FrancophonIA/ELRC3.0 huggingface dataset:
English: 14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets
Croatian: 14 tableta 28 tableta 56 tableta 98 tableta 28 x 1 tableta
English: Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.
Croatian: Obavezno obavijestite svog liječnika ako uzimate lijek za kontrolu krvnog tlaka.
English: Maternal toxicity occurred at doses similar to those eliciting developmental toxicity.
Croatian: Toksičnost za majku nastupila je pri dozama sličnima onima koje izazivaju razvojnu toksičnost.
English: NMS is a potentially fatal symptom complex associated with antipsychotics.
Croatian: NMS je potencijalno smrtonosni skup simptoma povezan s antipsihoticima.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove
English: Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status.
Croatian: Prilagodba dnevne doze, uključujući smanjenje doze, mora se razmotriti na temelju kliničkog statusa bolesnika.
English: Pharmacokinetics in special patient groups
Croatian: Farmakokinetika u posebnih skupina bolesnika
English: No long term data are available with regard to the efficacy and the safety of aripiprazole in this fluctuating disorder.
Croatian: Nisu dostupni podaci o dugotrajnoj djelotvornosti i sigurnosti aripiprazola u ovom promjenjivom poremećaju.
English: Patients with rare glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim glukoza galaktoza malapsorpcijom ne smiju uzimati ovaj lijek.
English: In subgroup 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.
Croatian: U analizi podskupine procjena HR-a bila je 0,495 za ispitanike u dobi od 13 do 14 godina u usporedbi s 0,454 za ispitanike u dobi od 15 do 17 godina.
English: • The active substance is aripiprazole.
Croatian: • Djelatna tvar je aripiprazole.
English: While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic medicinal products.
Croatian: Iako se ti simptomi mogu javiti i pri niskim dozama, češći su i teži uz visoku potentnost i pri višim dozama prve generacije antipsihotika.
English: However, your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
Croatian: Međutim, liječnik Vam može propisati nižu ili višu dozu, koja smije iznositi maksimalno 30 mg jedanput dnevno.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.1, međutim nije moguće dati preporuke o doziranju.
English: The recommended dose for adults is 15 mg once a day.
Croatian: Preporučena doza za odrasle je 15 mg jedanput dnevno.
English: Prolactin levels were evaluated in all trials of all doses of aripiprazole (n = 28,242).
Croatian: Razine prolaktina evaluirane su u svim ispitivanjima svih doza aripiprazola (n = 28,242).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 June 2015
Croatian: Datum prvog odobrenja: 04. lipnja 2015.
English: Animal studies could not exclude potential developmental toxicity (see section 5.3).
Croatian: U ispitivanjima na životinjama nije se mogla isključiti moguća razvojna toksičnost (vidjeti dio 5.3).
English: Suicidality
Croatian: Suicidalnost
English: Elderly patients with dementia-related psychosis
Croatian: Stariji bolesnici sa psihozom povezanom s demencijom
English: Try to take Aripiprazole Mylan Pharma at the same time each day.
Croatian: Pokušajte uzimati lijek Aripiprazole Mylan Pharma svaki dan u isto vrijeme.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
English: Interaction with receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of aripiprazole.
Croatian: Interakcija s drugim receptorima osim dopaminskog i serotoninskog podtipa može objasniti neke druge kliničke učinke aripiprazola.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
English: Aripiprazole undergoes minimal pre-systemic metabolism.
Croatian: Aripiprazol prolazi minimalno predsistemsko metaboliziranje.
English: Due to insufficient safety information in humans and concerns raised by animal reproductive studies, this medicinal product should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the foetus.
Croatian: Zbog nedostatnih informacija o sigurnosti primjene u ljudi i zabrinjavajućih rezultata ispitivanja reprodukcijske toksičnosti u životinja, ovaj se lijek ne smije koristiti u trudnoći, osim ako očekivana korist za majku jasno opravdava mogući rizik za fetus.
English: Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Croatian: Učinak klase - Simptomi distonije, produžene abnormalne kontrakcije mišićnih skupina, mogu nastati u podložnih pojedinaca tijekom prvih nekoliko dana liječenja.
English: Each tablet of 5, 10, 15, 30 mg containing 5, 10, 15, 30 mg of aripiprazole respectively.
Croatian: Svaka tableta od 5, 10, 15, 30 mg koje sadrže 5, 10, 15, 30 mg aripiprazola respektivno.
English: The table is based on adverse events reported during clinical trials and/or postmarketing use.
Croatian: Tablica se temelji na nuspojavama prijavljenima tijekom kliničkih ispitivanja i/ili nakon stavljanja lijeka u promet.
English: Blood pressure-lowering medicines: Aripiprazole Mylan Pharma may increase the effect of medicines used to lower the blood pressure.
Croatian: Lijekovi za snižavanje krvnog tlaka: Aripiprazole Mylan Pharma može pojačati učinak lijekova koji se koriste za snižavanje krvnog tlaka.
English: Toxicologically significant effects were observed only at doses or exposures that were sufficiently in excess of the maximum human dose or exposure, indicating that these effects were limited or of no relevance to clinical use.
Croatian: Toksikološki značajni učinci bili su primijećeni samo pri dozama ili izloženosti koje su bile dovoljno veće od maksimalne doze ili izloženosti u ljudi, što ukazuje da su ti učinci ograničeni ili da nisu važni za kliničku primjenu.
English: Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking aripiprazole.
Croatian: Bolesnici mogu osjetiti pojačane porive, osobito za kockanjem, te nemogućnost kontroliranja tih poriva dok uzimaju aripiprazol.
English: The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day.
Croatian: Doza se može postupno povećavati do preporučene doze za adolescente od 10 mg jedanput dnevno.
English: Doses higher than 10 mg/day should therefore only be used in exceptional cases and with close clinical monitoring (see sections 4.4, 4.8 and 5.1).
Croatian: Doze veće od 10 mg/dan stoga treba primjenjivati samo u iznimnim slučajevima i uz strog klinički nadzor (vidjeti dijelove 4.4, 4.8 i 5.1).
English: Patients were stabilised for at least 12 consecutive weeks with the combination of aripiprazole and the same mood stabilizer.
Croatian: Bolesnici su bili stabilizirani tijekom najmanje 12 uzastopnih tjedana na kombinaciji aripiprazola i jednakog stabilizatora raspoloženja.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Croatian: Farmakoterapijska skupina: Psiholeptici, ostali antipsihotici, ATK oznaka: N05AX12
English: If you stop taking Aripiprazole Mylan Pharma Do not stop your treatment just because you feel better.
Croatian: Ako prestanete uzimati lijek Aripiprazole Mylan Pharma Nemojte prekinuti liječenje samo zato što se osjećate bolje.
English: Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Croatian: Obavijestite liječnika ako Vi ili Vaša obitelj/njegovatelj(ica) primijetite da razvijate snažnu potrebu ili žudnju za ponašanjem na za Vas neobičan način, te se ne možete oduprijeti nagonu, porivu ili iskušenju da vršite određene aktivnosti koje bi mogle naškoditi Vama ili drugima.
English: If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke.
Croatian: Ako ste starija osoba i bolujete od demencije (gubitka pamćenja i drugih mentalnih sposobnosti), Vi ili Vaš skrbnik/član obitelji morate obavijestiti liječnika ako ste preboljeli moždani udar ili „mali“ moždani udar.
English: In patients with severe hepatic impairment, the data available are insufficient to establish recommendations.
Croatian: U bolesnika s teškim oštećenjem funkcije jetre, dostupni podaci nisu dostatni za izradu preporuka.
English: Aripiprazole is effective in maintaining the clinical improvement during continuation therapy in adult patients who have shown an initial treatment response.
Croatian: Aripiprazol je učinkovit u održavanju kliničkog poboljšanja tijekom kontinuirane terapije u odraslih bolesnika koji su na početku liječenja pokazali terapijski odgovor.
English: Among the patients included in the primary efficacy analysis, 139 patients had a current co-morbid diagnosis of ADHD.
Croatian: Među bolesnicima uključenima u primarnu analizu djelotvornosti, njih 139 u tom je trenutku imalo dijagnosticiran ADHD kao popratnu bolest.
English: If you have the impression that the effect of Aripiprazole Mylan Pharma is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako imate dojam da je učinak Vaših Aripiprazole Mylan Pharma tableta prejak ili preslab, obratite se svom liječniku ili ljekarniku.
English: Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Mylan Pharma without first consulting your doctor.
Croatian: Čak i ako se osjećate bolje, nemojte mijenjati dozu niti prekidati svakodnevno uzimanje lijeka Aripiprazole Mylan Pharma bez prethodnog savjetovanja s liječnikom.
English: Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
Croatian: Obavijestite liječnika ako primijetite neko od ovih ponašanja, tako da možete raspraviti o načinima njihova zbrinjavanja ili smanjivanja simptoma.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu
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.
Croatian: Potrebno je imati na umu da simptomi poremećaja kontrole nagona mogu biti povezani s osnovnim poremećajem; međutim, u nekim slučajevima, zabilježen je prestanak poriva sa sniženjem doze ili prestankom primjene lijeka.
English: In a sub-analysis of the adolescent patients between the ages of 15 to 17 years, representing 74 % of the total enrolled population, maintenance of effect was observed over the 26-week open-label extension trial.
Croatian: U podanalizi adolescentnih bolesnika u dobi od 15 do 17 godina, koji su činili 74 % ukupne populacije uključene u ispitivanje, primijećeno je održanje učinka tijekom 26-tjednog otvorenog produžetka ispitivanja.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: The possibility of multiple medicinal product involvement should be considered.
Croatian: Mora se razmotriti i mogućnost predoziranja većim brojem lijekova.
English: In these patients dosing should be managed cautiously.
Croatian: U tih se bolesnika doziranje mora provesti s oprezom.
English: It is important that you carry on taking Aripiprazole Mylan Pharma for as long as your doctor has told you to.
Croatian: Važno je da nastavite uzimati lijek Aripiprazole Mylan Pharma onoliko dugo koliko Vam je to rekao liječnik.
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.
Croatian: Aktivni ugljen (50 g), primijenjen jedan sat nakon aripiprazola, smanjio je Cmax aripiprazola za otprilike 41 %, a AUC za 51 %, što ukazuje na to da bi ugljen mogao biti učinkovit u liječenju predoziranja.
English: This medicinal product may be started at a low dose with the oral solution (liquid) form.
Croatian: Liječenje ovim lijekom može se započeti nižom dozom lijeka u obliku oralne otopine (tekućim oblikom lijeka).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from aripiprazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja aripiprazolom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotics, including aripiprazole, must be discontinued.
Croatian: Ako bolesnik razvije znakove i simptome koji ukazuju na NMS ili neobjašnjivo visoku tjelesnu temperaturu bez dodatnih kliničkih manifestacija NMS-a, mora prekinuti s uzimanjem svih antipsihotika, uključujući aripiprazol.
English: Contact your doctor or hospital immediately if you experience any of the above.
Croatian: Odmah se javite liječniku ili u bolnicu ako osjetite bilo koji od gore opisanih simptoma.
English: The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 0.242-0.879) in the full population.
Croatian: Procjena omjera hazarda (HR) bila je 0,461 (95 %-tni interval pouzdanosti, 0,242 - 0,879) u cijeloj populaciji.
English: An elevated risk of acute dystonia is observed in males and younger age groups.
Croatian: Povišen rizik od akutne distonije primijećen je u muškaraca i mlađih dobnih skupina.
English: Pathological gambling and other impulse control disorders
Croatian: Patološko kockanje i drugi poremećaji kontrole nagona
English: However, the concentrations of the sulphate conjugates of hydroxy aripiprazole in human bile at the highest dose proposed, 30 mg per day, were no more than 6 % of the bile concentrations found in the monkeys in the 39-week study and are well below (6 %) their limits of in vitro solubility.
Croatian: Međutim, koncentracije sulfatnih konjugata hidroksi-aripiprazola u ljudskoj žuči pri najvišoj predloženoj dozi od 30 mg dnevno nisu bile veće od 6 % koncentracije u žuči pronađene u majmuna u 39-tjednom ispitivanju i daleko su ispod (6 %) njihovih granica topljivosti in vitro.
English: Potential for aripiprazole to affect other medicinal products
Croatian: Potencijal aripiprazola da utječe na druge lijekove
English: Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
Croatian: Samoubilačke misli i ponašanja prijavljena su tijekom liječenja aripiprazolom.
English: Aripiprazole is effective in a dose range of 10 to 30 mg/day.
Croatian: Aripiprazole je učinkovit u rasponu doza od 10 do 30 mg/dan.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: 2D barkod koji nosi jedinstvenu identifikacijsku oznaku je uključen.
English: Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.
Croatian: Aripiprazol se opsežno metabolizira u jetri, prvenstveno putem tri biotransformacijska puta: dehidrogenacije, hidroksilacije i N-dealkilacije.
English: Patients must be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with aripiprazole.
Croatian: Bolesnice se mora savjetovati da obavijeste svog liječnika u slučaju da tijekom liječenja aripiprazolom zatrudne ili planiraju trudnoću.
English: However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported.
Croatian: Međutim, bile su prijavljene i povišena kreatin fosfokinaza i rabdomioliza koje nisu nužno bile povezane s NMS-om.
English: Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic hypoactivity.
Croatian: Aripiprazol je pokazao antagonistička svojstva u životinjskim modelima dopaminergičke hiperaktivnosti i agonistička svojstva u životinjskim modelima dopaminergičke hipoaktivnosti.
English: Gender No dosage adjustment is required for female patients as compared to male patients (see section 5.2).
Croatian: Nije potrebno prilagođivati dozu u žena u usporedbi s muškarcima (vidjeti dio 5.2).
English: Following any confirmed or suspected overdose with aripiprazole, close medical supervision and monitoring should continue until the patient recovers.
Croatian: Nakon potvrde ili sumnje na predoziranje aripiprazolom, mora se nastaviti sa strogim liječničkim nadzorom i praćenjem bolesnika do oporavka.
English: At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99 % bound to serum proteins, binding primarily to albumin.
Croatian: Pri terapijskim koncentracijama, više od 99 % aripiprazola i dehidro-aripiprazola vezano je za serumske proteine, prvenstveno za albumin.
English: Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Croatian: Aripiprazol je potrebno primjenjivati s oprezom u bolesnika s rizikom za aspiracijsku upalu pluća.
English: Caution should be taken, particularly if you are an elderly patient or have some debility.
Croatian: Potreban je oprez, osobito ako ste starije dobi ili Vam je zdravstveno stanje narušeno.
English: If you notice you are gaining weight, develop unusual movements, experience somnolence that interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell your doctor.
Croatian: Ako primijetite povećanje tjelesne težine, pojavu neuobičajenih pokreta, izrazitu pospanost koja Vas ometa u obavljanju normalnih svakodnevnih aktivnosti, poteškoće s gutanjem ili alergijske simptome, molimo obavijestite o tome svog liječnika.
English: Congenital anomalies have been reported; however, causal relationship with aripiprazole could not be established.
Croatian: Prijavljene su kongenitalne anomalije, međutim, uzročno-posljedična veza tih anomalija s aripiprazolom nije se mogla ustanoviti.
English: These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.
Croatian: Oni se nazivaju poremećajima kontrole nagona te mogu uključivati ponašanja kao što je ovisničko kockanje, prekomjerno jedenje ili trošenje, abnormalno izražen seksualni poriv ili učestalo razmišljanje s povećanom količinom seksualnih misli ili osjećaja.
English: If you forget to take your Aripiprazole Mylan Pharma If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.
Croatian: Ako ste propustili uzeti dozu, uzmite je čim se sjetite, ali nemojte uzeti dvije doze u jednom danu.
English: All ADRs are listed by system organ class and frequency; very common (≥ 1 /10), common (≥ 1/100 to< 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Sve nuspojave navedene su prema klasifikaciji organskih sustava i učestalosti; vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10000 do < 1/1000), vrlo rijetko (< 1/10000) i nepoznato (ne može se procijeniti na temelju dostupnih podataka).
English: Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Croatian: Odmah obavijestite svog liječnika ako bolujete od ukočenosti ili nesavitljivost mišića s visokom vrućicom, znojenjem, promijenjenim mentalnim statusom ili jako ubrzanim ili nepravilnim otkucajima srca.
English: In repeat-dose studies in juvenile rats and dogs, the toxicity profile of aripiprazole was comparable to that observed in adult animals, and there was no evidence of neurotoxicity or adverse reactions on development.
Croatian: U ispitivanjima ponovljenih doza u potomstva štakora i pasa, profil toksičnosti aripiprazola bio je usporediv s onima u odraslih životinja i nije bilo dokaza neurotoksičnosti ni štetnih učinaka na razvoj.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with aripiprazole and preventive measures undertaken.
Croatian: Budući da bolesnici liječeni antipsihoticima često već imaju stečene čimbenike rizika za VTE, prije i tijekom liječenja aripiprazolommoraju se utvrditi svi mogući čimbenici rizika za VTE i poduzeti preventivne mjere.
English: Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3-5 hours after dosing.
Croatian: Aripiprazol se dobro apsorbira i postiže vršnu koncentraciju u plazmi u roku od 3 do 5 sati nakon doziranja.
English: However, the estimation of the HR for the younger (13-14 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.
Croatian: Međutim, procjena HR-a za mlađu skupinu (13 - 14 godina) nije precizna jer odražava manji broj ispitanika u toj skupini (aripiprazol, n = 29; placebo, n = 12) i interval pouzdanosti za tu procjenu (u rasponu od 0,151 do 1,628) nije omogućio donošenje zaključaka o prisutnosti učinka liječenja.
English: Weight gain should be monitored in adolescent patients with bipolar mania.
Croatian: Treba pratiti povećanje tjelesne težine u adolescentnih bolesnika s bipolarnom manijom.
English: Schizophrenia in adolescents
Croatian: Shizofrenija u adolescenata
English: In addition, cases of stroke or "mini" stroke have been reported.
Croatian: Osim toga, prijavljeni su slučajevi moždanog udara ili „malog“ moždanog udara.