FrancophonIA/ELRC3.0 huggingface dataset:
English: Additionally, aripiprazole and dehydro-aripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
Croatian: Osim toga, aripiprazol i dehidro-aripiprazol in vitro nisu pokazali potencijal da mijenjaju metabolizam posredovan enzimom CYP1A2 pa stoga nije vjerojatno da će aripiprazol prouzročiti klinički važne interakcije s drugim lijekovima koji se metaboliziraju putem navedenih enzima.
English: Rectangular and pink, engraved with "A-008" and "10" on one side.
Croatian: Pravokutna i ružičasta s utisnutim oznakama "A-008" i "10" na jednoj strani.
English: • difficulty in passing urine,
Croatian: • poteškoće pri mokrenju,
English: Suicide attempt, suicidal ideation and completed suicide (see section 4.4)
Croatian: kompulzivno kupovanje i kompulzivno prejedanje (vidjeti dio 4.4).
English: • high blood sugar,
Croatian: • povišen šećer u krvi,
English: • agitation,
Croatian: • uznemirenost,
English: ABILIFY tablets contain lactose.
Croatian: ABILIFY tablete sadrže laktozu.
English: If you stop receiving ABILIFY
Croatian: Ako prestanete primati ABILIFY
English: Schizophrenia with oral aripiprazole
Croatian: Shizofrenija kod oralno primijenjenog aripiprazola
English: • decreased number of or difficulty making bowel movements,
Croatian: • rjeđe ili otežano pražnjenje crijeva,
English: EU/1/04/276/033 (1 mg/mL, 50 mL per bottle) EU/1/04/276/034 (1 mg/mL, 150 mL per bottle) EU/1/04/276/035 (1 mg/mL, 480 mL per bottle)
Croatian: EU/1/04/276/033 (1 mg/ml, boca od 50 ml) EU/1/04/276/034 (1 mg/ml, boca od 150 ml) EU/1/04/276/035 (1 mg/ml, boca od 480 ml)
English: • pain killers (such as tramadol and pethidine) used for pain relief
Croatian: • lijekovi protiv bolova (kao što su tramadol i petidin) koji se primjenjuju za ublažavanje boli
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.
Croatian: I jest da je ono posredovano kombinacijom djelomičnog agonizma s dopaminskim D2 i serotoninskim 5-HT1A
English: ABILIFY 7.5 mg/mL solution for injection
Croatian: ABILIFY 7,5 mg/ml otopina za injekciju
English: The pharmacokinetics of aripiprazole and dehydro-aripiprazole in paediatric patients 10 to 17 years of age were similar to those in adults after correcting for the differences in body weights.
Croatian: 10 do 17 godina bila je slična onoj u odraslih bolesnika nakon korekcije za razliku u tjelesnoj težini.
English: ABILIFY contains fructose and sucrose
Croatian: ABILIFY sadrži fruktozu i saharozu
English: ABILIFY 5 mg tablets are rectangular and blue, marked with ‘A-007' and ‘5' on one side.
Croatian: ABILIFY 5 mg tablete su pravokutne i plave, s oznakama ‘A-007' i ‘5' na jednoj strani.
English: ABILIFY 1 mg/mL oral solution aripiprazole
Croatian: ABILIFY 1 mg/ml oralna otopina aripiprazol
English: Orodispersible tablets
Croatian: Raspadljive tablete za usta
English: In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13 to 17 years), presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Croatian: U šestotjednom, placebom kontroliranom ispitivanju u koje su bila uključena 302 adolescentna bolesnika sa shizofrenijom (u dobi od 13 do 17 godina) i prisutnim pozitivnim ili negativnim simptomima, aripiprazol je bio povezan sa statistički značajno većim poboljšanjem psihotičnih simptoma u usporedbi s placebom.
English: In clinical studies, oral doses of 10 mg/day to 30 mg/day of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
Croatian: Potencijal aripiprazola da utječe na druge lijekove U kliničkim ispitivanjima, doze aripiprazola od 10 mg/dan do 30 mg/dan nisu imale značajnog učinka na metabolizam supstrata CYP2D6 (omjer dekstrometorfan/3-metoksimorfinan), CYP2C9 (varfarin), CYP2C19 (omeprazol) ni CYP3A4 (dekstrometorfan).
English: Each mL contains 1 mg of aripiprazole.
Croatian: Jedan ml sadrži 1 mg aripiprazola.
English: In both of these short-term trials, the clinical relevance of the efficacy findings has not been established, considering the magnitude of treatment effect compared to the large placebo effect and the unclear effects regarding psycho-social functioning.
Croatian: S obzirom na veličinu terapijskog učinka u odnosu na veliki učinak placeba i nejasne učinke u pogledu psihosocijalnog funkcioniranja, u ova dva kratkotrajna ispitivanja nije ustanovljena klinička važnost pronađene djelotvornosti.
English: ABILIFY 15 mg orodispersible tablets: This medicine contains 3 mg aspartame in each tablet.
Croatian: ABILIFY 15 mg raspadljive tablete za usta: Ovaj lijek sadrži 3 mg aspartama u jednoj tableti.
English: ABILIFY 7.5 mg/mL solution for injection aripiprazole
Croatian: ABILIFY 7,5 mg/ml otopina za injekciju aripiprazol
English: EU/1/04/276/033 - 50 mL bottle EU/1/04/276/034 - 150 mL bottle EU/1/04/276/035 - 480 mL bottle
Croatian: EU/1/04/276/033 - boca od 50 ml EU/1/04/276/034 - boca od 150 ml EU/1/04/276/035 - boca od 480 ml
English: • weight loss,
Croatian: • smanjenje tjelesne težine,
English: OUTER CARTON AND BOTTLE LABEL
Croatian: NALJEPNICA BOČICE
English: Solution for injection Clear, colourless, aqueous solution.
Croatian: Otopina za injekciju Bistra, bezbojna, vodena otopina
English: ABILIFY 30 mg orodispersible tablets: This medicine contains 6 mg aspartame in each tablet.
Croatian: ABILIFY 30 mg raspadljive tablete za usta: Ovaj lijek sadrži 6 mg aspartama u jednoj tableti.
English: Each mL contains 7.5 mg of aripiprazole.
Croatian: Jedan ml sadrži 7,5 mg aripiprazola.
English: Impulse control disorders may result in harm to the patient and others if not recognised.
Croatian: Ako se ne prepoznaju, poremećaji kontrole nagona mogu naškoditi kako bolesniku,
English: Renal impairment No dosage adjustment is required in patients with renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega.
English: 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.
Croatian: Djelotvornost aripiprazola bila je ispitana u pedijatrijskih ispitanika s Touretteovim sindromom (aripiprazol: n = 99, placebo: n = 44) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 8 tjedana u kojem su terapijske skupine primale fiksne doze na temelju tjelesne težine u rasponu od 5 mg na dan do 20 mg na dan, uz početnu dozu od 2 mg.
English: Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1 tablets.
Croatian: Aluminijski perforirani blisteri djeljivi na jedinične doze u kutijama s 14 × 1, 28 × 1, 49 × 1 tabletom.
English: In the adolescent (13 to 17 years) schizophrenia population with aripiprazole exposure of 5 mg 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.
Croatian: U populaciji adolescenata (u dobi od 13 do 17 godina) sa shizofrenijom koji su bili izloženi aripiprazolu u dozi od 5 mg do 30 mg do 72 mjeseca, incidencija niskih razina prolaktina u serumu u djevojaka (< 3 ng/ml) iznosila je 25,6 %, a u mladića (< 2 ng/ml) 45,0 %.
English: • The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose and magnesium stearate.
Croatian: • Drugi sastojci su laktoza hidrat, kukuruzni škrob, mikrokristalična celuloza,
English: In clinical trials oral aripiprazole has not been shown to induce clinically relevant weight gain.
Croatian: U kliničkim se ispitivanjima nije pokazalo da oralni aripiprazol inducira klinički značajno povećanje tjelesne težine.
English: ABILIFY 15 mg orodispersible tablets 15 mg: Round and yellow, marked with "A" over "641" on one side and "15" on the other.
Croatian: ABILIFY 15 mg raspadljive tablete za usta 15 mg: Okrugla i žuta s oznakom "A" iznad "641" na jednoj strani i "15" na drugoj.
English: once a day.
Croatian: 30 mg jedanput dnevno.
English: ABILIFY 10 mg orodispersible tablets: This medicine contains 2 mg aspartame in each tablet.
Croatian: ABILIFY 10 mg raspadljive tablete za usta: Ovaj lijek sadrži 2 mg aspartama u jednoj tableti.
English: ABILIFY solution for injection contains sodium.
Croatian: Natrij ABILIFY otopina za injekciju sadrži natrij.
English: When appropriate, subsequent dose increases should be administered in 5 mg increments without exceeding the maximum daily dose of 30 mg (see section 5.1).
Croatian: Po potrebi, doza se može dalje povećavati u koracima od po 5 mg, s time da se ne smije prekoračiti maksimalna dnevna doza od
English: ABILIFY orodispersible tablets contain aspartame.
Croatian: Aspartam ABILIFY raspadljive tablete za usta sadrže aspartam.
English: Each carton contains one single-use type I glass vial with a rubber butyl stopper and a "tear-off" aluminium seal.
Croatian: I za jednokratnu uporabu, s čepom od butilne gume i aluminijskim prstenom.
English: Blood glucose fluctuation Creatine phosphokinase increased
Croatian: Nepoznato fosfataze produljen QT interval povišena glukoza u krvi povišen glikirani hemoglobin fluktuacija glukoze u krvi povišena vrijednost kreatin fosfokinaze
English: How to store ABILIFY
Croatian: Kako primjenjivati ABILIFY
English: In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult patients, presenting with positive or negative symptoms, oral aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Croatian: U tri kratkotrajna (4 do 6 tjedana), placebom kontrolirana ispitivanja koja su uključila 1228 odraslih bolesnika s pozitivnim ili negativnim simptomima shizofrenije, oralni aripiprazol je bio povezan sa statistički značajno većim poboljšanjima psihotičnih simptoma u usporedbi s placebom.
English: In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult patients, presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Croatian: U tri kratkotrajna (4 do 6 tjedana), placebom kontrolirana ispitivanja koja su uključila 1228 odraslih bolesnika s pozitivnim ili negativnim simptomima shizofrenije, aripiprazol je bio povezan sa statistički značajno većim poboljšanjima psihotičnih simptoma u usporedbi s placebom.
English: ABILIFY 30 mg tablets are round and pink, marked with ‘A-011' and ‘30' on one side.
Croatian: ABILIFY 30 mg tablete su okrugle i ružičaste, s oznakama ‘A-011' i ‘30' na jednoj strani.
English: ABILIFY 30 mg tablets:
Croatian: ABILIFY 30 mg tablete:
English: Sulfobutylether β-cyclodextrin (SBECD) Tartaric acid
Croatian: 6.1 Popis pomoćnih tvari sulfobutileter β-ciklodekstrin (SBECD) tartaratna kiselina natrijev hidroksid voda za injekcije
English: ABILIFY 15 mg tablets are round and yellow, marked with ‘A-009' and ‘15' on one side.
Croatian: ABILIFY 15 mg tablete Okrugla i žuta s utisnutim oznakama "A-009" i "15" na jednoj strani.
English: Hyperhidrosis
Croatian: Parahidroksibenzoat
English: • vomiting,
Croatian: • povraćanje,
English: Concomitant administration of aripiprazole and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
Croatian: Slični učinci mogu se očekivati i kod istodobne primjene aripiprazola i drugih induktora CYP3A4 (kao što su rifampicin, rifabutin, fenitoin,
English: Magnesium stearate
Croatian: tartaratna kiselina magnezijev stearat
English: Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja štucavica aspiracijska pneumonija laringospazam orofaringealni spazam
English: ABILIFY 1 mg/mL oral solution
Croatian: ABILIFY 1 mg/ml oralna otopina
English: ABILIFY 10 mg tablets are rectangular and pink, marked with ‘A-008' and ‘10' on one side.
Croatian: ABILIFY 10 mg tablete su pravokutne i ružičaste, s oznakama ‘A-008' i ‘10' na jednoj strani.
English: Each vial contains 9.75 mg aripiprazole.
Croatian: Jedna bočica sadrži 9,75 mg aripiprazola.
English: Only take other medicines while you are on ABILIFY if your doctor tells you that you can.
Croatian: Za vrijeme liječenja ABILIFY, druge lijekove smijete uzimati samo ako Vam je to dopustio liječnik
English: ABILIFY 10 mg orodispersible tablets Each orodispersible tablet contains 10 mg of aripiprazole.
Croatian: ABILIFY 10 mg raspadljive tablete za usta Jedna raspadljiva tableta za usta sadrži 10 mg aripiprazola.
English: • seizure,
Croatian: • ukočenost,
English: Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain
Croatian: Nepoznato reakcije na mjestu primjene temperature (npr. hipotermija, pireksija) bol u prsištu periferni edem
English: ABILIFY 30 mg tablets
Croatian: ABILIFY 30 mg tablete
English: In two long-term trials with adolescent (13 to 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.
Croatian: U dva dugotrajna ispitivanja u adolescenata (u dobi od 13 do 17 godina) sa shizofrenijom i bolesnika s bipolarnim poremećajem liječenih aripiprazolom, incidencija niskih razina prolaktina u serumu u djevojaka (< 3 ng/ml) iznosila je 37,0 %, a u mladića (< 2 ng/ml) 59,4 %.
English: • antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,
Croatian: • antidepresive ili biljne lijekove koji se primjenjuju za liječenje depresije i tjeskobe (kao što su fluoksetin, paroksetin, venlafaksin, gospina trava)
English: ABILIFY orodispersible tablets contain lactose.
Croatian: ABILIFY raspadljive tablete za usta sadrže laktozu.
English: Hepatic failure Hepatitis Jaundice
Croatian: Poremećaji jetre i žuči zatajenje jetre hepatitis žutica
English: • stiffness,
Croatian: • ošamućenost,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU VANJSKO PAKIRANJE I NALJEPNICA BOCE
English: ABILIFY 10 mg tablets:
Croatian: ABILIFY 10 mg tablete:
English: ABILIFY 15 mg orodispersible tablets Yellow iron oxide (E 172)
Croatian: ABILIFY 15 mg raspadljive tablete za usta Željezov oksid, žuti (E 172)
English: • The other ingredients are calcium silicate, croscarmellose sodium, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, vanilla flavour (contains lactose), tartaric acid and magnesium stearate.
Croatian: ksilitol, mikrokristalična celuloza, aspartam, acesulfamkalij, aroma vanilije (sadrži laktozu),
English: Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1, 56 × 1, 98 × 1 tablets.
Croatian: Aluminijski perforirani blisteri djeljivi na jedinične doze u kutijama s 14 × 1, 28 × 1, 49 × 1, 56 × 1,
English: ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"' on one side and ‘15' on the other.
Croatian: ABILIFY 15 mg raspadljive tablete za usta su okrugle i žute, s oznakom ‘"A" iznad "641"' na jednoj strani i ‘15' na drugoj.
English: Read the package leaflet before use.
Croatian: koje su priložene u pakiranju.
English: • feeling aggressive,
Croatian: • agresivnost,
English: In the pooled adolescent schizophrenia population (13 to 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.
Croatian: U cjelokupno ispitanoj populaciji adolescenata sa shizofrenijom (u dobi od 13 do 17 godina) koji su primali lijek u trajanju do 2 godine, incidencija niske razine prolaktina u serumu u djevojaka (< 3 ng/ml) bila je 29,5 %, a u mladića (< 2 ng/ml) 48,3 %.
English: ABILIFY 10 mg tablets
Croatian: ABILIFY 10 mg tablete
English: In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged.
Croatian: Kinidin i drugi inhibitori CYP2D6 U kliničkom ispitivanju sa zdravim ispitanicima, jaki inhibitor CYP2D6 (kinidin) povećao je površinu ispod krivulje (AUC) aripiprazola za 107 %, dok je maksimalna koncentracija (Cmax) ostala neizmijenjena.
English: Administration of ABILIFY solution for injection was well tolerated and produced no direct target organ toxicity in rats or monkeys after repeated dosing at systemic exposures (AUC) that were 15 and 5 times, respectively, human exposure at the maximum recommended human dose of 30 mg intramuscular.
Croatian: Pimjena ABILIFY otopina za injekciju dobro se podnosila i nije imala nikakve izravne toksične učinke na ciljne organe u štakora i majmuna nakon ponovljene primjene i pri sistemskoj izloženosti
English: • feeling anxious,
Croatian: • osjećaj tjeskobe,
English: ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"' on one side and ‘30' on the other.
Croatian: ABILIFY 30 mg raspadljive tablete za usta su okrugle i ružičaste, s oznakom ‘"A" iznad "643"' na jednoj strani i ‘30' na drugoj.
English: • 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
Croatian: • povišenog šećera u krvi (karakteriziranog simptomima poput pretjerane žeđi, obilnog mokrenja,
English: ABILIFY 30 mg orodispersible tablets Red iron oxide (E 172)
Croatian: ABILIFY 30 mg raspadljive tablete za usta Željezov oksid, crveni (E 172)
English: ABILIFY 15 mg tablets:
Croatian: ABILIFY 15 mg tablete:
English: Peripheral oedema
Croatian: Oralna otopina
English: ABILIFY 10 mg orodispersible tablets are round and pink, marked with ‘"A" over "640"' on one side and ‘10' on the other.
Croatian: ABILIFY 10 mg raspadljive tablete za usta su okrugle i ružičaste, s oznakom ‘"A" iznad "640"' na jednoj strani i ‘10' na drugoj.
English: ABILIFY 10 mg orodispersible tablets Red iron oxide (E 172)
Croatian: ABILIFY 10 mg raspadljive tablete za usta Željezov oksid, crveni (E 172)
English: Each tablet contains 30 mg of aripiprazole.
Croatian: Jedna tableta sadrži 30 mg aripiprazola.
English: ABILIFY 15 mg tablets
Croatian: ABILIFY 15 mg tablete
English: ABILIFY 5 mg tablets:
Croatian: ABILIFY 5 mg tablete:
English: ABILIFY 30 mg tablets aripiprazole
Croatian: ABILIFY 30 mg tablete aripiprazol
English: The effective dose range of ABILIFY solution for injection is 5.25 mg to 15 mg as a single injection.
Croatian: 5,25 mg do 15 mg u obliku jednokratne injekcije.
English: In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, aripiprazole had significantly greater reduction in relapse rate, 34 % in aripiprazole group and 57 % in placebo.
Croatian: U placebom kontroliranom ispitivanju u trajanju od 26 tjedana koje je uključilo stabilne odrasle bolesnike s kroničnom shizofrenijom, aripiprazol je imao značajno veće smanjenje stope relapsa, 34 %
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 SouthKorea.
Croatian: 20 mg na dan uz početnu dozu od 2 mg u pedijatrijskih ispitanika s Touretteovim sindromom (aripiprazol: n = 32, placebo: n = 29) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 10 tjedana provedenom u Južnoj Koreji.
English: ABILIFY 10 mg tablets aripiprazole
Croatian: ABILIFY 10 mg tablete aripiprazol
English: EU/1/04/276/016 (30 mg, 14 × 1 tablets) EU/1/04/276/017 (30 mg, 28 × 1 tablets) EU/1/04/276/018 (30 mg, 49 × 1 tablets) EU/1/04/276/019 (30 mg, 56 × 1 tablets) EU/1/04/276/020 (30 mg, 98 × 1 tablets)
Croatian: EU/1/04/276/016 (30 mg, 14 × 1 tableta) EU/1/04/276/017 (30 mg, 28 × 1 tableta) EU/1/04/276/018 (30 mg, 49 × 1 tableta) EU/1/04/276/019 (30 mg, 56 × 1 tableta) EU/1/04/276/020 (30 mg, 98 × 1 tableta)
English: Photosensitivity reaction Alopecia
Croatian: Poremećaji kože i potkožnog tkiva osip fotosenzitivna reakcija alopecija hiperhidroza
English: Each tablet contains 5 mg of aripiprazole.
Croatian: Jedna tableta sadrži 5 mg aripiprazola.
English: ABILIFY 5 mg tablets
Croatian: ABILIFY 5 mg tablete
English: Tardive dyskinesia Dystonia
Croatian: Tardivna diskinezija
English: In the paediatric bipolar population (10 to 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 28.0 % and 53.3 %, respectively.
Croatian: U pedijatrijskoj populaciji s bipolarnim poremećajem (10 do 17 godina), koja je lijeku bila izložena tijekom najviše 30 tjedana, incidencija niskih vrijednosti prolaktina u serumu iznosila je 28,0 % u djevojčica (< 3 ng/ml) i 53,3 % u dječaka (< 2 ng/ml).
English: Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Croatian: Tel: +31 (0) 20 85 46 555
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.
Croatian: 12 tjedana, incidencija EPS-a bila je 23,5 % u bolesnika liječenih aripiprazolom i 53,3 % u bolesnika liječenih haloperidolom.
English: EU/1/04/276/030 (30 mg, 14 × 1 orodispersible tablets) EU/1/04/276/031 (30 mg, 28 × 1 orodispersible tablets) EU/1/04/276/032 (30 mg, 49 × 1 orodispersible tablets)
Croatian: EU/1/04/276/030 (30 mg, 14 × 1 raspadljiva tableta za usta) EU/1/04/276/031 (30 mg, 28 × 1 raspadljiva tableta za usta) EU/1/04/276/032 (30 mg, 49 × 1 raspadljiva tableta za usta)
English: Each orodispersible tablet contains 10 mg of aripiprazole.
Croatian: Jedna raspadljiva tableta za usta sadrži 10 mg aripiprazola.
English: Each orodispersible tablet contains 30 mg of aripiprazole.
Croatian: Jedna raspadljiva tableta za usta sadrži 30 mg aripiprazola.
English: Immune system disorders
Croatian: Nepoznato limfnog sustava neutropenija trombocitopenija
English: Pathological gambling Impulse-control disorder Binge eating
Croatian: (vidjeti dio 4.4) patološko kockanje poremećaj kontrole nagona kompulzivno prejedanje kompulzivno kupovanje
English: ABILIFY 5 mg tablets aripiprazole
Croatian: ABILIFY 5 mg tablete aripiprazol
English: The safety and efficacy of ABILIFY in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established.
Croatian: Sigurnost i djelotvornost lijeka ABILIFY u liječenju shizofrenije ili maničnih epizoda kod bipolarnog poremećaja tipa
English: Each orodispersible tablet contains 15 mg of aripiprazole.
Croatian: Jedna raspadljiva tableta za usta sadrži 15 mg aripiprazola.
English: Each tablet contains 10 mg of aripiprazole.
Croatian: Jedna tableta sadrži 10 mg aripiprazola.
English: ABILIFY 15 mg tablets aripiprazole
Croatian: ABILIFY 15 mg tablete aripiprazol
English: Among the patients included in the primary efficacy analysis,
Croatian: U dva ispitivanja u zdravih ispitanika,
English: Methyl parahydroxybenzoate (E 218) Propylene glycol
Croatian: 6.1 Popis pomoćnih tvari dinatrijev edetat fruktoza glicerin laktatna kiselina metilparahidroksibenzoat (E 218) propilenglikol propilparahidroksibenzoat (E 216) natrijev hidroksid saharoza voda, pročišćena aroma naranče
English: • dry mouth.
Croatian: Primjena kroz usta.