FrancophonIA/ELRC3.0 huggingface dataset:
English: Unless your doctor tells you otherwise, you should stop taking Haldol gradually.
Croatian: Osim ako Vam liječnik ne kaže drugačije, Haldol morate prestati uzimati postupno.
English: • Problems having sex.
Croatian: • poteškoće sa spolnim odnosom
English: <Other sources of information> <Detailed information on this medicine is available on the website of {MS/Agency}>
Croatian: <Ostali izvori informacija> <Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici {naziv nadležnog tijela države članice (poveznica)}>
English: Your doctor will normally give you a low dose to start, and then adjust the dose to suit you.
Croatian: Liječnik će Vam obično na početku dati nisku dozu, a zatim je prilagođavati onako kako odgovara Vama.
English: The safety of haloperidol was evaluated in 284 haloperidol-treated patients who participated in 3 placebo-controlled clinical studies and in 1295 haloperidol-treated patients who participated in 16 double-blind active comparator-controlled clinical studies.
Croatian: Sigurnost haloperidola ocjenjivala se u 284 bolesnika liječena haloperidolom koja su sudjelovala u 3 placebom kontrolirana klinička ispitivanja te u 1295 bolesnika liječenih haloperidolom koji su sudjelovali u 16 dvostruko slijepih kliničkih ispitivanja kontroliranih aktivnim usporednim lijekom.
English: Your doctor will tell you how many tablets to take and for how long.
Croatian: Liječnik će Vam reći koliko tableta trebate uzeti i koliko ih dugo trebate uzimati.
English: • Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe
Croatian: • Liječenje dugotrajne agresije i psihotičnih simptoma u bolesnika s umjerenom do teškom
English: • Adolescents up to 17 years of age being treated for schizophrenia or behavioural problems may have a higher dose, up to 5 mg each day.
Croatian: • Adolescentima u dobi do 17 godina koji se liječe zbog shizofrenije ili probleme u ponašanju može se propisati i veća doza, do 5 mg na dan.
English: System Organ
Croatian: Organski sustav
English: Doses above 5 mg/day 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 5 mg/dan 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: Your doctor may want to check the levels of potassium or magnesium (or other ‘electrolyte') in your blood before or during your treatment with Haldol.
Croatian: Vaš će liječnik možda htjeti provjeriti razine kalija ili magnezija (ili nekog drugog ‘elektrolita') u krvi prije ili tijekom liječenja lijekom Haldol.
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,
English: Haldol can cause problems with the heart, problems controlling body or limb movements and a serious side effect called ‘neuroleptic malignant syndrome'.
Croatian: Haldol može uzrokovati srčane tegobe, poteškoće s kontroliranjem kretnji tijela ili udova te ozbiljnu nuspojavu koja se zove ‘neuroleptički maligni sindrom'.
English: • Doses above 10 mg/day have not demonstrated superior efficacy to lower doses in the majority of patients and may cause an increased incidence of extrapyramidal symptoms.
Croatian: • U većine bolesnika, doze veće od 10 mg na dan nisu pokazale superiornu djelotvornost u odnosu na niže doze, a mogu povećati incidenciju ekstrapiramidnih simptoma.
English: You must be aware of serious side effects while you are taking Haldol because you may need urgent medical treatment.
Croatian: Morate biti svjesni ozbiljnih nuspojava tijekom liječenja lijekom Haldol jer će Vam možda biti potrebno hitno liječenje.
English: Monitoring of patients for the switch to a depressive episode with the accompanying risks such as suicidal behaviour is important in order to intervene when such switches occur.
Croatian: Važno je pratiti bolesnike kako bi se uočio mogući prelazak u depresivnu epizodu, praćenu rizicima poput suicidalnog ponašanja, i interveniralo kada do takvih prelazaka dođe.
English: Due to the high inter-subject variability in haloperidol pharmacokinetics and the concentration-effect relationship, it is recommended to adjust the individual haloperidol dose based on the patient's response, taking into account data suggesting a lag time of 5 days to reach half of the maximal therapeutic response.
Croatian: Zbog visoke interindividualne varijabilnosti farmakokinetike haloperidola te odnosa između koncentracija haloperidola i njegova učinka, preporučuje se prilagoditi individualnu dozu haloperidola prema bolesnikovu odgovoru, uzimajući u obzir podatke koji ukazuju na to da se polovica maksimalnog terapijskog odgovora postiže s 5-dnevnom odgodom.
English: • The treatment duration must be individually evaluated.
Croatian: • Trajanje liječenja mora se procijeniti u svakog bolesnika pojedinačno.
English: • Dry mouth or increased saliva
Croatian: • suha usta ili pojačano stvaranje sline
English: A low initial dose is recommended, and this must be adjusted according to the patient's response in order to determine the minimal effective dose (see section 5.2).
Croatian: Preporučuje se niska početna doza, koja se mora prilagođavati sukladno bolesnikovu odgovoru kako bi se utvrdila minimalna učinkovita doza (vidjeti dio 5.2).
English: Haloperidol is an antipsychotic belonging to the butyrophenones group.
Croatian: Haloperidol je antipsihotik iz skupine butirofenona.
English: A low initial dose is recommended, which subsequently may be adjusted according to the patient's response.
Croatian: Preporučuje se niska početna doza, koja se kasnije može prilagoditi sukladno bolesnikovu odgovoru.
English: In cases of severe extrapyramidal reactions, parenteral administration of an antiparkinson medicinal product is recommended.
Croatian: U slučaju teških ekstrapiramidnih reakcija preporučuje se parenteralna primjena antiparkinsonika.
English: • Hold the ampoule between the thumb and index finger, leaving the tip of the ampoule free.
Croatian: • Primite ampulu između palca i kažiprsta, tako da vrh ampule ostane slobodan.
English: Treatment with HALDOL solution for injection must be discontinued as soon as clinically indicated and, if further treatment is needed, oral haloperidol should be initiated at a 1:1 dose conversion rate followed by dose adjustment according to clinical response.
Croatian: Liječenje HALDOL otopinom za injekciju mora se prekinuti što je prije moguće sukladno kliničkoj indikaciji, a ako je potrebno daljnje liječenje, potrebno je uvesti oralni haloperidol uz pretvorbu doze u omjeru 1:1, a zatim prilagođavati dozu u skladu s kliničkim odgovorom.
English: If concomitant treatment with an antiparkinson medicinal product is required, it may have to be continued after stopping HALDOL 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 kako bi se izbjegao nastup ili pogoršanje ekstrapiramidnih simptoma.
English: • Flaking or peeling skin
Croatian: • perutanje ili ljuštenje kože
English: Acute dystonia may occur during the first few days of treatment with HALDOL, but later onset as well as onset after dose increases has been reported.
Croatian: Akutna distonija može se javiti tijekom prvih nekoliko dana liječenja lijekom HALDOL, ali prijavljen je i kasniji nastup, kao i nastup nakon povećanja doze.
English: • The maximum dose is 20 mg/day because safety concerns outweigh the clinical benefits of treatment at higher doses.
Croatian: • Maksimalna doza je 20 mg na dan jer potencijalni sigurnosni problemi nadmašuju kliničku korist od liječenja većim dozama.
English: It is recommended that patients who take haloperidol concomitantly with such medicinal products be monitored for signs or symptoms of increased or prolonged pharmacologic effects of haloperidol, and the HALDOL dose be decreased as deemed necessary.
Croatian: Preporučuje se nadzirati bolesnike koji uzimaju haloperidol istodobno s takvim lijekovima zbog mogućih znakova ili simptoma pojačanih ili produljenih farmakoloških učinaka haloperidola te prema potrebi smanjiti dozu lijeka HALDOL.
English: HALDOL has a moderate influence on the ability to drive and use machines.
Croatian: HALDOL umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The recommended initial haloperidol dose in elderly patients is half the lowest adult dose.
Croatian: Preporučena početna doza haloperidola za starije bolesnike je polovica najniže doze za odrasle.
English: Your doctor may advise you not to take Haldol while you are pregnant.
Croatian: Liječnik će Vam možda savjetovati da ne uzimate Haldol dok ste trudni.
English: Talk to your doctor about drinking alcohol while using Haldol, and let your doctor know how much you drink.
Croatian: Razgovarajte sa svojim liječnikom o konzumaciji alkohola tijekom liječenja lijekom Haldol i recite mu koliko alkohola pijete.
English: • The need for continued treatment must be reassessed every 6 to 12 months.
Croatian: • Potreba za nastavkom liječenja mora se ponovno procijeniti svakih 6 - 12 mjeseci.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with HALDOL and preventive measures undertaken.
Croatian: Budući da bolesnici liječeni antipsihoticima često imaju stečene faktore rizika za VTE, prije i tijekom liječenja lijekom HALDOL treba utvrditi sve moguće faktore rizika za VTE i poduzeti preventivne mjere.
English: Haldol is sometimes used when other medicines or treatments have not worked or caused unacceptable side effects.
Croatian: Haldol se ponekad koristi kada drugi lijekovi ili terapije nisu bili djelotvorni ili su uzrokovali neprihvatljive nuspojave.
English: How much should you take
Croatian: Koliko lijeka trebam uzeti
English: Drinking alcohol while you are using Haldol might make you feel sleepy and less alert.
Croatian: Konzumacija alkohola tijekom liječenja lijekom Haldol može Vas učiniti pospanima i manje pozornima.
English: • While holding the lower ring on the oral syringe, pull the top ring of the plunger upwards.
Croatian: • Držeći donji prsten štrcaljke za usta, povucite gornji prsten klipa prema gore.
English: HALDOL must be used with caution in patients with risk factors for stroke.
Croatian: HALDOL se mora primjenjivati uz oprez u bolesnika s faktorima rizika za moždani udar.
English: What you need to know before you take Haldol
Croatian: Što morate znati prije nego počnete uzimati Haldol
English: Haldol should not be used after the expiry date which is stated on the label and the carton.
Croatian: Haldol se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji.
English: • Drink the solution straight away.
Croatian: • Odmah popijte otopinu.
English: • The maximum dose is 15 mg/day because safety concerns outweigh the clinical benefits of treatment at higher doses.
Croatian: • Maksimalna doza je 15 mg na dan jer potencijalni sigurnosni problemi nadmašuju kliničku korist od liječenja većim dozama.
English: Haldol may be used on its own or with other medicine, and is sometimes used when other medicines or treatments have not worked, caused unacceptable side effects, or cannot be taken by mouth.
Croatian: Haldol se može primjenjivati sam ili u kombinaciji s drugim lijekovima, a ponekad se koristi kada drugi lijekovi ili terapije nisu bili djelotvorni, kada su uzrokovali neprihvatljive nuspojave ili kada se ne mogu uzeti kroz usta.
English: • Empty the contents of the oral syringe onto a spoon or into a cup.
Croatian: • Ispraznite sadržaj štrcaljke za usta u žlicu ili čašu.
English: Special monitoring may be needed if you are taking lithium and Haldol at the same time.
Croatian: Možda će Vas trebati posebno pratiti ako istodobno uzimate litij i Haldol.
English: • Swelling caused by fluid build up in the body.
Croatian: • oticanje uzrokovano nakupljanjem tekućine u tijelu
English: • Adjustments to the dose may be made every 1 to 7 days.
Croatian: • Doza se može prilagođavati svakih 1 - 7 dana.
English: Caution is advised when HALDOL is used in combination with medicinal products known to cause electrolyte imbalance (see section 4.4).
Croatian: Preporučuje se oprez kada se HALDOL primjenjuje u kombinaciji s lijekovima za koje se zna da uzrokuju neravnotežu elektrolita (vidjeti dio 4.4).
English: • In the majority of patients, doses of up to 15 mg/day are sufficient.
Croatian: • U većine su bolesnika dovoljne doze do 15 mg na dan.
English: • Turn the bottle upside down over a spoon.
Croatian: • Okrenite bocu naopako iznad žlice.
English: The terminal elimination half-life of haloperidol is on average 21 hours (range 13 to 36 hours) after intramuscular administration.
Croatian: Prosječno terminalno poluvrijeme eliminacije haloperidola nakon intramuskularne primjene iznosi 21 sat (raspon: 13 - 36 sati).
English: • Elderly people will normally start on 0.5 mg each day or half the lowest adult dose.
Croatian: • Uobičajena početna doza za starije osobe je 0,5 mg na dan ili pola najmanje doze za odrasle.
English: Treatment response and withdrawal
Croatian: Odgovor na liječenje i prekid primjene
English: • To prevent or treat nausea and vomiting (feeling and being sick) after surgery.
Croatian: • za sprječavanje ili liječenje mučnine i povraćanja nakon kirurškog zahvata
English: In rare cases the following symptoms were reported during the concomitant use of lithium and haloperidol: encephalopathy, extrapyramidal symptoms, tardive dyskinesia, neuroleptic malignant syndrome, acute brain syndrome and coma.
Croatian: U rijetkim su slučajevima tijekom istodobne primjene litija i haloperidola prijavljeni sljedeći simptomi: encefalopatija, ekstrapiramidni simptomi, tardivna diskinezija, neuroleptički maligni sindrom, akutni moždani sindrom i koma.
English: Talk to your doctor before being given Haldol if you are elderly, particularly if you have dementia.
Croatian: Razgovarajte sa svojim liječnikom prije nego primite Haldol ako ste starija osoba, osobito ako bolujete od demencije.
English: What Haldol contains
Croatian: Haldol sadrži
English: After withdrawal of the CYP3A4 inducer, the concentration of haloperidol may gradually increase and therefore it may be necessary to reduce the HALDOL dose.
Croatian: Nakon prekida primjene induktora CYP3A4, koncentracija haloperidola može se postupno povećati pa će stoga možda biti potrebno smanjiti dozu lijeka HALDOL.
English: During combination treatment with inducers of CYP3A4, it is recommended that patients be monitored and the HALDOL dose increased as deemed necessary.
Croatian: Tijekom liječenja u kombinaciji s induktorima CYP3A4, preporučuje se nadzirati bolesnike i po potrebi povećati dozu lijeka HALDOL.
English: Gradual withdrawal is advisable as a precautionary measure.
Croatian: Kao mjera opreza, preporučuje se postupni prekid primjene.
English: This is because it has not been studied adequately in this age group.
Croatian: Naime, njegova primjena nije dovoljno ispitana u toj dobnoj skupini.
English: • Problems with vision, such as blurred vision
Croatian: • vidne tegobe, poput zamagljena vida
English: ml HALDOL (bottle with oral syringe)
Croatian: ml lijeka HALDOL (boca sa štrcaljkom za usta)
English: In patients with first-episode schizophrenia, 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: 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 - 80% najprikladnija za postizanje terapijskog odgovora i ograničavanje ekstrapiramidnih simptoma.
English: • The continued use of HALDOL should be evaluated early in treatment (see section 4.4).
Croatian: • Nastavak primjene lijeka HALDOL potrebno je procijeniti u ranoj fazi liječenja (vidjeti dio 4.4).
English: The name of your medicine is Haldol.
Croatian: Ovaj se lijek zove Haldol.
English: HALDOL tablets are for oral use.
Croatian: HALDOL tablete namijenjene su za peroralnu primjenu.
English: • Your starting dose will normally be between 1 and 5 mg.
Croatian: • Uobičajena početna doza je između 1 i 5 mg.
English: • The recommended doses are 0.5 to 3 mg/day in children aged 6 to 11 years and 0.5 to 5 mg/day in adolescents aged 12 to 17 years, administered orally in divided doses (2 to 3 times a day).
Croatian: • Preporučene doze su 0,5 - 3 mg na dan za djecu u dobi od 6 do 11 godina odnosno 0,5 - 5 mg na dan za adolescente u dobi od 12 do 17 godina, a primjenjuju se peroralno, podijeljene na više doza (2 - 3 puta na dan).
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 CYP2D6.
English: • Adjustments to the dose may be made every 1 to 3 days.
Croatian: • Doza se može prilagođavati svakih 1 - 3 dana.
English: As in adults, high inter-subject variability in plasma concentrations was observed.
Croatian: Kao i u odraslih, primijećena je visoka interindividualna varijabilnost plazmatskih koncentracija.
English: It 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: u SŽS-u, koji u preporučenim dozama ostvaruje nisku alfa-1 antiadrenergičku aktivnost, ali nema antihistaminergičku ni antikolinergičku aktivnost.
English: • Narrowed airways in the lungs, causing difficulty breathing
Croatian: • suženje dišnih putova u plućima, koje otežava disanje
English: Your doctor will decide how much Haldol you need and for how long.
Croatian: Liječnik će odlučiti koliko lijeka Haldol Vam je potrebno i koliko dugo ga trebate primati.
English: Your doctor will discuss the risks and benefits of breast-feeding while you are using Haldol.
Croatian: Liječnik će razgovarati s Vama o rizicima i koristima dojenja tijekom liječenja lijekom Haldol.
English: Hyperprolactinaemia Inappropriate antidiuretic hormone secretion
Croatian: Endokrini poremećaji hiperprolaktinemija neodgovarajuće lučenje antidiuretskog hormona
English: Talk to your doctor or pharmacist before taking Haldol if you are elderly, particularly if you have dementia.
Croatian: Razgovarajte sa svojim liječnikom ili ljekarnikom prije nego uzmete Haldol ako ste starija osoba, osobito ako bolujete od demencije.
English: Talk to your doctor or pharmacist if you have:
Croatian: Razgovarajte sa svojim liječnikom ili ljekarnikom:
English: Table 2: Adverse reactions System Organ
Croatian: Tablica 2: Nuspojave Organski sustav
English: Austria, Belgium, Cyprus, France, Italy, Luxembourg, Netherlands, Portugal, Sweden, United Kingdom:
Croatian: Austrija, Belgija, Cipar, Francuska, Italija, Luksemburg, Nizozemska, Portugal, Švedska, Ujedinjeno Kraljevstvo:
English: • Low body temperature.
Croatian: • niska tjelesna temperatura
English: Nonetheless, it is advised that in patients who are treated concomitantly with lithium and HALDOL, therapy must be stopped immediately if such symptoms occur.
Croatian: Ipak, ako se u bolesnika koji istodobno primaju litij i HALDOL pojave navedeni simptomi, liječenje se mora odmah prekinuti.
English: Measurement of haloperidol blood concentrations may be considered in individual cases.
Croatian: U pojedinim se slučajevima može razmotriti mjerenje koncentracija haloperidola u krvi.
English: Haloperidol elevates prolactin level.
Croatian: Haloperidol povisuje razinu prolaktina.
English: HALDOL solution for injection is indicated in adult patients for:
Croatian: 4.1 Terapijske indikacije HALDOL otopina za injekciju indicirana je u odraslih bolesnika za:
English: Further doses may be administered and adjusted according to the patient's response.
Croatian: Daljnje doze mogu se primjenjivati i prilagođavati sukladno bolesnikovu odgovoru.
English: The maximum dose in elderly patients is 5 mg/day.
Croatian: Maksimalna doza za starije bolesnike je 5 mg na dan.
English: • Treatment of schizophrenia and schizoaffective disorder.
Croatian: • Liječenje shizofrenije i shizoafektivnog poremećaja.
English: • The need for continued treatment must be reassessed after 6 weeks.
Croatian: • Potreba za nastavkom liječenja mora se ponovno procijeniti nakon 6 tjedana.
English: • Place the bottle on a flat surface.
Croatian: • Stavite bocu na ravnu površinu.
English: Cogwheel rigidity Masked facies
Croatian: cogwheel rigidity) hipomimija
English: • Excessive sweating
Croatian: • svrbež • prekomjerno znojenje
English: The safety and efficacy of HALDOL solution for injection in children and adolescents below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost HALDOL otopine za injekciju u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: HALDOL solution for injection is recommended for intramuscular use only (see section 4.4).
Croatian: Način primjene HALDOL otopina za injekciju preporučuje se samo za intramuskularnu primjenu (vidjeti dio 4.4).
English: Following intramuscular administration, haloperidol is completely absorbed.
Croatian: Nakon intramuskularne primjene, haloperidol se apsorbira u potpunosti.
English: Limited plasma concentration data were established in paediatric studies including 78 patients with various disorders (schizophrenia, psychotic disorder, Tourette's syndrome, autism) who received oral haloperidol doses up to a maximum of 30 mg/day.
Croatian: U pedijatrijskim ispitivanjima, koja su uključivala 78 bolesnika s različitim poremećajima (shizofrenija, psihotični poremećaj, Touretteov sindrom, autizam) liječenih oralnim haloperidolom u dozama do najviše
English: HALDOL is contraindicated in combination with medicinal products known to prolong the QTc interval (see section 4.3).
Croatian: HALDOL je kontraindiciran u kombinaciji s lijekovima za koje se zna da produljuju QTc interval (vidjeti dio 4.3).
English: What Haldol looks like and contents of the pack [To be completed nationally]
Croatian: Kako Haldol izgleda i sadržaj pakiranja
English: • May be repeated hourly until sufficient symptom control is achieved or up to a maximum of
Croatian: • Primjena se može ponavljati svakih sat vremena do postizanja dostatne kontrole simptoma ili do maksimalno 10 mg na dan.
English: • Swelling around the voice box or brief spasm of the vocal cords, which may cause difficulty speaking or breathing
Croatian: • niska razina šećera u krvi • oticanje oko grkljana ili kratkotrajno grčenje glasnica, što može otežati govor ili disanje
English: Torticollis Muscle rigidity Muscle spasms Musculoskeletal stiffness
Croatian: ukočenost mišića mišićni spazmi mišićno-koštana ukočenost trizmus trzanje mišića rabdomioliza
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Croatian: Prijavljeni su agitacija, hipertonija, hipotonija, tremor, somnolencija,
English: Further doses may be administered and adjusted according to the patient's response (see sections 4.4 and 5.2).
Croatian: Daljnje doze mogu se primjenjivati i prilagođavati sukladno bolesnikovu odgovoru (vidjeti dijelove 4.4 i 5.2).
English: Do not take Haldol if you are taking certain medicines for:
Croatian: Nemojte uzeti Haldol ako uzimate određene lijekove za:
English: HALDOL 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 je potrebno koristiti s oprezom u bolesnika za koje se zna da su spori metabolozatori citokroma P450 (CYP) 2D6 i kojima je istodobno primijenjen CYP3A4 inhibitor.