FrancophonIA/ELRC3.0 huggingface dataset:
English: • withdrawal symptoms in newborn babies in case of exposure during pregnancy,
Croatian: • simptomi ustezanja u novorođenčadi u slučaju izloženosti tijekom trudnoće,
English: • fits (seizures) since your doctor may want to monitor you more closely
Croatian: • napadaja budući da će Vas liječnik možda željeti pažljivije nadzirati
English: The medical supervision and monitoring should continue until the patient recovers.
Croatian: S medicinskim nadzorom i praćenjem treba nastaviti sve dok se bolesnik ne oporavi.
English: A second injection may be administered 2 hours after the first injection, on the basis of individual clinical status and no more than three injections should be given in any 24-hour period.
Croatian: Druga injekcija može se primijeniti 2 sata nakon prve injekcije, na temelju kliničkog statusa pojedinog bolesnika, ali se ne smiju dati više od tri injekcije u razdoblju od 24 sata.
English: • difficulty sleeping,
Croatian: • poteškoće sa spavanjem,
English: • if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na aripiprazol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
Croatian: • serotoninski sindrom (reakcija koje može dovesti do osjećaja velike sreće, omamljenosti,
English: • difficulty controlling core body temperature or overheating,
Croatian: • poteškoće s kontroliranjem osnovne tjelesne temperature ili pregrijavanje,
English: Blood pressure-lowering medicines: ABILIFY may increase the effect of medicines used to lower the blood pressure.
Croatian: Lijekovi za snižavanje krvnog tlaka: ABILIFY može pojačati učinak lijekova koji se koriste za snižavanje krvnog tlaka.
English: If you have the impression that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako imate dojam da je učinak lijeka ABILIFY prejak ili preslab, obratite se svom liječniku ili ljekarniku.
English: • loss of appetite (anorexia),
Croatian: • gubitak apetita (anoreksija),
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: If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.
Croatian: Ako propustite injekciju, trebate se obratiti liječniku radi dogovora da što prije primite sljedeću injekciju.
English: Blood pressure, pulse, respiratory rate and level of consciousness should be monitored regularly.
Croatian: Krvni tlak, puls, frekvencija disanja i razina svijesti moraju se redovito nadzirati.
English: Contents of the pack and other information What ABILIFY contains
Croatian: Sadržaj pakiranja i druge informacije Što ABILIFY sadrži
English: Other medicines and ABILIFY
Croatian: Drugi lijekovi i ABILIFY
English: Therefore cardiovascular monitoring should be started immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Croatian: Stoga se odmah mora započeti s kardiovaskularnim nadzorom i uključiti kontinuirano elektrokardiografsko praćenje kako bi se otkrile moguće aritmije.
English: • more saliva in mouth than normal,
Croatian: • veća količina sline u ustima no obično,
English: Contains fructose, sucrose, E218, and E216.
Croatian: Sadrži fruktozu, saharozu, E218 i E216.
English: Your doctor will decide how much ABILIFY you need and how long you need it for.
Croatian: Liječnik će odlučiti koja vam je količina lijeka ABILIFY potrebna i koliko je dugo morate primati.
English: This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
Croatian: To je potrebno uzeti u obzir u slučajevima u kojima je potrebna puna pozornost, npr., prilikom upravljanja vozilom ili rukovanja strojevima.
English: • sensitivity to light,
Croatian: • osjetljivost na svjetlost,
English: Alternatively, disperse the tablet in water and drink the resulting suspension.
Croatian: Alternativna je mogućnost rastopiti tabletu u vodi i popiti tako nastalu suspenziju.
English: It is important not to miss your dose.
Croatian: Važno je da ne propustite primiti planiranu dozu.
English: What ABILIFY is and what it is used for
Croatian: Što je ABILIFY i za što se koristi
English: If you realise you have taken more ABILIFY than your doctor has recommended (or if someone else has taken some of your ABILIFY), contact your doctor right away.
Croatian: Ako shvatite da ste uzeli više lijeka ABILIFY nego što Vam je preporučio liječnik (ili ako je neka druga osoba popila dio Vašeg lijeka ABILIFY), odmah o tome obavijestite svog liječnika.
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 reproduktivne toksičnosti u životinja, ovaj se lijek ne smije koristiti u trudnoći, osim ako očekivana korist za majku jasno opravdava mogući rizik za fetus.
English: Use within 6 months after first opening.
Croatian: Upotrijebiti unutar 6 mjeseci nakon prvoga otvaranja.
English: Consequently, newborn infants should be monitored carefully (see section 4.8).
Croatian: Posljedično, novorođenčad se mora pažljivo motriti (vidjeti dio 4.8).
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“
English: Do not use this medicine in children and adolescents under 18 years of age.
Croatian: Nemojte primjenjivati ovaj lijek u djece i adolescenata mlađih od 18 godina.
English: The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disperse in saliva.
Croatian: Raspadljiva tableta za usta stavlja se u usta na jezik, gdje će se brzo rastopiti u slini.
English: Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Croatian: Budući da je raspadljiva tableta za usta krhka, mora se uzeti odmah po otvaranju blistera.
English: Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.
Croatian: Čak i ako se osjećate bolje, nemojte mijenjati dozu niti prekidati svakodnevno uzimanje lijeka ABILIFY bez prethodnog savjetovanja s liječnikom.
English: Consequently, the frequency of these adverse events is qualified as "not known".
Croatian: Posljedično tome, učestalost ovih nuspojava navodi se kao „nepoznata“.
English: Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primite ovaj lijek jer sadrži Vama važne podatke.
English: • too much sugar in the blood,
Croatian: • previše šećera u krvi,
English: The maximum daily dose of aripiprazole is 30 mg (including all formulations of ABILIFY).
Croatian: Maksimalna dnevna doza aripiprazola iznosi 30 mg (uključujući sve formulacije lijeka ABILIFY).
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Croatian: Farmakoterapijska skupina: Psiholeptici, ostali antipsihotici, ATK oznaka: N05AX12 Mehanizam djelovanja
English: Before treatment with ABILIFY, tell your doctor if you suffer from
Croatian: Prije liječenja lijekom ABILIFY, obavijestite svog liječnika ako bolujete od
English: It can be taken with or without liquid.
Croatian: Može se uzeti s tekućinom ili bez nje.
English: Indigo carmine aluminium lake (E 132)
Croatian: boja “indigo carmine aluminium lake” (E 132)
English: Sucrose may be harmful to the teeth.
Croatian: Saharoza može štetiti zubima.
English: Contains aspartame and lactose.
Croatian: Sadrži aspartam i laktozu.
English: • yellowing of the skin and white part of eyes,
Croatian: • žuta boja kože i bjeloočnica,
English: Fructose may damage teeth.
Croatian: Fruktoza može oštetiti zube.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koje ste nabavili bez recepta.
English: What ABILIFY looks like and contents of the pack
Croatian: Kako ABILIFY izgleda i sadržaj pakiranja
English: Simultaneous administration of injectable antipsychotics and parenteral benzodiazepine may be associated with excessive sedation and cardiorespiratory depression.
Croatian: Istodobna primjena antipsihotika u injekciji i benzodiazepina parenteralno može biti povezana s pretjeranom sedacijom i kardiorespiratornom depresijom.
English: Excipients with known effect (per mL)
Croatian: Pomoćne tvari s poznatim učinkom (po ml):
English: Aripiprazole administered intramuscularly as a single-dose to healthy subjects is well absorbed and has an absolute bioavailability of 100 %.
Croatian: Aripiprazol primijenjen intramuskularno u obliku jednokratne doze u zdravih ispitanika dobro se apsorbira i ima apsolutnu biološku raspoloživost od 100 %.
English: • feeling restless and unable to keep still, difficulty sitting still,
Croatian: • osjećaj uznemirenosti i nemogućnost mirovanja, poteškoće s mirnim sjedenjem,
English: • accidental inhalation of food with risk of pneumonia (lung infection),
Croatian: • slučajno udisanje hrane uz rizik od razvoja pneumonije (upale pluća),
English: If you see more than one doctor, be sure to tell them that you are receiving ABILIFY.
Croatian: Ako se liječite kod više od jednog liječnika, obavezno im recite da primate ABILIFY.
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 antihipertenzivnih lijekova.
English: Talk to your doctor about the best way to feed your baby if you are receiving this medicine.
Croatian: Razgovarajte sa svojim liječnikom o najboljem načinu na koji hraniti svoje dijete ako primate ovaj lijek.
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: A lower dose of 5.25 mg (0.7 mL) may be given, on the basis of individual clinical status, which should also include consideration of medicinal products already administered either for maintenance or acute treatment (see section 4.5).
Croatian: Može se dati i niža doza od 5,25 mg (0,7 ml) na temelju kliničkog statusa pojedinog bolesnika, s time da se moraju uzeti u obzir lijekovi koje je bolesnik već primio kao dozu održavanja ili radi liječenja akutnog stanja (vidjeti dio 4.5).
English: In subpopulation analyses on patients with mixed episodes or on patients with severe agitation, a similar pattern of efficacy to the overall population was observed but statistical significance could not be established due to a reduced sample size.
Croatian: U analizama podskupina bolesnika s miješanim epizodama ili bolesnika s teškom agitacijom, primijećen je sličan obrazac djelotvornosti kao i u ukupne populacije, ali se statistička značajnost nije mogla utvrditi zbog premalog uzorka.
English: • onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
Croatian: • početak ili pogoršanje šećerne bolesti, ketoacidoza (ketoni u krvi i mokraći) ili koma,
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 heartbeat.
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 adults it also prevents this condition from returning in patients who have responded to the treatment with ABILIFY.
Croatian: Također sprječava povratak takvog stanja u odraslih bolesnika koji su prethodno imali odgovor na liječenje lijekom ABILIFY.
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 podskupina, točkovna procjena HR-a iznosila je 0,495 u ispitanika u dobi od 13 do 14 godina u odnosu na 0,454 u ispitanika u dobi od 15 do 17 godina.
English: ABILIFY is not recommended for use in patients with schizophrenia below 15 years of age due to insufficient data on safety and efficacy (see sections 4.8 and 5.1).
Croatian: ABILIFY se ne preporučuje za primjenu u bolesnika sa shizofrenijom mlađih od 15 godina, zbog nedostatnih podataka o sigurnosti i djelotvornosti (vidjeti dijelove 4.8 i 5.1).
English: • blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately),
Croatian: • krvni ugrušci u venama osobito nogu (simptomi uključuju oticanje, bol i crvenilo noge), koji mogu putovati kroz krvne žile do pluća i tamo prouzročiti bol u prsištu i otežano disanje (ako primijetite neki od navedenih simptoma, odmah potražite liječničku pomoć);
English: The orodispersible tablet can be taken with or without liquid.
Croatian: Raspadljiva tableta za usta može se uzeti s tekućinom ili bez nje.
English: • The active substance is aripiprazole.
Croatian: • Djelatna tvar je aripiprazol.
English: Sudden death unexplained Torsades de pointes Ventricular arrhythmia Cardiac arrest Bradycardia
Croatian: Srčani poremećaji tahikardija iznenadna neobjašnjiva smrt torsades de pointes ventrikularna aritmija srčani arest bradikardija
English: 18 months After opening: use product immediately.
Croatian: Nakon otvaranja: lijek upotrijebiti odmah.
English: • certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
Croatian: • određene antibiotike koji se primjenjuju za liječenje tuberkuloze (rifabutin, rifampicin).
English: To enhance absorption and minimise variability, injection into the deltoid or deep within the gluteus maximus muscle, avoiding adipose regions, is recommended.
Croatian: Kako bi se pojačala apsorpcija i minimalizirala varijabilnost, preporučuje se primijeniti injekciju u deltoidni mišić ili duboko u veliki glutealni mišić, izbjegavajući pritom adipozna područja.
English: Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3 to 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: ABILIFY is given when treatment with oral formulations is not appropriate.
Croatian: ABILIFY se primjenjuje kad liječenje oralnim pripravcima nije prikladno.
English: Treatment with ABILIFY solution for injection should be discontinued as soon as clinically appropriate and the use of oral aripiprazole should be initiated.
Croatian: Liječenje ABILIFY otopinom za injekciju mora se prekinuti čim to bude klinički prikladno i započeti s oralnom terapijom aripiprazolom.
English: clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
Croatian: nespretnosti, nemira, osjećaja pijanstva, vrućice, znojenja ili ukočenih mišića),
English: The point estimate of the hazard ratio (HR) was 0.461 (95 % confidence interval, 0.242 to 0.879) in the full population.
Croatian: (HR) iznosila je 0,461 (95 % interval pouzdanosti: 0,242 do 0,879) u ukupnoj populaciji.
English: The information below is obtained from studies with oral aripiprazole.
Croatian: Sljedeće informacije dobivene su iz ispitivanja s oralnim aripiprazolom.
English: Therefore, ABILIFY is not recommended for use in patients below 13 years of age (see sections 4.8 and 5.1).
Croatian: Stoga se ABILIFY ne preporučuje za primjenu u bolesnika mlađih od 13 godina (vidjeti dijelove 4.8 i 5.1).
English: Patients who have taken too much aripiprazole have experienced the following symptoms:
Croatian: Bolesnici koji su uzeli previše aripiprazola imali su sljedeće simptome:
English: If you miss an injection of ABILIFY
Croatian: Ako propustite injekciju ABILIFY
English: Following any confirmed or suspected accidental overdose/inadvertent intravenous administration, close observation of the patient is needed and if any potentially medically serious sign or symptom develops, monitoring, which should include continuous electrocardiographic monitoring, is required.
Croatian: Nakon što se potvrdi ili posumnja na slučajno predoziranje/nehotičnu intravensku primjenu, potrebno je pažljivo promatrati bolesnika te u slučaju razvoja nekog medicinski potencijalno ozbiljnog znaka ili simptoma, potreban je nadzor, koji bi trebao uključivati kontinuirano elektrokardiografsko praćenje.
English: A combination of ABILIFY with medicines taken for anxiety might make you feel drowsy or dizzy.
Croatian: Kombinacija ABILIFY i lijekova koji se uzimaju protiv tjeskobe može izazvati osjećaj omamljenosti ili omaglice.
English: ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Croatian: ABILIFY je indiciran za liječenje shizofrenije u odraslih i adolescenata u dobi od 15 i više godina.
English: • abnormal muscle breakdown which can lead to kidney problems,
Croatian: • abnormalna razgradnja mišića koja može dovesti do bubrežnih tegoba,
English: The safety and efficacy of ABILIFY solution for injection has not been evaluated in patients with alcohol or medicinal product intoxication (either with prescribed or illicit medicinal products).
Croatian: Sigurnost i djelotvornost ABILIFY otopine za injekciju nije se procjenjivala u bolesnika intoksiciranih alkoholom ili lijekovima (bilo onima koji se izdaju na liječnički recept ili ilegalnim lijekovima).
English: The total dose of ABILIFY (all formulations) should not exceed 30 mg per day.
Croatian: Ukupna doza lijeka ABILIFY (svi oblici) ne smije biti veća od 30 mg dnevno.
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: ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
Croatian: ABILIFY sadrži djelatnu tvar aripiprazol i pripada skupini lijekova koji se zovu antipsihotici.
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).
Croatian: U bolesnika liječenih aripiprazolom prijavljeni su slučajevi serotoninskog sindroma, a mogući znakovi i simptomi ovog stanja osobito se mogu pojaviti u slučajevima istodobne primjene drugih serotoninergičkih lijekova, kao što su selektivni inhibitori ponovne pohrane serotonina / selektivni inhibitori ponovne pohrane serotonina i noradrenalina (SSRI/SNRI), odnosno lijekova za koje se zna da povećavaju koncentraciju aripiprazola (vidjeti dio 4.8).
English: • feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Croatian: • “povišeno” raspoloženje, pretjerana količina energije, potreba za manjom količinom sna nego obično, vrlo brz govor i ubrzan tijek misli te ponekad teška razdražljivost.
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 aripiprazolom i drugim atipičnim antipsihoticima nije dostupna, tako da se ne mogu raditi izravne usporedbe.
English: • blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
Croatian: • krvnih ugrušaka ili krvnih ugrušaka u obiteljskoj povijesti bolesti, jer su antipsihotici povezani s razvojem krvnih ugrušaka
English: Orodispersible tablets or oral solution may be used as an alternative to ABILIFY tablets for patients who have difficulty swallowing ABILIFY tablets (see section 5.2).
Croatian: Raspadljive tablete za usta ili oralna otopina mogu se primjenjivati kao zamjena za ABILIFY tablete u bolesnika kojima je teško progutati ABILIFY tablete (vidjeti dio 5.2).
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 zdravstvenim stanjem, vidjeti dio 4.2).
English: • rapid heartbeat, agitation/aggressiveness, problems with speech.
Croatian: • ubrzane otkucaje srca, uznemirenost/agresivnost, otežan govor,
English: Gender No dosage adjustment is required for female patients as compared to male patients (see section 5.2).
Croatian: Spol Nije potrebno prilagođivati dozu u žena u usporedbi s muškarcima (vidjeti dio 5.2).
English: • Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Croatian: • nemogućnost odupiranja nagonu, porivu ili iskušenju za vršenje radnji koje bi mogle naškoditi
English: • uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
Croatian: • nekontrolirani pokreti usta, jezika i udova (tardivna diskinezija),
English: The safety profile in a 26-week open-label extension trial was similar to that observed in the shortterm, placebo-controlled trial.
Croatian: Sigurnosni profil u 26-tjednom otvorenom produžetku ispitivanja bio je sličan onome opaženom u kratkotrajnom,
English: Aripiprazole/metabolites are excreted in human milk.
Croatian: Aripiprazol/metaboliti se izlučuju u majčino mlijeko u ljudi.
English: • spasm of the muscles around the voice box,
Croatian: • grč mišića oko govornog aparata,
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 aripiprazola u promet, ali njihova učestalost nije poznata:
English: • allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
Croatian: • alergijska reakcija (npr. oticanje usta, jezika, lica i grla, svrbež, koprivnjača),
English: Outer carton:
Croatian: Vanjsko pakiranje:
English: 200 mg fructose, 400 mg sucrose, 1.8 mg methyl parahydroxybenzoate (E218), 0.2 mg propyl parahydroxybenzoate (E 216)
Croatian: 200 mg fruktoze, 400 mg saharoze, 1,8 mg metilparahidroksibenzoata (E 218), 0,2 mg propilparahidroksibenzoata (E 216)
English: This medicine can be taken regardless of meals.
Croatian: Ovaj se lijek može uzimati neovisno o obrocima.
English: It is important that you carry on taking ABILIFY for as long as your doctor has told you to.
Croatian: Važno je da nastavite uzimati ABILIFY onoliko dugo koliko Vam je to rekao liječnik.