 
26-tedenski vzdrževalni fazi s placebom nadzorovanega preskušanja je bila pojavnost EPS pri bolnikih, ki so se zdravili z aripiprazolom 18,2 %, pri bolnikih, ki so prejemali placebo pa 15,7 %.
• Pain killers (such as tramadol and pethidine) used for pain relief 
• zdravila proti bolečinam (kot sta tramadol in petidin) uporabljamo za ublažitev bolečine,
Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1). 
Zdravilo Aripiprazol Zentiva je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I pri mladostnikih, starih 13 let in več.
These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole Zentiva, you should see your doctor. 
Če opazite kakršen koli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom Aripiprazol Zentiva, obiščite zdravnika.
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate. 
Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza, krospovidon, hidroksipropilceluloza, brezvodni koloidni silicijev dioksid, premrežen natrijev karmelozat,
Renal impairment No dosage adjustment is required in patients with renal impairment. 
Ledvična okvara Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
SN: 
(MNS)
Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase 
zvišana aktivnost gama glutamiltransferaze (GGT)
What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 10 mg orodispersible tablets are white to off-white round tablets debossed ‘10' on one side and snap break line on other side with diameter approx. 7 mm. 
Izgled zdravila Aripiprazol Zentiva in vsebina pakiranja Aripiprazol Zentiva 10 mg orodisperzibilne tablete so bele do umazano bele, okrogle tablete z oznako ‘10' na eni strani in zarezo na drugi strani, s premerom približno 7 mm.
Excipient with known effect: each orodispersible tablet contains 37 mg of lactose (as monohydrate) and 1.31 mg of sodium. 
Pomožna snov z znanim učinkom: ena orodisperzibilna tableta vsebuje 37 mg laktoze (v obliki monohidrata) in 1,31 mg natrija.
strong impulse to gamble excessively despite serious personal or family consequences altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) a tendency to wander away. 
− prenajedanje (uživanje velikih količin hrane v kratkem obdobju) ali kompulzivno uživanje hrane (uživanje večjih količin hrane od normalnih in več, kot je potrebno za potešitev lakote),
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 weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg. 
Trzaji, povezani s Tourettovim sindromom, pri pediatričnih bolnikih (glejte poglavje 4.2) Učinkovitost aripiprazola je bila raziskana pri pediatrični populaciji s Tourettovo motnjo (aripiprazol: n = 99, placebo: n = 44) v 8-tedenski randomizirani, dvojno slepi, s placebom nadzorovani študiji, zasnovani z zdravljenimi skupinami, ki so prejemale nespremenjen odmerek glede na telesno maso posameznika v razponu od 5 mg/dan do 20 mg/dan, z začetnim odmerkom 2 mg. Bolniki so bili stari od 7 do 17 let, povprečni izhodiščni rezultat njihovega števila trzajev po skupni oceni resnosti trzajev na lestvici TTS-YYGTSS (angl. Total Tic Severity Score - Yale Global Tic Severity Scale) pa je bil 30.
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, 
Manične epizode pri bipolarni motnji I pri mladostnikih, starih 13 let in več Pri mladostnikih z bipolarno motnjo I so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih: somnolence (23,0 %), ekstrapiramidnih motenj (18,4 %), akatizije (16,0 %) in utrujenosti (11,8 %), ki so bili zelo pogosti (≥ 1/10), ter bolečine v zgornjem predelu trebuha, hitrejšega srčnega utripa, povečanja telesne mase, povečanega apetita, trzanja mišic in diskinezije, ki so bili pogosti (≥ 1/100, < 1/10).
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, 
• serotoninski sindrom (reakcija, ki lahko povzroči močan občutek sreče, omotico, okornost, nemir, občutek pijanosti, zvišano telesno temperaturo, znojenje in togost mišic),
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 %
In the adolescent (13 - 17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 25.6% and 45.0%, respectively. 
Pri populaciji mladostnikov (starosti od 13 do 17 let) s shizofrenijo, ki so največ 72 mesecev izpostavljeni apriprazolu 5 do 30 mg, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah (< 3 ng/ml) 25,6 % in pri moških (< 2 ng/ml) 45,0 %.
Aripiprazole Zentiva 30 mg orodispersible tablets are white to off-white round tablets debossed ‘30' on one side and snap break line on the other side with diameter approx. 10.2 mm. 
Aripiprazol Zentiva 30 mg tablete so bele do umazano bele, okrogle tablete z oznako ‘30' na eni strani in razdelilno zarezo na drugi strani, s premerom približno 10,2 mm.
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or “mini” stroke, abnormal blood pressure 
• imate srčnožilne bolezni (bolezni srca in ožilja), srčnožilne bolezni v družini, možgansko kap ali
• agitation, 
• hujšanje,
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/027 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1009/027
Blood glucose fluctuation Increased creatine phosphokinase 
Preiskave zvišana vrednost glukoze v krvi zvišana vrednost glikoziliranega hemoglobina nihanje vrednosti glukoze v krvi zvišana aktivnost kreatinfosfokinaze
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/021 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1009/021
Aripiprazole demonstrated statistically superior efficacy compared to placebo on the Aberrant Behaviour Checklist Irritability subscale. 
Pri vrednotenju po podlestvici razdražljivosti na osnovi kontrolnega seznama odklonskega vedenja (“Aberrant Behaviour Checklist Irritability subscale”) se je izkazalo, da je aripiprazol statistično učinkovitejši od placeba, vendar pa pomen te ugotovitve za klinično uporabo ostaja neznan.
In two long term trials with adolescent (13 - 17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 37.0 % and 59.4 %, respectively. 
Pri dveh dolgotrajnih preskušanjih pri mladostnikih s shizofrenijo in bipolarno motnjo (starosti od 13 do 17 let), ki so se zdravili z aripiprazolom, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah 37,0 % (< 3 ng/ml) in pri moških (< 2 ng/ml) 59,4 %.
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1009/024 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1009/024
What Aripiprazole Zentiva looks like and contents of the pack Aripiprazole Zentiva 5 mg are white to off-white round flat bevel edged uncoated tablets with ‘5' debossed on one side and plain on the other side with diameter approx. 6 mm. 
Izgled zdravila Aripiprazol Zentiva in vsebina pakiranja Aripiprazol Zentiva 5 mg so bele do umazano bele, okrogle, ploske, neobložene tablete s poševnim robom, z oznako ‘5' na eni strani in brez oznake na drugi strani, s premerom približno 6 mm.
In the pooled adolescent schizophrenia population (13 - 17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 29.5% and 48.3%, respectively. 
V populaciji mladostnikov s shizofrenijo (13-17 let), ki so se zdravili do 2 leti, je bila pogostnost nizke ravni prolaktina v serumu pri ženskah (< 3 ng/ml) 29,5 % in pri moških (< 2 ng/ml) 48,3 %.
• uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia), 
• nenadzorovani gibi ust, jezika in udov, (tardivna diskinezija),
Aspiration pneumonia Laryngospasm Oropharyngeal spasm 
prsnega koša in mediastinalnega prostora kolcanje aspiracijska pljučnica laringospazem orofaringealni spazem
• fast heart beat, 
• pospešen srčni utrip,
Photosensitivity reaction Alopecia 
Bolezni kože in podkožja izpuščaj fotosenzibilnostna reakcija alopecija hiperhidroza
Name and address of the manufacturer responsible for batch release Zentiva SA 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Zentiva, k.s.
White to off-white round tablets debossed ‘30' on one side and snap break line on the other side with diameter approx. 10.2 mm. 
Bele do umazano bele, okrogle tablete z oznako ‘30' na eni strani in zarezo na drugi strani, s premerom približno 10,2 mm.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Zdravilo Aripiprazol Zentiva vsebuje laktozo Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.