FrancophonIA/ELRC3.0 huggingface dataset:
English: A small increase in deaths and strokes has been reported for elderly people with dementia who are taking antipsychotic medicines.
Danish: Der er rapporteret en lille stigning i dødsfald og slagtilfælde hos ældre mennesker med demens, der tager antipsykotiske lægemidler.
English: If you miss a dose or stop using Haldol Decanoate You should not stop this medicine unless told to do so by your doctor as your symptoms may return.
Danish: Hvis du har glemt en dosis eller stopper med af få Haldol Dekanoat Du bør ikke stoppe dette lægemiddel, medmindre din læge har bedt dig om det, da dine symptomer kan vende tilbage.
English: • Recent acute myocardial infarction.
Danish: • Nyligt akut myokardieinfarkt.
English: Observational studies suggest that treatment of elderly patients with haloperidol is also associated with increased mortality.
Danish: Observationsstudier indikerer, at behandling af ældre patienter med haloperidol også er associeret med en øget dødsrisiko.
English: Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death.
Danish: Ældre patienter med demensrelateret psykose, der behandles med antipsykotika, har en øget risiko for død.
English: • Based on this conversion, the haloperidol decanoate dose will be 25 to150 mg for most patients.
Danish: • Baseret på denne konvertering vil dosis af haloperidoldecanoat være 25-150 mg for de fleste patienter.
English: This causes a high fever, severe muscle stiffness, confusion and loss of consciousness.
Danish: Dette forårsager høj feber, udtalt muskelstivhed, forvirring og bevidsthedstab.
English: Extrapyramidal symptoms can occur within the therapeutic range, although the frequency is usually higher with doses producing higher than therapeutic concentrations.
Danish: Ekstrapyramidale symptomer kan indtræde inden for det terapeutiske interval, selvom hyppigheden som regel er højere ved doser, der medfører højere koncentrationer end de terapeutiske.
English: Cerebrovascular events
Danish: Cerebrovaskulære hændelser
English: Examples of medicinal products that may increase haloperidol plasma concentrations (based on clinical experience or drug interaction mechanism) include:
Danish: Eksempler på lægemidler, der kan øge plasmakoncentrationen af haloperidol (baseret på klinisk erfaring eller interaktionsmekanismer), omfatter:
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.
Danish: Behandling med haloperidol er blevet forbundet med udvikling af akathisi, som er kendetegnet ved en subjektivt ubehagelig eller generende rastløshed og behov for at bevæge sig, der ofte er ledsaget af manglende evne til at sidde eller stå stille.
English: • Feeling restless or difficulty sitting still, increased body movements
Danish: • rastløshed eller besvær med at sidde stille, øgede kropsbevægelser
English: Fertility - Haldol Decanoate may increase your levels of a hormone called ‘prolactin', which may affect fertility in men and women.
Danish: Frugtbarhed - Haldol Dekanoat kan øge niveauet af et hormon, der hedder prolaktin, hvilket kan påvirke frugtbarheden hos mænd og kvinder.
English: • Being unable to pass urine or empty the bladder completely
Danish: • Manglende evne til at lade vandet eller tømme blæren helt
English: The extent to which this association is attributable to the medicinal product, as opposed to being confounded by patient characteristics, has not yet been elucidated.
Danish: Det er endnu ikke klarlagt, i hvor stor udstrækning denne association kan henføres til lægemidlet i modsætning til at være konfunderet af patientkarakteristika.
English: • Muscle spasms, twitching or contractions that you cannot control, including a spasm in the neck causing the head to twist to one side
Danish: • Muskelspasmer, muskeltrækninger eller muskelsammentrækninger, som du ikke kan kontrollere, herunder spasmer i nakken, der bevirker, at hovedet drejes til den ene side
English: About one-third of a haloperidol dose is excreted in urine, mostly as metabolites.
Danish: Cirka en tredjedel af haloperidoldosis udskilles i urinen, primært som metabolitter.
English: • Elderly people will normally start on a lower dose, usually 12.5 mg to 25 mg every 4 weeks.
Danish: • Ældre vil normal starte med en lavere dosis, som regel 12,5 til 25 mg hver 4. uge.
English: However, there have been isolated case reports of birth defects following foetal exposure to haloperidol in combination with other medicinal products.
Danish: Der er imidlertid rapporteret om enkeltstående tilfælde af fødselsdefekter efter føtal eksponering for haloperidol i kombination med andre lægemidler.
English: Talk to your doctor about drinking alcohol while using Haldol Decanoate, and let your doctor know how much you drink.
Danish: Tal med din læge om at drikke alkohol, mens du bruger Haldol Dekanoat, og fortæl lægen hvor meget du drikker.
English: • Feeling dizzy, including upon sitting up or standing up
Danish: • Svimmelhed, herunder når du sætter dig op eller rejser dig op
English: Side effects, such as feeling sleepy, may affect your alertness, particularly when you first start using it or after a high dose.
Danish: Bivirkninger såsom søvnighed kan påvirke din opmærksomhed, især når du begynder at tage lægemidlet eller efter en høj dosis.
English: Antagonism of the effect of the anticoagulant phenindione has been reported.
Danish: Der er rapporteret om antagonisering af virkningen af det antikoagulerende middel phenindion.
English: Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for ventricular arrhythmias and must be corrected before treatment with haloperidol is started.
Danish: Elektrolytforstyrrelser såsom hypokaliæmi og hypomagnesiæmi øger risikoen for ventrikulære arytmier og skal korrigeres, inden behandling med haloperidol iværksættes.
English: If you miss an appointment, contact your doctor right away to make a new appointment.
Danish: Hvis du ikke når en tid hos lægen, skal du kontakte lægen hurtigst muligt for at aftale en ny tid.
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)
Danish: • du har en hjertesygdom, der kaldes ”forlænget QT-interval” eller andre problemer med din hjerterytme, der kan ses på et EKG (elektrokardiogram)
English: • Depression (‘tricyclic antidepressants')
Danish: • depression (tricykliske antidepressiva)
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.
Danish: Maksimal enzyminduktion ses generelt efter ca. 2 uger og kan derefter opretbeholdes i lige så lang tid efter seponering af lægemidlet.
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.
Danish: Dette er længere end for andre formuleringer af haloperidol, hvor haloperidols terminale eliminationshalveringstid i gennemsnit er 24 timer efter oral administration og 21 timer efter intramuskulær administration.
English: • Rifampicin (for bacterial infections)
Danish: • Rifampicin (mod bakterie-infektioner)
English: Occasionally, patients had previously been treated orally with another antipsychotic medicinal product.
Danish: Undertiden havde patienterne fået forudgående oral behandling med et andet antipsykotikum.
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)
Danish: • har et højt indhold af hormonet prolaktin i blodet, eller hvis du har kræft, som kan være forårsaget af et højt prolaktinniveau (såsom brystkræft)
English: Based on pooled safety data from these clinical studies, the most commonly reported adverse reactions were: extrapyramidal disorder (14%), tremor (8%), parkinsonism (7%), muscle rigidity (6%) and somnolence (5%).
Danish: Baseret på de samlede sikkerhedsdata fra disse kliniske studier var de hyppigst rapporterede bivirkninger ekstrapyramidale forstyrrelser (14 %), tremor (8 %), parkinsonisme (7 %), muskelrigiditet (6 %) og døsighed (5 %).
English: The ECG measures the electrical activity of your heart.
Danish: EKG'et måler hjertets elektriske aktivitet.
English: Blood clots in the veins, usually in the legs (deep vein thrombosis or DVT).
Danish: Blodpropper i venerne, som regel i benene (dyb venetrombose (DVT)).
English: The individual dose will depend on both the severity of the symptoms and the current oral haloperidol dose.
Danish: Den individuelle dosis afhænger både af symptomernes sværhedsgrad og af den aktuelle orale haloperidoldosis.
English: Hypotension Orthostatic hypotension
Danish: Hypotension Ortostatisk hypotension
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).
Danish: Fortæl det også til lægen, hvis du tager bepridil (mod brystsmerter eller forhøjet blodtryk) eller methadon (mod smerter eller til behandling af stofafhængighed).
English: Haloperidol is excreted in human milk.
Danish: Haloperidol udskilles i human mælk.
English: Caution is advised in patients suffering from epilepsy and in conditions predisposing to seizures (e.g. alcohol withdrawal and brain damage).
Danish: Der skal udvises forsigtighed hos patienter, der lider af epilepsi, og ved tilstande, som er prædisponerende for krampeanfald (f.eks. alkoholafvænning og hjerneskade).
English: The syndrome is mainly characterized by rhythmic involuntary movements of the tongue, face, mouth or jaw.
Danish: Syndromet er hovedsageligt karakteriseret ved ufrivillige rytmiske bevægelser af tunge, ansigt, mund eller kæbe.
English: • Ever had bleeding in the brain, or your doctor has told you that you are more likely than other people to have a stroke
Danish: • tidligere har haft en hjerneblødning, eller lægen har fortalt dig, at du har en øget risiko for at få et slagtilfælde
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY} Date of latest renewal: {DD month YYYY}
Danish: Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ} Dato for seneste fornyelse: {DD måned ÅÅÅÅ} [Udfyldes nationalt]
English: Haldol Decanoate should not be used in children and adolescents below 18 years.
Danish: Haldol Dekanoat må ikke anvendes til børn og unge under 18 år.
English: • Known QTc interval prolongation or congenital long QT syndrome.
Danish: • Kendt QTc-forlængelse eller medfødt langt QT-syndrom.
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).
Danish: Forlængelse af QTc er observeret, når haloperidol bliver givet i kombination med de metaboliske inhibitorer ketoconazol (400 mg/dag) og paroxetin (20 mg/dag).
English: Acute dystonia may necessitate stopping the medicinal product.
Danish: Akut dystoni kan gøre det nødvendigt at seponere lægemidlet.
English: Heart problems are uncommon in people using Haldol Decanoate (may affect up to 1 in 100 people).
Danish: Hjerteproblemer er ikke almindelige hos personer, der får Haldol Dekanoat (kan berøre op til 1 ud af 100 personer).
English: Continuation of treatment
Danish: Fortsættelse af behandlingen
English: • Parkinson's disease (such as levodopa)
Danish: • Parkinsons sygdom (såsom levodopa)
English: Because of the high haloperidol distribution volume and its high protein binding, only very small amounts are removed by dialysis.
Danish: Som følge af haloperidols store distributionsvolumen og høje proteinbindingsgrad fjernes kun meget små mængder ved dialyse.
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.
Danish: Haloperidol er en potent central dopamin type 2-receptorantagonist som ved de anbefalede doser har lav alfa-1-antiadrenerg aktivitet og ingen antihistaminerg eller antikolinerg aktivitet.
English: Examples include:
Danish: Det gælder eksempelvis:
English: The most prominent symptoms are severe extrapyramidal reactions, hypotension and sedation.
Danish: De mest fremtrædende symptomer er svære ekstrapyramidale reaktioner, hypotension og sedation.
English: Results from small clinical studies suggest a lower clearance and a longer elimination half-life of haloperidol in elderly patients.
Danish: Resultater fra små kliniske studier tyder på en lavere clearance og længere eliminationshalveringstid hos ældre patienter.
English: Tardive dyskinesia may appear in some patients on long-term therapy or after discontinuation of the medicinal product.
Danish: Tardiv dyskinesi kan optræde hos visse patienter i langvarig behandling eller efter seponering.
English: • Believe things that are not true (delusions)
Danish: • tro på ting, der ikke findes (vrangforestillinger)
English: • A swollen face, lips, mouth, tongue or throat
Danish: • hævelse af ansigt, læber, mund, tunge eller svælg
English: Adrenaline must not be used because it might cause profound hypotension in the presence of haloperidol.
Danish: Adrenalin må ikke anvendes, da det kan forårsage udtalt hypotension ved tilstedeværelse af haloperidol.
English: During therapy, the need for ECG monitoring for QTc interval prolongation and for ventricular arrhythmias must be assessed in all patients.
Danish: Under behandlingen skal behovet for EKG-monitorering for forlængelse af QTc-intervallet og for ventrikulære arytmier evalueres hos alle patienter.
English: Haloperidol may antagonise the effect of levodopa and other dopamine agonists.
Danish: Haloperidol kan antagonisere virkningen af levodopa og andre dopaminagonister.
English: Drinking alcohol while you are using Haldol Decanoate might make you feel sleepy and less alert.
Danish: Hvis du drikker alkohol, mens du er i behandling med Haldol Dekanoat, kan det bevirke, at du føler dig søvnig og bliver mindre opmærksom.
English: If you used Haldol Decanoate while pregnant and your baby develops any of these side effects, contact your doctor.
Danish: Hvis du har fået Haldol Dekanoat under graviditeten, og dit barn får en eller flere af disse bivirkninger, skal du kontakte lægen.
English: Haloperidol crosses the blood-brain barrier easily.
Danish: Haloperidol passerer let blod-hjernebarrieren.
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.
Danish: I randomiserede, placebokontrollerede kliniske studier hos en demenspopulation var der en cirka tre gange højere risiko for cerebrovaskulære bivirkninger med visse atypiske antipsykotika.
English: Haloperidol causes efficient psychomotor sedation, which explains the favourable effect on mania and other agitation syndromes.
Danish: Haloperidol har en effektiv psykomotorisk sedativ effekt, hvilket forklarer den gunstige virkning på mani og andre agitationssyndromer.
English: Adverse reaction frequencies are based on (or estimated from) clinical trials or epidemiology studies with haloperidol decanoate, and classified using the following convention:
Danish: Bivirkningernes hyppighed er baseret på (eller estimeret ud fra) kliniske forsøg eller epidemiologiske studier med haloperidoldecanoat og klassificeret i henhold til følgende konvention:
English: You must be aware of serious side effects while you are using Haldol Decanoate because you may need urgent medical treatment.
Danish: Du skal være opmærksom på alvorlige bivirkninger, mens du er i behandling med Haldol Dekanoat, da du kan have brug for hurtig behandling.
English: • The combined total dose of haloperidol from both formulations must not exceed the corresponding maximum oral haloperidol dose of 20 mg/day.
Danish: • Den samlede totale dosis af haloperidol fra begge formuleringer må ikke overstige den tilsvarende maksimale orale haloperidoldosis på 20 mg/dag.
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.
Danish: I løbet af et typisk 10-ugers kontrolleret studie var dødsrisikoen for de patienter, der blev behandlet med antipsykotika, ca. 4,5 % mod ca. 2,6 % for placebogruppen.
English: Haldol Decanoate can cause problems with the heart, problems controlling body or limb movements and a serious side effect called ‘neuroleptic malignant syndrome'.
Danish: Haldol Dekanoat kan forårsage problemer med hjertet, problemer med at kontrollere kropsbevægelser eller bevægelser af arme og ben og en alvorlig bivirkning kaldet ”malignt neuroleptikasyndrom”.
English: The central dopamine blocking effect has activity on the basal ganglia (nigrostriatal bundles).
Danish: Den centrale dopaminblokerende virkning påvirker de basale ganglier (nigrostriatale bundter).
English: An extrapyramidal reaction is manifest by muscular rigidity and a generalised or localised tremor.
Danish: Ekstrapyramidale reaktioner manifesterer sig som muskelrigiditet og generaliseret eller lokaliseret tremor.
English: • Movements of the mouth, tongue, jaw and sometimes limbs (tardive dyskinesia)
Danish: • bevægelser af mund, tunge, kæbe og undertiden arme og ben (tardiv dyskinesi)
English: posaconazole, saquinavir, verapamil, voriconazole.
Danish: posaconazol, saquinavir, verapamil, voriconazol.
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.
Danish: Baseret på begrænsede og undertiden modstridende oplysninger kan den potentielle stigning i plasmakoncentrationen af haloperidol ved samtidig administration af en CYP3A4- og/eller en CYP2D6-hæmmer variere mellem 20 og 40 %, men der er i visse tilfælde rapporteret om stigninger på op til 100 %.
English: Talk to your doctor before being given Haldol Decanoate if you are elderly, particularly if you have dementia.
Danish: Tal med lægen, før du får Haldol Dekanoat, hvis du er ældre, især hvis du lider af demens.
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.
Danish: Sikkerheden af haloperidoldecanoat er vurderet hos 410 patienter, som deltog i 3 komparatorstudier (1 sammenlignede haloperidoldecanoat med fluphenazin, og 2 sammenlignede decanoatformuleringen med oral haloperidol), 9 åbne studier og 1 dosisresponsstudie.
English: • Slow or reduced body movements, jerking or twisting movements
Danish: • langsomme eller reducerede kropsbevægelser, spjættende eller vridende bevægelser
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.
Danish: Baseret på publicerede data fra flere kliniske studier opnås der terapeutisk respons hos de fleste patienter med akut eller kronisk skizofreni ved plasmakoncentrationer på 1-10 ng/ml.
English: • The most effective dose is expected to range between 50 and 200 mg.
Danish: • Den mest effektive dosis forventes at være mellem 50 og 200 mg.
English: Haldol Decanoate can affect the way the following types of medicine work Tell your doctor if you are taking medicines for:
Danish: Haldol Dekanoat kan påvirke virkningen af følgende typer medicin Fortæl det til lægen, hvis du tager lægemidler mod:
English: Pharmacokinetic/pharmacodynamics relationships
Danish: Farmakokinetiske/farmakodynamiske forhold
English: The safety and efficacy of HALDOL Decanoate in children and adolescents below 18 years of age have not been established.
Danish: HALDOL Dekanoats sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Look out for serious side effects
Danish: Vær opmærksom på alvorlige bivirkninger
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.
Danish: Da patienter i behandling med antipsykotika ofte har erhvervede risikofaktorer for VTE, bør alle potentielle risikofaktorer for VTE klarlægges før og under behandling med HALDOL Dekanoat, og der bør tages forebyggende forholdsregler.
English: Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haldol Decanoate.
Danish: Din læge vil muligvis tage et elektrokardiogram (EKG) før eller under behandlingen med Haldol Dekanoat.
English: Table 3 lists adverse reactions as follows:
Danish: Tabel 3 inkluderer følgende bivirkninger:
English: Pharmacotherapeutic group: psycholeptics; antipsychotics; butyrophenone derivatives, ATC code: N05AD01.
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, antipsykotika, butyrophenonderivater, ATC-kode: N05AD01.
English: Caution is advised in patients with bradycardia, cardiac disease, family history of QTc prolongation or history of heavy alcohol exposure.
Danish: Det anbefales at udvise forsigtighed hos patienter med bradykardi, hjertesygdom, QTc-forlængelse i familieanamnesen eller stort alkoholforbrug i anamnesen.
English: This may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients (see section 4.4).
Danish: Dette kan hæmme reproduktionsfunktionen som følge af nedsat steroidsyntese i gonaderne hos både kvindelige og mandlige patienter (se pkt.
English: HALDOL Decanoate is not indicated for the treatment of dementia-related behavioural disturbances.
Danish: HALDOL Dekanoat er ikke indiceret til behandling af demensrelaterede adfærdsforstyrrelser.
English: • Dementia with Lewy bodies.
Danish: • Lewy Body demens.
English: • Whether you have problems with your kidneys or liver
Danish: • om du har problemer med nyrerne eller leveren
English: A subset of patients may require higher concentrations as a consequence of a high inter-subject variability in haloperidol pharmacokinetics.
Danish: En undergruppe af patienter kan dog have brug for højere koncentrationer som en konsekvens af en høj inter-individuel variabilitet i haloperidols farmakokinetik.
English: • Irritation, pain or collection of pus (abscess) where the injection is given
Danish: • Irritation, smerter eller pusansamling (byld) på injektionsstedet
English: Tachycardia and hypotension (including orthostatic hypotension) have also been reported (see section 4.8).
Danish: Takykardi og hypotension (herunder ortostatisk hypotension) er også rapporteret (se pkt.
English: • You are allergic to haloperidol or any of the other ingredients of this medicine (listed in section 6)
Danish: • du er allergisk over for haloperidol eller et af de øvrige indholdsstoffer i Haldol Dekanoat (angivet i afsnit 6).
English: • Concomitant treatment with medicinal products that prolong the QT interval (see section 4.5).
Danish: • Samtidig behandling med lægemidler, der forlænger QT-intervallet (se pkt.
English: The main metabolic pathways of haloperidol in humans include glucuronidation, ketone reduction, oxidative N-dealkylation and formation of pyridinium metabolites.
Danish: De vigtigste metaboliseringsveje for haloperidol hos mennesker omfatter glukuronidering, ketonreduktion, oxidativ N-dealkylering og dannelse af pyridiniummetabolitter.
English: • Adjustment of the dosing interval may be required (based on individual patient response).
Danish: • Det kan være nødvendigt at justere doseringsintervallet (baseret på individuelt patientrespons).