FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients must always be maintained on the minimal effective dose (see section 5.2).
Danish: Patienten skal altid have den mindste effektive vedligeholdelsesdosis (se pkt.
English: Sudden deaths have occurred in patients taking this medicine, but the exact frequency of these deaths is unknown.
Danish: Der er set pludseligt død hos patienter i behandling med dette lægemiddel, men den præcise hyppighed af disse dødsfald er ikke kendt.
English: Rhabdomyolysis
Danish: Rhabdomyolose
English: The possible increase in intraocular pressure must be considered when anticholinergic medicinal products, including antiparkinson medicinal products, are administered concomitantly with HALDOL.
Danish: Der skal tages højde for den potentielle stigning i det intraokulære tryk ved administration af antikolinerge lægemidler, herunder lægemidler mod Parkinsons sygdom, sammen med HALDOL.
English: Very rare: Not known:
Danish: Meget sjælden: <1/10.000 Ikke kendt:
English: • In adults to help control movements in Huntington's disease.
Danish: • til voksne for at hjælpe med at kontrollere bevægelser ved Huntingtons sygdom.
English: Careful and gradual dose up-titration in elderly patients is recommended.
Danish: En forsigtig og gradvis optitrering af dosis anbefales til ældre patienter.
English: Peak plasma concentrations of haloperidol are attained within 20 to 40 minutes.
Danish: Den maksimale plasmakoncentration af haloperidol opnås efter 20 til 40 minutter.
English: Special monitoring may be needed if you are using lithium and Haldol at the same time.
Danish: Du kan have brug for særlig overvågning, hvis du bruger lithium og Haldol på samme tid.
English: • High body temperature
Danish: • Høj kropstemperatur
English: There is a risk in the treatment of manic episodes of bipolar disorder for patients to switch from mania to depression.
Danish: Ved behandling af maniske episoder hos patienter med bipolar lidelse, er der risiko for, at de skifter fra mani til depression.
English: Haldol should not be used in children and adolescents below 18 years.
Danish: Haldol må ikke anvendes til børn og unge under 18 år.
English: Drinking alcohol while you are taking Haldol might make you feel sleepy and less alert.
Danish: Hvis du drikker alkohol, mens du tager Haldol, kan det bevirke, at du føler dig søvnig og bliver mindre opmærksom.
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including HALDOL, must be considered.
Danish: Hvis en patient udvikler tegn eller symptomer på tardiv dyskinesi, bør det overvejes at seponere alle antipsykotika, herunder HALDOL.
English: • Depression, or you have bipolar disorder and start to feel depressed.
Danish: • lider af depression eller har bipolar lidelse og begynder at føle dig deprimeret.
English: Adverse reaction frequencies are based on (or estimated from) clinical trials or epidemiology studies with haloperidol, and classified using the following convention:
Danish: Bivirkningernes hyppighed er baseret på (eller estimeret fra) kliniske forsøg eller epidemiologiske studier med haloperidol og klassificeret i henhold til følgende konvention:
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.
Danish: Din læge vil muligvis måle indholdet af kalium eller magnesium (eller andre salte (elektrolytter)) i dit blod før eller under behandlingen med Haldol.
English: Monitoring of patients for the switch to a depressive episode with the accompanying risks such as suicidal behaviour is important in order to intervene when such switches occur.
Danish: For at kunne intervenere under sådanne skift med de ledsagende risici såsom suicidal adfærd er det vigtigt at overvåge patienter for skift til depressive episoder.
English: You must be aware of serious side effects while you are taking Haldol because you may need urgent medical treatment.
Danish: Du skal være opmærksom på alvorlige bivirkninger, mens du tager Haldol, da du kan have brug for øjeblikkelig lægebehandling.
English: HALDOL has a moderate influence on the ability to drive and use machines.
Danish: HALDOL påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: • Inflamed liver, or liver problem that causes yellowing of the skin or eyes (jaundice)
Danish: • Leverbetændelse eller leverproblemer, der medfører gulfarvning af huden eller øjnene
English: 4.6 Fertility, pregnancy and lactation
Danish: 4.6 Fertilitet, graviditet and amning
English: During combination treatment with inducers of CYP3A4, it is recommended that patients be monitored and the HALDOL dose increased as deemed necessary.
Danish: Ved samtidig behandling med CYP3A4-induktorer anbefales det, at patienterne monitoreres, og at dosis af HALDOL øges efter behov.
English: • The maximum dose is 20 mg/day because safety concerns outweigh the clinical benefits of treatment at higher doses.
Danish: • Den maksimale døgndosis er 20 mg, da sikkerhedshensyn vejer tungere end de kliniske fordele ved behandling med højere doser.
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 3 gange højere risiko for cerebrovaskulære bivirkninger med visse atypiske antipsykotika.
English: Hyperprolactinaemia Inappropriate antidiuretic hormone secretion
Danish: Hyperprolaktinæmi Uhensigtsmæssig sekretion af antidiuretisk hormon
English: the number of millilitres (ml) is just visible (figure 2).
Danish: Gør dette, indtil det mærke, der svarer til antallet af milliliter (ml), lige netop er synligt (figur 2).
English: ECG monitoring is recommended up to 6 hours after administration of HALDOL solution for injection to patients for prophylaxis or treatment of postoperative nausea and vomiting.
Danish: EKG-monitorering anbefales op til 6 timer efter administration af HALDOL injektionsvæske som profylakse eller behandling af postoperativ kvalme og opkastning.
English: Haldol is used in adults for illnesses affecting the way you think, feel or behave.
Danish: Haldol bruges til voksne for sygdomme, der påvirker tanker, følelser eller adfærd.
English: The individual benefit-risk should be assessed when considering doses above 10 mg/day.
Danish: Benefit/risk-forholdet skal vurderes individuelt, hvis doser over 10 mg/dag overvejes.
English: • May be repeated hourly until sufficient symptom control is achieved or up to a maximum of
Danish: • Kan gentages hver time, indtil der opnås tilstrækkelig symptomkontrol eller op til maks.
English: It is recommended that patients who take haloperidol concomitantly with such medicinal products be monitored for signs or symptoms of increased or prolonged pharmacologic effects of haloperidol, and the HALDOL dose be decreased as deemed necessary.
Danish: Det anbefales, at patienter, der tager haloperidol sammen med sådanne lægemidler, monitoreres for symptomer på øgede eller forlængede farmakologiske virkninger af haloperidol, og at dosis af HALDOL om nødvendigt reduceres.
English: A linear relationship exists between haloperidol dose and plasma concentrations in adults.
Danish: Der eksisterer et lineært forhold mellem haloperidol-dosis og -plasmakoncentration hos voksne.
English: Convulsion Parkinsonism Sedation Muscle contractions involuntary
Danish: Kramper Parkinsonisme Sedation Ufrivillige muskelsammentrækninger
English: Also tell your doctor if you are taking any other medicines to lower blood pressure, such as water tablets (diuretics).
Danish: Du skal også fortælle det til lægen, hvis du tager blodtrykssænkende medicin, som f.eks. vanddrivende tabletter (diuretika).
English: Talk to your doctor about drinking alcohol while using Haldol, and let your doctor know how much you drink.
Danish: Tal med din læge om at drikke alkohol, mens du bruger Haldol, og fortæl lægen, hvor meget du drikker.
English: Talk to your doctor or pharmacist if you have:
Danish: Tal med lægen eller apotekspersonalet, hvis du:
English: • Low body temperature.
Danish: • Lav kropstemperatur.
English: Treatment of schizophrenia and schizoaffective disorder
Danish: Behandling af skizofreni og skizoaffektive lidelser
English: Special monitoring may be needed if you are taking lithium and Haldol at the same time.
Danish: Du kan have brug for særlig overvågning, hvis du tager lithium og Haldol på samme tid.
English: Haldol contains [To be completed nationally]
Danish: Haldol indeholder [Udfyldes nationalt]
English: Pancytopenia Agranulocytosis Thrombocytopenia Neutropenia
Danish: Pancytopeni Agranulocytose Trombocytopeni Neutropeni
English: • You will not be given more than a total of 5 mg each day unless your doctor decides a higher dose is needed.
Danish: • Du får ikke mere end 5 mg i alt om dagen med mindre din læge beslutter, at en højere dosis er nødvendig.
English: In patients with first-episode schizophrenia, therapeutic response may be obtained at concentrations as low as 0.6 to 3.2 ng/ml, as estimated based on measurements of D2 receptor occupancy and assuming that a D2 receptor occupancy level of 60 to 80% is most appropriate for obtaining therapeutic response and limiting extrapyramidal symptoms.
Danish: Hos patienter med første-episode skizofreni kan terapeutisk respons opnås ved koncentrationer, der er så lave som 0,6-3,2 ng/ml, estimeret ud fra målinger af D2-receptoroptagelse, og hvis det antages, at et D2receptoroptagelsesniveau på 60-80 % er bedst egnet til at opnå terapeutisk respons og begrænse ekstrapyramidale symptomer.
English: Talk to your doctor about drinking alcohol while taking Haldol, and let your doctor know how much you drink.
Danish: Tal med din læge om at drikke alkohol, mens du tager Haldol, og fortæl lægen, hvor meget du drikker.
English: HALDOL solution for injection is recommended for intramuscular administration only.
Danish: HALDOL injektionsvæske anbefales kun til intramuskulær administration.
English: Table 5: Adverse reactions
Danish: Tabel 5: Bivirkninger
English: Do not use this medicine after the expiry date which is stated on the bottle label or carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flaskens etiket eller pakningen.
English: The maximum dose in elderly patients is 5 mg/day.
Danish: Den maksimale dosis til ældre patienter er 5 mg/dag.
English: Additionally, the antidopaminergic effect on the chemoreceptor-trigger zone of the area postrema explains the activity against nausea and vomiting.
Danish: Derudover forklarer den antidopaminerge effekt på kemoreceptor-triggerzonen i area postrema virkningen ved kvalme og opkastning.
English: There have been very rare reports of acute withdrawal symptoms (including nausea, vomiting and insomnia) after abrupt withdrawal of high doses of antipsychotics.
Danish: Der har været meget sjældne rapporter om akutte seponeringsymptomer (herunder kvalme, opkastning og insomni) efter pludselig seponering af høje doser antipsykotika.
English: During therapy, the need for ECG monitoring for QTc interval prolongation and for ventricular arrhythmias must be assessed in all patients, but continuous ECG monitoring is recommended for repeated intramuscular doses.
Danish: Under behandlingen skal behovet for EKGmonitorering for forlængelse af QTc-intervallet og for ventrikulære arytmier evalueres hos alle patienter, men kontinuerlig EKG-monitorering anbefales ved gentagne intramuskulære doser.
English: • Your doctor may adjust this to find the dose that suits you best.
Danish: • Din læge vil muligvis justere dette for at finde den dosis, der passer bedst til dig.
English: Using the oral syringe from then on:
Danish: Sådan bruger du den orale sprøjte fra nu af:
English: Menorrhagia Menstrual disorder Sexual dysfunction
Danish: Menstruationsforstyrrelser Seksuel dysfunktion
English: • The maximum recommended dose is 5 mg/day.
Danish: • Den anbefalede maksimale dosis er 5 mg/dag.
English: Table 5 lists adverse reactions as follows:
Danish: Tabel 5 inkluderer følgende bivirkninger:
English: • Pull the oral syringe out of its case (figure 2).
Danish: • Træk den orale sprøjte ud af hylsteret (figur 2).
English: • The maximum dose is 15 mg/day because safety concerns outweigh the clinical benefits of treatment at higher doses.
Danish: • Den maksimale døgndosis er 15 mg, da sikkerhedshensyn vejer tungere end de kliniske fordele ved behandling med højere doser.
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.
Danish: Haloperidol er blevet forbundet med malignt neuroleptikasyndrom: Et sjældent idiosynkratisk respons, som er karakteriseret ved hypertermi, generaliseret muskelrigiditet, autonom ustabilitet, påvirket bevidsthedsniveau og forhøjet serumkreatinkinase.
English: Haldol and alcohol
Danish: Brug af Haldol sammen med alkohol
English: Table 2 lists adverse reactions as follows:
Danish: Tabel 2 inkluderer følgende bivirkninger:
English: After withdrawal of the CYP3A4 inducer, the concentration of haloperidol may gradually increase and therefore it may be necessary to reduce the HALDOL dose.
Danish: Efter seponering af CYP3A4-induktoren kan haloperidol-koncentrationen stige gradvist, og det kan derfor være nødvendigt at reducere dosis af HALDOL.
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 (angivet i afsnit 6)
English: Haldol can affect your ability to drive and use tools or machines.
Danish: Haldol kan påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: It is recommended that HALDOL is not used alone in patients in whom depression is predominant.
Danish: Det frarådes at anvende HALDOL som monoterapi hos patienter, hvor depression er fremherskende.
English: • Problems with vision, such as blurred vision
Danish: • Synsforstyrrelser, såsom sløret syn
English: A baseline ECG is recommended before intramuscular dosing.
Danish: Et baseline-EKG anbefales inden intramuskulær behandling.
English: • Low level of sugar in the blood
Danish: • Lavt blodsukker
English: • The highest dose elderly people should take is 5 mg each day unless your doctor decides a higher dose is needed.
Danish: • Den højeste dosis, som ældre mennesker må få, er 5 mg hver dag, medmindre din læge beslutter, at en højere dosis er nødvendig.
English: • Reported in clinical studies with haloperidol.
Danish: • Rapporteret i kliniske studier med haloperidol.
English: Do not take Haldol if:
Danish: Tag ikke Haldol, hvis:
English: HALDOL oral solution is for oral use.
Danish: HALDOL oral opløsning er til oral anvendelse.
English: HALDOL is contraindicated in combination with medicinal products known to prolong the QTc interval (see section 4.3).
Danish: HALDOL er kontraindiceret i kombination med lægemidler, der vides at forlænge QTc-intervallet (se pkt.
English: Then keep taking your medicine as your doctor has told you.
Danish: Fortsæt derefter med at tage lægemidlet efter lægens anvisning.
English: Do not use this medicine after the expiry date which is stated on the blister or carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet eller pakningen.
English: promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine and ziprasidone)
Danish: promazin, sertindol, thiorizadin, trifluoperazin, triflupromazin og ziprasidon)
English: Your doctor will tell you how much Haldol to take and for how long.
Danish: Lægen vil fortælle dig, hvor meget Haldol du skal tage, og i hvor lang tid.
English: Small amounts of haloperidol have been detected in plasma and urine of breast-fed newborns of mothers treated with haloperidol.
Danish: Små mængder haloperidol er påvist i plasma og urin hos nyfødte ammet af kvinder, som er i behandling med haloperidol.
English: Treatment response and withdrawal
Danish: Behandlingsrespons og seponering
English: A low initial dose is recommended, and this must be adjusted according to the patient's response in order to determine the minimal effective dose (see section 5.2).
Danish: Det anbefales at give en lav startdosis og derefter justere dosis i henhold til patientens respons for at fastsætte den mindste effektive dosis (se pkt.
English: • In adolescents and children aged 10 to 17 years and in adults for movements or sounds you can't control (tics), for example in severe Tourette's syndrome
Danish: • til unge og børn fra 10-17 år og til voksne mod bevægelser eller lyde, du ikke kan kontrollere (tics),
English: Haldol may be used on its own or with other medicine, and is sometimes used when other medicines or treatments have not worked, caused unacceptable side effects, or cannot be taken by mouth.
Danish: Haldol kan anvendes alene eller sammen med andre lægemidler og anvendes nogle gange, når andre lægemidler eller behandlinger ikke har virket eller har forårsaget uacceptable bivirkninger, eller patienten ikke kan tage lægemidler gennem munden.
English: Your doctor will discuss the risks and benefits of breast-feeding while you are taking Haldol.
Danish: Din læge vil tale med dig om risici og fordele ved at amme, mens du tager Haldol.
English: HALDOL must be used with caution in patients with risk factors for stroke.
Danish: HALDOL skal anvendes med forsigtighed hos patienter med risikofaktorer for apopleksi.
English: 1 drop
Danish: 1 dråbe
English: • The recommended doses are 0.5 to 3 mg/day in children aged 6 to 11 years and 0.5 to 5 mg/day in adolescents aged 12 to 17 years, administered orally in divided doses (2 to 3 times a day).
Danish: • Den anbefalede dosis er 0,5-3 mg/dag til børn i alderen 6 til 11 år og 0,5-5 mg/dag til unge i alderen 12 til 17 år, administreret oralt i delte doser (fordelt på 2-3 doser).
English: Your doctor will discuss the risks and benefits of breast-feeding while you are using Haldol.
Danish: Din læge vil tale med dig om risici og fordele ved at amme, mens du bruger Haldol.
English: • To prevent or treat nausea and vomiting (feeling and being sick) after surgery.
Danish: • til at forebygge eller behandle kvalme og opkastning efter en operation
English: The terminal elimination half-life of haloperidol is on average 21 hours (range 13 to 36 hours) after intramuscular administration.
Danish: Haloperidols terminale eliminationshalveringstid efter intramuskulær administration er gennemsnitligt 21 timer (13-36 timer).
English: • The need for continued treatment must be reassessed every 6 to 12 months.
Danish: • Behovet for fortsat behandling skal revurderes hver 6.-12. måned.
English: You must be aware of serious side effects while you are using Haldol because you may need urgent medical treatment.
Danish: Du skal være opmærksom på alvorlige bivirkninger, mens du er i behandling med Haldol, da du kan have brug for hurtig behandling.
English: • Screw the oral syringe back on the bottle.
Danish: • Skru den orale sprøjte tilbage på flasken.
English: As in adults, high inter-subject variability in plasma concentrations was observed.
Danish: Som hos voksne blev der observeret en høj inter-individuel variabilitet i plasmakoncentrationen.
English: Torticollis Muscle rigidity Muscle spasms Musculoskeletal stiffness
Danish: Torticollis Muskelrigiditet Muskelspasmer Muskuloskeletal stivhed
English: If concomitant treatment with an antiparkinson medicinal product is required, it may have to be continued after stopping HALDOL if its excretion is faster than that of haloperidol in order to avoid the development or aggravation of extrapyramidal symptoms.
Danish: Hvis samtidig behandling med antiparkinson-medicin er nødvendig, skal denne behandling muligvis fortsættes efter seponering af HALDOL, hvis antiparkinson-medicinen udskilles hurtigere end haloperidol, for at forhindre udvikling af ekstrapyramidale symptomer eller forværring af disse.
English: Peak plasma levels of haloperidol are generally attained within 2 to 6 hours of oral dosing.
Danish: Den maksimale plasmakoncentration af haloperidol opnås generelt inden for 2 til 6 timer efter oral administration.
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, Cyprus, France, Iceland, Italy, Luxembourg, Netherlands, Norway, Sweden, United Kingdom:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Østrig, Belgien, Cypern, Frankrig, Italien, Luxembourg, Holland, Portugal, Sverige, Storbritannien:
English: Talk to your doctor before being given Haldol if you are elderly, particularly if you have dementia.
Danish: Tal med lægen, før du får Haldol, hvis du er ældre, især hvis du lider af demens.
English: There is insufficient information on the effects of haloperidol in breast-fed infants.
Danish: Der er utilstrækkelige data vedrørende virkningerne af haloperidol hos ammede spædbørn.
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: • Elderly people will normally start on 0.5 mg each day or half the lowest adult dose.
Danish: • Ældre mennesker får normalt en startdosis på 0,5 mg dagligt eller en dosis, der er halvt så stor som den laveste startdosis til voksne.
English: Neuroleptic malignant syndrome Motor dysfunction Nystagmus
Danish: Malignt neuroleptikasyndrom Motorisk dysfunktion Nystagmus
English: Hepatitis Jaundice
Danish: Hepatitis Gulsot
English: If you took Haldol while pregnant and your baby develops any of these side effects, contact your doctor.
Danish: Hvis du tog Haldol under graviditeten, og dit barn får en eller flere af disse bivirkninger, skal du kontakte lægen.
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.
Danish: Analyse af sytten placebokontrollerede studier (modal varighed på 10 uger), hovedsageligt med patienter, der tog atypiske antipsykotika, viste at dødsrisikoen for behandlede patienter var 1,6-1,7 gange højere end for patienter i placebogruppen.
English: • Thinning the blood (phenindione).
Danish: • blodpropper (phenindion).
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.
Danish: • Lad tommelfingeren blive på prikken og bræk spidsen af ampullen samtidig med, at du holder den anden del af ampullen godt fast i hånden.
English: • Acute treatment of delirium when non-pharmacological treatments have failed.
Danish: • Akut behandling af delirium, når ikke-farmakologisk behandling har slået fejl.
English: • Schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated.
Danish: • Skizofreni hos unge i alderen 13 til 17 år, når andre farmakologiske behandlinger har slået fejl eller ikke tolereres.
English: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotics.
Danish: Tilfælde af venøs tromboemboli, herunder tilfælde af lungeemboli og tilfælde af dyb venetrombose, er blevet rapporteret under behandling med antipsykotika.
English: If patients miss a dose, it is recommended that they take the next dose as usual, and do not take a double dose.
Danish: Hvis patienten springer en dosis over/glemmer at tage en dosis, anbefales det, at den næste dosis tages som sædvanligt.