FrancophonIA/ELRC3.0 huggingface dataset:
English: • The combined total dose of haloperidol from both formulations must not exceed the corresponding maximum oral haloperidol dose of 5 mg/day or the previously administered oral haloperidol dose in patients who have received long-term treatment with oral haloperidol.
Croatian: • Kombinirana ukupna doza haloperidola iz obje formulacije ne smije biti veća od odgovarajuće maksimalne doze oralnog haloperidola od 5 mg na dan ili prethodno primijenjene doze oralnog haloperidola u bolesnika koji su primali dugotrajno liječenje oralim haloperidolom.
English: Tachycardia and hypotension (including orthostatic hypotension) have also been reported (see section 4.8).
Croatian: Također su prijavljene tahikardija i hipotenzija (uključujući ortostatsku hipotenziju) (vidjeti dio 4.8).
English: Poor metabolisers of CYP2D6
Croatian: Spori metabolizatori CYP2D6
English: A subset of patients may require higher concentrations as a consequence of a high inter-subject variability in haloperidol pharmacokinetics.
Croatian: Određenoj će podskupini bolesnika možda biti potrebne više koncentracije zbog visoke interindividualne varijabilnosti farmakokinetike haloperidola.
English: • Stiff muscles and joints
Croatian: • ukočeni mišići i zglobovi
English: Ventricular fibrillation Torsade de pointes Ventricular tachycardia Extrasystoles
Croatian: Srčani poremećaji tahikardija ventrikularna fibrilacija torsade de pointes ventrikularna tahikardija ekstrasistole
English: Although no clear association with the administration of antipsychotics and human breast tumours has been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.
Croatian: Iako u kliničkim i epidemiološkim ispitivanjima nije utvrđena jasna veza između primjene antipsihotika i tumora dojke u ljudi, preporučuje se oprez u bolesnica s relevantnom anamnezom.
English: • The most effective dose is expected to range between 25 and 75 mg.
Croatian: • Očekuje se da će se najučinkovitija doza kretati u rasponu od 25 do 75 mg.
English: If you are worried, tell the doctor or nurse.
Croatian: Ako ste zabrinuti, obratite se liječniku ili medicinskoj sestri.
English: • Ever had bleeding in the brain, or your doctor has told you that you are more likely than other people to have a stroke
Croatian: • ako ste ikada imali krvarenje u mozgu ili ako Vam je liječnik rekao da ste skloniji moždanom udaru nego drugi ljudi • ako bolujete od epilepsije ili ste nekada imali napadaje (konvulzije)
English: • Known QTc interval prolongation or congenital long QT syndrome.
Croatian: • Poznato produljenje QTc intervala ili prirođeni sindrom dugog QT intervala
English: Acute dystonia may occur during the first few days of treatment with haloperidol, but later onset as well as onset after dose increases has been reported.
Croatian: Akutna distonija može se javiti tijekom prvih nekoliko dana liječenja haloperidolom, ali prijavljen je i kasniji nastup, kao i nastup nakon povećanja doze.
English: Increased haloperidol plasma concentrations may result in an increased risk of adverse events, including QTc-prolongation (see section 4.4).
Croatian: Povišene plazmatske koncentracije haloperidola mogu povećati rizik od nuspojava, uključujući produljenje QTc intervala (vidjeti dio 4.4).
English: The frequency is unknown.
Croatian: Učestalost nije poznata.
English: If concomitant treatment with an antiparkinson medicinal product is required, it may have to be continued after stopping HALDOL Decanoate if its excretion is faster than that of haloperidol in order to avoid the development or aggravation of extrapyramidal symptoms.
Croatian: Ako je potrebno istodobno liječenje antiparkinsonikom i ako se on izlučuje brže od haloperidola, njegova će se primjena možda morati nastaviti nakon prekida primjene lijeka HALDOL Decanoate kako bi se izbjegao nastup ili pogoršanje ekstrapiramidnih simptoma.
English: Based on published data from multiple clinical studies, therapeutic response is obtained in most patients with acute or chronic schizophrenia at plasma concentrations of 1 to 10 ng/ml.
Croatian: Prema objavljenim podacima iz većeg broja kliničkih ispitivanja, terapijski se odgovor u većine bolesnika s akutnom ili kroničnom shizofrenijom postiže pri plazmatskim koncentracijama od 1 do 10 ng/ml.
English: Hyperprolactinaemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion.
Croatian: Hiperprolaktinemija može suprimirati GnRH u hipotalamusu i tako smanjiti lučenje gonadotropina iz hipofize.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika traži se da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V. 4.9 Predoziranje
English: Haloperidol is extensively metabolised in the liver.
Croatian: Haloperidol se opsežno metabolizira u jetri.
English: • Problems with vision, such as blurred vision.
Croatian: • vidne tegobe, poput zamagljena vida
English: HALDOL Decanoate should be used with caution in patients who are known poor metabolisers of cytochrome P450 (CYP) 2D6 and who are coadministered a CYP3A4 inhibitor.
Croatian: HALDOL Decanoate je potrebno koristiti s oprezom u bolesnika za koje se zna da su spori metabolizatori citokroma P450 (CYP) 2D6 i kojima je istodobno primijenjen CYP3A4 inhibitor.
English: ≥1/100 to <1/10
Croatian: ≥ 1/100 i < 1/10
English: Isolated cases of liver function abnormalities or hepatitis, most often cholestatic, have been reported (see section 4.8).
Croatian: Prijavljeni su izolirani slučajevi poremećaja jetrene funkcije ili hepatitisa, najčešće kolestatskog (vidjeti dio 4.8).
English: Haldol Decanoate contains the active substance haloperidol (as haloperidol decanoate).
Croatian: Haldol Decanoate sadrži djelatnu tvar haloperidol (u obliku haloperidoldekanoata).
English: Thyroxin may facilitate haloperidol toxicity.
Croatian: Tiroksin može pridonijeti toksičnosti haloperidola.
English: • Breakdown of muscle tissue (rhabdomyolysis)
Croatian: • razgradnja mišićnog tkiva (rabdomioliza)
English: Whilst on therapy, it is recommended to reduce the dose if QTc is prolonged, but haloperidol must be discontinued if the QTc exceeds 500 ms.
Croatian: Preporučuje se smanjiti dozu haloperidola tijekom liječenja ako je QTc interval produljen, a liječenje se mora prekinuti ako QTc interval premaši 500 ms.
English: Your doctor will discuss the risks and benefits of breast-feeding while you are using Haldol Decanoate.
Croatian: Liječnik će razgovarati s Vama o rizicima i koristima dojenja tijekom liječenja lijekom Haldol Decanoate.
English: Breast-feeding - talk to your doctor if you are breast-feeding or planning to breast-feed.
Croatian: Dojenje - obratite se svom liječniku ako dojite ili planirate dojiti.
English: Continuation of treatment
Croatian: Nastavak liječenja
English: • Changes in the blood, such as: o Effects on blood cells - low number of all types of blood cells, including severe decreases in white blood cells and low number of ‘platelets' (cells that help blood to clot)
Croatian: o učinci na krvne stanice - nizak broj svih vrsta krvnih stanica, uključujući znatan pad broja bijelih krvnih stanica i nizak broj krvnih pločica (stanica koje pomažu u zgrušavanju krvi) o visoka razina određenih hormona - ‘prolaktina' i 'antidiuretskog hormona' - u krvi
English: Acute dystonia may necessitate stopping the medicinal product.
Croatian: Akutna distonija može zahtijevati prekid primjene lijeka.
English: HALDOL Decanoate must be used with caution in patients with risk factors for stroke.
Croatian: HALDOL Decanoate mora se primjenjivati uz oprez u bolesnika s faktorima rizika za moždani udar.
English: Haloperidol apparent clearance after extravascular administration ranges from 0.9 to 1.5 l/h/kg and is reduced in poor metabolisers of CYP2D6.
Croatian: Prividni klirens haloperidola nakon ekstravaskularne primjene kreće se u rasponu od 0,9 do 1,5 l/h/kg, a smanjen je u osoba koje su spori metabolizatori CYP2D6.
English: • You take any of the medicines listed under ‘Other medicines and Haldol Decanoate - Do not use
Croatian: • ako uzimate bilo koji od lijekova navedenih u odlomku ‘Drugi lijekovi i Haldol Decanoate
English: • Malaria (such as halofantrine)
Croatian: • malariju (kao što je halofantrin)
English: The extent to which this association is attributable to the medicinal product, as opposed to being confounded by patient characteristics, has not yet been elucidated.
Croatian: Još nije razjašnjeno do koje se mjere ta povezanost može pripisati lijeku, a do koje mjere na nju utječu značajke bolesnika.
English: • Cancer (such as toremifene and vandetanib).
Croatian: • rak (kao što su toremifen i vandetanib)
English: • With the other hand, hold the tip of ampoule putting the index finger against the neck of ampoule, and the thumb on the coloured point parallel to the identification coloured rings.
Croatian: • Drugom rukom uhvatite vrh ampule tako da kažiprst položite uz vrat ampule, a palac na obojenu točku paralelnu s identifikacijskim obojenim prstenima.
English: The antidopaminergic effects of haloperidol on lactotropes in the anterior pituitary explain hyperprolactinaemia due to inhibition of dopamine-mediated tonic inhibition of prolactin secretion.
Croatian: Antidopaminergički učinci haloperidola na laktotrope u prednjem režnju hipofize objašnjavaju hiperprolaktinemiju izazvanu inhibicijom dopaminom posredovane toničke inhibicije lučenja prolaktina.
English: In some animal studies, higher intravenous haloperidol doses of 1 mg/kg or greater caused QTc prolongation and/or ventricular arrhythmias at Cmax plasma levels at least 38 to 137 times higher than the therapeutic plasma concentrations that were effective in the majority of patients in clinical studies.
Croatian: U nekim su ispitivanjima na životinjama veće intravenske doze haloperidola, od 1 mg/kg ili više, uzrokovale produljenje QTc intervala i/ili ventrikularne aritmije pri maksimalnim plazmatskim razinama (Cmax) najmanje 38 - 137 puta višima od terapijskih plazmatskih koncentracija koje su se pokazale djelotvornima kod većine bolesnika u kliničkim ispitivanjima.
English: Table 2: Haloperidol decanoate dose recommendations for elderly patients
Croatian: Tablica 2: Preporučene doze haloperidoldekanoata za starije bolesnike
English: The terminal elimination half-life of haloperidol after intramuscular injection with haloperidol decanoate is on average 3 weeks.
Croatian: Prosječno terminalno poluvrijeme eliminacije haloperidola nakon intramuskularne injekcije haloperidoldekanoata iznosi 3 tjedna.
English: The safety of haloperidol decanoate was evaluated in 410 patients who participated in 3 comparator studies (1 comparing haloperidol decanoate versus fluphenazine and 2 comparing the decanoate formulation to oral haloperidol), 9 open label studies and 1 dose response study.
Croatian: 4.8 Nuspojave Sigurnost haloperidoldekanoata ocjenjivala se u 410 bolesnika koji su sudjelovali u 3 ispitivanja s usporednim lijekom (u jednom se haloperidoldekanoat uspoređivao s flufenazinom, a u druga 2 s oralnom formulacijom haloperidola), 9 otvorenih ispitivanja i 1 ispitivanju odgovora na dozu.
English: Due to the high inter-subject variability in haloperidol pharmacokinetics and the concentration-effect relationship, it is recommended to adjust the individual haloperidol decanoate dose based on the patient's response.
Croatian: Zbog visoke interindividualne varijabilnosti farmakokinetike haloperidola te odnosa između koncentracija haloperidola i njegova učinka, preporučuje se prilagoditi individualnu dozu haloperidoldekanoata prema bolesnikovu odgovoru.
English: Do not use Haldol Decanoate if you are taking certain medicines for:
Croatian: Nemojte primiti Haldol Decanoate ako uzimate određene lijekove za:
English: During combination treatment with inducers of CYP3A4, it is recommended that patients be monitored and the HALDOL Decanoate dose increased as deemed necessary.
Croatian: Tijekom liječenja u kombinaciji s induktorima CYP3A4, preporučuje se nadzirati bolesnike i po potrebi povećati dozu lijeka HALDOL Decanoate.
English: • Nausea and vomiting (such as dolasetron)
Croatian: • mučninu i povraćanje (kao što je dolazetron)
English: In patients with first-episode schizophrenia treated with short-acting haloperidol formulations, therapeutic response may be obtained at concentrations as low as 0.6 to 3.2 ng/ml, as estimated based on measurements of D2 receptor occupancy and assuming that a D2 receptor occupancy level of 60 to 80% is most appropriate for obtaining therapeutic response and limiting extrapyramidal symptoms.
Croatian: U bolesnika s prvom epizodom shizofrenije liječenih kratkodjelujućim formulacijama haloperidola, terapijski se odgovor može postići već pri koncentracijama od 0,6 do 3,2 ng/ml, što je procijenjeno na temelju mjerenja zauzetosti receptora D2, pod pretpostavkom da je stopa zauzetosti receptora D2 od 60
English: The risk of QTc prolongation increases with haloperidol dose and with haloperidol plasma concentrations.
Croatian: Rizik od produljenja QTc intervala povećava se s povećanjem doze i plazmatskih koncentracija haloperidola.
English: These tumours may be caused by prolonged dopamine D2 antagonism and hyperprolactinaemia.
Croatian: Uzroci tih tumora mogli bi biti dugotrajan antagonizam dopaminskih D2-receptora i hiperprolaktinemija.
English: DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Croatian: DATUM REVIZIJE TEKSTA {MM/GGGG}
English: After withdrawal of the CYP3A4 inducer, the concentration of haloperidol may gradually increase and therefore it may be necessary to reduce the HALDOL Decanoate dose.
Croatian: Nakon prekida primjene induktora CYP3A4, koncentracija haloperidola može se postupno povećati pa će stoga možda biti potrebno smanjiti dozu lijeka HALDOL
English: Dosing interval
Croatian: Interval doziranja
English: Your dose of haloperidol decanoate will depend on:
Croatian: Doza haloperidoldekanoata ovisit će o:
English: • Difficulty swallowing or breathing
Croatian: • otežano gutanje ili disanje
English: Less than 3% of the dose is excreted unchanged in the urine.
Croatian: Manje od 3% doze izlučilo se mokraćom u neizmijenjenom obliku.
English: You may need to be more closely monitored, and the amount of Haldol Decanoate you are given may have to be altered.
Croatian: Možda će Vas trebati pažljivije pratiti i prilagoditi količinu lijeka Haldol Decanoate koju primate.
English: If you miss a dose or stop using Haldol Decanoate You should not stop this medicine unless told to do so by your doctor as your symptoms may return.
Croatian: Ne biste trebali prestati s ovim lijekom osim ako Vam to ne kaže Vaš liječnik budući da Vam se mogu vratiti simptomi.
English: Haldol Decanoate and alcohol
Croatian: Haldol Decanoate i alkohol
English: • Certain medicinal products used in cancer (e.g. toremifene, vandetanib).
Croatian: • određene lijekove koji se koriste za liječenje raka (npr. toremifen, vandetanib)
English: • It is recommended only to adjust the haloperidol decanoate dose if required (based on individual patient response) until an optimal therapeutic effect is obtained.
Croatian: Nastavak liječenja • Dozu haloperidoldekanoata preporučuje se prilagođavati samo ako je to potrebno (na temelju individualnog odgovora bolesnika) dok se ne postigne optimalan terapijski učinak.
English: In a carcinogenicity study of haloperidol, dose-dependent increases in pituitary gland adenomas and mammary gland carcinomas were seen in female mice.
Croatian: U ispitivanju kancerogenosti haloperidola primijećena su o dozi ovisna povećanja adenoma hipofize i karcinoma mliječnih žlijezda u ženki miševa.
English: ≥1/10,000 to <1/1,000
Croatian: ≥ 1/10 000 i < 1/1000
English: Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Croatian: Ispitivanja tkivnih kultura pokazuju da prolaktin možda stimulira stanični rast kod tumora dojke u ljudi.
English: The results are within the observed variability in haloperidol pharmacokinetics.
Croatian: Ti su rezultati unutar raspona opažene varijabilnosti farmakokinetike haloperidola.
English: HALDOL Decanoate is indicated for the maintenance treatment of schizophrenia and schizoaffective disorder in adult patients currently stabilised with oral haloperidol (see section 5.1).
Croatian: 4.1 Terapijske indikacije HALDOL Decanoate indiciran je za terapiju održavanja kod shizofrenije i shizoafektivnog poremećaja u odraslih bolesnika čije je stanje trenutno stabilizirano oralnim haloperidolom (vidjeti dio 5.1).
English: Tell your doctor if you notice or suspect any of the following side effects.
Croatian: Odmah obavijestite svog liječnika ako primijetite ili posumnjate na bilo koju od sljedećih nuspojava.
English: An enhanced CNS effect, when combined with methyldopa, has also been reported.
Croatian: Pojačan učinak na SŽS prijavljen je i kod primjene u kombinaciji s metildopom.
English: Dystonic symptoms can include, but are not limited to, torticollis, facial grimacing, trismus, tongue protrusion, and abnormal eye movements, including oculogyric crisis.
Croatian: Simptomi distonije mogu uključivati (između ostaloga) tortikolis, grimase, trizmus, protruziju jezika i neuobičajene kretnje oka, uključujući okulogirnu krizu.
English: Greece:
Croatian: Grčka:
English: ≥1/1,000 to <1/100
Croatian: ≥ 1/1000 i < 1/100
English: • A haloperidol decanoate dose of 10 to 15 times the previous daily dose of oral haloperidol is recommended.
Croatian: • Preporučuje se doza haloperidoldekanoata 10 - 15 puta veća od dotadašnje dnevne doze oralnog haloperidola.
English: • Muscle tremors, stiff or weak muscles
Croatian: • nevoljno drhtanje mišića, ukočenost ili slabost mišića
English: Since haloperidol is extensively metabolised in the liver, it is recommended to halve the initial dose, and adjust the dose with smaller increments and at longer intervals than in patients without hepatic impairment (see sections 4.4 and 5.2).
Croatian: Budući da se haloperidol opsežno metabolizira u jetri, preporučuje se prepoloviti početnu dozu i prilagođavati je u manjim koracima i duljim intervalima nego u bolesnika bez oštećenja jetrene funkcije (vidjeti dijelove 4.4 i 5.2).
English: • Uncertain mechanism - buspirone.
Croatian: • lijekove s nerazjašnjenim mehanizmom djelovanja - buspiron
English: • CYP3A4 inhibitors - alprazolam, fluvoxamine, indinavir, itraconazole, ketoconazole, nefazodone,
Croatian: • inhibitore CYP3A4 - alprazolam, fluvoksamin, indinavir, itrakonazol, ketokonazol, nefazodon,
English: Haloperidol decanoate is an ester of haloperidol and decanoic acid, and as such, a depot antipsychotic belonging to the butyrophenones group.
Croatian: Haloperidoldekanoat je ester haloperidola i dekanoatne kiseline, što ga čini depo antipsihotikom iz skupine butirofenona.
English: • CYP2D6 inhibitors - bupropion, chlorpromazine, duloxetine, paroxetine, promethazine, sertraline,
Croatian: • inhibitore CYP2D6 - bupropion, klorpromazin, duloksetin, paroksetin, prometazin, sertralin,
English: HALDOL Decanoate has a moderate influence on the ability to drive and use machines.
Croatian: HALDOL Decanoate umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Inhibition or induction of CYP3A4, or inhibition of CYP2D6, may affect haloperidol metabolism.
Croatian: Inhibicija ili indukcija CYP3A4 te inhibicija CYP2D6 mogu utjecati na metabolizam haloperidola.
English: The cytochrome P450 enzyme system is also involved, particularly CYP3A4 and, to a lesser extent, CYP2D6.
Croatian: Sudjeluje i sustav enzima citokroma P450, osobito CYP3A4, a u manjoj mjeri i
English: • Irritation, pain or collection of pus (abscess) where the injection is given
Croatian: • nadraženost, bol ili nakupljanje gnoja (apsces) na mjestu primjene injekcije
English: In a number of in vivo studies, intravenous administration of haloperidol in some animal models has caused significant QTc prolongation at doses around 0.3 mg/kg, producing Cmax plasma levels at least 7 to 14 times higher than the therapeutic plasma concentrations of 1 to 10 ng/ml that were effective in the majority of patients in clinical studies.
Croatian: U nizu ispitivanja in vivo, intravenska primjena haloperidola u nekih životinjskih modela uzrokovala je značajno produljenje QTc intervala pri dozama od približno 0,3 mg/kg, koje su dovele do maksimalnih plazmatskih razina (Cmax) najmanje 7 - 14 puta viših od terapijskih plazmatskih koncentracija od 1 - 10 ng/ml koje su se pokazale djelotvornima kod većine bolesnika u kliničkim ispitivanjima.
English: Adults • Your starting dose will normally be between 25 mg and 150 mg.
Croatian: • Uobičajena početna doza je između 25 mg i 150 mg.
English: Haloperidol is excreted in human milk.
Croatian: Haloperidol se izlučuje u majčino mlijeko.
English: posaconazole, saquinavir, verapamil, voriconazole.
Croatian: posakonazol, sakvinavir, verapamil, vorikonazol
English: Adverse reaction frequencies are based on (or estimated from) clinical trials or epidemiology studies with haloperidol decanoate, and classified using the following convention:
Croatian: Učestalost nuspojava određena je (ili procijenjena) na temelju kliničkih ili epidemioloških ispitivanja haloperidoldekanoata, a definira se kao:
English: Hepatobiliary disorders
Croatian: Hepatobilijarni sustav
English: Haloperidol suppresses delusions and hallucinations as a direct consequence of blocking dopaminergic signalling in the mesolimbic pathway.
Croatian: Supresija deluzija i halucinacija kod primjene haloperidola izravna je posljedica njegova blokiranja dopaminergičke signalizacije u mezolimbičkom putu.
English: • Whether you have problems with your kidneys or liver
Croatian: • Vašoj dobi • tome imate li tegoba s bubrezima ili jetrom
English: Coadministration of haloperidol with potent enzyme inducers of CYP3A4 may gradually decrease the plasma concentrations of haloperidol to such an extent that efficacy may be reduced.
Croatian: Lijekovi koji mogu sniziti plazmatske koncentracije haloperidola Istodobna primjena haloperidola sa snažnim induktorima enzima CYP3A4 može postupno sniziti plazmatske koncentracije haloperidola do te mjere da njegova djelotvornost može biti smanjena.
English: • Combined CYP3A4 and CYP2D6 inhibitors: fluoxetine, ritonavir.
Croatian: • kombinirane inhibitore CYP3A4 i CYP2D6 - fluoksetin, ritonavir
English: Psychotic disorder Agitation Confusional state Loss of libido Libido decreased Restlessness
Croatian: Psihijatrijski poremećaji depresija nesanica psihotični poremećaj agitacija stanje konfuzije gubitak libida smanjen libido nemir
English: Keep out of the sight and reach of children
Croatian: I DOHVATA DJECE Čuvati izvan pogleda i dohvata djece.
English: The pharmacokinetics of haloperidol following intramuscular injections of haloperidol decanoate are dose-related.
Croatian: Farmakokinetika haloperidola nakon intramuskularne injekcije haloperidoldekanoata povezana je s dozom.
English: Haldol Decanoate must not be injected into a vein.
Croatian: Haldol Decanoate ne smije se injicirati u venu.
English: • Certain antimalarials (e.g. halofantrine).
Croatian: • određene antimalarike (npr. halofantrin)
English: Metabolic and nutritional disorders
Croatian: Poremećaji metabolizma i prehrane hipoglikemija
English: In rodents, haloperidol administration showed a decrease in fertility, limited teratogenicity as well as embryo-toxic effects.
Croatian: U glodavaca je primjena haloperidola dovela do smanjenja plodnosti, ograničene teratogenosti te embriotoksičnih učinaka.
English: Administration of haloperidol decanoate as a depot intramuscular injection results in a slow and sustained release of free haloperidol.
Croatian: Apsorpcija Primjena haloperidoldekanoata u obliku depo intramuskularne injekcije dovodi do polaganog i postupnog oslobađanja slobodnog haloperidola.
English: Finland:
Croatian: Finska: