FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood glucose increased Glycosylated haemoglobin increased
Slovak: Zvýšenie glykozylovaného hemoglobínu
English: Gender No dosage adjustment is required for female patients as compared to male patients (see section 5.2).
Slovak: Nie je potrebná žiadna úprava dávkovania u ženských pacientov v porovnaní s mužskými pacientmi
English: Package leaflet: Information for the user ABILIFY 7.5 mg/mL solution for injection aripiprazole
Slovak: Písomná informácia pre používateľa ABILIFY 7,5 mg/ml injekčný roztok aripiprazol
English: Weight gain has been reported post-marketing among patients prescribed oral aripiprazole.
Slovak: Po uvedení lieku na trh sa hlásil prírastok telesnej hmotnosti u pacientov užívajúcich aripiprazol.
English: ABILIFY 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).
Slovak: I a na prevenciu novej manickej epizódy u dospelých, ktorí mali prevažne manické epizódy a ktorých manické epizódy odpovedali na liečbu aripiprazolom (pozri časť 5.1).
English: Otsuka Pharmaceuticals (UK) Ltd. Tel: +44 (0) 203 747 5300
Slovak: Ltd. Tel: +44 (0) 203 747 5300
English: Round and pink, engraved with "A-011" and "30" on one side.
Slovak: Okrúhla a ružová s označením ‘A-011' a ‘30' na jednej strane.
English: Solution for injection Clear, colourless, aqueous solution.
Slovak: Injekčný roztok Číry, bezfarebný, vodný roztok.
English: Treatment should be initiated at 2 mg (using ABILIFY 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.
Slovak: 1 mg/ml) prvé 2 dni, titrovanou na 5 mg ďalšie 2 dni, aby sa dosiahla odporúčaná denná dávka 10 mg.
English: However, in a single-dose, intramuscular study of aripiprazole (dose 15 mg) in healthy subjects, administered simultaneously with intramuscular lorazepam (dose 2 mg), the intensity of sedation was greater with the combination as compared to that observed with aripiprazole alone.
Slovak: Avšak pri jednorazovom podaní bola intenzita sedácie u zdravých jedincov v štúdii s intramuskulárnym aripiprazolom (dávka 15 mg) podávaným súčasne s intramuskulárnym lorazepamom (dávka 2 mg) vyššia pri kombinovanom podaní ako pri podaní samotného aripiprazolu.
English: Schizophrenia in adolescents aged 15 years and older: the recommended dose for ABILIFY is 10 mg/day administered on a once-a-day schedule without regard to meals.
Slovak: Schizofrénia u dospievajúcich vo veku od 15 rokov a starších: odporúčaná dávka ABILIFY je 10 mg/deň podávaná podľa dávkovacej schémy raz denne, bez ohľadu na príjem potravy.
English: If you stop taking ABILIFY
Slovak: Ak prestanete užívať ABILIFY
English: No specific interaction studies have been performed with ABILIFY solution for injection.
Slovak: S liekom ABILIFY injekčný roztok sa neuskutočnili žiadne špecifické interakčné štúdie.
English: However, the estimation of the HR for the younger (13 to 14 years) group was not precise, reflecting the smaller number of subjects in that group (aripiprazole, n = 29; placebo, n = 12), and the confidence interval for this estimation (ranging from 0.151 to 1.628) did not allow conclusions to be drawn on the presence of a treatment effect.
Slovak: Odhadovaný pomer rizika v skupine mladších pacientov (13 až 14 rokov) však nebol presný, pretože odzrkadľoval nízky počet účastníkov v tejto skupine (aripiprazol, n = 29, placebo, n =
English: If you are taking ABILIFY, 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.
Slovak: Ak užívate ABILIFY, váš lekár s vami po zvážení prínosu liečby pre vás a prínosu dojčenia pre vaše dieťa prekonzultuje, či máte dojčiť.
English: No cases of overdose associated with adverse reactions were reported in clinical studies with ABILIFY solution for injection.
Slovak: Počas klinických štúdií s liekom ABILIFY injekčný roztok neboli hlásené žiadne prípady predávkovania spojené s nežiaducimi reakciami.
English: ABILIFY solution for injection is for intramuscular use.
Slovak: ABILIFY injekčný roztok na intramuskulárne podanie.
English: ABILIFY contains lactose
Slovak: ABILIFY obsahuje laktózu
English: Aripiprazole doses ranging from 0.5 mg 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, to the caudate and putamen detected by positron emission tomography.
Slovak: 2 týždňov vyvolali dávkovo závislú redukciu väzby 11C-raklopridu, ligandu D2/D3 receptora na caudatus a putamen zistenú pozitrónovou emisnou tomografiou.
English: ABILIFY 15 mg tablets are round and yellow, marked with ‘A-009' and ‘15' on one side.
Slovak: ABILIFY 15 mg tablety sú okrúhle a žlté označené s ‘A-009' a ‘15' na jednej strane.
English: Rectangular and blue, engraved with "A-007" and "5" on one side.
Slovak: Obdĺžniková a modrá s označením ‘A-007' a ‘5' na jednej strane.
English: ABILIFY is effective in a dose range of 10 mg/day to 30 mg/day (i.e. 10 mL to 30 mL solution/day).
Slovak: ABILIFY je účinný v rozsahu dávky od 10 mg/deň do 30 mg/deň (t.j.
English: • inflammation of the pancreas,
Slovak: • zápal pankreasu,
English: However, you should not dilute with other liquids or mix with other food prior to taking ABILIFY oral solution.
Slovak: Avšak, ABILIFY nerieďte s inými tekutinami alebo nemiešajte s inou potravou predtým ako ho užijete.
English: Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including accelerated or malignant.
Slovak: Aripiprazol sa má opatrne používať u pacientov so známou kardiovaskulárnou chorobou (anamnéza infarktu myokardu alebo ischemickej choroby srdca, srdcového zlyhania alebo abnormality vedenia),
English: However, the oral solution should not be diluted with other liquids or mixed with any food prior to administration.
Slovak: Avšak, pred užitím sa perorálny roztok nesmie riediť s inými tekutinami alebo miešať s jedlom.
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.
Slovak: Manické epizódy u bipolárnej poruchy typu I: v 12 týždňov trvajúcom kontrolovanom skúšaní mali pacienti liečení aripiprazolom incidenciu EPS 23,5
English: Diabetic ketoacidosis
Slovak: Diabetes mellitus
English: Each mL contains 7.5 mg of aripiprazole.
Slovak: Každý ml obsahuje 7,5 mg aripiprazolu.
English: ABILIFY contains parahydroxybenzoates
Slovak: ABILIFY obsahuje parahydroxybenzoáty
English: • difficulty swallowing,
Slovak: • mdloby,
English: Population pharmacokinetic evaluation of oral aripiprazole has revealed no evidence of clinically relevant effects from smoking on the pharmacokinetics of aripiprazole.
Slovak: Hodnotenie farmakokinetických vlastností populácie s perorálnym aripiprazolom nepreukázalo výskyt žiadnych klinicky relevantných vplyvov fajčenia na farmakokinetické vlastnosti aripiprazolu.
English: In clinical trials oral aripiprazole has not been shown to induce clinically relevant weight gain.
Slovak: V klinických štúdiách sa nedokázalo, že by perorálny aripiprazol vyvolával klinicky relevantný prírastok hmotnosti.
English: Non-clinical data reveal no special hazard for humans based on conventional oral aripiprazole studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Slovak: Predklinické údaje o bezpečnosti na základe obvyklých štúdií farmakologickej bezpečnosti, toxicity po opakovanom podávaní, genotoxicity, karcinogénneho potenciálu a vývojovej a reprodukčnej toxicity u perorálneho aripiprazolu neodhalili žiadne osobitné riziko pre ľudí.
English: However your doctor may prescribe a lower or higher dose to a maximum of 30 mg (i.e. 30 mL) once a day.
Slovak: Avšak, váš lekár vám môže predpísať nižšiu alebo vyššiu dávku maximálne však 30 mg (t.j. 30 ml) raz denne.
English: If you are receiving ABILIFY, 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.
Slovak: Ak dostávate ABILIFY, váš lekár s vami po zvážení prínosu liečby pre vás a prínosu dojčenia pre vaše dieťa prekonzultuje, či máte dojčiť.
English: The Kaplan-Meier rates for recurrence to any mood episode for the adjunctive treatment arm were 16 % in aripiprazole + lithium and 18 % in aripiprazole + valproate compared to 45 % in placebo + lithium and 19 % in placebo + valproate.
Slovak: % pre aripiprazol + valproát oproti 45 % pre placebo +lítium a 19 % pre placebo + valproát.
English: ABILIFY 10 mg orodispersible tablets ABILIFY 15 mg orodispersible tablets ABILIFY 30 mg orodispersible tablets
Slovak: ABILIFY 10 mg orodispergovateľné tablety ABILIFY 15 mg orodispergovateľné tablety ABILIFY 30 mg orodispergovateľné tablety
English: ABILIFY orodispersible tablets contain aspartame.
Slovak: ABILIFY orodispergovateľné tablety obsahujú aspartam.
English: 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).
Slovak: 1/10), suchosť v ústach, zvýšená chuť do jedla, a ortostatická hypotenzia boli hlásené ako časté (≥
English: Each mL contains 1 mg of aripiprazole.
Slovak: Každý ml obsahuje 1 mg aripiprazolu.
English: Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.
Slovak: Aripiprazol sa v rozsiahlej miere metabolizuje v pečeni hlavne tromi biotransformačnými cestami:
English: It should be noted that impulse-control symptoms can be associated with the underlying disorder; however, in some cases, urges were reported to have stopped when the dose was reduced or the medication was discontinued.
Slovak: v niektorých prípadoch však bolo hlásené, že nutkania prestali po znížení dávky alebo po prerušení užívania liekov.
English: • The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose and magnesium stearate.
Slovak: Ďalšie zložky sú monohydrát laktózy, kukuričný škrob, mikrokryštalická celulóza,
English: These included: dose-dependent adrenocortical toxicity (lipofuscin pigment accumulation and/or parenchymal cell loss) in rats after 104 weeks at 20 mg/kg/day to 60 mg/kg/day (3 to 10 times the mean steady-state AUC at the maximum recommended human dose) and increased adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats at 60 mg/kg/day (10 times the mean steady-state AUC at the maximum recommended human dose).
Slovak: Tieto účinky zahŕňali: dávkovo závislú adrenokortikálnu toxicitu (kumulácia lipofuscínu a/alebo strata parenchymálnych buniek) u potkanov po 104 týždňoch pri dávke od 20 mg/kg/deň do 60 mg/kg/deň (3 až 10-násobok priemernej hodnoty
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.
Slovak: Podanie injekčného roztoku aripiprazolu bolo dobre tolerované a nespôsobovalo žiadnu priamu orgánovú toxicitu po opakovanom podávaní u potkanov alebo opíc pri systémových expozíciách
English: ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"' on one side and ‘15' on the other.
Slovak: ABILIFY 15 mg orodispergovateľné tablety sú okrúhle a žlté označené s ‘"A" nad "641" ' na jednej strane a ‘15' na druhej.
English: What you need to know before you take ABILIFY Do not take ABILIFY
Slovak: Čo potrebujete vedieť predtým, ako dostanete ABILIFY
English: ABILIFY 30 mg tablets are round and pink, marked with ‘A-011' and ‘30' on one side.
Slovak: ABILIFY 30 mg tablety sú okrúhle a ružové označené s ‘A-011' a ‘30' na jednej strane.
English: In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary endpoint 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 oral aripiprazole (n = 18, or 13 % of evaluable patients), compared to oral olanzapine (n = 45, or 33 % of evaluable patients).
Slovak: V 26-týždňovej, olanzapínom kontrolovanej, dvojito zaslepenej, medzinárodnej štúdii schizofrénie, ktorá zahŕňala 314 dospelých pacientov, v ktorej bol primárne sledovaným parametrom prírastok telesnej hmotnosti, malo najmenej 7 % prírastok telesnej hmotnosti od počiatočnej hodnoty signifikantne menej pacientov (t.j. prírastok najmenej 5,6 kg pri počiatočnej hodnote hmotnosti ~80,5 kg) na aripiprazole (n =
English: Posology
Slovak: PAPIEROVA
English: Lactic acid
Slovak: Kyselina vínna
English: Orodispersible tablets
Slovak: Orodispergovateľná tablety
English: ABILIFY 5 mg tablets Indigo carmine aluminium lake (E 132)
Slovak: 5 mg tablety hlinitý lak indigokarmínu (E 132)
English: Rectangular and pink, engraved with "A-008" and "10" on one side.
Slovak: Obdĺžniková a ružová s označením ‘A-008 a ‘10' na jednej strane.
English: ABILIFY 5 mg tablets are rectangular and blue, marked with ‘A-007' and ‘5' on one side.
Slovak: 5 mg tablety sú obdĺžnikové a modré označené s ‘A-007' a ‘5' na jednej strane.
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).
Slovak: U dospievajúcich vo veku od 13 rokov a starších sa vyskytli vedľajšie účinky podobného typu a s podobnou frekvenciou ako u dospelých, okrem ospalosti, nekontrolovateľného mykania alebo šklbania, nepokoja a únavy, ktoré sa vyskytli veľmi často (výskyt u viac ako 1 z 10 pacientov)
English: All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to
Slovak: Všetky nežiaduce reakcie lieku sú zoradené podľa triedy orgánových systémov a frekvencie: veľmi časté (≥
English: ABILIFY 10 mg tablets are rectangular and pink, marked with ‘A-008' and ‘10' on one side.
Slovak: ABILIFY 10 mg tablety sú obdĺžnikové a ružové označené s ‘A-008' a ‘10' na jednej strane.
English: ABILIFY orodispersible tablets are supplied in perforated unit dose blisters packed in cartons containing 14 × 1, 28 × 1, or 49 × 1 orodispersible tablets.
Slovak: ABILIFY orodispergovateľné tablety sú dodávané v perforovaných blistroch balených v papierových skladačkách obsahujúcich 14 ×
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Slovak: Tento liek obsahuje menej ako 1 mmol sodíka (23 mg) v jednotke dávkovania, t. j. v podstate zanedbateľné množstvo sodíka.
English: Adjunctive aripiprazole demonstrated superiority over placebo on the secondary outcome measure in Clinical Global Impression - Bipolar version (CGI-BP) Severity of Illness (SOI; mania) scores.
Slovak: Bipolar version (CGI-BP) skóre závažnosti ochorenia (mánia).
English: • excessive sweating,
Slovak: • nadmerné potenie,
English: ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"' on one side and ‘30' on the other.
Slovak: ABILIFY 30 mg orodispergovateľné tablety sú okrúhle a ružové označené s ‘"A" nad "643" ' na jednej strane a ‘30' na druhej.
English: A vial provides 9.75 mg in 1.3 mL.
Slovak: Injekčná liekovka obsahuje 9,75 mg v 1,3 ml.
English: ABILIFY 1 mg/mL oral solution aripiprazole
Slovak: ABILIFY 1 mg/ml perorálny roztok aripiprazol
English: Insomnia Anxiety Restlessness
Slovak: Psychické poruchy Insomnia
English: 2 mg aspartame (E 951) and 0.075 mg lactose per orodispersible tablet
Slovak: Pomocná látka so známym účinkom2 mg aspartamu (E 951) a 0,075 mg laktózy na orodispergovateľnú tabletu
English: • antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,
Slovak: • antidepresíva alebo bylinné prípravky na liečbu depresie a úzkosti (napr. fluoxetín, paroxetín, venlafaxín, ľubovník bodkovaný),
English: ABILIFY 7.5 mg/mL solution for injection
Slovak: ABILIFY 7,5 mg/ml injekčný roztok
English: ABILIFY 30 mg tablets:
Slovak: ABILIFY 30 mg tablety:
English: ABILIFY contains sodium
Slovak: ABILIFY obsahuje sodíka
English: • agitation,
Slovak: • nepokoj,
English: once a day.
Slovak: 30 mg) raz denne.
English: The recommended dose is 9.75 mg (1.3 mL) for the first injection.
Slovak: Odporúčaná dávka je 9,75 mg (1,3 ml)
English: • inflammation of the liver,
Slovak: • zápal pečene,
English: Otsuka Pharmaceutical, S.A. Tel: +34 93 550 01 00
Slovak: Tel: +34 93 550 01 00
English: • difficulty in passing urine,
Slovak: • ťažkosť s močením,
English: The oral solution contains sodium.
Slovak: Perorálny roztok obsahuje sodík.
English: What you need to know before you are given ABILIFY Do not use ABILIFY
Slovak: Čo potrebujete vedieť predtým, ako užijete ABILIFY
English: ABILIFY 10 mg tablets
Slovak: ABILIFY 10 mg tablety
English: • muscle pain,
Slovak: • svalová bolesť,
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Slovak: Tento liek obsahuje menej ako 1 mmol sodíka (23 mg) na tabletu, t. j. v podstate zanedbateľné množstvo sodíka.
English: ABILIFY 7.5 mg/mL solution for injection aripiprazole
Slovak: ABILIFY 7,5 mg/ml injekčný roztok aripiprazol
English: The overall completion rate was significantly higher for patients on oral aripiprazole (43 %) than for oral haloperidol (30 %).
Slovak: Celkový konečný pomer bol signifikantne vyšší u pacientov liečených perorálnym aripiprazolom (43
English: ABILIFY 30 mg tablets
Slovak: ABILIFY 30 mg tablety
English: These medicines may increase the risk of side effects or reduce the effect of ABILIFY; if you get any unusual symptom taking any of these medicines together with ABILIFY you should see your doctor.
Slovak: Tieto lieky môžu zvyšovať riziko výskytu vedľajších účinkov alebo znížiť účinok lieku ABILIFY.
English: 14 × 1 orodispersible tablets 28 × 1 orodispersible tablets 49 × 1 orodispersible tablets
Slovak: 1 orodispergovateľná tableta 49 ×
English: Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Slovak: Tel: +31 (0) 20 85 46 555
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.
Slovak: V populácii dospievajúcich pacientov (vo veku 13 až 17 rokov) trpiacich schizofréniou, ktorí boli vystavení 5 mg až 30 mg aripiprazolu až po dobu 72 mesiacov, bol výskyt nízkej hladiny prolaktínu v sére u žien (<
English: No dosage adjustment is required for patients with mild to moderate hepatic impairment.
Slovak: U pacientov s miernou až stredne ťažkou poruchou funkcie pečene nie je potrebná žiadna úprava dávkovania.
English: Not known disorders
Slovak: Neznáme systému
English: 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 %).
Slovak: %) EPS zahŕňajúcich parkinsonizmus, akatíziu, dystóniu a dyskinézu v porovnaní s pacientmi liečenými haloperidolom (57,3
English: Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41 % and AUC by about 51 %, suggesting that charcoal may be effective in the treatment of overdose.
Slovak: (50 g) podané po jednej hodine po podaní aripiprazolu znížilo hodnoty Cmax aripiprazolu asi o 41
English: ABILIFY 15 mg tablets
Slovak: ABILIFY 15 mg tablety
English: Do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP.
Slovak: Nepoužívajte tento liek po dátume exspirácie, ktorý je uvedený na papierovej skladačke a na injekčnej liekovke po EXP.
English: 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.
Slovak: %. V dlhodobom 26 týždňov trvajúcom placebom kontrolovanom skúšaní bola u pacientov liečených aripiprazolom incidencia EPS 18,2
English: • skin rash,
Slovak: • kožná vyrážka,
English: Each vial contains 9.75 mg aripiprazole.
Slovak: Injekčná liekovka obsahuje 9,75 mg aripiprazolu.
English: Excipient with known effect 62.18 mg lactose (as monohydrate) per tablet
Slovak: 62,18 mg laktózy (vo forme monohydrátu) na tabletu ABILIFY 15 mg tablety
English: Blood glucose fluctuation Creatine phosphokinase increased
Slovak: Zvýšenie kreatínfosfokinázy
English: Psychiatric disorders
Slovak: Klinickými prejavmi
English: Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Slovak: Laryngospazmus Orofaryngeálny spazmus
English: ABILIFY orodispersible tablets contain lactose.
Slovak: ABILIFY orodispergovateľné tablety obsahujú laktózu.
English: ABILIFY 15 mg tablets:
Slovak: ABILIFY 15 mg tablety:
English: ABILIFY 10 mg tablets:
Slovak: ABILIFY 10 mg tablety:
English: Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1 tablets.
Slovak: Hliníkové perforované blistre s jednotlivými dávkami v papierových skladačkách s 14 ×
English: Agitation in schizophrenia and Bipolar I Disorder with ABILIFY solution for injection In two short- term (24-hour) placebo-controlled trials involving 554 schizophrenic adult patients presenting with agitation and disturbed behaviours, ABILIFYsolution for injection was associated with statistically significant greater improvements in agitation/behavioural symptoms compared to placebo and was similar to haloperidol.
Slovak: dospelých schizofrenických pacientov, u ktorých bola prítomná agitácia a porucha správania, bol injekčný roztok ABILIFY spájaný so štatisticky významnejším zlepšením agitácie a behaviorálnych symptómov v porovnaní s placebom, účinok bol podobný ako pri haloperidole.
English: Sudden death unexplained Torsades de pointes Ventricular arrhythmia Cardiac arrest Bradycardia
Slovak: Ventrikulárne arytmie Zástava srdca
English: ABILIFY orodispersible tablets contain sodium.
Slovak: Sodík ABILIFY orodispergovateľné tablety obsahujú sodíka.
English: The oral solution contains fructose and sucrose.
Slovak: Fruktóza a sacharóza Perorálny roztok obsahuje fruktózu a sacharózu.
English: Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP.
Slovak: Nepoužívajte tento liek po dátume exspirácie, ktorý je uvedený na blistri a na papierovej skladačke po
English: In contrast the 95 % confidence interval for the HR in the older subgroup (aripiprazole, n = 69; placebo, n = 36) was 0.242 to 0.879 and hence a treatment effect could be concluded in the older patients.
Slovak: n = 36), interval bol v rozsahu 0,242 až 0,879, čo umožňovalo vykonať záver týkajúci sa účinku liečby u starších pacientov.
English: ABILIFY 30 mg orodispersible tablets:
Slovak: ABILIFY 30 mg orodispergovateľné tablety:
English: ABILIFY 30 mg tablets aripiprazole
Slovak: ABILIFY 30 mg tablety aripiprazol