FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Usporedbe između aripiprazola i placeba u udjelima bolesnika u kojih su se razvile potencijalno klinički značajne promjene u rutinskim laboratorijskim pretragama i parametrima lipida (vidjeti dio 5.1) nisu otkrile nikakve medicinski važne razlike.
English: Irritability associated with autistic disorder: the safety and efficacy of aripiprazole in children and adolescents aged below 18 years have not yet been established.
Croatian: Razdražljivost povezana s autističnim poremećajem: sigurnost i djelotvornost aripiprazola u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: Warnings and precautions Talk to your doctor before taking Aripiprazole Mylan Pharma
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego što uzmete Aripiprazole Mylan Pharma
English: Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Croatian: Rizični čimbenici koji mogu predisponirati bolesnike za teške komplikacije uključuju pretilost i šećernu bolest u obiteljskoj anamnezi.
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: Farmakokinetika aripiprazola i dehidro-aripiprazola u pedijatrijskih bolesnika u dobi od 10 do 17 godina bila je slična onoj u odraslih bolesnika nakon korekcije za razliku u tjelesnoj težini.
English: Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive extravascular distribution.
Croatian: Aripiprazol se opsežno raspodjeljuje po cijelom tijelu uz prividan volumen raspodjele od 4,9 l/kg, koji ukazuje na opsežnu ekstravaskularnu raspodjelu.
English: The safety profile included weight gain and changes in prolactin levels.
Croatian: Profil sigurnosti uključio je povećanje tjelesne težine i promjene razine prolaktina.
English: Extrapyramidal symptoms were mainly reported during the stabilisation phase in 17% of patients, with tremor accounting for 6.5%.
Croatian: Ekstrapiramidni simptomi uglavnom su prijavljeni tijekom faze stabilizacije u 17 % bolesnika, pri čemu se u 6,5 % bolesnika pojavio i tremor.
English: Aripiprazole Mylan Pharma contains the active substance aripiprazole and belong to a group of medicines called antipsychotics.
Croatian: Aripiprazole Mylan Pharma sadrži djelatnu tvar aripiprazol i pripada skupini lijekova koji se zovu antipsihotici.
English: Keep this medicine out of the sight and reach of children.
Croatian: Lijekčuvajte izvan pogleda i dohvata djece.
English: Although the causes of deaths were varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature (see section 4.8).
Croatian: Premda su uzroci smrti bili raznoliki, većina smrti činila se ili kardiovaskularne (npr. zatajenje srca, iznenadna smrt) ili infektivne (npr. upala pluća) naravi (vidjeti dio 4.8).
English: If you are taking, Aripiprazole Mylan Pharma 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.
Croatian: Ako uzimate lijek Aripiprazole Mylan Pharma, Vaš će liječnik razgovarati s Vama o tome trebate li dojiti uzimajući u obzir korist liječenja za Vas i korist dojenja za dijete.
English: Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue.
Croatian: Simptomi distonije uključuju spazam mišića vrata, koji ponekad napreduje do stezanja grla, poteškoće s gutanjem, poteškoće s disanjem i/ili protruziju jezika.
English: Taking Aripiprazole Mylan Pharma with some medicines may mean the doctor will need to change your dose of Aripiprazole Mylan Pharma or the other medicines.
Croatian: Uzimanje lijeka Aripiprazole Mylan Pharma s nekim lijekovima može značiti da će Vam liječnik morati promijeniti dozu lijeka Aripiprazole Mylan Pharma ili tih drugih lijekova.
English: Caution should be taken when treating patients at higher risk and a lower starting dose should be considered (e.g. elderly or debilitated patients; see section 4.2).
Croatian: Potreban je oprez pri liječenju bolesnika s povećanim rizikom te treba razmotriti primjenu niže početne doze (npr. stariji bolesnici ili bolesnici s narušenim zdravstveniom stanjem; vidjeti dio 4.2).
English: Less than 1 % of unchanged aripiprazole was excreted in the urine and approximately 18% was recovered unchanged in the faeces.
Croatian: Manje od 1 % neizmijenjenog aripiprazola izluči se mokraćom, a oko 18 % se otkrije u neizmijenjenom obliku u stolici.
English: It is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Croatian: Koristi se za liječenje odraslih i adolescenata u dobi od 15 ili više godina koji boluju od bolesti karakterizirane simptomima kao što su da bolesnik čuje vidi ili osjeća stvari kojih nema, sumnjičavost, pogrešno vjerovanje, nepovezan govor i ponašanje te emocionalna tupost.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Croatian: Prijavljeni su agitacija, hipertonija, hipotonija, tremor, somnolencija, respiratorni distres ili poremećaj hranjenja.
English: The safety profile in a 26-week open-label extension trial was similar to that observed in the short-term, placebo-controlled trial.
Croatian: 26-tjednom otvorenom produžetku ispitivanja bio je sličan onome opaženom u kratkotrajnom, placebom kontroliranom ispitivanju.
English: Tics associated with Tourette's disorder: the safety and efficacy of aripiprazole in children and adolescents 6 to 18 years of age have not yet been established.
Croatian: Tikovi povezani s Touretteovim poremećajem: sigurnost i djelotvornost aripiprazola u djece i adolescenata u dobi od 6 do 18 godina nisu još ustanovljene.
English: The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole Mylan Pharma tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Croatian: Sljedeći simptomi se mogu javiti u novorođenčadi majki koje su uzimale Aripiprazole Mylan Pharma tablete u posljednjem tromjesečju (posljednja tri mjeseca trudnoće): tresavica, ukočenost i/ili slabost mišića, pospanost, uznemirenost, tegobe s disanjem i poteškoće s hranjenjem.
English: Although there is no information on the effect of haemodialysis in treating an overdose with aripiprazole, haemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.
Croatian: Premda nema podataka o učinku hemodijalize u liječenju predoziranja aripiprazolom, nije vjerojatno da bi hemodijaliza mogla biti korisna u zbrinjavanju predoziranja, jer se aripiprazol u velikoj mjeri veže za proteine u plazmi.
English: Treatment should be initiated at 2 mg (using an appropriate aripiprazole containing medicinal product) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg.
Croatian: Liječenje se mora započeti dozom od 2 mg (koristeći odgovarajući lijek koji sadrži aripiprazol) tijekom prva 2 dana, a potom titrirati do 5 mg tijekom sljedeća 2 dana kako bi se postigla preporučena dnevna doza od 10 mg.
English: A single-dose study in subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole and dehydro-aripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity.
Croatian: Ispitivanje jednokratne doze u ispitanika s različitim stupnjevima ciroze jetre (Child-Pugh stadij A, B, i C) nije pokazalo da postoji značajan učinak oštećenja funkcije jetre na farmakokinetiku aripiprazola i dehidro-aripiprazola, ali ispitivanje je uključilo samo 3 bolesnika s cirozom jetre u stadiju C, što nije dovoljno da bi se mogli izvući zaključci o njihovom metaboličkom kapacitetu.
English: If aripiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.
Croatian: Ako se aripiprazol primjenjuje istodobno s lijekovima koji izazivaju produženje QT intervala ili neravnotežu elektrolita, nužan je oprez.
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 30 mg (vidjeti dio 5.1).
English: The overall completion rate was significantly higher for patients on aripiprazole (43 %) than for haloperidol (30 %).
Croatian: Ukupna stopa dovršetka ispitivanja bila je značajno viša u skupini bolesnika koji su uzimali aripiprazol (43 %) nego u onih na haloperidolu (30 %).
English: It is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole.
Croatian: Važno je da liječnici koji propisuju lijek konkretno pitaju bolesnike ili njihove njegovatelje jesu li razvili nov ili pojačan poriv za kockanjem, seksualni poriv, kompulzivno kupovanje, kompulzivno prejedanje ili druge porive dok se liječe aripiprazolom.
English: Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
Croatian: Zbog antagonističkog djelovanja na α1- adrenergičke receptore, aripiprazol može pojačati učinak određenih antihipertenziva.
English: In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse reactions (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
Croatian: U kliničkim ispitivanjima s aripiprazolom nije bilo značajnih razlika u stopama incidencije nuspojava povezanih s hiperglikemijom (uključujući šećernu bolest) ni u abnormalnim laboratorijskim vrijednostima glikemije u odnosu na placebo.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with aripiprazole 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).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Aripiprazole Mylan Pharma u jednoj ili više podskupina pedijatrijske populacije u liječenju shizofrenije te u liječenju bipolarnog afektivnog poremećaja (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Potential for other medicinal products to affect aripiprazole
Croatian: Potencijal drugih lijekova da utječu na aripiprazol
English: Based on results of a full range of standard genotoxicity tests, aripiprazole was considered nongenotoxic.
Croatian: Na temelju rezultata punog raspona standardnih testova genotoksičnosti, smatra se da aripiprazol nije genotoksičan.
English: In a post-hoc analysis, the improvement over placebo was more pronounced in the patients with associated co-morbidity of ADHD compared to the group without ADHD, where there was no difference from placebo.
Croatian: U post-hoc analizi je poboljšanje u odnosu na placebo bilo izraženije u bolesnika s ADHD-om kao povezanom popratnom bolešću nego u skupini koja nije imala ADHD i u kojoj nije primijećena razlika u odnosu na placebo.
English: The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
Croatian: Potencijalno medicinski ozbiljni znakovi i simptomi koji su bili prijavljeni uključivali su somnolenciju, prolazni gubitak svijesti i ekstrapiramidne simptome.
English: Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Croatian: Aripiprazole Mylan Pharma je indiciran za liječenje shizofrenije u odraslih i adolescenata u dobi od 15 i više godina.
English: Owing to the greater sensitivity of this population, a lower starting dose should be considered when clinical factors warrant (see section 4.4).
Croatian: Zbog veće osjetljivosti ove populacije, potrebno je razmotriti primjenu niže početne doze kad to zahtijevaju klinički čimbenici (vidjeti dio 4.4).
English: Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including aripiprazole.
Croatian: Hiperglikemija, koja je u nekim slučajevima bile izrazita i povezana s ketoacidozom, hiperosmolarnom komom ili smrću, bila je prijavljena u bolesnika liječenih atipičnim antipsihoticima, uključujući aripiprazol.
English: In clinical studies, 10-30 mg/day doses 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: U kliničkim ispitivanjima, doze aripiprazola od 10 do 30 mg/dan nisu imale značajnog učinka na metabolizam supstrata CYP2D6 (omjer dekstrometorfan/3-metoksimorfinan), CYP2C9 (varfarin), CYP2C19 (omeprazol) ni CYP3A4 (dekstrometorfan).
English: The mean elimination half-lives for aripiprazole are approximately 75 hours in extensive metabolisers of CYP2D6 and approximately 146 hours in poor metabolisers of CYP2D6.
Croatian: Srednja vrijednost poluvremena eliminacije aripiprazola iznosi oko 75 sati u brzih CYP2D6 metabolizatora i otprilike 146 sati u sporih CYP2D6 metabolizatora.
English: Precise risk estimates for hyperglycaemia-related adverse reactions in patients treated with aripiprazole and with other atypical antipsychotics are not available to allow direct comparisons.
Croatian: Točna procjena rizika za nuspojave povezane s hiperglikemijom u bolesnika liječenih lijekom aripiprazoli drugim atipičnim antipsihoticima nije dostupna, tako da se ne mogu raditi izravne usporedbe.
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.
Croatian: Nasuprot tome, 95 %-tni interval pouzdanosti HR-a u starijoj podskupini (aripiprazol, n = 69; placebo, n = 36) bio je 0,242 do 0,879 i prema tome mogao se donijeti zaključak o učinku liječenja u starijih bolesnika.
English: In this trial, patients were assigned by investigators with either open-label lithium or valproate monotherapy to determine partial non-response.
Croatian: U ovom ispitivanju, bolesnicima su ispitivači dodijelili otvorenu monoterapiju litijem ili valproatom da se utvrdi djelomičan izostanak odgovora.
English: Dosing in these trials was initiated at 2 mg/day, increased to 5 mg/day after one week, and increased by 5 mg/day in weekly increments to the target dose.
Croatian: Početna doza u ovim ispitivanjima iznosila je 2 mg/dan te je bila povećana na 5 mg/dan nakon tjedan dana, a potom se povećavala za 5 mg/dan svakih tjedan dana sve dok se nije postigla ciljna doza.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obavijestite svog liječnika prije nego što počnete uzimati ovaj lijek.
English: The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:
Croatian: Sljedeće nuspojave prijavljene su nakon stavljanja oralnog aripiprazola u promet, ali nije poznato kojom su se učestalošću javljale:
English: The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
Croatian: Učestalost nuspojava prijavljenih nakon stavljanja lijeka u promet ne može se odrediti jer proizlaze iz spontanih prijava.
English: Therefore, aripiprazole is not recommended for use in patients below 13 years of age (see sections 4.8 and 5.1).
Croatian: Stoga se aripiprazol ne preporučuje za primjenu u bolesnika mlađih od 13 godina (vidjeti dijelove 4.8 i 5.1).
English: In clinical trials and post-marketing experience, accidental or intentional acute overdose of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg with no fatalities.
Croatian: U kliničkim ispitivanjima i iskustvima nakon stavljanja lijeka u promet, u odraslih bolesnika bila su ustanovljena slučajna ili namjerna akutna predoziranja samo aripiprazolom u dozama koje su, prema procjeni, iznosile do 1260 mg bez smrtnih ishoda.
English: Aripiprazole is not indicated for the treatment of patients with dementia-related psychosis.
Croatian: Aripiprazol nije indiciran za liječenje bolesnika s psihozom povezanom s demencijom.
English: Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for muscarinic receptors.
Croatian: Aripiprazol je također pokazao umjeren afinitet vezanja za mjesto ponovne pohrane serotonina i zanemariv afinitet za muskarinske receptore.
English: In clinical trials of adolescent patients with bipolar mania, aripiprazole has been shown to be associated with weight gain after 4 weeks of treatment.
Croatian: U kliničkim ispitivanjima u adolescentnih bolesnika s bipolarnom manijom, pokazalo se da je aripiprazol povezan s povećanjem tjelesne težine nakon 4 tjedna liječenja.
English: Orodispersible tablets or oral solution may be used as an alternative to Aripiprazole Mylan Pharma tablets for patients who have difficulty swallowing Aripiprazole Mylan Pharma tablets (see section 5.2).
Croatian: Raspadljive tablete za usta ili oralna otopina mogu se primjenjivati kao zamjena za Aripiprazole Mylan Pharma tablete u bolesnika kojima je teško progutati Aripiprazole Mylan Pharma tablete (vidjeti dio 5.2).
English: When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma.
Croatian: Kad je prisutno, obično se vidi u onih sa značajnim rizičnim čimbenicima kao što su šećerna bolest, poremećaji štitne žlijezde ili pituitarni adenom u anamnezi.
English: Manic episodes in Bipolar I Disorder
Croatian: Manične epizode u bipolarnom poremećaju tipa
English: The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with aripiprazole (see section 4.8).
Croatian: Pojava suicidalnog ponašanja svojstvena je psihozama i poremećajima raspoloženja te je u nekim slučajevima bila prijavljena rano nakon početka ili promjene liječenja antipsihoticima, uključujući terapiju aripiprazolom (vidjeti dio 4.8).
English: Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls.
Croatian: Aripiprazol može uzrokovati pospanost, pad krvnog tlaka pri ustajanju, omaglicu i promjene u sposobnosti kretanja i održavanja ravnoteže, što može dovesti do padova.
English: However, in one of these trials, a fixed-dose trial, there was a significant dose response relationship for cerebrovascular adverse reactions in patients treated with aripiprazole (see section 4.8).
Croatian: Međutim, u jednom od tih ispitivanja - ispitivanju fiksne doze - postojala je značajna povezanost između odgovora na dozu i cerebrovaskularnih nuspojava u bolesnika liječenih aripiprazolom (vidjeti dio 4.8).
English: Patients should be closely monitored throughout this period.
Croatian: Tijekom tog razdoblja, bolesnici moraju biti pod strogim nadzorom.
English: Medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain:
Croatian: Lijekovi koji povisuju razinu serotonina obično se primjenjuju u stanjima koja uključuju depresiju, generalizirani anksiozni poremećaj, opsesivno-kompulzivni poremećaj (OKP) i socijalnu fobiju, kao i migrenu i bol:
English: Carbamazepine and other CYP3A4 inducers
Croatian: Karbamazepin i drugi induktori CYP3A4
English: Following a single oral dose of [14C]-labelled aripiprazole, approximately 27% of the administered radioactivity was recovered in the urine and approximately 60 % in the faeces.
Croatian: Nakon jednokratne oralne doze aripiprazola obilježenog izotopom [14C], oko 27 % primijenjene radioaktivnosti pojavi se u mokraći, a oko 60 % u stolici.
English: Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5-HT1A and 5-HT2A receptors and moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha-1 adrenergic and histamine H1 receptors.
Croatian: Aripiprazol je in vitro pokazao visok afinitet vezanja za dopaminske D2 i D3, serotoninske 5HT1A i 5HT2A receptore i umjeren afinitet za dopaminske D4, serotoninske 5HT2C i 5-HT7, alfa-1 adrenergičke i histaminske H1 receptore.
English: Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, and a daily dose of 30 mg is associated with a substantially higher incidence of significant adverse reactions including EPS related events, somnolence, fatigue and weight gain (see section 4.8).
Croatian: Nije dokazano da doze veće od 10 mg dnevno imaju veću djelotvornost, a doza od 30 mg dnevno povezuje se sa znatno većom incidencijom značajnih nuspojava, uključujući događaje povezane s ekstrapiramidnim simptomima, somnolenciju, umor i povećanje tjelesne težine (vidjeti dio 4.8).
English: Ketoconazole and other CYP3A4 inhibitors
Croatian: Ketokonazol i drugi inhibitori CYP3A4
English: Mylan S.A.S, 117, Allée des Parcs, 69800 Saint-Priest, France
Croatian: 117 Allée des parcs 69800 Saint Priest Francuska
English: Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including aripiprazole.
Croatian: Poremećaj motiliteta jednjaka i aspiracija povezani su s primjenom antipsihotika, uključujući aripiprazol.
English: A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Croatian: H2 receptora, smanjuje stopu apsorpcije aripiprazola, ali taj se učinak ne smatra klinički značajnim.
English: Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls.
Croatian: Aripiprazol može uzrokovati somnolenciju, posturalnu hipotenziju te motoričku i senzoričku nestabilnost, što može dovesti do padova.
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Croatian: NMS se klinički manifestira hiperpireksijom, rigiditetom mišića, promjenama mentalnog statusa i znakovima autonomne nestabilnosti (nepravilan puls ili krvni tlak, tahikardija, diaforeza i srčana disritmija).