FrancophonIA/ELRC3.0 huggingface dataset:
English: Over the course of a typical 10 week controlled study, the rate of death in patients treated with antipsychotics was about 4.5%, compared to a rate of about 2.6% in the placebo group.
Croatian: Tijekom tipičnog 10-tjednog kontroliranog ispitivanja, stopa smrti u bolesnika liječenih antipsihoticima iznosila je približno 4,5%, dok je u skupini koja je primala placebo iznosila približno 2,6%.
English: The use of haloperidol has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still.
Croatian: Primjena haloperidola povezana je s razvojem akatizije, koju karakterizira subjektivno neugodan ili tjeskoban nemir i potreba za kretanjem, često praćena nesposobnošću bolesnika da mirno sjedi ili stoji.
English: • The combined total dose of haloperidol from both formulations must not exceed the corresponding maximum oral haloperidol dose of 20 mg/day.
Croatian: • Kombinirana ukupna doza haloperidola iz obje formulacije ne smije biti veća od odgovarajuće maksimalne doze oralnog haloperidola od 20 mg na dan.
English: As a precautionary measure, it is preferable to avoid the use of HALDOL Decanoate during pregnancy.
Croatian: Kao mjera opreza, poželjno je izbjegavati primjenu lijeka HALDOL Decanoate u trudnoći.
English: • Progressive supranuclear palsy.
Croatian: • Progresivna supranuklearna paraliza
English: • Recent acute myocardial infarction.
Croatian: • Nedavno pretrpljen akutni infarkt miokarda
English: Certain medicines may affect the way that Haldol Decanoate works or may make heart problems more likely
Croatian: Određeni lijekovi mogu utjecati na način na koji Haldol Decanoate djeluje ili povećati vjerojatnost razvoja srčanih tegoba
English: In randomised, placebo-controlled clinical studies in the dementia population, there was an approximately 3-fold increased risk of cerebrovascular adverse events with some atypical antipsychotics.
Croatian: U randomiziranim, placebom kontroliranim kliničkim ispitivanjima provedenima u populaciji bolesnika s demencijom zabilježeno je približno trostruko povećanje rizika od cerebrovaskularnih štetnih događaja kod primjene nekih atipičnih antipsihotika.
English: • Alprazolam or buspirone (for anxiety)
Croatian: • alprazolam ili buspiron (za tjeskobu)
English: Special monitoring may be needed if you are using lithium and Haldol Decanoate at the same time.
Croatian: Možda će Vas trebati posebno pratiti ako istodobno primjenjujete litij i Haldol Decanoate.
English: Seizures/convulsions
Croatian: Napadaji/konvulzije
English: An extrapyramidal reaction is manifest by muscular rigidity and a generalised or localised tremor.
Croatian: Ekstrapiramidna reakcija manifestira se mišićnom ukočenošću i generaliziranim ili lokaliziranim tremorom.
English: Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death.
Croatian: Starije osobe oboljele od psihoze povezane s demencijom koje se liječe antipsihoticima imaju povećan rizik od smrti.
English: Caution is recommended when haloperidol is administered to patients manifesting hypotension or orthostatic hypotension.
Croatian: Preporučuje se oprez kada se haloperidol daje bolesnicima s manifestnom hipotenzijom ili ortostatskom hipotenzijom.
English: • Keeping the thumb on the point, sharply break the tip of ampoule while holding firmly the other part of the ampoule in the hand.
Croatian: • Držeći palac na toj točki, naglo prelomite vrh ampule držeći drugi dio ampule čvrsto u ruci.
English: The following problems may occur in newborn babies of mothers that use Haldol Decanoate in the last 3 months of their pregnancy (the last trimester):
Croatian: U novorođenčadi majki koje primaju Haldol Decanoate tijekom posljednja 3 mjeseca trudnoće (posljednjeg tromjesečja) mogu se javiti sljedeće tegobe:
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 Decanoate and preventive measures undertaken.
Croatian: Budući da bolesnici liječeni antipsihoticima često imaju stečene faktore rizika za VTE, prije i tijekom liječenja lijekom HALDOL Decanoate treba utvrditi sve moguće faktore rizika za VTE i poduzeti preventivne mjere.
English: Haldol Decanoate can cause problems with the heart, problems controlling body or limb movements and a serious side effect called ‘neuroleptic malignant syndrome'.
Croatian: Haldol Decanoate može uzrokovati srčane tegobe, poteškoće s kontroliranjem kretnji tijela ili udova te ozbiljnu nuspojavu koja se zove ‘neuroleptički maligni sindrom'.
English: • Swelling caused by fluid build up in the body
Croatian: • oticanje uzrokovano nakupljanjem tekućine u tijelu
English: However, there have been isolated case reports of birth defects following foetal exposure to haloperidol in combination with other medicinal products.
Croatian: Međutim, prijavljeni su izolirani slučajevi prirođenih mana nakon izlaganja ploda haloperidolu u kombinaciji s drugim lijekovima.
English: The risk of ventricular arrhythmias, possibly associated with QTc prolongation, must be considered.
Croatian: Mora se uzeti u obzir rizik od ventrikularnih aritmija, koje mogu biti povezane s produljenjem QTc intervala.
English: • Comatose state.
Croatian: • Komatozno stanje
English: If you are not sure, talk to your doctor, pharmacist or nurse before being given Haldol Decanoate.
Croatian: Ako niste sigurni, razgovarajte s liječnikom, ljekarnikom ili medicinskom sestrom prije nego primite Haldol Decanoate.
English: • Nausea, vomiting
Croatian: • mučnina, povraćanje
English: Transition from oral haloperidol • A low haloperidol decanoate dose of 12.5 to 25 mg is recommended.
Croatian: Prelazak s oralnog haloperidola • Preporučuje se niska doza haloperidoldekanoata, od 12,5 do 25 mg.
English: In addition, 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: Osim toga, sigurnost haloperidola ocjenjivala se i 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: Haldol Decanoate is used in adults whose condition has previously been treated with haloperidol taken by mouth.
Croatian: Haldol Decanoate se koristi u odraslih osoba čije se stanje prethodno liječilo haloperidolom za primjenu kroz usta.
English: These are very common in people using Haldol Decanoate (may affect more than 1 in 10 people).
Croatian: Ove su tegobe vrlo česte u osoba koje primaju Haldol Decanoate (mogu se javiti u više od 1 na 10 osoba).
English: Because of the high haloperidol distribution volume and its high protein binding, only very small amounts are removed by dialysis.
Croatian: Zbog velikog volumena distribucije haloperidola i visokog stupnja vezivanja za proteine, dijalizom se mogu ukloniti samo vrlo male količine.
English: • Hold the ampoule between the thumb and index finger, leaving the tip of the ampoule free.
Croatian: • Držite ampulu između palca i kažiprsta, tako da vrh ampule ostane slobodan.
English: Also tell your doctor if you are taking bepridil (for chest pain or to lower blood pressure) or methadone (a pain killer or to treat drug addiction).
Croatian: Obavijestite svog liječnika i ako uzimate bepridil (za bol u prsnom košu ili snižavanje krvnog tlaka) ili metadon (za ublažavanje bolova ili liječenje ovisnosti o drogi).
English: What Haldol Decanoate is and what it is used for
Croatian: Što je Haldol Decanoate i za što se koristi
English: However, hepatic impairment may have significant effects on the pharmacokinetics of haloperidol because it is extensively metabolised in the liver.
Croatian: Međutim, oštećenje jetrene funkcije moglo bi značajno utjecati na farmakokinetiku haloperidola jer se on opsežno metabolizira u jetri.
English: • Feel very excited, agitated, enthusiastic, impulsive or hyperactive
Croatian: • možete biti neuobičajeno sumnjičavi (paranoja) • možete biti vrlo uzbuđeni, uznemireni, entuzijastični, impulzivni ili hiperaktivni
English: Haloperidol may antagonise the action of adrenaline and other sympathomimetic medicinal products (e.g. stimulants like amphetamines) and reverse the blood pressure-lowering effects of adrenergic-blocking medicinal products such as guanethidine.
Croatian: Haloperidol može antagonizirati djelovanje adrenalina i drugih simpatomimetika (npr. stimulansa poput amfetamina) i poništiti antihipertenzivne učinke adrenergičkih blokatora poput gvanetidina.
English: Maximal enzyme induction is generally seen in about 2 weeks and may then be sustained for the same period of time after the cessation of therapy with the medicinal product.
Croatian: Maksimalna indukcija enzima obično je primjetna nakon približno 2 tjedna, a jednako se dugo može održati i nakon prekida primjene lijeka.
English: Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haldol Decanoate.
Croatian: Vaš će liječnik možda htjeti napraviti elektrokardiogram (EKG) prije ili tijekom liječenja lijekom Haldol Decanoate.
English: These have been reported in people taking antipsychotic medicines.
Croatian: Oni su prijavljeni u osoba koje su uzimale antipsihotike.
English: Sodium valproate is known to inhibit glucuronidation, but does not affect haloperidol plasma concentrations.
Croatian: Poznato je da natrijev valproat inhibira glukuronidaciju, ali ne utječe na plazmatske koncentracije haloperidola.
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 Decanoate.
Croatian: Vaš će liječnik možda htjeti provjeriti razine kalija ili magnezija (ili nekog drugog ‘elektrolita') u krvi prije ili tijekom liječenja lijekom Haldol Decanoate.
English: The relevance of these tumour findings in rodents in terms of human risk is unknown.
Croatian: Nije poznat značaj nalaza tih tumora u glodavaca za rizik u ljudi.
English: • Difficulty sleeping or feeling sleepy
Croatian: • poteškoće sa spavanjem ili pospanost
English: The relationship between dose and plasma haloperidol level is approximately linear for doses below 450 mg.
Croatian: Odnos između doze i plazmatske razine haloperidola kod primjene doza manjih od 450 mg približno je linearan.
English: It may be combined with antidepressants to treat those conditions in which depression and psychosis coexist (see section 4.5).
Croatian: Može se kombinirati s antidepresivima za liječenje stanja kod kojih su istodobno prisutne depresija i psihoza (vidjeti dio 4.5).
English: Analyses of seventeen placebo-controlled studies (modal duration of 10 weeks), largely in patients taking atypical antipsychotics, revealed a risk of death in treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients.
Croatian: Analize sedamnaest placebom kontroliranih ispitivanja (najčešće u trajanju od 10 tjedana), uglavnom provedenih u bolesnika koji su uzimali atipične antipsihotike, pokazale su da je rizik od smrti među liječenim bolesnicima bio 1,6 - 1,7 puta veći nego u bolesnika koji su primali placebo.
English: Newborn infants exposed to antipsychotics (including haloperidol) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Croatian: U novorođenčadi izložene antipsihoticima (uključujući haloperidol) u trećem tromjesečju trudnoće postoji rizik da se nakon rođenja pojave nuspojave, uključujući ekstrapiramidne i/ili simptome ustezanja, koji mogu biti različite težine i trajanja.
English: It is recommended that HALDOL Decanoate is not used alone in patients in whom depression is predominant.
Croatian: Preporučuje se da se HALDOL Decanoate ne primjenjuje samostalno u bolesnika u kojih je depresija predominantna.
English: Drinking alcohol while you are using Haldol Decanoate might make you feel sleepy and less alert.
Croatian: Konzumacija alkohola tijekom liječenja lijekom Haldol Decanoate može Vas učiniti pospanima i manje pozornima.
English: Talk to your doctor about drinking alcohol while using Haldol Decanoate, and let your doctor know how much you drink.
Croatian: Razgovarajte sa svojim liječnikom o konzumaciji alkohola tijekom liječenja lijekom Haldol Decanoate i recite mu koliko alkohola pijete.
English: Antiparkinson medicinal products of the anticholinergic type may be prescribed as required to manage extrapyramidal symptoms, but it is recommended that they are not prescribed routinely as a preventive measure.
Croatian: Za liječenje ekstrapiramidnih simptoma mogu se po potrebi propisati antiparkinsonici antikolinergičkog tipa, ali se ne preporučuje rutinsko propisivanje tih lijekova kao preventivna mjera.
English: Caution is also required in patients with potentially high plasma concentrations (see section 4.4, Poor metabolisers of CYP2D6).
Croatian: Oprez je potreban i u bolesnika koji bi mogli imati visoke plazmatske koncentracije (vidjeti dio 4.4, Spori metabolizatori CYP2D6).
English: Dialysis is not recommended in the treatment of overdose because it removes only very small amounts of haloperidol (see section 5.2).
Croatian: Ne preporučuje se dijaliza za liječenje predoziranja jer se njome uklanjaju samo vrlo male količine haloperidola (vidjeti dio 5.2).
English: Belgium, France, Italy, Luxembourg, Netherlands: Haldol Decanoas Cyprus, Ireland, Malta, United Kingdom:
Croatian: Belgija, Francuska, Italija, Luksemburg, Nizozemska:
English: Observational studies comparing the stroke rate in elderly patients exposed to any antipsychotic to the stroke rate in those not exposed to such medicinal products found an increased stroke rate among exposed patients.
Croatian: Opservacijska ispitivanja u kojima se uspoređivala stopa moždanog udara u starijih bolesnika izloženih bilo kojem antipsihotiku i onih koji nisu bili izloženi takvim lijekovima pokazala su povećanu stopu moždanog udara među bolesnicima izloženima antipsihoticima.
English: Haloperidol has been associated with neuroleptic malignant syndrome: a rare idiosyncratic response characterized by hyperthermia, generalised muscle rigidity, autonomic instability, altered consciousness and increased serum creatine phosphokinase levels.
Croatian: Haloperidol se dovodi u vezu s neuroleptičkim malignim sindromom - rijetkim idiosinkratskim odgovorom koji karakteriziraju hipertermija, generalizirana ukočenost mišića, nestabilnost autonomnog živčanog sustava, promjene svijesti i povišene vrijednosti kreatin fosfokinaze u serumu.
English: There is insufficient information on the effects of haloperidol in breast-fed infants.
Croatian: Nema dovoljno podataka o učincima haloperidola u dojenčadi.
English: After intramuscular injection, haloperidol decanoate is gradually released from muscle tissue and hydrolysed slowly into free haloperidol, which enters the systemic circulation.
Croatian: Nakon intramuskularne injekcije, haloperidoldekanoat se postupno oslobađa iz mišićnog tkiva i polako hidrolizira u slobodni haloperidol, koji zatim ulazi u sistemsku cirkulaciju.
English: Table 3: Adverse reactions System Organ
Croatian: Tablica 3: Nuspojave Organski sustav
English: Antiparkinson medicinal products must be withdrawn very cautiously as extrapyramidal symptoms may emerge.
Croatian: Primjena antiparkinsonika mora se prekidati vrlo oprezno jer se pritom mogu pojaviti ekstrapiramidni simptomi.
English: HALDOL Decanoate is not indicated for the treatment of dementia-related behavioural disturbances.
Croatian: HALDOL Decanoate nije indiciran za liječenje poremećaja ponašanja povezanih s demencijom.
English: • Feeling restless or difficulty sitting still, increased body movements
Croatian: • osjećaj nemira ili nemogućnost mirnog sjedenja, povećan broj tjelesnih kretnji
English: Caution is advised when HALDOL Decanoate is used in combination with medicinal products known to cause electrolyte imbalance (see section 4.4).
Croatian: Preporučuje se oprez kada se HALDOL Decanoate primjenjuje u kombinaciji s lijekovima za koje se zna da uzrokuju neravnotežu elektrolita (vidjeti dio 4.4).
English: The manifestations of haloperidol overdose are an exaggeration of the known pharmacological effects and adverse reactions.
Croatian: Manifestacije predoziranja haloperidolom su prekomjerno izraženi poznati farmakološki učinci i nuspojave.
English: The individual dose will depend on both the severity of the symptoms and the current oral haloperidol dose.
Croatian: Doza za pojedinog bolesnika ovisit će o težini simptoma i trenutnoj dozi oralnog haloperidola.
English: Even though impairment of renal function is not expected to affect haloperidol elimination to a clinically relevant extent, caution is advised in patients with renal impairment, and especially those with severe impairment, due to the long half-life of haloperidol and its reduced metabolite, and the possibility of accumulation (see section 4.2).
Croatian: Iako se ne očekuje da će oštećenje bubrežne funkcije utjecati na eliminaciju haloperidola u klinički značajnoj mjeri, preporučuje se oprez u bolesnika s oštećenjem bubrežne funkcije, osobito onih s teškim oštećenjem, zbog dugog poluvijeka haloperidola i njegova reduciranog metabolita te mogućnosti akumulacije (vidjeti dio 4.2).
English: Patients being considered for HALDOL Decanoate therapy must be initially treated with oral haloperidol to reduce the possibility of an unexpected adverse sensitivity to haloperidol.
Croatian: Bolesnike u kojih se razmatra liječenje lijekom HALDOL Decanoate mora se najprije liječiti oralnim haloperidolom kako bi se smanjila mogućnost razvoja neočekivane štetne osjetljivosti na haloperidol.
English: Haldol Decanoate should not be used after the expiry date which is stated on the label and the carton.
Croatian: Haldol Decanoate se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici ili kutiji.
English: • Confused, disoriented, a headache, balance problems and feel sleepy.
Croatian: • smetenost, dezorijentiranost, glavobolja, poteškoće s ravnotežom i pospanost
English: Tell your doctor straight away if you notice any of the serious side effects above.
Croatian: Odmah obavijestite liječnika ako primijetite bilo koju od gore navedenih ozbiljnih nuspojava.
English: Caution is advised in patients with bradycardia, cardiac disease, family history of QTc prolongation or history of heavy alcohol exposure.
Croatian: Preporučuje se oprez u bolesnika s bradikardijom, srčanom bolešću, produljenjem QTc intervala u obiteljskoj anamnezi ili značajnom konzumacijom alkohola u osobnoj anamnezi.
English: • The most effective dose is expected to range between 50 and 200 mg.
Croatian: • Očekuje se da će se najučinkovitija doza kretati u rasponu od 50 do 200 mg.
English: Heart problems are uncommon in people using Haldol Decanoate (may affect up to 1 in 100 people).
Croatian: Srčane tegobe nisu česte kod osoba koje primaju Haldol Decanoate (mogu se javiti u do 1 na 100 osoba).
English: Endocrine system concerns
Croatian: Endokrini sustav
English: The central dopamine blocking effect has activity on the basal ganglia (nigrostriatal bundles).
Croatian: Blokada dopamina u SŽS-u utječe na bazalne ganglije (nigrostrijatalne putove).
English: • Your doctor may adjust the dose by up to 50 mg every 4 weeks to find the dose that suits you best
Croatian: • Liječnik će možda prilagođavati dozu za najviše 50 mg svaka 4 tjedna kako bi utvrdio dozu koja
English: Increases in QTc have been observed when haloperidol was given with a combination of the metabolic inhibitors ketoconazole (400 mg/day) and paroxetine (20 mg/day).
Croatian: Produljenja QTc intervala opažena su kada se haloperidol primjenjivao zajedno s kombinacijom metaboličkih inhibitora ketokonazola (400 mg na dan) i paroksetina
English: Antipsychotic therapy in patients with hyperthyroidism must be used only with caution and must always be accompanied by therapy to achieve a euthyroid state.
Croatian: Antipsihotici se u bolesnika s hipertireozom smiju primjenjivati samo uz oprez i uvijek u kombinaciji s terapijom za postizanje eutiroidnog stanja.
English: Contents of the pack and other information What Haldol Decanoate contains The active substance is haloperidol.
Croatian: Sadržaj pakiranja i druge informacije Što Haldol Decanoate sadrži Djelatna tvar je haloperidol.
English: Small amounts of haloperidol have been detected in plasma and urine of breast-fed newborns of mothers treated with haloperidol.
Croatian: Male količine haloperidola pronađene su u plazmi i mokraći dojenčadi majki liječenih haloperidolom.
English: The metabolites of haloperidol are not considered to make a significant contribution to its activity; however, the reduction pathway accounts approximately for 23% of the biotransformation, and back-conversion of the reduced metabolite of haloperidol to haloperidol cannot be fully ruled out.
Croatian: Smatra se da metaboliti haloperidola ne pridonose značajno njegovoj aktivnosti; međutim, redukcijski put čini približno 23% biotransformacije, a ne može se potpuno isključiti povratna pretvorba reduciranog metabolita haloperidola u haloperidol.
English: Tell your doctor or nurse straight away if you notice or suspect any of the following.
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite ili posumnjate na bilo što od sljedećega.
English: Talk to your doctor if you have:
Croatian: Razgovarajte sa svojim liječnikom:
English: • Based on this conversion, the haloperidol decanoate dose will be 25 to150 mg for most patients.
Croatian: • Prema toj pretvorbi, doza haloperidoldekanoata za većinu će bolesnika biti 25 - 150 mg.
English: The effect of CYP3A4 inhibition and of decreased CYP2D6 enzyme activity may be additive (see section 5.2).
Croatian: Učinak inhibicije CYP3A4 i smanjene aktivnosti enzima CYP2D6 mogao bi biti aditivan (vidjeti dio 5.2).
English: Table 1: Haloperidol decanoate dose recommendations for adults aged 18 years and above
Croatian: Tablica 1: Preporučene doze haloperidoldekanoata za odrasle u dobi od 18 ili više godina
English: • Indinavir, ritonavir or saquinavir (for human immunodeficiency virus or HIV)
Croatian: • indinavir, ritonavir ili sakvinavir (za virus humane imunodeficijencije ili HIV)
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 Decanoate 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 Decanoate.
English: • Fungal infections (such as pentamidine)
Croatian: • gljivične infekcije (kao što je pentamidin)
English: Respiratory depression may necessitate artificial respiration.
Croatian: Depresija disanja može zahtijevati mehaničku ventilaciju.
English: What you need to know before you are given Haldol Decanoate
Croatian: Što morate znati prije nego počnete primati Haldol Decanoate
English: It also crosses the placenta and is excreted in breast milk.
Croatian: Također prolazi kroz posteljicu i izlučuje se u majčino mlijeko.
English: However, patients with severe renal impairment may require a lower initial dose, with subsequent adjustments at smaller increments and at longer intervals than in patients without renal impairment (see section 5.2).
Croatian: Međutim, bolesnicima s teškim oštećenjem bubrežne funkcije možda će biti potrebna niža početna doza, koja se kasnije prilagođava u manjim koracima i duljim intervalima nego u bolesnika bez oštećenja bubrežne funkcije (vidjeti dio 5.2).
English: A baseline ECG is recommended before treatment.
Croatian: Preporučuje se provesti EKG snimanje prije početka liječenja.