FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1: Haloperidol decanoate dose recommendations for adults aged 18 years and above
Slovenian: Preglednica 1: Priporočila za odmerjanje haloperidildekanoata pri odraslih, starih 18 let ali več
English: Dialysis is not recommended in the treatment of overdose because it removes only very small amounts of haloperidol (see section 5.2).
Slovenian: Za zdravljenje v primeru prevelikega odmerjanja se ne priporoča odstranjevanje z dializo, saj se na ta način odstrani le majhna količina haloperidola (glejte poglavje 5.2).
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.
Slovenian: Najbolj izrazito indukcijo encimov je večinoma mogoče opaziti po približno 2 tednih in prav toliko časa lahko vztraja tudi po prenehanju zdravljenja.
English: What Haldol Decanoate is and what it is used for What you need to know before you are given Haldol Decanoate How to use Haldol Decanoate
Slovenian: Kaj je zdravilo Haldol Decanoate in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Haldol Decanoate Kako uporabljati zdravilo Haldol Decanoate
English: • Reported in clinical studies with haloperidol (non-decanoate formulations) and relate to the active moiety.
Slovenian: • neželeni učinki, o katerih so poročali v kliničnih študijah s haloperidolom (s formulacijo, ki ni dekanoat), in se nanašajo na aktivni del učinkovine,
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use only
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Samo za intramuskularno uporabo.
English: • Adjustment of the dosing interval may be required (based on individual patient response).
Slovenian: • Odmerni interval je v nekaterih primerih treba prilagoditi (glede na odziv pri posameznem bolniku).
English: ≥1/1,000 to <1/100
Slovenian: ≥1/1.000 do <1/100
English: Sodium valproate is known to inhibit glucuronidation, but does not affect haloperidol plasma concentrations.
Slovenian: Znano je, da natrijev valproat zavira glukuronidacijo, vendar ne vpliva na koncentracijo haloperidola v plazmi.
English: • Parkinson's disease (such as levodopa)
Slovenian: • za zdravljenje Parkinsonove bolezni (na primer levodopa),
English: This may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients (see section 4.4).
Slovenian: To lahko zmanjša sposobnost razmnoževanja, ker zmanjša tvorbo steroidov v spolnih žlezah bolnikov tako pri ženskah kot pri moških (glejte poglavje 4.4).
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
Slovenian: o izpuščaj ali srbenje o povečana občutljivost kože na sončno svetlobo o luščenje kože o vnetje malih krvnih žil, ki povzroči kožni izpuščaj z majhnimi rdečimi ali vijoličnimi bunčicami
English: • Comatose state.
Slovenian: • komatozna stanja
English: • Uncompensated heart failure.
Slovenian: • dekompenzirano srčno popuščanje
English: The relationship between dose and plasma haloperidol level is approximately linear for doses below 450 mg.
Slovenian: Odvisnost koncentracije haloperidola v plazmi od velikosti odmerka je približno linearna pri odmerkih, ki ne presegajo 450 mg.
English: As the initial dose of haloperidol decanoate is based on a multiple of the daily oral haloperidol dose, specific guidance on switching from other antipsychotics cannot be provided (see section 5.1).
Slovenian: Začetni odmerek haloperidildekanoata temelji na večkratniku dnevnega odmerka peroralnega haloperidola, zato specifičnih smernic za odmerjanje pri prehodu z uporabe drugih antipsihotikov ni mogoče dati (glejte poglavje 5.1).
English: However, there have been isolated case reports of birth defects following foetal exposure to haloperidol in combination with other medicinal products.
Slovenian: Poročali pa so o posameznih primerih prirojenih okvar po izpostavljenosti ploda haloperidolu, večinoma v kombinaciji z drugimi zdravili.
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.
Slovenian: V nekaterih študijah na živalih so veliki intravenski odmerki haloperidola 1 mg/kg ali več povzročili podaljšanje intervala QTc in/ali ventrikularne aritmije pri doseženi najvišji koncentraciji Cmax v plazmi, ki je bila najmanj 38- do 137-krat višja od terapevtskih koncentracij, ki so bile učinkovite pri večini bolnikov v kliničnih študijah.
English: Tardive dyskinesia may appear in some patients on long-term therapy or after discontinuation of the medicinal product.
Slovenian: Pri nekaterih bolnikih se pri dolgotrajnem zdravljenju ali po prekinitvi jemanja zdravila lahko pojavi tardivna diskinezija.
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).
Slovenian: Čeprav ni pričakovati, da bi zmanjšanje ledvične funkcije lahko v klinično pomembni meri motilo izločanje haloperidola, je pri bolnikih z okvaro ledvic, zlasti pri tistih s hudo okvaro, priporočena previdnost pri uporabi, ker imajo haloperidol in njegovi reducirani presnovki dolg razpolovni čas in obstaja možnost kopičenja (glejte poglavje 4.2).
English: These have been reported in people taking antipsychotic medicines.
Slovenian: O trombozi so poročali pri ljudeh, ki so prejemali antipsihotična zdravila.
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).
Slovenian: Pri bolnikih s hudo okvaro ledvic je kljub vsemu lahko potrebna uporaba manjšega začetnega odmerka in nato prilagajanje v manjših korakih ter z daljšimi intervali kot pri bolnikih brez okvare ledvic (glejte poglavje 5.2).
English: HALDOL Decanoate is not indicated for the treatment of dementia-related behavioural disturbances.
Slovenian: Zdravilo HALDOL Decanoate ni indicirano za zdravljenje vedenjskih motenj pri demenci.
English: • Dry mouth or increased saliva
Slovenian: • suha usta ali prekomerno slinjenje
English: Haloperidol decanoate is an ester of haloperidol and decanoic acid, and as such, a depot antipsychotic belonging to the butyrophenones group.
Slovenian: Haloperidildekanoat je ester haloperidola in dekanojske kisline in je kot tak depo oblika antipsihotika iz skupine butirofenonov.
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.
Slovenian: Haloperidol lahko deluje antagonistično na učinek adrenalina in drugih simpatikomimetikov (npr. psihostimulansov, kot je amfetamin) in izniči učinek zniževanja krvnega tlaka, ki ga sicer povzročajo antagonisti adrenergičnih receptorjev, kot je gvanetidin.
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.
Slovenian: Pri antipsihotičnem zdravljenju bolnikov s hipertiroidizmom je potrebna previdnost, vedno morajo hkrati prejemati zdravila za doseganje evtirotičnega stanja.
English: Results from small clinical studies suggest a lower clearance and a longer elimination half-life of haloperidol in elderly patients.
Slovenian: Rezultati manjših kliničnih študij kažejo, da imajo starejši bolniki manjši očistek in daljši razpolovni čas izločanja haloperidola.
English: Haloperidol is metabolised by several routes (see section 5.2).
Slovenian: Presnova haloperidola poteka po več poteh (glejte poglavje 5.2).
English: (Hypericum, perforatum) or venlafaxine (for depression)
Slovenian: (Hypericum, perforatum) ali venlafaksin (za zdravljenje depresije),
English: Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haldol Decanoate.
Slovenian: Pri zdravniku vam bodo verjetno posneli elektrokardiogram (EKG) pred ali med zdravljenjem z zdravilom Haldol Decanoate.
English: Haloperidol is extensively metabolised in the liver.
Slovenian: Haloperidol se obsežno presnavlja v jetrih.
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.
Slovenian: Pri novorojenčkih, ki so bili izpostavljeni antipsihotikom (kar vključuje haloperidol) v tretjem trimesečju nosečnosti, obstaja tveganje za pojav neželenih učinkov, vključno z ekstrapiramidnimi in/ali odtegnitvenimi simptomi, katerih izraženost in čas trajanja po porodu sta lahko različna.
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.
Slovenian: Varnost haloperidildekanoata so ocenjevali pri 410 bolnikih, ki so bili vključeni v katero izmed 3 primerjalnih študij (v eni so primerjali haloperidildekanoat s flufenazinom, v dveh pa so primerjali formulacijo dekanoata s peroralno formulacijo haloperidola), v katero izmed 9 odprtih študij ali v študijo odziva na velikost odmerka.
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.
Slovenian: Za obvladovanje ekstrapiramidnih simptomov je bolniku mogoče predpisati antiparkinsonike antiholinergičnega tipa, vendar rutinsko predpisovanje teh zdravil kot preventivni ukrep ni priporočljivo.
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):
Slovenian: Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti (v zadnjem trimesečju) prejemale zdravilo Haldol Decanoate se lahko pojavijo naslednje težave:
English: Tachycardia and hypotension (including orthostatic hypotension) have also been reported (see section 4.8).
Slovenian: Poročali so tudi o tahikardiji in hipotenziji (vključno z ortostatsko hipotenzijo) (glejte poglavje 4.8).
English: The central dopamine blocking effect has activity on the basal ganglia (nigrostriatal bundles).
Slovenian: Zaviranje centralnega dopaminskega delovanja vpliva na aktivnost v bazalnih ganglijih (v nigrostriatalnih svežnjih).
English: The risk of these events appears to increase with high doses, high plasma concentrations, in predisposed patients or with parenteral use, particularly intravenous administration.
Slovenian: Kot kaže, je tveganje za te dogodke večje pri velikih odmerkih, visoki koncentraciji zdravila v plazmi, pri bolnikih, ki so bolj dovzetni za delovanje haloperidola, ter pri parenteralni uporabi zdravila, zlasti pri intravenskem odmerjanju.
English: It is recommended that patients be advised not to drive or operate machines during treatment, until their susceptibility is known.
Slovenian: naj med zdravljenjem ne vozijo ali upravljajo strojev, dokler ne ugotovijo, kako dovzetni so za učinke zdravila.
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.
Slovenian: Po objavljenih podatkih več kliničnih študij je za terapevtski odziv pri večini bolnikov z akutno ali kronično shizofrenijo treba doseči koncentracijo v plazmi od 1 do 10 ng/ml.
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.
Slovenian: Presnovki haloperidola verjetno ne prispevajo bistveno k aktivnosti učinkovine, vendar redukcijska prenovna pot predstavlja približno 23% celotne biotransformacije, pri čemer ni mogoče povsem izključiti možnosti, da se reducirani presnovki haloperidola pretvarjajo nazaj v haloperidol.
English: The manifestations of haloperidol overdose are an exaggeration of the known pharmacological effects and adverse reactions.
Slovenian: Preveliko odmerjanje haloperidola se kaže kot okrepljeni znani farmakološki in neželeni učinki.
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).
Slovenian: Haloperidol se hitro porazdeli po različnih tkivih in organih, kar kaže njegov velik volumen porazdelitve (v povprečju 8 do
English: • Changes in menstrual cycle (periods), such as no periods, or long, heavy, painful periods
Slovenian: • motnje menstrualnega ciklusa, kot so izostanek menstruacije ali dolgotrajne, obilne ali boleče menstrualne krvavitve
English: Haloperidol suppresses delusions and hallucinations as a direct consequence of blocking dopaminergic signalling in the mesolimbic pathway.
Slovenian: Haloperidol umirja blodnje in halucinacije, kar je neposredna posledica zaviranja dopaminske signalne poti v mezolimbičnem sistemu.
English: • Hold the ampoule between the thumb and index finger, leaving the tip of the ampoule free.
Slovenian: • Ampulo primite s palcem in kazalcem, tako da bo vrh ampule prost.
English: Do not use Haldol Decanoate if you are taking certain medicines for:
Slovenian: Ne uporabljajte zdravila Haldol Decanoate, če jemljete določena zdravila zaradi naslednjih stanj:
English: Administration of haloperidol decanoate as a depot intramuscular injection results in a slow and sustained release of free haloperidol.
Slovenian: Odmerjanje haloperidildekanoata v obliki depo intramuskularne injekcije povzroči počasno in dolgotrajno sproščanje prostega haloperidola.
English: Based on limited and sometimes conflicting information, the potential increase in haloperidol plasma concentrations when a CYP3A4 and/or CYP2D6 inhibitor is coadministered may range between 20 to 40%, although in some cases, increases of up to 100% have been reported.
Slovenian: Po maloštevilnih in v nekaterih primerih nasprotujočih si podatkih bi lahko pri sočasni uporabi katerega od zaviralcev CYP3A4 in/ali CYP2D6 prišlo do zvišanja koncentracije haloperidola v plazmi za 20 do 40%, poročali pa so tudi o nekaj primerih zvišanja koncentracije za 100%.
English: The effect of CYP3A4 inhibition and of decreased CYP2D6 enzyme activity may be additive (see section 5.2).
Slovenian: Učinka zaviranja CYP3A4 in zmanjšanja encimske aktivnosti CYP2D6 sta lahko aditivna (glejte poglavje 5.2).
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).
Slovenian: Zdravilo HALDOL Decanoate je indicirano za vzdrževalno zdravljenje shizofrenije in shizoafektivne motnje pri odraslih bolnikih, katerih stanje je trenutno stabilizirano s peroralnim haloperidolom (glejte poglavje 5.1).
English: Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Slovenian: Rezultati raziskav na tkivnih kulturah kažejo, da prolaktin lahko stimulira razmnoževanje celic humanih tumorjev dojke.
English: The individual dose will depend on both the severity of the symptoms and the current oral haloperidol dose.
Slovenian: Odmerek pri posameznem bolniku je odvisen od izraženosti simptomov in od trenutnega odmerka peroralnega haloperidola.
English: Tell your doctor or nurse straight away if you notice or suspect any of the following.
Slovenian: Takoj obvestite zdravnika ali medicinsko sestro, če opazite ali posumite na katero od naslednjih težav.
English: • Feeling agitated or confused
Slovenian: • občutek hudega nemira (agitacija) ali zmedenosti
English: Caution is advised in patients suffering from epilepsy and in conditions predisposing to seizures (e.g. alcohol withdrawal and brain damage).
Slovenian: Pri bolnikih z epilepsijo in v pogojih, ki povečajo možnost epileptičnih krčev, (na primer po odtegnitvi alkohola ali možganski poškodbi) je priporočljiva previdnost.
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.
Slovenian: • Celotni kombinirani odmerek haloperidola iz obeh formulacij ne sme presegati ustreznega največjega peroralnega odmerka haloperidola 5 mg na dan ali predhodnega odmerka peroralnega haloperidola pri bolnikih, ki že dalj časa prejemajo peroralni haloperidol.
English: Drinking alcohol while you are using Haldol Decanoate might make you feel sleepy and less alert.
Slovenian: Pitje alkohola v času zdravljenja z zdravilom Haldol Decanoate lahko povzroči zaspanost in zmanjšano pozornost.
English: Haloperidol is excreted in human milk.
Slovenian: Haloperidol se izloča v materino mleko.
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.
Slovenian: Akutna distonija se lahko pojavi v prvih nekaj dneh zdravljenja s haloperidolom, poročali pa so tudi o pojavljanju kasneje v poteku zdravljenja in po zvečevanju odmerka.
English: The results are within the observed variability in haloperidol pharmacokinetics.
Slovenian: Ti rezultati so znotraj opaženega okvira variabilnosti farmakokinetike haloperidola.
English: Therefore, baseline and periodic electrolyte monitoring is recommended.
Slovenian: Zato je priporočljivo izhodiščno določanje in kasnejše redno spremljanje vrednosti elektrolitov.
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.
Slovenian: Zlasti pri zdravljenju z večjimi odmerki in na začetku zdravljenja se lahko pojavi določena stopnja sedacije ali zmanjšana budnost, ki pa se lahko še stopnjujeta ob uživanju alkohola.
English: • Cancer (such as toremifene and vandetanib).
Slovenian: • rak (na primer toremifen in vandetanib).
English: The relevance of these tumour findings in rodents in terms of human risk is unknown.
Slovenian: Ni jasno, ali imajo lahko navedene ugotovitve o tumorjih pri glodalcih kakršenkoli pomen glede tveganja pri ljudeh.
English: Treatment initiation
Slovenian: Začetek zdravljenja
English: If you are worried, tell the doctor or nurse.
Slovenian: Če vas to skrbi, se pogovorite z zdravnikom ali medicinsko sestro.
English: It is recommended that ECG and vital signs be monitored, and that monitoring continues until the ECG is normal.
Slovenian: S spremljanjem EKG je treba nadaljevati, dokler EKG izvid ni normalen.
English: If you are not sure, talk to your doctor, pharmacist or nurse before being given Haldol Decanoate.
Slovenian: Če ste negotovi, se pred začetkom prejemanja zdravila Haldol Decanoate pogovorite z zdravnikom, farmacevtom ali medicinsko sestro.
English: HALDOL Decanoate is contraindicated in combination with medicinal products known to prolong the QTc interval (see section 4.3).
Slovenian: Zdravilo HALDOL Decanoate je kontraindicirano v kombinaciji z zdravili, za katera je znano, da podaljšujejo interval QTc (glejte poglavje 4.3).
English: • Muscle spasms, twitching or contractions that you cannot control, including a spasm in the neck causing the head to twist to one side
Slovenian: • mišični spazmi, nehoteno trzanje ali krčenje mišic, vključno s krčem vratnih mišic, ki povzroči nagnjenost glave v eno stran
English: • Central nervous system (CNS) depression.
Slovenian: • depresija centralnega živčevja
English: Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT).
Slovenian: Krvni strdki v venah, običajno v venah nog (globoka venska tromboza).
English: Ventricular fibrillation Torsade de pointes Ventricular tachycardia Extrasystoles
Slovenian: Srčne bolezni tahikardija ventrikularna fibrilacija torsade de pointes ventrikularna tahikardija ekstrasistole
English: For instructions on handling HALDOL Decanoate, see section 6.6.
Slovenian: Za navodila za ravnanje z zdravilom HALDOL Decanoate glejte poglavje 6.6. 4.3 Kontraindikacije
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.
Slovenian: Po prekinitvi zdravljenja z induktorjem CYP3A4 se koncentracija haloperidola lahko postopoma zvišuje, tako da bo morda potrebno zmanjšati odmerek zdravila HALDOL Decanoate.
English: Examples include:
Slovenian: Primeri takšnih zdravil so med drugim:
English: prochlorperazine, promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine and ziprasidone)
Slovenian: promazin, sertindol, tiorizadin, trifluoperazin, triflupromazin in ziprasidon),
English: You may need to be more closely monitored, and the amount of Haldol Decanoate you are given may have to be altered.
Slovenian: Morda vas bodo morali natančneje opazovati in vam spremeniti dosedanji odmerek zdravila Haldol
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.
Slovenian: • S palcem na barvni piki sunkovito odlomite vrh ampule, medtem ko z roko trdno držite preostali del ampule.
English: • Indinavir, ritonavir or saquinavir (for human immunodeficiency virus or HIV)
Slovenian: • indinavir, ritonavir ali sakvinavir (za zdravljenje okužbe z virusom humane imunske pomanjkljivosti - HIV),
English: Medicinal products that may increase haloperidol plasma concentrations
Slovenian: Zdravila, ki lahko zvišajo koncentracijo haloperidola v plazmi
English: For comatose patients, a patent airway must be established by use of an oropharyngeal airway or endotracheal tube.
Slovenian: Pri bolnikih v komi je treba vzpostaviti prehodnost dihalnih poti in jo vzdrževati s pomočjo orofaringealnega ali endotrahealnega tubusa.
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.
Slovenian: Če v času zdravljenja pride do podaljšanja intervala QTc, je priporočljivo zmanjšanje odmerka, če pa interval QTc preseže 500 ms, je treba haloperidol ukiniti.
English: • Muscle tremors, stiff or weak muscles
Slovenian: • mišični tremor (tresenje), okorelost ali šibkost mišic,
English: Treatment initiation and dose titration must be carried out under close clinical supervision.
Slovenian: Začetek zdravljenja in prilagajanje odmerjanja morata potekati pod skrbnim zdravniškim nadzorom.
English: As a precautionary measure, it is preferable to avoid the use of HALDOL Decanoate during pregnancy.
Slovenian: Iz previdnosti se je v času nosečnosti bolje izogibati uporabi zdravila HALDOL Decanoate.
English: • Fungal infections (such as pentamidine)
Slovenian: • glivične okužbe (na primer pentamidin),
English: The inter-subject variability (coefficient of variation, %) in haloperidol clearance was estimated to be 44% in a population pharmacokinetic analysis in patients with schizophrenia.
Slovenian: Z analizo populacijske farmakokinetike so ocenili, da je interindividualna variabilnost očistka haloperidola (koeficient variacije, izražen v odstotkih) pri bolnikih s shizofrenijo 44%.
English: Dose adjustment is recommended in elderly patients (see section 4.2).
Slovenian: Pri starejših bolnikih je priporočljivo prilagajanje odmerkov (glejte poglavje 4.2).