FrancophonIA/ELRC3.0 huggingface dataset:
English: If continued treatment is indicated with oral aripiprazole, see the Summary of Product Characteristics for ABILIFY tablets, ABILIFY orodispersible tablets, or ABILIFY oral solution.
Slovenian: Če je indicirano nadaljevanje zdravljenja s peroralnimi oblikami aripiprazola, glejte povzetke glavnih značilnosti zdravila za zdravila ABILIFY tablete, ABILIFY orodisperzibilne tablete ali ABILIFY
English: Sudden death unexplained Torsades de pointes Ventricular arrhythmia Cardiac arrest Bradycardia
Slovenian: Srčne bolezni tahikardija nenadna nepojasnjena smrt torsades de pointes ventrikularna aritmija zastoj srca bradikardija
English: Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
Slovenian: Aripiprazol deluje antagonistično na adrenergične receptorje α1, zato lahko stopnjuje učinek nekaterih antihipertenzivnih zdravil.
English: Aripiprazole/metabolites are excreted in human milk.
Slovenian: Aripiprazol/presnovki se izločajo v materino mleko.
English: It has been proposed that aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism of serotonin 5-HT2A receptors.
Slovenian: Učinkovitost aripiprazola pri shizofreniji in bipolarni motnji I je domnevno posledica kombinacije delnega agonizma na dopaminskih receptorjih D2 in serotoninskih receptorjih 5-HT1A ter antagonizma na serotoninskih receptorjih 5-HT2A.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo jemati tega zdravila.
English: The dose of ABILIFY must be measured using the calibrated cup or the 2 mL calibrated dropping pipette supplied in the carton.
Slovenian: Odmerek zdravila ABILIFY morate odmeriti z umerjeno odmerno čašo ali umerjeno 2 ml kapalko, ki sta priloženi v škatli.
English: The safety profile of a long-term, double-blind, placebo-controlled trial was also similar except for the following reactions that were reported more frequently than paediatric patients taking placebo: weight decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly (≥ 1/100,
Slovenian: Profil varnosti v dolgotrajnem dvojnoslepem, s placebom nadzorovanem kliničnem preskušanju je bil prav tako podoben, razen pri naslednjih reakcijah, o katerih so poročali pogosteje pri pediatričnih bolnikih, ki so jemali placebo: pogosto so navajali zmanjšanje telesne mase, zvišano vrednost inzulina v krvi, aritmijo in levkopenijo (≥ 1/100, < 1/10).
English: 14 × 1 tablets 28 × 1 tablets 49 × 1 tablets 56 × 1 tablets 98 × 1 tablets
Slovenian: 14 × 1 tableta 28 × 1 tableta 49 × 1 tableta 56 × 1 tableta 98 × 1 tableta
English: In a 60- to 89-week, randomised, double-blind, placebo-controlled trial in adolescent subjects (n = 146; ages 13 to 17 years) with schizophrenia, there was a statistically significant difference in the rate of relapse of psychotic symptoms between the aripiprazole (19.39 %) and placebo (37.50 %) groups.
Slovenian: V 60- do 89-tedenskem, randomiziranem, dvojnoslepem, s placebom kontroliranem preskušanju pri mladostnikih s shizofrenijo (n = 146; v starosti od 13 do 17 let) je bilo opaziti statistično značilno razliko v stopnji ponovitve psihotičnih simptomov med skupinama bolnikov, zdravljenih z aripiprazolom (19,39 %) in s placebom (37,50 %).
English: The safety and efficacy of ABILIFY solution for injection in children and adolescents aged 0 to 17 years have not been established.
Slovenian: Varnost in učinkovitost zdravila ABILIFY pri otrocih in mladostnikih, starih od 0 do 17 let, še nista bili dokazani.
English: Outer carton: abilify 1 mg/mL
Slovenian: Zunanja ovojnina: abilify 1 mg/ml
English: Gender No dosage adjustment is required for female patients as compared to male patients (see section 5.2).
Slovenian: Pri bolnicah v primerjavi z bolniki odmerka ni treba prilagajati (glejte poglavje 5.2).
English: • acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
Slovenian: • akutno zmedenost, krče (epilepsijo), komo, kombinacijo zvišane telesne temperature, hitrega dihanja, znojenja,
English: Aripiprazole showed an improvement on TTS-YGTSS change from baseline to week 8 of 13.35, for the low dose group (5 mg or 10 mg) and 16.94 for the high dose group (10 mg or 20 mg) as compared with an improvement of 7.09 in the placebo group.
Slovenian: Po jemanju aripiprazola je bilo 8. teden vidno izboljšanje s spremembo od izhodiščne vrednosti rezultata TTS-YGTSS za 13,35 točk pri skupini z nizkim odmerkom (5 mg ali 10 mg) in za 16,94 točk pri skupini z visokim odmerkom (10 mg ali 20 mg) v primerjavi z izboljšanjem za 7,09 točk pri skupini, ki je prejemala placebo.
English: At steady state, dehydro-aripiprazole, the active metabolite, represents about 40 % of aripiprazole AUC in plasma.
Slovenian: V stanju dinamičnega ravnovesja predstavlja aktivni presnovek dehidroaripiprazol okrog 40 % AUC aripiprazola v plazmi.
English: In sub-group analyses the point estimate of the HR was 0.495 for subjects 13 to 14 years of age compared to 0.454 for subjects 15 to 17 years of age.
Slovenian: Pri analizi podskupin je bila ocenjena vrednost RO pri preskušancih, starih od 13 do 14 let, 0,495 v primerjavi s preskušanci, starimi od 15 do 17 let, pri katerih je razmerje bilo 0,454.
English: Irritability associated with autistic disorder: the safety and efficacy of ABILIFY in children and adolescents aged below 18 years have not yet been established.
Slovenian: Razdražljivost, povezana z avtistično motnjo: varnost in učinkovitost zdravila ABILIFY pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: Each carton contains 1 bottle and both a calibrated polypropylene measuring cup with a graduation interval of 2.5 mL and a calibrated polypropylene low-density polyethylene dropping pipette with a graduation interval of 0.5 mL.
Slovenian: Ena škatla vsebuje 1 plastenko, umerjeno odmerno čašo iz polipropilena z graduacijskim intervalom2,5 ml in umerjeno kapalko iz polipropilena in polietilena majhne gostote z graduacijskim intervalom 0,5 ml.
English: If you miss an injection of ABILIFY
Slovenian: Če ste izpustili injekcijo zdravila ABILIFY
English: Tablet disintegration occurs rapidly in saliva.
Slovenian: Tableta v slini hitro razpade.
English: The ABILIFY solution for injection is a clear, colourless, aqueous solution.
Slovenian: Raztopina za injiciranje ABILIFY je bistra, brezbarvna, vodna raztopina.
English: Sucrose may be harmful to the teeth.
Slovenian: Saharoza lahko škoduje zobem.
English: • combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
Slovenian: • kombinacija zvišane telesne temperature, togosti mišic, hitrega dihanja, znojenja, zmanjšane stopnje zavesti in nenadne spremembe krvnega tlaka ter hitrosti srčnega utripa, omedlevica (nevroleptični maligni sindrom),
English: It is important that you carry on taking ABILIFY for as long as your doctor has told you to.
Slovenian: ABILIFY nadaljujete tako dolgo, kot vam je svetoval zdravnik.
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).
Slovenian: Zdravilo ABILIFY je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I ter za preprečevanje novih maničnih epizod pri odraslih bolnikih, ki so doživljali pretežno manične epizode, ki so bile odzivne na zdravljenje z aripiprazolom (glejte poglavje 5.1).
English: paroxetine, venlafaxine, St. John's Wort)
Slovenian: paroksetin, venlafaksin, šentjanževka),
English: According to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers (see section 4.5).
Slovenian: Glede na presnovno pot aripiprazola odmerka pri kadilcih ni treba prilagajati (glejte poglavje 4.5).
English: ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Slovenian: Zdravilo ABILIFY je indicirano za zdravljenje shizofrenije pri odraslih in mladostnikih, starih 15 let in več.
English: 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 to 17 years), who met DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders) for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a YMRS score ≥ 20 at baseline.
Slovenian: Uporabo aripiprazola so raziskovali v 30-tedenskem s placebom nadzorovanem preskušanju, ki je vključevalo 296 otrok in mladostnikov (10 do 17 let), ki so ustrezali kriterijem DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) za bipolarno motnjo I z maničnimi ali mešanimi epizodami s psihotičnimi lastnostmi ali brez njih, in so imeli v izhodišču oceno ≥ 20 po lestvici YMRS.
English: ABILIFY in one or more subsets of the paediatric population in the treatment of schizophrenia and in the treatment of bipolar affective disorder (see section 4.2 for information on paediatric use).
Slovenian: ABILIFY za eno ali več podskupin pediatrične populacije pri zdravljenju shizofrenije in bipolarne afektivne motnje (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In 2 studies in healthy subjects the median times to the peak plasma concentrations were 1 and 3 hours after dosing.
Slovenian: V dveh študijah pri zdravih osebah so bile največje koncentracije v plazmi dosežene v povprečju eno oziroma
English: The following adverse reactions had a possible dose response relationship; extrapyramidal disorder (incidences were 10 mg, 9.1 %; 30 mg, 28.8 %; placebo, 1.7 %); and akathisia (incidences were 10 mg, 12.1 %; 30 mg, 20.3 %; placebo, 1.7 %).
Slovenian: Naslednji neželeni učinki bi lahko bili povezani z velikostjo odmerka: ekstrapiramidne motnje (pri uporabi 10 mg odmerka je bila pojavnost 9,1 %; pri uporabi 30 mg odmerka 28,8 %; pri uporabi placeba pa 1,7 %) in akatizija (pri uporabi 10 mg odmerka je bila pojavnost 12,1 %; pri uporabi 30 mg odmerka 20,3 %; pri uporabi placeba pa 1,7 %).
English: The oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Slovenian: Peroralna raztopina vsebuje metilparahidroksibenzoat in propilparahidroksibenzoat.
English: When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
Slovenian: Pri odločanju o sočasni uporabi ketokonazola ali drugih močnih zaviralcev CYP3A4 z aripiprazolom morajo biti možne koristi za bolnika večje od možnih tveganj.
English: Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially clinically significant changes in routine laboratory and lipid parameters (see section 5.1) revealed no medically important differences.
Slovenian: Laboratorijski parametri Primerjava deležev bolnikov s klinično pomembnimi spremembami vrednosti rutinskih laboratorijskih parametrov in vrednosti lipidov (glejte poglavje 5.1) ni pokazala medicinsko pomembnih razlik med aripiprazolom in placebom.
English: If you see more than one doctor, be sure to tell them that you are receiving ABILIFY.
Slovenian: Če obiskujete več zdravnikov, jih morate seznaniti s tem, da prejemate zdravilo ABILIFY.
English: • sensitivity to light,
Slovenian: • kožni izpuščaj, • občutljivost na svetlobo,
English: ABILIFY is ready to use.
Slovenian: Zdravilo ABILIFY je že pripravljeno za uporabo.
English: Additionally, aripiprazole and dehydro-aripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
Slovenian: Poleg tega aripiprazol in dehidroaripiprazol in vitro nista pokazala potenciala za spreminjanje presnove s CYP1A2.
English: In the placebocontrolled trials, the mean weight gain was 0.4 kg for placebo and 1.6 kg for aripiprazole.
Slovenian: V s placebom nadzorovanih preskušanjih se je telesna masa pri uporabi placeba v povprečju povečala za 0,4 kg, pri uporabi aripiprazola pa za 1,6 kg.
English: The observed mean improvement from baseline on the PANSS Excitement Component score at the primary 2-hour endpoint was 5.8 for placebo, 9.6 for lorazepam, and 8.7 for ABILIFY solution for injection.
Slovenian: Ugotovljeno povprečno izboljšanje od izhodišča po ocenjevalni lestvici PANSS za komponento razburjenja je bilo po dveh urah (primarna končna točka) pri bolnikih, ki so jemali placebo 5,8, pri bolnikih, ki so jemali lorazepam 9,6 in pri bolnikih, ki so jemali zdravilo ABILIFY raztopina za injiciranje 8,7.
English: Parahydroxybenzoate
Slovenian: Parahidroksibenzoati
English: • feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Slovenian: • evforično razpoloženje, pretirana energija, zmanjšana potreba po spanju, hitro govorjenje s prehitevajočimi mislimi in občasno huda razdražljivost.
English: 2 mg aspartame (E 951) and 0.075 mg lactose per orodispersible tablet
Slovenian: 2 mg aspartama (E 951) in 0,075 mg laktoze na orodisperzibilno tableto
English: PET-bottles with polypropylene child-resistant closure containing 50 mL, 150 mL or 480 mL per bottle.
Slovenian: Plastenke iz PET, ki imajo polipropilensko za otroke varno zaporko in vsebujejo 50 ml, 150 ml ali 480 ml na plastenko.
English: ABILIFY solution for injection should not be administered intravenously or subcutaneously.
Slovenian: Zdravila ABILIFY raztopina za injiciranje se ne sme dajati intravensko ali subkutano.
English: The following symptoms may occur in newborn babies, of mothers that have used ABILIFY in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Slovenian: Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale zdravilo ABILIFY, se lahko pojavijo naslednji simptomi: tresenje, okornost ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension
Slovenian: Žilne bolezni ortostatska hipotenzija venska trombembolija (vključno s pljučno embolijo in globoko vensko trombozo) hipertenzija sinkopa
English: 5 How to store ABILIFY Contents of the pack and other information
Slovenian: Shranjevanje zdravila ABILIFY Vsebina pakiranja in dodatne informacije
English: The aripiprazole AUC in the first 2 hours after an intramuscular injection was 90 % greater than the AUC after the same dose as a tablet; systemic exposure was generally similar between the 2 formulations.
Slovenian: Prvi 2 uri po intramuskularnem injiciranju je vrednost AUC aripiprazola za 90 % večja od vrednosti AUC po prejemu istega odmerka v obliki tablet.
English: ABILIFY is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Slovenian: Zdravilo ABILIFY uporabljamo za zdravljenje odraslih in mladostnikov, starih 13 let in več, ki imajo težave s simptomi, kot so evforično razpoloženje, pretirana energija, zmanjšana potreba po spanju, hitro govorjenje s prehitevajočimi mislimi in občasno huda razdražljivost.
English: ABILIFY is effective in a dose range of 10 mg/day to 30 mg/day.
Slovenian: Zdravilo ABILIFY je učinkovito v razponu odmerkov od 10 mg/dan do 30 mg/dan.
English: Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as selective serotonin reuptake inhibitor/selective serotonin noradrenalin reuptake inhibitor (SSRI/SNRI), or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Slovenian: Znaki in simptomi serotoninskega sindroma se lahko pojavijo še posebej pri sočasni uporabi z drugimi serotoninergičnimi zdravili, kot so selektivni zaviralci privzema serotonina/selektivni zaviralci privzema serotonina in noradrenalina ali z zdravili, ki zvišujejo koncentracijo aripiprazola (glejte poglavje 4.8).
English: Tics associated with Tourette's disorder: the safety and efficacy of ABILIFY in children and adolescents 6 to 18 years of age have not yet been established.
Slovenian: Trzaji, povezani s Tourettovim sindromom: varnost in učinkovitost zdravila ABILIFY pri otrocih in mladostnikih, starih od 6 do 18 let, še ni bila dokazana.
English: ABILIFY solution for injection is indicated for the rapid control of agitation and disturbed behaviours in adult patients with schizophrenia or with manic episodes in Bipolar I Disorder, when oral therapy is not appropriate.
Slovenian: ABILIFY raztopina za injiciranje je indicirana za dosego hitre nadzorovanosti agitacije in vedenjskih motenj pri odraslih bolnikih s shizofrenijo in pri maničnih epizodah pri bipolarni motnji I, kadar peroralno zdravljenje ni primerno.
English: Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors may be expected to have similar effects and similar dose reductions should therefore be applied (see section 4.2).
Slovenian: Pričakovati je mogoče, da imajo drugi močni zaviralci CYP3A4, npr. itrakonazol in zaviralci proteaz HIV, podobne učinke, zato je treba odmerjanje podobno zmanjšati (glejte poglavje 4.2).
English: Receiving ABILIFY with some medicines may mean the doctor will need to change your dose of ABILIFY or the other medicines.
Slovenian: Če prejemate zdravilo ABILIFY z nekaterimi drugimi zdravili, bo morda zdravnik moral spremeniti vaš odmerek zdravila ABILIFY ali drugih zdravil.
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).
Slovenian: 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.
English: A vial provides 9.75 mg in 1.3 mL.
Slovenian: Viala vsebuje 9,75 mg v 1,3 ml.
English: • certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, ritonavir)
Slovenian: • določena zdravila za zdravljenje okužbe s HIV (kot so efavirenz, nevirapin, zaviralci proteaz,
English: A combination of ABILIFY with medicines taken for anxiety might make you feel drowsy or dizzy.
Slovenian: Zdravilo ABILIFY skupaj z zdravili za zdravljenje anksioznosti (tesnobe) lahko povzroči zaspanost ali omotičnost.
English: If you take more ABILIFY than you should
Slovenian: Če ste dobili večji odmerek zdravila ABILIFY, kot bi smeli
English: Taking ABILIFY with some medicines may mean the doctor will need to change your dose of ABILIFY or the other medicines.
Slovenian: Če jemljete zdravilo ABILIFY z nekaterimi drugimi zdravili, bo morda zdravnik moral spremeniti vaš odmerek zdravila ABILIFY ali drugih zdravil.
English: Orodispersible tablets
Slovenian: Orodisperzibilne tablete
English: Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Slovenian: Učinek zdravil iz te skupine (“Class Effect”) - V prvih nekaj dneh zdravljenja se lahko pri dovzetnih posameznikih pojavijo simptomi distonije, podaljšane nenormalne kontrakcije mišičnih skupin.
English: In CYP2D6 poor metabolisers, concomitant use of strong inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.
Slovenian: 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.
English: In a haloperidol-controlled trial, the proportion of responder patients maintaining response to medicinal product at 52-weeks was similar in both groups (aripiprazole 77 % and haloperidol 73 %).
Slovenian: V preskušanju, nadzorovanems haloperidolom, je bil delež odzivnih bolnikov, pri katerih se je odziv na zdravilo ohranil po 52 tednih, v obeh skupinah podoben (peroralni aripiprazol 77 % in haloperidol 73 %).
English: In a relative bioavailability study comparing the pharmacokinetics of 30 mg aripiprazole as the oral solution to 30 mg aripiprazole tablets in healthy subjects, the solution to the tablet ratio of geometric mean Cmax values was 122 % (n = 30).
Slovenian: Ko so v študiji relativne biološke uporabnosti pri zdravih prostovoljcih primerjali farmakokinetiko 30 mg aripiprazola v peroralni raztopini s 30 mg aripiprazola v tabletah, je bilo razmerje vrednosti geometrijskih sredin Cmax med raztopino in tabletami 122 % (n = 30).
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.
Slovenian: Varnost in učinkovitost zdravila ABILIFY nista ugotovljeni pri zdravljenju shizofrenije ali maničnih epizod pri bipolarni motnji I pri bolnikih, starih 65 let in starejših.
English: • hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs,
Slovenian: • slišanje, videnje ali občutenje stvari, ki jih dejansko ni, sumničavost, zmotna prepričanja, nepovezano govorjenje in vedenje ter čustvena praznost.
English: What ABILIFY looks like and contents of the pack
Slovenian: Izgled zdravila ABILIFY in vsebina pakiranja
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.
Slovenian: Dodatno zdravljenje z aripiprazolom se je izkazalo za boljše od placeba tudi pri sekundarnem merilu izida, oceni resnosti bolezni (SOI, Severity of Illness; manija) po lestvici globalnega kliničnega vtisa glede na stopnjo bipolarne motnje (CGI-BP, Clinical Global Impression
English: ABILIFY is given when treatment with oral formulations is not appropriate.
Slovenian: Zdravilo ABILIFY uporabljamo, če zdravljenje s peroralnimi farmacevtskimi oblikami ni primerno.
English: The efficacy of ABILIFY solution for injection in patients with agitation and disturbed behaviours has not been established related to conditions other than schizophrenia and manic episodes in Bipolar I Disorder.
Slovenian: Učinkovitost zdravila ABILIFY raztopina za injiciranje pri bolnikih z agitacijo in vedenjskimi motnjami ni bila dokazana v povezavi z drugimi stanji razen s shizofrenijo in z maničnimi epizodami pri bipolarni motnji I.
English: Your doctor will change your treatment to oral ABILIFY as soon as appropriate.
Slovenian: Zdravnik bo takoj, ko bo to mogoče, zdravljenje spremenil in vam predpisal peroralno zdravljenje z zdravilom ABILIFY.
English: Also contains sulfobutylether b-cyclodextrin, tartaric acid, sodium hydroxide, and water for injections.
Slovenian: Vsebuje tudi sulfobutileter betaciklodekstrin, vinsko kislino, natrijev hidroksid in vodo za injekcije.
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.
Slovenian: Zdravljenje je treba uvesti v odmerku 2 mg (uporaba zdravila ABILIFY 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.