FrancophonIA/ELRC3.0 huggingface dataset:
English: • Gently press the sides of the bottle and count the number of drops you need to take.
Danish: • Tryk forsigtigt på flaskens sider, og tæl det antal dråber, du skal tage.
English: Antipsychotic treatment must be withdrawn immediately and appropriate supportive therapy and careful monitoring instituted.
Danish: Antipsykotisk behandling skal omgående afbrydes og passende understøttende behandling og omhyggelig monitorering iværksættes.
English: This is because it has not been studied adequately in this age group.
Danish: Det skyldes, at lægemidlet ikke er undersøgt tilstrækkeligt hos denne aldersgruppe.
English: Haldol is also used in adults:
Danish: Haldol anvendes også til voksne:
English: Place the other end into the solution in the bottle.
Danish: Anbring den anden ende i opløsningen i flasken.
English: • One end of the oral syringe has a plunger.
Danish: • Den ene ende af den orale sprøjte har et stempel.
English: Agitation Insomnia
Danish: Agitation Insomni
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.
Danish: Doser over 5 mg/dag bør kun overvejes hos patienter, som har tolereret højere doser, og kun efter revurdering af benefit/risk-forholdet hos den enkelte patient.
English: If antipsychotics are withdrawn, recurrence of symptoms related to the underlying condition may not become apparent for several weeks or months.
Danish: Hvis antipsykotika seponeres, vil recidiverende symptomer relateret til den underliggende sygdom muligvis ikke komme til udtryk før efter adskillige uger eller måneder.
English: • The continued use of HALDOL should be evaluated early in treatment (see section 4.4).
Danish: • Fortsat brug af HALDOL bør evalueres tidligt i behandlingen (se pkt.
English: • Swallow the tablets with some water.
Danish: • Synk tabletterne sammen med vand.
English: Do this by sliding the upper ring down while still holding the lower ring.
Danish: Det gøres ved at skubbe den øverste ring ned, mens du stadig holder på den nederste ring.
English: Children and adolescents 6 to 17 years of age
Danish: Børn og unge i alderen 6 til 17 år
English: • You will not be given more than a total of 20 mg each day.
Danish: • Du får ikke mere end 20 mg i alt om dagen.
English: Data are not available for children aged less than 3 years.
Danish: Der foreligger ingen data hos børn under 3 år.
English: • 1 to 2 mg intramuscularly, at induction or 30 minutes before the end of anaesthesia.
Danish: • 1-2 mg intramuskulært, ved induktion eller 30 minutter inden afsluttet anæstesi.
English: See ‘Look out for serious side effects' in section 4.
Danish: Se ”Vær opmærksom på alvorlige bivirkninger” i afsnit 4.
English: • Draw up the solution to the correct number of millilitres
Danish: • Træk opløsningen op til det korrekte antal milliliter (ml).
English: • If you forget to take a dose, take your next dose as usual.
Danish: • Hvis du glemmer at tage en dosis, skal du tage den næste dosis til sædvanlig tid.
English: On average, concentrations in this range would be obtained with doses of 1 to 4 mg daily.
Danish: I gennemsnit vil koncentrationer i dette område kunne opnås med doser på 1-4 mg dagligt.
English: It may be mixed with water to facilitate dose administration, but it must not be mixed with any other liquid.
Danish: Den kan blandes med vand for at gøre indgivelsen lettere, men den må ikke blandes med andre væsker.
English: Plasma concentrations measured at various time points and after various durations of treatment, were either undetectable or ranged up to a maximum of 44.3 ng/ml.
Danish: Plasmakoncentrationer målt på forskellige tidspunkter og efter forskellige behandlingsvarigheder var enten ikke-detekterbare eller lå i et interval op til maksimalt 44,3 ng/ml.
English: The following problems may occur in newborn babies of mothers that take Haldol in the last 3 months of their pregnancy (the last trimester):
Danish: Følgende problemer kan opstå hos nyfødte, hvis mødre har fået Haldol i de sidste 3 måneder af graviditeten (sidste trimester):
English: • You may be given extra doses, normally 1 to 4 hours apart.
Danish: • Du får måske flere doser, normalt med 1 til 4 timers mellemrum.
English: • 5 to 10 mg orally, repeated after 12 hours if necessary to a maximum of 20 mg/day.
Danish: • 5-10 mg oralt, om nødvendigt gentaget efter 12 timer, op til maksimalt 20 mg/dag.
English: • You can mix Haldol oral solution in some water before you take it, but don't mix it with any other liquids.
Danish: • Du kan blande Haldol oral opløsning med lidt vand, inden du tager det, men bland det ikke med andre væsker.
English: Based on pooled safety data from these clinical studies, the most commonly reported adverse reactions were: extrapyramidal disorder (34%), insomnia (19%), agitation (15%), hyperkinesia (13%), headache (12%), psychotic disorder (9%), depression (8%), weight increased (8%), tremor (8%), hypertonia (7%), orthostatic hypotension (7%), dystonia (6%) and somnolence (5%).
Danish: Baseret på de samlede sikkerhedsdata fra disse kliniske studier var de hyppigst rapporterede bivirkninger ekstrapyramidale forstyrrelser (34 %), insomni (19 %), agitation (15 %), hyperkinesi (13 %), hovedpine (12 %), psykose (9 %), depression (8 %), vægtstigning (8 %), tremor (8 %), hypertoni (7 %), ortostatisk hypotension (7 %), dystoni (6 %) og døsighed (5 %).
English: • Verapamil (for blood pressure or heart problems).
Danish: • Verapamil (mod problemer med blodtryk eller hjerte)
English: Table 1: Haloperidol dose recommendations for adults aged 18 years and above
Danish: Tabel 1: Dosisanbefalinger for haloperidol til voksne på 18 år og derover
English: • In the majority of patients, doses of up to 15 mg/day are sufficient.
Danish: • Hos de fleste patienter er doser op til 15 mg/døgn tilstrækkelig.
English: • Close the bottle, then rinse the oral syringe with some water.
Danish: • Luk flasken og skyl derefter den orale sprøjte med lidt vand.
English: Patients with first-episode schizophrenia generally respond to 2 to 4 mg/day, whereas patients with multiple-episode schizophrenia may need doses up to 10 mg /day.
Danish: Patienter med første episode af skizofreni responderer generelt på 2-4 mg/dag, hvorimod patienter med flere episoder af skizofreni kan have behov for doser op til 10 mg/dag.
English: Haldol should not be used in children below 6 years of age.
Danish: Haldol bør ikke anvendes til børn under 6 år.
English: The name of your medicine is Haldol.
Danish: Lægemidlets navn er Haldol.
English: This is because it has not been studied in these age groups.
Danish: Det skyldes, at medicinen ikke er undersøgt hos denne aldersgruppe.
English: Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Haldol.
Danish: Din læge vil muligvis tage et EKG (elektrokardiogram) før eller under behandlingen med Haldol.
English: The following side effects have also been reported, but their exact frequency is unknown:
Danish: Følgende bivirkninger er også rapporteret, men den præcise hyppighed af disse bivirkninger er ikke kendt:
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.
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, og der bør tages forebyggende forholdsregler.
English: The efficacy of activated charcoal has not been established.
Danish: Virkningen af aktivt kul er ikke klarlagt.
English: • Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe
Danish: • Behandling af vedvarende aggression og psykotiske symptomer hos patienter med moderat til svær
English: Haldol can affect the way the following types of medicine work Tell your doctor if you are taking medicines for:
Danish: Haldol kan påvirke virkningen af følgende typer medicin Fortæl det til lægen, hvis du tager lægemidler mod:
English: • Enlarged breasts in men
Danish: • Brystforstørrelse hos mænd
English: HALDOL oral solution should be used for single doses of less than 1 mg that cannot be achieved with HALDOL tablets.
Danish: HALDOL oral opløsning skal anvendes ved enkeltdoser under 1 mg, som ikke kan opnås med HALDOL tabletter.
English: • Feeling confused
Danish: • Føle sig forvirret
English: HALDOL solution for injection is not indicated for the treatment of dementia-related behavioural disturbances.
Danish: HALDOL injektionsvæske er ikke indiceret til behandling af demensrelaterede adfærdsforstyrrelser.
English: Your doctor will normally give you a low dose to start, and then adjust the dose to suit you.
Danish: Lægen vil normalt give dig en lav dosis i begyndelsen og derefter justere dosis, så den passer til dig.
English: Your doctor will tell you how many tablets to take and for how long.
Danish: Lægen vil fortælle dig, hvor mange tabletter du skal tage, og i hvor lang tid.
English: This belongs to a group of medicines called ‘antipsychotics'.
Danish: Det tilhører en gruppe af lægemidler, der kaldes antipsykotika.
English: If you take more Haldol than you were told to or if someone else has taken any Haldol, talk to a doctor or go to the nearest hospital casualty department straight away.
Danish: Hvis du tager mere Haldol, end du har fået at vide, eller hvis en anden har taget Haldol uanset mængde, skal du med det samme kontakte en læge eller tage til den nærmeste skadestue.
English: Haldol can cause problems with the heart, problems controlling body or limb movements and a serious side effect called ‘neuroleptic malignant syndrome'.
Danish: Haldol kan forårsage problemer med hjertet, problemer med at kontrollere kropsbevægelser eller bevægelser af arme og ben og en alvorlig bivirkning kaldet ”malignt neuroleptikasyndrom”.
English: • Problems having sex.
Danish: • Seksuelle problemer.
English: In cases of severe extrapyramidal reactions, parenteral administration of an antiparkinson medicinal product is recommended.
Danish: I tilfælde af svære ekstrapyramidale reaktioner anbefales parenteral administration af et antiparkinsonmiddel.
English: Mean haloperidol plasma protein binding in adults is approximately 88 to 92%.
Danish: Den gennemsnitlige plasmaproteinbinding af haloperidol hos voksne er cirka 88-92 %.
English: The following initial haloperidol doses are recommended in elderly patients:
Danish: Følgende startdoser af haloperidol anbefales til ældre patienter:
English: These include mental health problems (such as schizophrenia and bipolar disorder) and behavioural problems.
Danish: Det gælder blandt andet mentale lidelser (såsom skizofreni og bipolar lidelse (manio-depression)) og adfærdsproblemer.
English: HALDOL solution for injection is indicated in adult patients for:
Danish: HALDOL injektionsvæske er indiceret til voksne patienter til:
English: Loss of libido Libido decreased Restlessness
Danish: Konfusion Tab af libido Nedsat libido Rastløshed
English: Available safety data in the paediatric population indicate a risk of developing extrapyramidal symptoms, including tardive dyskinesia, and sedation.
Danish: De foreliggende sikkerhedsdata for den pædiatriske population indikerer en risiko for udvikling af ekstrapyramidale symptomer, herunder tardiv dyskinesi, og sedation.
English: HALDOL tablets are for oral use.
Danish: HALDOL-tabletter er til oral anvendelse.
English: Haldol is also used:
Danish: Haldol anvendes også:
English: The average bioavailability of haloperidol after administration of the tablet or oral solution is 60 to 70%.
Danish: Haloperidols gennemsnitlige biotilgængelighed efter administration af tabletter eller oral opløsning er 6070 %.
English: Fertility - Haldol may increase your levels of a hormone called ‘prolactin', which may affect fertility in men and women.
Danish: Frugtbarhed - Haldol kan øge niveauet af et hormon, der hedder 'prolaktin', hvilket kan påvirke frugtbarhed hos mænd og kvinder.
English: • While holding the lower ring on the oral syringe, pull the top ring of the plunger upwards.
Danish: • Mens du holder på den nederste ring på den orale sprøjte, skal du trække stemplets øverste ring opad.
English: In addition, 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: Derudover blev sikkerheden af haloperidoldecanoat evalueret 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: Your dose of haloperidol will depend on:
Danish: Den dosis haloperidol du får, afhænger af:
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.
Danish: På grund af den store inter-individuelle variabilitet i haloperidols farmakokinetik og forholdet mellem koncentration og virkning anbefales det at justere den individuelle haloperidoldosis på basis af patientens respons under hensyntagen til data, der tyder på et tidsinterval på 5 dage indtil opnåelse af 50% af det maksimale terapeutiske respons.
English: • The highest dose adults should take depends on the condition you are being treated for and varies between 5 mg and 20 mg each day.
Danish: • Den højeste dosis, som du må få, afhænger af den sygdom, du bliver behandlet for, og varierer mellem 5 mg og 20 mg hver dag.
English: Alzheimer's dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others - 0.5 mg/day.
Danish: Alzheimers demens og vaskulær demens, når ikke-farmakologisk behandling har slået fejl, og når der er risiko for, at patienten skader sig selv eller andre: 0,5 mg/dag.
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 af haloperidol hos ældre patienter.
English: ml HALDOL (bottle with oral syringe)
Danish: ml HALDOL (flaske med oral sprøjte)
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.
Danish: • Hos størstedelen af patienterne har doser over 10 mg/dag ikke vist superioritet i virkningen i forhold til lavere doser, og disse doser kan forårsage øget forekomst af ekstrapyramidale symptomer.
English: In adolescents and children, Haldol is used to treat schizophrenia in patients aged 13 to 17 years, and to treat behavioural problems in patients aged 6 to 17 years.
Danish: Hos unge og børn, bruges Haldol til behandling af skizofreni hos patienter fra 13-17 år og til behandling af adfærdsproblemer hos patienter fra 6-17 år.
English: Psychotic disorder Depression
Danish: Psykotisk forstyrrelse Depression
English: What Haldol contains
Danish: Haldol indeholder
English: However, there have been isolated case reports of birth defects following foetal exposure to haloperidol, mostly in combination with other medicinal products.
Danish: Der er imidlertid rapporteret om enkeltstående tilfælde af fødselsdefekter efter føtal eksponering for haloperidol, oftest i kombination med andre lægemidler.
English: • To help control movements in Huntington's disease
Danish: • til at hjælpe med at kontrollere bevægelser ved Huntingtons sygdom
English: • Narrowed airways in the lungs, causing difficulty breathing
Danish: • Forsnævring af luftvejene i lungerne, hvilket giver vejrtrækningsbesvær
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.
Danish: Den interindividuelle variabilitet (variationskoefficient, %) for haloperidol-clearance blev estimeret til 44 % i en populationsfarmakokinetisk analyse af patienter med skizofreni.
English: • High level of ‘antidiuretic hormone' in the blood (syndrome of inappropriate antidiuretic hormone secretion)
Danish: • Højt indhold af antidiuretisk hormon i blodet (syndrom med uhensigtsmæssig udskillelse af antidiuretisk hormon)
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.
Danish: Akut dystoni kan indtræde i løbet af de første par dage af behandlingen med HALDOL, men senere indtræden samt indtræden efter dosisøgning er rapporteret.
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.
Danish: Det 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: In 2 studies in children receiving haloperidol treatment for tics and Tourette's syndrome, a positive response was associated with plasma concentrations of 1 to 4 ng/ml
Danish: I 2 studier hos børn i behandling med haloperidol mod tics og Tourettes syndrom blev et positivt respons forbundet med plasmakoncentrationer på 1-4 ng/ml.
English: • Place the bottle on a flat surface.
Danish: • Sæt flasken på en plan overflade.
English: • When switching from haloperidol intramuscular injection, HALDOL orally should be initiated at a 1:1 dose conversion rate followed by dose adjustment according to clinical response.
Danish: • Ved skift fra intramuskulær injektion af haloperidol skal oral HALDOL startes med en dosis konverteringsratio på 1:1 efterfulgt af dosisjustering i henhold til klinisk respons.
English: Further doses may be administered and adjusted according to the patient's response.
Danish: Yderligere doser kan administreres og justeres i henhold til patientens respons.
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.
Danish: Der er begrænsede data for plasmakoncentrationen hos pædiatriske patienter fra studier hos 78 patienter med forskellige lidelser (skizofreni, psykose, Tourettes syndrom, autisme), som fik orale doser af haloperidol på op til maksimalt 30 mg/dag.
English: Measurement of haloperidol blood concentrations may be considered in individual cases.
Danish: Måling af haloperidol-koncentrationen i blodet kan overvejes individuelt.
English: • Treatment of schizophrenia and schizoaffective disorder.
Danish: • Behandling af skizofreni og skizoaffektive lidelser.
English: • Empty the contents of the oral syringe onto a spoon or into a cup.
Danish: • Tøm indholdet i den orale sprøjte over i en ske eller en kop.
English: Tardive dyskinesia Akathisia Bradykinesia Dyskinesia Dystonia Hypokinesia Hypertonia Dizziness Somnolence Tremor
Danish: Tardiv dyskinesi Akatisi Bradykinesi Dyskinesi Dystoni Hypokinesi Hypertoni Svimmelhed Døsighed Tremor
English: Non-clinical data reveal no special hazards for humans based on conventional studies of repeat dose toxicity and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser og genotoksicitet.
English: • Changes that show up in blood tests of the liver.
Danish: • Leverforandringer, der kan ses i blodprøver.
English: Unless your doctor decides otherwise, Haldol will be stopped gradually.
Danish: Medmindre lægen beslutter noget andet, nedtrappes Haldol gradvist.
English: Haloperidol is an antipsychotic belonging to the butyrophenones group.
Danish: Haloperidol er et antipsykotikum, som tilhører gruppen butyrophenoner.
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.
Danish: Sikkerheden af haloperidol er vurderet hos 284 haloperidol-behandlede patienter, som deltog i 3 placebokontrollerede kliniske studier, og hos 1.295 haloperidol-behandlede patienter, som deltog i 16 dobbeltblinde studier med aktiv kontrol.
English: Side effects, such as feeling sleepy, may affect your alertness, particularly when you first start taking 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: • Do not take a double dose.
Danish: Der må ikke tages en dobbelt dosis.
English: A low initial dose is recommended, which subsequently may be adjusted according to the patient's response.
Danish: Det anbefales at give en lav startdosis, som derefter kan justeres i henhold til patientens respons.
English: • Treatment should be started at the lowest possible dose, and the dose should be adjusted in increments at 2- to 4-hour intervals if agitation continues, up to a maximum of 10 mg/day.
Danish: • Behandlingen skal startes med lavest mulige dosis, og dosis bør justeres gradvist med 2-4 timers mellemrum, hvis agitation vedvarer, op til maks.
English: Your doctor will decide how much Haldol you need and for how long.
Danish: Din læge beslutter, hvor meget Haldol du har brug for, og i hvor lang tid.
English: A decision must be made whether to discontinue breastfeeding or to discontinue HALDOL therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med HALDOL skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Since haloperidol is extensively metabolised in the liver, it is recommended to halve the initial dose.
Danish: Eftersom haloperidol i vid udstrækning metaboliseres i leveren, anbefales det at halvere startdosis.
English: • It is recommended to assess the individual benefit-risk when considering doses above 3 mg/day.
Danish: • Det anbefales at vurdere benefit/risk-forholdet individuelt, hvis doser over 3 mg/dag overvejes.
English: Table 2: Adverse reactions System Organ
Danish: Tabel 2: Bivirkninger Systemorganklasse
English: • Confused, disoriented, a headache, balance problems and feel sleepy.
Danish: • forvirring, desorientering, hovedpine, balanceproblemer og søvnighed.
English: • Swelling around the voice box or brief spasm of the vocal cords, which may cause difficulty speaking or breathing
Danish: • Hævelse omkring strubehovedet eller kortvarige spasmer i stemmebåndene, der kan give talebesvær eller vejrtrækningsbesvær
English: You must take the solution using the oral syringe.
Danish: Du skal tage opløsningen ved hjælp af den orale sprøjte.
English: • Your starting dose will normally be between 1 and 5 mg.
Danish: • Din startdosis vil normalt være mellem 1 og 5 mg.
English: The recommended initial haloperidol dose in elderly patients is half the lowest adult dose.
Danish: Den anbefalede startdosis af haloperidol til ældre patienter er halvdelen af den voksendosis.
English: Haldol is used in adults, adolescents and children for illnesses affecting the way you think, feel or behave.
Danish: Haldol bruges hos voksne, unge og børn for sygdomme, der påvirker tanker, følelser eller adfærd.
English: Haldol is sometimes used when other medicines or treatments have not worked or caused unacceptable side effects.
Danish: Haldol anvendes nogle gange, når andre lægemidler eller behandlinger ikke har virket eller har forårsaget bivirkninger i uacceptabel grad.