FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical safety data for orally administered aripiprazole 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 o sigurnosti oralno primijenjenog aripiprazola ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: • weakness, loss of strength or extreme tiredness
Croatian: • slabost, gubitak snage ili krajnji umor
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25 °C.
Croatian: Pokazalo se da je lijek u primjeni kemijski i fizikalno stabilan 4 sata na temperaturi od 25 °C.
English: The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known (frequency cannot be estimated from the available data):
Croatian: Sljedeće nuspojave zabilježene su nakon stavljanja peroralnog aripiprazola u promet, ali učestalost njihove pojave nije poznata (učestalost se ne može procijeniti iz dostupnih podataka):
English: • increased sexual interest
Croatian: • povećano zanimanje za seks
English: After that, treatment is given with injections of Abilify Maintena unless your doctor tells you otherwise.
Croatian: Nakon toga, liječenje se provodi injekcijama lijeka Abilify Maintena osim ako Vam liječnik ne kaže drugačije.
English: The final efficacy analysis included 403 randomised patients and 80 exacerbations of psychotic symptoms/impending relapse events.
Croatian: Završna analiza djelotvornosti uključila je 403 randomizirana bolesnika i 80 događaja egzacerbacije psihotičkih simptoma/prijetećih relapsa.
English: • shaking or trembling
Croatian: • tresenje ili drhtanje
English: The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g. work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours.
Croatian: Ljestvica PSP validirana je ljestvica koju ispunjava liječnik, a mjeri osobno i društveno funkcioniranje u četiri područja: društveno korisne aktivnosti (npr. posao i učenje), osobne i društvene odnose, brigu za sebe i uznemiravajuće i agresivno ponašanje.
English: If 2nd or 3rd dose is missed and time since last injection is:
Croatian: Ako se propusti 2. ili 3. doza, a vrijeme proteklo od zadnje injekcije je:
English: What Abilify Maintena is and what it is used for
Croatian: Što je Abilify Maintena i za što se koristi
English: The table is based on adverse reactions reported during clinical trials and/or post-marketing use.
Croatian: Tablica se temelji na nuspojavama prijavljenima tijekom kliničkih ispitivanja i/ili primjene nakon stavljanja lijeka u promet.
English: The highest non-tumorigenic exposure in female rats was approximately 7 times the human exposure at the recommended dose.
Croatian: Najviša netumorogena izloženost u ženki štakora bila ja približno 7 puta veća od izloženosti ljudi kod preporučene doze.
English: Abilify Maintena with alcohol
Croatian: Abilify Maintena s alkoholom
English: Blood pressure-lowering medicines: Abilify Maintena may increase the effect of medicines used to lower the blood pressure.
Croatian: Lijekovi za sniženje krvnog tlaka: Abilify Maintena može pojačati učinak lijekova koji se primjenjuju za sniženje krvnog tlaka.
English: Step 4: Procedures after injection
Croatian: Korak 4: Postupci nakon injekcije
English: Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.
Croatian: Obvezno obavijestite liječnika ako uzimate lijekove za kontrolu krvnog tlaka.
English: At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99 % bound to serum proteins, binding primarily to albumin.
Croatian: Pri terapijskim koncentracijama, aripiprazol i dehidroaripiprazol više su od 99 % vezani za proteine seruma, prvenstveno za albumin.
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, dugotrajnih abnormalnih kontrakcija skupine mišića, mogu se pojaviti u podložnih pojedinaca tijekom prvih nekoliko dana liječenja.
English: Extrapyramidal Symptoms (EPS)
Croatian: Ektrapiramidalni simptomi (EPS)
English: • sensitivity to light
Croatian: • osjetljivost na svjetlo
English: It is not possible to re-suspend after the air in the syringe is expelled.
Croatian: Resuspendiranje nije moguće nakon što se zrak istisne iz štrcaljke.
English: If you notice you are gaining weight, develop unusual movements, experience sleepiness that interferes with normal daily activities, any difficulty in swallowing or have allergic symptoms, please talk to your doctor immediately.
Croatian: Ako primijetite da dobivate na tjelesnoj težini, razvijate neobične pokrete, osjećate pospanost koja Vam ometa uobičajene dnevne aktivnosti, poteškoće s gutanjem ili imate alergijske simptome, molimo Vas da se odmah obratite liječniku.
English: • unusual heartbeat, sudden unexplained death, heart attack
Croatian: • neuobičajen rad srca, iznenadna neobjašnjena smrt, srčani udar
English: Acute treatment of schizophrenia in adults
Croatian: Akutno liječenje shizofrenije u odraslih
English: • loss of strength
Croatian: • gubitak snage
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Croatian: Farmakoterapijska skupina: Psiholeptici, drugi antipsihotici, ATK oznaka: N05AX12 Mehanizam djelovanja
English: Full instructions for use and handling of Abilify Maintena are provided in the package leaflet (information intended for healthcare professionals).
Croatian: Potpune upute za primjenu i rukovanje lijekom Abilify Maintena nalaze se u uputi o lijeku (informacije namijenjene zdravstvenim radnicima).
English: In this context, and given the seriousness of the consequences of falls, especially in elderly, the PRAC believes that an update of the Product Information with inclusion of a warning in section 4.4 of the SmPC is recommended.
Croatian: U tom kontekstu te s obzirom na ozbiljnost posljedica pada, osobito u starijih osoba, PRAC smatra da je preporučeno ažuriranje informacija o lijeku, uz uključivanje upozorenja u dio 4.4 sažetka opisa svojstava lijeka.
English: Abilify Maintena comes as a powder which your doctor or nurse will make into a suspension.
Croatian: Abilify Maintena dolazi u obliku praška, koji će Vaš liječnik ili medicinska sestra pripremiti kao suspenziju.
English: In repeated 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 events on development.
Croatian: U ispitivanjima ponovljene doze u mladih štakora i pasa, profil toksičnosti aripiprazola bio je usporediv s onim opaženim u odraslih životinja i nije bilo dokaza neurotoksičnosti ili štetnih učinaka na razvoj.
English: Consequently, new-born infants should be monitored carefully (see section 4.8).
Croatian: Sukladno tome, novorođenčad treba pažljivo nadzirati (vidjeti dio 4.8).
English: Receiving Abilify Maintena with some medicines may mean the doctor will need to change your dose of Abilify Maintena or the other medicines.
Croatian: Primanje Abilify Maintena s nekim lijekovima može značiti da će Vam liječnik morati promijeniti dozu lijeka Abilify Maintena ili tih drugih lijekova.
English: • accidental inhalation of food with risk of pneumonia (lung infection)
Croatian: • slučajno udisanje hrane uz rizik od upale pluća (infekcije pluća)
English: For oral aripiprazole, 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: Za oralni aripiprazol, toksikološki značajni učinci bili su opaženi samo pri dozama ili izloženostima koje su bile dovoljno veće od maksimalne ljudske doze ili izloženosti, što pokazuje da su ti učinci bili ograničeni ili da nisu bili važni za kliničku primjenu.
English: If not used immediately, in-use storage times and conditions are the responsibility of user.
Croatian: Ako se ne primijeni odmah, trajanje i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika.
English: A decision must be made whether to discontinue breastfeeding 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: You should be given an injection every month but not before the 26 days has passed from the last injection.
Croatian: Trebate dobiti injekciju svakog mjeseca, ali ne prije nego što protekne 26 dana od prethodne injekcije.
English: • reduced sexual interest (libido is decreased)
Croatian: • smanjena spolna želja (oslabljen libido)
English: Talk to your doctor or nurse before you are given Abilify Maintena.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego dobijete Abilify Maintena.
English: • altered mood
Croatian: • promijenjeno raspoloženje
English: Based on the available data, this condition should be listed in all aripiprazole containing products formulations.
Croatian: Na temelju dostupnih podataka, ovo je stanje potrebno navesti u svim formulacijama lijekova koji sadrže aripiprazol.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Abilify Maintena in all subsets of the paediatric population in schizophrenia (see section 4.2).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Abilify Maintena u svim podskupinama pedijatrijske populacije u shizofreniji (vidjeti dio 4.2).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for aripiprazole, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za aripiprazol, znanstveni zaključci CHMP-a su sljedeći:
English: However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported.
Croatian: Međutim, zabilježene su i povišena kreatin fosfokinaza i rabdomioliza, koje nisu nužno povezane s NMS-om.
English: Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
Croatian: Zbog svog antagonističkog djelovanja na α1-adrenergičke receptore, aripiprazol može pojačati učinak određenih antihipertenzivnih lijekova.
English: If you are receiving Abilify Maintena, your doctor will discuss with you whether you should breastfeed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding.
Croatian: Ako primate Abilify Maintena, Vaš će liječnik razgovarati s Vama o tome trebate li dojiti uzimajući u obzir korist liječenja za Vas i korist dojenja za dijete.
English: Contents of the pack and other information What Abilify Maintena contains
Croatian: Sadržaj pakiranja i druge informacije Što Abilify Maintena sadrži
English: Do not inject into an area with signs of inflammation, skin damage, lumps and/or bruises.
Croatian: Nemojte ubrizgavati u područje gdje su prisutni znakovi upale, oštećenja kože, kvržice i/ili modrice.
English: They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis)
Croatian: To može biti posljedica abnormalne razgradnje mišića, što može biti opasno po život i dovesti do problema s bubrezima (stanje koje se naziva rabdomioliza)
English: If there are adverse reactions with the 400 mg dosage, reduction of the dose to 300 mg once monthly should be considered.
Croatian: Ako uz dozu od 400 mg nastanu nuspojave, potrebno je razmotriti smanjenje doze na 300 mg jedanput mjesečno.
English: • heart problems or have a history of stroke, especially if you know that you have other risks factors for stroke
Croatian: • srčanih tegoba ili ste imali moždani udar, osobito ako znate da imate druge čimbenike rizika za moždani udar
English: Before treatment with Abilify Maintena, tell your doctor if you suffer from
Croatian: Prije liječenja lijekom Abilify Maintena, obavijestite svog liječnika ako bolujete od
English: Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with aripiprazole.
Croatian: Hiperglikemija, u nekim slučajevima krajnje visoka i povezana s ketoacidozom ili hiperosmolarnom komom ili smrću, zabilježena je u bolesnika liječenih aripiprazolom.
English: Abilify Maintena also showed statistically significant improvement in symptoms represented by CGIS score change from baseline to week 10.
Croatian: Abilify Maintena također je pokazao statistički značajno poboljšanje u simptomima koje se očitovalo promjenom rezultata na ljestvici CGIS od početne vrijednosti do 10. tjedna.
English: Abilify Maintena contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
Croatian: Abilify Maintena sadrži djelatnu tvar aripiprazol i pripada skupini lijekova koji se zovu antipsihotici.
English: After the first injection, treatment with 10 mg to 20 mg oral aripiprazole per day should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.
Croatian: Nakon prve injekcije liječenje treba nastaviti oralnim aripiprazolom od 10 mg do 20 mg na dan tijekom 14 uzastopnih dana da bi se održale terapijske koncentracije aripiprazola tijekom započinjanja terapije.
English: Water c) Slowly inject the solvent into the vial containing the powder.
Croatian: Voda c) Polako ubrizgajte otapalo u bočicu koja sadrži prašak.
English: b) Select one of the following hypodermic safety needles depending on the injection site and patient's weight and attach the needle to the luer lock syringe containing the suspension for injection.
Croatian: b) Odaberite jednu od sljedećih hipodermalnih sigurnosnih igala ovisno o mjestu primjene injekcije i tjelesnoj težini bolesnika i spojite iglu na priključak tipa luer lock štrcaljke koja sadrži suspenziju za injekciju.
English: The suspension should be injected slowly as a single injection (doses must not be divided) into the gluteal or deltoid muscle.
Croatian: Suspenziju treba ubrizgati sporo, kao jednu injekciju (doza se ne smije podijeliti), u glutealni ili deltoidni mišić.
English: During the double-blind, controlled phases of the two long-term trials, injection site reactions were observed; those seen were generally mild to moderate in severity, and resolved over time.
Croatian: Tijekom dvostruko slijepih, kontroliranih faza u dva dugotrajna ispitivanja bile su opažene reakcije na mjestu injekcije; opažene su reakcije općenito bile blage do umjerene težine i povukle su se s vremenom.
English: e) Subsequently, remove the needle from the vial.
Croatian: e) Nakon toga izvucite iglu iz bočice.
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: Iako nema informacija o učinku hemodijalize u liječenju predoziranja aripiprazolom, hemodijaliza najvjerojatnije neće biti od koristi u liječenju predoziranja, jer je aripiprazol u visokom postotku vezan za proteine plazme.
English: 51 mm (2 inch) 21 gauge c) Slowly inject the recommended volume as a single intramuscular injection into the gluteal or deltoid muscle.
Croatian: 51 mm i 21 gaugea c) Polako ubrizgajte preporučeni volumen kao jednu intramuskularnu injekciju u glutealni ili deltoidni mišić.
English: Other medicines and Abilify Maintena
Croatian: Drugi lijekovi i Abilify Maintena
English: Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Croatian: Aripiprazol je potrebno primjenjivati s oprezom u bolesnika s rizikom od aspiracijske pneumonije.
English: • swelling of hands, ankles or feet
Croatian: • oticanje šaka, gležnjeva ili stopala
English: The possibility of multiple medicinal product involvement should be considered.
Croatian: Potrebno je uzeti u obzir mogućnost da se radi o predoziranju većim brojem lijekova.
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 medicinal productation 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: • certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
Croatian: • određene antibiotike koji se primjenjuju za liječenje tuberkuloze (rifabutin, rifampicin)
English: Absorption of aripiprazole from the IM depot formulation was complete relative to the IM standard (immediate-release) formulation.
Croatian: Aripiprazol iz intramuskularne depo-formulacije potpuno se apsorbirao u odnosu na intramuskularnu standardnu formulaciju (neposredno oslobađanje).
English: > 5 weeks
Croatian: > 5 tjedana
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: Iako su uzroci smrti bili razni, većina smrti činila se ili kardiovaskularne (npr. zatajenje srca, iznenadna smrt) ili infektivne (npr. pneumonija) naravi (vidjeti dio 4.8).
English: faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate)
Croatian: ubrzano disanje, znojenje, snižena razina svijesti i iznenadne promjene krvnog tlaka i brzine rada srca)
English: Treatment with aripiprazole by mouth is continued for 14 days after the first injection.
Croatian: Liječenje aripiprazolom nastavlja se kroz usta tijekom 14 dana nakon prve injekcije.
English: If it's not possible to advance plunger rod to expel the air, check that plunger rod is rotated to a complete stop.
Croatian: Ako nije moguće potisnuti klip da bi se istisnuo zrak, provjerite je li klip zakrenut do kraja.
English: The US Product Information already mentions a class warning for antipsychotics since 2017.
Croatian: Upozorenje za ovu skupinu antipsihotika je od 2017. godine već navedeno u informacijama o lijeku u SAD-u.
English: • medicines that are known to prolong QT prolongation.
Croatian: • lijekove za koje je poznato da produljuju QT-interval.
English: Abilify Maintena is only intended for intramuscular use and should not be administered intravenously or subcutaneously.
Croatian: Abilify Maintena namijenjen je samo intramuskularnoj primjeni i ne smije se primjenjivati intravenski ili supkutano.
English: The reconstituted product suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in colour.
Croatian: Suspenzija rekonstituiranog lijeka mora izgledati kao jednolična, homogena, neprozirna suspenzija mliječno bijele boje.
English: It is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Croatian: Primjenjuje se za liječenje shizofrenije - bolesti sa simptomima kao što su čuti, vidjeti ili osjećati stvari koje nisu prisutne, sumnjičavost, zablude, nesuvisao govor i ponašanje te emocionalna tupost.
English: In patients who are known to be CYP2D6 poor metabolisers, the starting and maintenance dose should be 300 mg.
Croatian: U bolesnika za koje se zna da su slabi CYP2D6 metabolizatori, početna doza i doza održavanja treba biti 300 mg.
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Croatian: Zabilježeni su slučajevi venske tromboembolije (VTE) kod primjene antipsihotičkih lijekova.
English: The PIL for these products have similar warnings regarding muscle spasms, swallowing difficulty and breathing difficulty but again no mention of eye movement disorders.
Croatian: Uputa o lijeku ovih lijekova sadrži slična upozorenja o grčevima mišića, otežanom gutanju i otežanom disanju, no opet se ne spominju poremećaji pokreta očiju.
English: The following symptoms may occur in new-born babies, of mothers that have received Abilify Maintena 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 mogu nastati u novorođenčadi majki koje su primale Abilify Maintena u zadnjem tromjesečju (posljednja tri mjeseca trudnoće): tresavica, ukočenost i/ili slabost mišića, pospanost, uznemirenost, poteškoće s disanjem i otežano hranjenje.
English: Personal and social functioning were evaluated using the Personal and Social Performance (PSP) scale.
Croatian: Osobno i društveno funkcioniranje bilo je procijenjeno ljestvicom Osobnog i društvenog funkcioniranja (engl.
English: • neuroleptic malignant syndrome ( a syndrome with symptoms such as fever, muscle stiffness,
Croatian: • maligni neuroleptični sindrom (sindrom sa simptomima kao što su vrućica, mišićna ukočenost,
English: - The active substance is aripiprazole.
Croatian: - Djelatna tvar je aripiprazol.
English: • jaundice (yellowing of the skin and white part of eyes)
Croatian: • žutica (žuta boja kože i bjeloočnica)
English: The injections will not be given intravenously.
Croatian: Injekcije se ne daju u venu.
English: • gastroesophageal reflux disease.
Croatian: • gastroezofagealna refluksna bolest.
English: From a microbiological point of view, unless the method of opening/ reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: mikrobiološkog gledišta, lijek treba primijeniti odmah osim ako način otvaranja/rekonstitucije ne uklanja rizik od mikrobiološke kontaminacije.
English: • changes in your level of alertness, drowsiness
Croatian: • promjene u razini budnosti, omamljenost
English: However, in one of these trials, a fixed-dose trial, there was a significant doseresponse relationship for cerebrovascular adverse reactions in patients treated with aripiprazole (see section 4.8).
Croatian: Međutim, u jednom od tih ispitivanja, ispitivanju fiksne doze, postojao je značajan odnos odgovor-doza za cerebrovaskularne nuspojave u bolesnika liječenih aripiprazolom (vidjeti dio 4.8).
English: • liver function tests may show abnormal results
Croatian: • tromost • rezultati pretraga jetrene funkcije mogu biti neuobičajeni
English: If you are given more Abilify Maintena than you should
Croatian: Ako primite više Abilify Maintena nego što ste trebali
English: The injection should be administered as soon as possible and then the monthly injection schedule should be resumed.
Croatian: Injekciju treba primijeniti čim prije, a potom nastaviti prema mjesečnom rasporedu injekcija.
English: Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Croatian: Faktori rizika zbog kojih bolesnici mogu biti skloni teškim komplikacijama uključuju pretilost i šećernu bolest u obiteljskoj anamnezi.
English: Neutropenia has been reported in the clinical program with Abilify Maintena and typically started around day 16 after first injection, and lasted a median of 18 days.
Croatian: Neutropenija je bila zabilježena u kliničkom programu lijeka Abilify Maintena i obično je započinjala oko 16 dana nakon prve injekcije i imala je medijan trajanja od 18 dana.