FrancophonIA/ELRC3.0 huggingface dataset:
English: These include mental health problems (such as schizophrenia).
Croatian: To uključuje psihičke tegobe (kao što je shizofrenija).
English: A serious problem called ‘neuroleptic malignant syndrome'.
Croatian: Ozbiljna tegoba koja se zove ‘neuroleptički maligni sindrom'.
English: These illnesses may make you:
Croatian: Zbog tih bolesti:
English: Look out for serious side effects
Croatian: Pripazite na ozbiljne nuspojave
English: Also tell your doctor if you are taking any other medicines to lower blood pressure, such as water tablets (diuretics).
Croatian: Obavijestite svog liječnika i ako uzimate bilo koje druge lijekove za snižavanje krvnog tlaka, kao što su tablete za izmokravanje (diuretici).
English: • You have Parkinson's disease
Croatian: • ako imate Parkinsonovu bolest
English: Haloperidol crosses the blood-brain barrier easily.
Croatian: Haloperidol lako prolazi kroz krvno-moždanu barijeru.
English: It is recommended that ECG and vital signs be monitored, and that monitoring continues until the ECG is normal.
Croatian: Preporučuje se praćenje EKG-a i vitalnih znakova sve dok se EKG ne normalizira.
English: Haldol Decanoate will be given by a doctor or nurse.
Croatian: Haldol Decanoate će Vam dati liječnik ili medicinska sestra.
English: On average, concentrations in this range would be obtained with doses of 1 to 4 mg daily.
Croatian: U prosjeku se koncentracije unutar tog raspona mogu postići dozama od 1 do 4 mg na dan.
English: There is a high inter-subject variability for plasma protein binding.
Croatian: Primijećena je visoka interindividualna varijabilnost vezivanja za proteine u plazmi.
English: Tell your doctor if you are taking:
Croatian: Obavijestite svog liječnika ako uzimate:
English: Talk to your doctor before being given Haldol Decanoate if you are elderly, particularly if you have dementia.
Croatian: Razgovarajte sa svojim liječnikom prije nego primite Haldol Decanoate ako ste starija osoba, osobito ako bolujete od demencije.
English: • Being unable to move
Croatian: • nemogućnost pokreta
English: Problems controlling movements of the body or limbs (extrapyramidal disorder), such as:
Croatian: Poteškoće s kontroliranjem kretnji tijela ili udova (ekstrapiramidni poremećaj), kao što su:
English: • Central nervous system (CNS) depression.
Croatian: • Depresija središnjeg živčanog sustava (SŽS)
English: This must take into account the time after a change in dose to achieve a new steady state plasma concentration and the additional time to elicit a therapeutic response.
Croatian: Pritom se mora uzeti u obzir vrijeme nakon promjene doze potrebno za postizanje novih plazmatskih koncentracija u stanju dinamičke ravnoteže i dodatno vrijeme potrebno za postizanje terapijskog odgovora.
English: A doctor or nurse will give this medicine to you, so it is unlikely that you will be given too much.
Croatian: Budući da će Vam ovaj lijek dati liječnik ili medicinska sestra, malo je vjerojatno da ćete primiti previše lijeka.
English: [To be completed nationally] <Other sources of information> <Detailed information on this medicine is available on the website of {MS/Agency}> [To be completed nationally]
Croatian: <Ostali izvori informacija> <Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici {naziv nadležnog tijela države članice}> [Ispunjava država članica]
English: Haloperidol is rapidly distributed to various tissues and organs, as indicated by the large volume of distribution (mean values 8 to 21 l/kg after intravenous dosing).
Croatian: Haloperidol se brzo raspodjeljuje u različita tkiva i organe, na što ukazuje velik volumen distribucije (srednja vrijednost nakon intravenske primjene: 8 - 21 l/kg).
English: These intravenous doses, which prolonged QTc, did not cause arrhythmias.
Croatian: Te intravenske doze koje su produljile QTc interval nisu uzrokovale aritmije.
English: The safety and efficacy of HALDOL Decanoate in children and adolescents below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka HALDOL Decanoate u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: • Abnormal heart rhythm - this stops the heart working normally and may cause loss of consciousness
Croatian: Srčane tegobe: • nepravilan srčani ritam - on onemogućuje normalan rad srca i može dovesti do gubitka svijesti
English: • Uncompensated heart failure.
Croatian: • Nekompenzirano zatajenje srca
English: It is administered as a deep intramuscular injection in the gluteal region.
Croatian: Primjenjuje se kao duboka intramuskularna injekcija u glutealno područje.
English: The major pathways are glucuronidation and ketone reduction.
Croatian: Glavni putovi su glukuronidacija i redukcija ketona.
English: Haloperidol plasma concentrations in elderly patients were higher than in younger adults administered the same dose.
Croatian: Plazmatske koncentracije haloperidola u starijih bolesnika bile su više nego u mlađih odraslih osoba koje su primile istu dozu.
English: Fertility - Haldol Decanoate may increase your levels of a hormone called ‘prolactin', which may affect fertility in men and women.
Croatian: Plodnost - Haldol Decanoate može povisiti razine hormona koji se zove ‘prolaktin', što može utjecati na plodnost u muškaraca i žena.
English: Patients with depression
Croatian: Bolesnici oboljeli od depresije
English: Haldol Decanoate should not be used in children and adolescents below 18 years.
Croatian: Haldol Decanoate ne smije se koristiti u djece i adolescenata mlađih od 18 godina.
English: Observational studies suggest that treatment of elderly patients with haloperidol is also associated with increased mortality.
Croatian: Opservacijska ispitivanja ukazuju na to da je liječenje starijih bolesnika haloperidolom također povezano s povećanom smrtnošću.
English: Effect of haloperidol on other medicinal products
Croatian: Učinak haloperidola na druge lijekove
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu naknadno ažurirati informacije o lijeku, gdje je prikladno u suradnji s referentnom državom članicom, u skladu s postupcima navedenim u Poglavlju 4 Glave III.
English: • Upward movement of the eyes or fast eye movements that you cannot control
Croatian: • zakretanje očnih jabučica prema gore ili brze kretnje oka koje ne možete kontrolirati
English: Hypertension rather than hypotension is also possible.
Croatian: Moguća je i hipertenzija (češće nego hipotenzija).
English: • Feeling dizzy, including upon sitting up or standing up
Croatian: • omaglica, uključujući pri ustajanju u sjedeći ili stajaći položaj
English: Pharmacotherapeutic group: psycholeptics; antipsychotics; butyrophenone derivatives, ATC code: N05AD01.
Croatian: Farmakoterapijska skupina: psiholeptici; antipsihotici; derivati butirofenona; ATK oznaka: N05AD01.
English: • Loss of sex drive or decreased sex drive
Croatian: • gubitak spolnog nagona ili smanjen spolni nagon
English: This association may be stronger for haloperidol than for atypical antipsychotic medicinal products, is most pronounced in the first 30 days after the start of treatment, and persists for at least 6 months.
Croatian: Ta bi veza mogla biti snažnija kod primjene haloperidola nego kod atipičnih antipsihotika, najizraženija je tijekom prvih 30 dana nakon početka liječenja, a traje najmanje 6 mjeseci.
English: Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT).
Croatian: Krvni ugrušci u venama, obično nogu (duboka venska tromboza ili DVT).
English: • Parkinson's disease.
Croatian: • Parkinsonova bolest
English: If you used Haldol Decanoate while pregnant and your baby develops any of these side effects, contact your doctor.
Croatian: Ako ste primali Haldol Decanoate tijekom trudnoće i kod Vašeg se djeteta pojavi bilo koja od tih nuspojava, obratite se svom liječniku.
English: Examples of medicinal products that may increase haloperidol plasma concentrations (based on clinical experience or drug interaction mechanism) include:
Croatian: Primjeri lijekova koji mogu povisiti koncentracije haloperidola u plazmi (na temelju kliničkog iskustva ili mehanizma u pozadini interakcija između lijekova) uključuju:
English: Haloperidol causes efficient psychomotor sedation, which explains the favourable effect on mania and other agitation syndromes.
Croatian: Haloperidol izaziva učinkovitu psihomotoričku sedaciju, što objašnjava povoljan učinak na maniju i druge agitacijske sindrome.
English: • Low blood pressure, or feel dizzy upon sitting up or standing up
Croatian: • ako imate nizak krvni tlak ili osjećate omaglicu pri ustajanju u sjedeći ili stajaći položaj
English: It is for intramuscular use, and is given as an injection deep into a muscle.
Croatian: Namijenjen je za intramuskularnu primjenu, što znači da se daje injekcijom duboko u mišić.
English: Antagonism of the effect of the anticoagulant phenindione has been reported.
Croatian: Prijavljen je antagonizam učinka antikoagulansa fenindiona.
English: • Elderly people will normally start on a lower dose, usually 12.5 mg to 25 mg every 4 weeks.
Croatian: • Liječenje starijih osoba obično započinje nižom dozom, najčešće od 12,5 do 25 mg svaka 4 tjedna.
English: • Abnormal muscle tension
Croatian: • neuobičajena napetost mišića
English: In extreme cases, the patient would appear comatose with respiratory depression and hypotension that could be severe enough to produce a shock-like state.
Croatian: U iznimnim slučajevima bolesnik može pasti u komu praćenu depresijom disanja i hipotenzijom, koje mogu biti dovoljno teške izazovu stanje nalik na šok.
English: The syndrome is mainly characterized by rhythmic involuntary movements of the tongue, face, mouth or jaw.
Croatian: Taj sindrom uglavnom karakteriziraju ritmični nevoljni pokreti jezika, lica, usta ili čeljusti.
English: • You have a heart condition called ‘prolonged QT interval', or any other problem with your heart rhythm that shows as an abnormal tracing on an ECG (electrocardiogram)
Croatian: • ako imate srčanu bolest koja se zove ‘produljen QT interval' ili bilo koji drugi problem sa srčanim ritmom koji se vidi kao odstupanje na elektrokardiogramu (EKG)
English: • Uncorrected hypokalaemia.
Croatian: • Nekorigirana hipokalijemija
English: Treatment of severe arrhythmias with appropriate anti-arrhythmic measures is recommended.
Croatian: Preporučuje se liječenje teških aritmija odgovarajućim antiaritmičkim mjerama.
English: Haldol Decanoate can affect the way the following types of medicine work Tell your doctor if you are taking medicines for:
Croatian: Haldol Decanoate može utjecati na način djelovanja sljedećih lijekova Obavijestite svog liječnika ako uzimate lijekove za:
English: • A slow heart beat, heart disease or anyone in your close family has died suddenly of heart problems
Croatian: • ako imate usporene otkucaje srca ili srčanu bolest ili ako je netko u Vašoj užoj obitelji iznenada umro od srčanih tegoba
English: Occasionally, patients had previously been treated orally with another antipsychotic medicinal product.
Croatian: U nekim su slučajevima bolesnici prethodno bili peroralno liječeni nekim drugim antipsihotikom.
English: • Changes in menstrual cycle (periods), such as no periods, or long, heavy, painful periods
Croatian: • promjene menstrualnog ciklusa (mjesečnice), poput izostanka mjesečnice ili dugotrajnih, obilnih i bolnih mjesečnica
English: Treatment initiation and dose titration must be carried out under close clinical supervision.
Croatian: Liječenje se mora uvesti i doza titrirati pod strogim kliničkim nadzorom.
English: A single dose of Haldol Decanoate will normally last for 4 weeks.
Croatian: Jedna doza lijeka Haldol Decanoate obično traje 4 tjedna.
English: Results from small clinical studies suggest a lower clearance and a longer elimination half-life of haloperidol in elderly patients.
Croatian: Rezultati malih kliničkih ispitivanja ukazuju na manji klirens i dulje poluvrijeme eliminacije haloperidola u starijih bolesnika.
English: This increase may be higher with all butyrophenones, including haloperidol.
Croatian: To povećanje može biti izraženije kod primjene svih butirofenona, uključujući haloperidol.
English: • You are allergic to haloperidol or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na haloperidol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) [Ispunjava država članica]
English: Therapeutic concentrations
Croatian: Terapijske koncentracije
English: • Movements of the mouth, tongue, jaw and sometimes limbs (tardive dyskinesia)
Croatian: • pokreti usta, jezika, čeljusti i ponekad udova (tardivna diskinezija)
English: About one-third of a haloperidol dose is excreted in urine, mostly as metabolites.
Croatian: Približno jedna trećina doze haloperidola izlučuje se mokraćom, uglavnom u obliku metabolita.
English: • Breast problems, such as: o Pain or discomfort o Unexpected production of breast milk o Enlarged breasts in men
Croatian: • tegobe s dojkama, kao što su: o bol ili nelagoda o neočekivano stvaranje mlijeka o rast dojki u muškaraca
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including HALDOL Decanoate, must be considered.
Croatian: Ako se pojave znakovi i simptomi tardivne diskinezije, mora se razmotriti prekid primjene svih antipsihotika, uključujući HALDOL Decanoate.
English: • Adjustment of the dosing interval may be required (based on individual patient response).
Croatian: • Možda će biti potrebno prilagoditi interval doziranja (na temelju individualnog odgovora bolesnika).
English: For instructions on handling HALDOL Decanoate, see section 6.6.
Croatian: HALDOL Decanoate vidjeti dio 6.6.
English: Haloperidol is an inhibitor of CYP2D6.
Croatian: Haloperidol je inhibitor CYP2D6.
English: It is recommended that patients be advised not to drive or operate machines during treatment, until their susceptibility is known.
Croatian: Preporučuje se savjetovati bolesnicima da tijekom liječenja ne upravljaju vozilima i ne rade sa strojevima dok se ne utvrdi kako lijek djeluje na njih.
English: In cases of severe extrapyramidal reactions, it is recommended that an antiparkinson medicinal product be administered, and continued for several weeks.
Croatian: U slučaju teških ekstrapiramidnih reakcija preporučuje se primijeniti antiparkinsonik i nastaviti s njegovom primjenom nekoliko tjedana.
English: Do not drive or use any tools or machines without discussing this with your doctor first.
Croatian: Nemojte upravljati vozilom niti rukovati alatima ili raditi sa strojevima bez prethodnog razgovora sa svojim liječnikom.
English: Caution is advised in patients suffering from epilepsy and in conditions predisposing to seizures (e.g. alcohol withdrawal and brain damage).
Croatian: Preporučuje se oprez u bolesnika koji imaju epilepsiju ili neko stanje koje stvara predispoziciju za napadaje (npr. ustezanje od alkohola i oštećenje mozga).
English: This causes a high fever, severe muscle stiffness, confusion and loss of consciousness.
Croatian: Ona uzrokuje visoku vrućicu, izraženu mišićnu ukočenost, smetenost i gubitak svijesti.
English: Your doctor will decide how much Haldol Decanoate you need and for how long.
Croatian: Liječnik će odlučiti koliko lijeka Haldol Decanoate Vam je potrebno i koliko dugo ga trebate primati.
English: Antipsychotic treatment must be withdrawn immediately and appropriate supportive therapy and careful monitoring instituted.
Croatian: Odmah se mora prekinuti liječenje antipsihotikom te uvesti odgovarajuća potporna terapija i pažljivo praćenje.
English: After intravenous haloperidol administration, 21% of the dose was eliminated in the faeces and 33% in the urine.
Croatian: Nakon intravenske primjene haloperidola, 21% doze izlučilo se fecesom, a 33% mokraćom.
English: Your doctor may advise you not to use Haldol Decanoate while you are pregnant.
Croatian: Liječnik će Vam možda savjetovati da ne primate Haldol Decanoate dok ste trudni.
English: • Depression (such as citalopram and escitalopram)
Croatian: • depresiju (kao što su citalopram i escitalopram)
English: Haloperidol may antagonise the effect of levodopa and other dopamine agonists.
Croatian: Haloperidol može antagonizirati učinak levodope i drugih agonista dopamina.
English: • Usually 4 weeks between injections.
Croatian: • Interval između dviju injekcija obično iznosi 4 tjedna.
English: Haloperidol is a potent central dopamine type 2 receptor antagonist, and at recommended doses, has low alpha-1 antiadrenergic activity and no antihistaminergic or anticholinergic activity.
Croatian: Haloperidol je snažan antagonist dopaminskih receptora tipa 2 u SŽS-u, koji u preporučenim dozama ostvaruje nisku alfa-1 antiadrenergičku aktivnost, ali nema antihistaminergičku ni antikolinergičku aktivnost.
English: Some degree of sedation or impairment of alertness may occur, particularly with higher doses and at the start of treatment and may be potentiated by alcohol.
Croatian: Može doći do određenog stupnja sedacije ili smanjene budnosti, osobito kod primjene većih doza i na početku liječenja; alkohol može dodatno pojačati te učinke.
English: • Difficulty or being unable to open the mouth
Croatian: • otežano otvaranje usta ili nemogućnost njihova otvaranja
English: These medicines may make heart problems more likely, so talk to your doctor if you are taking any of these and do not use Haldol Decanoate (see ‘Do not use Haldol Decanoate if').
Croatian: Budući da ti lijekovi mogu povećati vjerojatnost razvoja srčanih tegoba, razgovarajte sa svojim liječnikom ako uzimate bilo koji od njih i nemojte primiti Haldol Decanoate (vidjeti ‘Nemojte primiti Haldol Decanoate').
English: You must be aware of serious side effects while you are using Haldol Decanoate because you may need urgent medical treatment.
Croatian: Morate biti svjesni ozbiljnih nuspojava tijekom liječenja lijekom Haldol Decanoate jer će Vam možda biti potrebno hitno liječenje.
English: This may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients (see section 4.4).
Croatian: To može inhibirati reproduktivnu funkciju narušavanjem steroidogeneze u gonadama i kod žena i kod muškaraca (vidjeti dio 4.4).
English: • Problems walking
Croatian: • poteškoće s hodanjem
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Croatian: Prijavljeni su agitacija, hipertonija, hipotonija, tremor, somnolencija, respiratorni distres i poremećaj hranjenja.
English: • Skin problems, such as: o Rash or itching o Increased sensitivity to sunlight o Flaking or peeling skin o Inflamed small blood vessels, leading to a skin rash with small red or purple bumps
Croatian: • kožne tegobe, kao što su: o osip ili svrbež o pojačana osjetljivost kože na sunčevu svjetlost o perutanje ili ljuštenje kože o upala malih krvnih žila, koja može uzrokovati kožni osip praćen malim crvenim ili ljubičastim kvržicama
English: Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for ventricular arrhythmias and must be corrected before treatment with haloperidol is started.
Croatian: Neravnoteže elektrolita, kao što su hipokalijemija i hipomagnezijemija, povećavaju rizik od ventrikularnih aritmija i moraju se korigirati prije nego što se započne liječenje haloperidolom.
English: Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma or concentrated albumin and vasopressor agents, such as dopamine or noradrenaline.
Croatian: Hipotenzija i cirkulatorni kolaps mogu se neutralizirati primjenom intravenskih tekućina, plazme ili koncentriranog albumina i vazopresora, poput dopamina ili noradrenalina.
English: This is longer than for the non-decanoate formulations, where the haloperidol terminal elimination half-life is on average 24 hours after oral administration and 21 hours after intramuscular administration.
Croatian: To je dulje nego kod primjene formulacija koje nisu u obliku dekanoata, a čije prosječno terminalno poluvrijeme eliminacije iznosi 24 sata nakon peroralne primjene odnosno 21 sat nakon intramuskularne primjene.
English: • Slow or reduced body movements, jerking or twisting movements
Croatian: • usporene ili smanjene tjelesne kretnje, trzajući ili svijajući pokreti
English: The most prominent symptoms are severe extrapyramidal reactions, hypotension and sedation.
Croatian: Najizraženiji simptomi su teške ekstrapiramidne reakcije, hipotenzija i sedacija.
English: Adrenaline must not be used because it might cause profound hypotension in the presence of haloperidol.
Croatian: Ne smije se primijeniti adrenalin jer može izazvati izraženu hipotenziju u prisutnosti haloperidola.
English: The signs of a DVT in the leg include swelling, pain and redness in the leg, but the clot may move to the lungs causing chest pain and difficulty in breathing.
Croatian: Znakovi DVT-a u nozi uključuju oticanje, bol i crvenilo noge, ali ugrušak može otići u pluća te uzrokovati bol u prsnom košu i otežano disanje.
English: Class effects of antipsychotics
Croatian: Učinci skupine antipsihotika
English: This is because it has not been studied in these age groups.
Croatian: Naime, njegova primjena nije ispitana u tim dobnim skupinama.
English: Pharmacokinetic/pharmacodynamics relationships
Croatian: Farmakokinetički/farmakodinamički odnosi
English: (Hypericum, perforatum) or venlafaxine (for depression)
Croatian: (Hypericum perforatum) ili venlafaksin (za depresiju)
English: • Doses above 75 mg every 4 weeks should only be considered in patients who have tolerated higher doses and after reassessment of the patient's individual benefit-risk profile.
Croatian: • Doze iznad 75 mg svaka 4 tjedna smiju se uzeti u obzir samo u bolesnika koji su podnosili više doze te nakon ponovne procjene profila omjera koristi i rizika za pojedinog bolesnika.
English: • A high level of the hormone 'prolactin' in your blood, or cancer that may be caused by high prolactin levels (such as breast cancer)
Croatian: • ako imate visoku razinu hormona koji se zove ‘prolaktin' u krvi ili ako bolujete od raka koji bi mogao biti uzrokovan visokim razinama prolaktina (poput raka dojke)
English: • You will only be given a higher dose than 75 mg every 4 weeks if your doctor decides it is safe to do so.
Croatian: • Doza viša od 75 mg svaka 4 tjedna primijenit će Vam se samo ako Vaš liječnik odluči da je to sigurno.
English: • Concomitant treatment with medicinal products that prolong the QT interval (see section 4.5).
Croatian: • Istodobno liječenje lijekovima koji produljuju QT interval (vidjeti dio 4.5).
English: Dose adjustment is recommended in elderly patients (see section 4.2).
Croatian: Preporučuje se prilagoditi dozu u starijih bolesnika (vidjeti dio 4.2).
English: Sudden deaths have occurred in patients using this medicine, but the exact frequency of these deaths is unknown.
Croatian: U bolesnika koji su primali ovaj lijek zabilježeni su slučajevi iznenadne smrti, ali je njihova točna učestalost nepoznata.
English: The main metabolic pathways of haloperidol in humans include glucuronidation, ketone reduction, oxidative N-dealkylation and formation of pyridinium metabolites.
Croatian: Glavni putovi metabolizma haloperidola u ljudi uključuju glukuronidaciju, redukciju ketona, oksidacijsku N-dealkilaciju i nastanak piridinskih metabolita.
English: (normally between 50 mg and 200 mg every 4 weeks).
Croatian: Vam najbolje odgovara (obično između 50 mg i 200 mg svaka 4 tjedna).
English: Extrapyramidal symptoms can occur within the therapeutic range, although the frequency is usually higher with doses producing higher than therapeutic concentrations.
Croatian: Ekstrapiramidni simptomi mogu nastupiti unutar terapijskog raspona, ali je njihova učestalost obično veća kod primjene doza koje dovode do koncentracija viših od terapijskih.
English: • Problems breathing or feeding.
Croatian: • poteškoće s disanjem ili hranjenjem