natgillin/translations-raw huggingface dataset:
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. 
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).
Treatment should be initiated at 2 mg (using aripiprazole oral solution 1 mg/ml) 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 (uporaba aripiprazola v obliki peroralne raztopine 1 mg/ml), ki ga bolnik jemlje 2 dni, nato pa se odmerek poveča do odmerka 5 mg, ki ga bolnik jemlje še dodatna 2 dni.
Hyperprolactinaemia Diabetic hyperosmolar coma Diabetic ketoacidosis 
Bolezni hiperprolaktinemija diabetična hiperosmolarna koma
• combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome), 
• kombinacija zvišane telesne temperature, togosti mišic, hitrega dihanja, znojenja, zmanjšane stopnje zavesti in nenadne spremembe krvnega tlaka ter hitrosti srčnega utripa, omedlevica
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), 
• serotoninski sindrom (reakcija, ki lahko povzroči močan občutek sreče, omotico, okornost,
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): 
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):
Before treatment with Aripiprazole Accord, tell your doctor if you suffer from 
Pred začetkom zdravljenja z zdravilom Aripiprazol Accord morate obvestiti zdravnika, če:
Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8). 
Pri aripiprazolu se lahko pojavijo preobčutljivostne reakcije v obliki simptomov alergije (glejte poglavje 4.8).
Aripiprazole Accord contains lactose. 
Zdravilo Aripiprazol Accord vsebuje laktozo.
Aripiprazole Accord 5/10/15/30 mg tablets are available in perforated unit dose blister packs (Aluminium/Aluminium) containing 14 x 1, 28 x 1, 49 x 1, 56 x 1, or 98 x 1 tablet. 
Aripiprazol Accord 5/10/15/30 mg tablete so na voljo v perforiranem pretisnem omotu za posamezni odmerek (aluminij/aluminijasti) v pakiranjih po 14x1, 28x1, 49x1, 56x1 ali 98x1 tablet.
Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase 
Neznana pogostnost glutamiltransferaze (GGT) zvišana aktivnost alkalne fosfataze
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 krvi pri bolnikih, zdravljenih z aripiprazolom (0,3 %), je bila enaka tistim pri skupini s placebom (0,2 %).
• high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite, and feeling weak) or family history of diabetes fits (seizures) since your doctor may want to monitor you more closely 
• imate visok krvni sladkor (značilni simptomi so prekomerna žeja, izločanje velikih količin urina, povečanje apetita in šibkost) ali sladkorno bolezen v družini,
What you need to know before you take Aripiprazole Accord 
Kaj morate vedeti, preden boste vzeli zdravilo Aripiprazol Accord Ne jemljite zdravila Aripiprazol Accord
Aripiprazole Accord contains lactose 
Zdravilo Aripiprazol Accord vsebuje laktozo
Aripiprazole Accord 5 mg tablets Aripiprazole Accord 10 mg tablets Aripiprazole Accord 15 mg tablets Aripiprazole Accord 30 mg tablets 
Aripiprazol Accord 5 mg tablete Aripiprazol Accord 10 mg tablete Aripiprazol Accord 15 mg tablete Aripiprazol Accord 30 mg tablete
Aripiprazole Accord 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 Accord je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I pri mladostnikih, starih 13 let in več, zdravljenje sme trajati do največ 12 tednov (glejte poglavje 5.1).
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for Aripiprazole Accord 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 Accord je 10 mg enkrat na dan ne glede na obrok hrane.
In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13-17 years), presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo. 
Shizofrenija pri mladostnikih V 6-tedenskem s placebom nadzorovanem preskušanju, ki je vključevalo 302 mladostnika (13-17 let) s shizofrenijo s pozitivnimi in negativnimi simptomi, je bil aripiprazol povezan s statistično značilno večjim izboljšanjem psihotičnih simptomov v primerjavi s placebom.
Kaplan-Meier relapse rates at week 16 were 35 % for aripiprazole and 52 % for placebo; the hazard ratio for relapse within 16 weeks (aripiprazole/placebo) was 0.57 (non-statistically significant difference). 
Razmerje ogroženosti za ponovitev v 16 tednih (aripiprazol/placebo) je bilo 0,57 (statistično nepomembna razlika).
Aripiprazole Accord 5 mg tablets Aripiprazole Accord 10 mg tablets Aripiprazole Accord 15 mg tablets Aripiprazole Accord 30 mg tablets aripiprazole 
Aripiprazol Accord 5 mg tablete Aripiprazol Accord 10 mg tablete Aripiprazol Accord 15 mg tablete Aripiprazol Accord 30 mg tablete aripiprazol
Schizophrenia in adolescents aged 15 years and older: the recommended dose for Aripiprazole Accord is 10 mg/day administered on a once-a-day schedule without regard to meals. 
Shizofrenija pri mladostnikih, starih 15 let in več: priporočeni odmerek zdravila Aripiprazol Accord je 10 mg enkrat na dan ne glede na obroke hrane.
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. 
Med sočasno uporabo aripiprazola in šibkih zaviralcev CYP3A4 (npr. diltiazema) ali CYP2D6 (npr. escitaloprama) je mogoče pričakovati zmerno zvišanje koncentracije plazemskega aripiprazola.
EU/1/15/1045/017- 30 tablets EU/1/15/1045/018- 100 tablets 
EU/1/15/1045/017- 30 tablet EU/1/15/1045/018- 100 tablet
EU/1/15/1045/011- 30 tablets EU/1/15/1045/012- 100 tablets 
EU/1/15/1045/011- 30 tablet EU/1/15/1045/012- 100 tablet
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).
What Aripiprazole Accord tablets looks like and contents of the pack 
Izgled zdravila Aripiprazol Accord tablete in vsebina pakiranja
Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, 
Bolezni imunskega sistema alergijska reakcija (npr. anafilaksijska reakcija, angioedem, vključno z oteklino jezika, edem jezika, edem obraza, srbenje ali urtikarija)
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.
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 - Attention deficit hyperactivity disorder).
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. 
V dolgotrajni 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 %.
Aripiprazole Accord is for oral use. 
Način uporabe Zdravilo Aripiprazol Accord je namenjeno za peroralno uporabo.
To allow the start of the treatment at a low dose you can use an alternative formulation (oral solutionliquid) more suitable than Aripiprazole Accord.The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. 
Da se omogoči začetek zdravljenja v majhnem odmerku, lahko uporabite drugo farmacevtsko obliko (peroralno raztopino − tekočino), ki je primernejša od zdravila Aripiprazol Accord.
Each 30 mg tablet contains 177 mg lactose (as monohydrate). 
Pomožna(e) snov(i) z znanim učinkom Ena 30 mg tableta vsebuje 177 mg laktoze (v obliki monohidrata).
HDPE bottle pack should be used within 30 days after first opening. 
HDPE vsebnik je treba uporabiti v 30 dneh po prvem odprtju (za pakiranje po 30 tablet).
Aripiprazole Accord with food, drink and alcohol 
Zdravilo Aripiprazol Accord skupaj s hrano, pijačo in alkoholom To zdravilo lahko jemljete ne glede na obroke.
Each 15 mg tablet contains 88 mg lactose (as monohydrate). 
Pomožna(e) snov(i) z znanim učinkom Ena 15 mg tableta vsebuje 88 mg laktoze (v obliki monohidrata).
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 hiperprolaktinemije ali znižane ravni prolaktina v krvi pri bolnikih, zdravljenih z aripiprazolom, je bila 0,4 % v primerjavi s skupino s placebom (0,2 %).
These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ARIPIPRAZOLE ACCORD, you should see your doctor. 
Če opazite kakršen koli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom Aripiprazol Accord, obiščite zdravnika.
Each 10 mg tablet contains 59 mg lactose (as monohydrate). 
Pomožna(e) snov(i) z znanim učinkom Ena 10 mg tableta vsebuje 59 mg laktoze (v obliki monohidrata).
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 %.
(for 100's count) Open date: 
Datum odprtja:
Hydroxypropylcellulose Magnesium stearate Indigo carmine aluminium lake (E132) 
Aripiprazol Accord 5 mg tablete laktoza monohidrat mikrokristalna celuloza koruzni škrob hidroksipropilceluloza magnezijev stearat indigotin (E 132)
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, 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.
Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain 
Splošne težave in spremembe na mestu aplikacije izčrpanost motnje uravnavanja telesne temperature (npr. hipotermija, pireksija) bolečine v prsih periferni edemi
• 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
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 %.
Each 5 mg tablet contains 63 mg lactose (as monohydrate). 
Pomožna(e) snov(i) z znanim učinkom Ena 5 mg tableta vsebuje 63 mg laktoze (v obliki monohidrata).
Aripiprazole Accord 15 mg tablets are yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain. 
Aripiprazol Accord 15 mg tablete so rumene, okrogle, bikonveksne, neobložene tablete z zaobljenim robom, dolžine približno 7,14 mm, z vtisnjeno oznako “A15” na eni strani in brez oznake na drugi strani.
INFORMATION IN BRAILLE Aripiprazole Accord 30 mg 
PODATKI V BRAILLOVI PISAVI Aripiprazol Accord 30 mg
(for 30's count) HDPE bottle pack should be used within 100 days after first opening. 
HDPE vsebnik je treba uporabiti v 100 dneh po prvem odprtju (za pakiranje po 100 tablet).
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 %.
Grand mal convulsion Serotonin syndrome Speech disorder 
Bolezni živčevja akatizija ekstrapiramidne motnje tremor glavobol sedacija somnolenca omotica tardivna diskinezija distonija maligni nevroleptični sindrom (MNS) generalizirana konvulzija serotoninski sindrom motnje govora
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). 
za vsaj 5,6 kg pri povprečni izhodiščni masi ~ 80,5 kg) značilno redkejše pri bolnikih, ki so dobivali aripiprazol, (n = 18 ali 13 % ocenljivih bolnikov) kot pri tistih, ki so dobivali olanzapin (n = 45 ali 33 % ocenljivih bolnikov).
INFORMATION IN BRAILLE Aripiprazole Accord 5 mg 
PODATKI V BRAILLOVI PISAVI Aripiprazol Accord 5 mg
INFORMATION IN BRAILLE Aripiprazole Accord 10 mg 
PODATKI V BRAILLOVI PISAVI Aripiprazol Accord 10 mg
Hydroxypropylcellulose Magnesium stearate Iron oxide yellow (E172) 
Aripiprazol Accord 15 mg tablete laktoza monohidrat mikrokristalna celuloza koruzni škrob hidroksipropilceluloza magnezijev stearat rumen železov oksid (E 172)
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1045/005- 30 tablets EU/1/15/1045/006- 100 tablets 
EU/1/15/1045/005- 30 tablet EU/1/15/1045/006- 100 tablet
These medicines may increase the risk of side effects or reduce the effect of ARIPIPRAZOLE ACCORD; if you get any unusual symptom taking any of these medicines together with ARIPIPRAZOLE ACCORD you should see your doctor. 
Ta zdravila lahko povečajo tveganje za neželene učinke ali zmanjšajo učinek zdravila Aripiprazol Accord.
Aripiprazole Accord 30 mg tablets: each tablet contains 30 mg of aripiprazole. 
Aripiprazol Accord 30 mg tablete : Ena tableta vsebuje 30 mg aripiprazola.
Aripiprazole Accord 30 mg tablets Each tablet contains 30 mg of aripiprazole. 
Aripiprazol Accord 30 mg tablete Ena tableta vsebuje 30 mg aripiprazola.
In CYP2D6 poor metabolisers, concomitant use of potent inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient. 
Pri osebah, ki slabo presnavljajo s CYP2D6 lahko sočasna uporaba z močnimi zaviralci CYP3A4 povzroči večjo koncentracijo aripiprazola v plazmi kot pri osebah, ki dobro presnavljajo s CYP2D6.
Other medicines and Aripiprazole Accord 
Shranjevanje zdravila Aripiprazol Accord
Aripiprazole Accord 5 mg tablets are blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain. 
Aripiprazol Accord 5 mg tablete so modre, bikonveksne, neobložene pravokotniku podobne tablete, dolžine približno 8,1 mm in širine 4,6 mm, z vtisnjeno oznako “A5” na eni strani in brez oznake na drugi strani.
Aripiprazole Accord 10 mg tablets are pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain. 
Aripiprazol Accord 10 mg tablete so roza, bikonveksne, neobložene pravokotniku podobne tablete, dolžine približno 8,1 mm in širine 4,6 mm, z vtisnjeno oznako “A10” na eni strani in brez oznake na drugi strani.
Aripiprazole Accord 15 mg tablets Each tablet contains 15 mg of aripiprazole. 
Aripiprazol Accord 15 mg tablete Ena tableta vsebuje 15 mg aripiprazola.
Aripiprazole Accord 10 mg tablets Each tablet contains 10 mg of aripiprazole. 
Aripiprazol Accord 10 mg tablete Ena tableta vsebuje 10 mg aripiprazola.
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 30 mg tablets aripiprazole 
IME ZDRAVILA Aripiprazol Accord 30 mg tablete aripiprazol
QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Accord 5 mg tablets Each tablet contains 5 mg of aripiprazole. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Aripiprazol Accord 5 mg tablete
Aripiprazole Accord 10 mg tablets: each tablet contains 10 mg of aripiprazole. 
Aripiprazol Accord 10 mg tablete : Ena tableta vsebuje 10 mg aripiprazola.
Aripiprazole Accord 5 mg tablets: each tablet contains 5 mg of aripiprazole. 
Aripiprazol Accord 5 mg tablete : Ena tableta vsebuje 5 mg aripiprazola.
Pink colored, approximately 9.1 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A30” on one side and another side is plain. 
Roza, okrogle, bikonveksne, neobložene tablete z zaobljenim robom, dolžine približno 9,1 mm, z vtisnjeno oznako “A30” na eni strani in brez oznake na drugi strani.
Aripiprazole Accord 15 mg tablets: each tablet contains 15 mg of aripiprazole. 
Aripiprazol Accord 15 mg tablete : Ena tableta vsebuje 15 mg aripiprazola.
Yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain. 
Rumene, okrogle, bikonveksne, neobložene tablete z zaobljenim robom, dolžine približno 7,14 mm, z vtisnjeno oznako “A15” na eni strani in brez oznake na drugi strani.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/ALUMINIUM BLISTERS 
ALUMINIJ/ALUMINIJASTI PRETISNI OMOTI
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 10 mg tablets aripiprazole 
IME ZDRAVILA Aripiprazol Accord 10 mg tablete aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 15 mg tablets aripiprazole 
IME ZDRAVILA Aripiprazol Accord 15 mg tablete aripiprazol
NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 5 mg tablets aripiprazole 
IME ZDRAVILA Aripiprazol Accord 5 mg tablete aripiprazol
• a tendency to wander away. 
- nagnjenost k tavanju.
If you get any side effects, talk to your doctor or pharmacist. 
Če imate kateri koli zgoraj omenjeni simptom, se takoj obrnite na zdravnika ali bolnišnico.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of aripiprazole. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 10 mg aripiprazola.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of aripiprazole. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 5 mg aripiprazola.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 15 mg aripiprazola.
Jaundice 
Distonija
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 30 mg aripiprazola.
In two 12-week, placebo- and active-controlled monotherapy trials in patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, aripiprazole demonstrated superior efficacy to placebo at week 3 and a maintenance of effect comparable to lithium or haloperidol at week 12. 
V dveh 12-tedenskih s placebom in zdravilno učinkovino nadzorovanih preskušanjih samostojnega zdravljenja pri bolnikih z manično ali mešano epizodo pri bipolarni motnji I s psihotičnimi simptomi ali brez njih se je po 3 tednih izkazalo, da je aripiprazol učinkovitejši od placeba.
Hydroxypropylcellulose Magnesium stearate Iron oxide red (E172) 
Aripiprazol Accord 10 mg/30 mg tablete laktoza monohidrat mikrokristalna celuloza koruzni škrob hidroksipropilceluloza magnezijev stearat rdeč železov oksid (E 172)