FrancophonIA/ELRC3.0 huggingface dataset:
English: Haloperidol metabolites are not considered to make a significant contribution to its activity, although for the reduced metabolite of haloperidol, back-conversion to haloperidol cannot be fully ruled out.
Danish: Det vurderes, at haloperidols metabolitter ikke bidrager til aktiviteten i signifikant grad, dog kan tilbagekonvertering af den reducerede haloperidolmetabolit til haloperidol ikke fuldstændigt udelukkes.
English: • Extra heart beats.
Danish: • ekstra hjerteslag.
English: It may be combined with antidepressants to treat those conditions in which depression and psychosis coexist (see section 4.5).
Danish: HALDOL kan kombineres med antidepressiva for at behandle tilstande med samtidig depression og psykose (se pkt.
English: However, patients with severe renal impairment may require a lower initial dose, with further doses administered and adjusted according to the patient's response (see section 5.2).
Danish: Patienter med svært nedsat nyrefunktion kan imidlertid have behov for en lavere startdosis, hvor efterfølgende doser administreres og justeres i henhold til patientens respons (se pkt.
English: • Your dose will normally be between 0.5 mg and 10 mg each day.
Danish: • Din dosis vil normalt være på mellem 0,5 mg og 10 mg hver dag.
English: The safety and efficacy of HALDOL tablets in children below the ages defined in the indications have not been established.
Danish: HALDOL-tabletters sikkerhed og virkning hos børn yngre end den alder, der er defineret i indikationerne, er ikke klarlagt.
English: • Certain gastrointestinal medicinal products (e.g. dolasetron).
Danish: • Visse gastrointestinale lægemidler (f.eks. dolasetron).
English: • High level of the hormone ‘prolactin' in the blood
Danish: • Højt indhold af hormonet prolaktin i blodet
English: Other medicines and Haldol
Danish: Brug af anden medicin sammen med Haldol
English: HALDOL must be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours (see section 5.3).
Danish: HALDOL skal anvendes med forsigtighed hos patienter med præeksisterende hyperprolaktinæmi og hos patienter med mulige prolaktinafhængige tumorer (se pkt.
English: • Your dose will normally be between 0.5 mg and 3 mg each day.
Danish: • Dosis vil normalt være mellem 0,5 mg og 3 mg hver dag.
English: HALDOL solution for injection is recommended for intramuscular use only (see section 4.4).
Danish: HALDOL injektionsvæske anbefales kun til intramuskulær anvendelse (se pkt.
English: • Certain other medicinal products (e.g. bepridil, methadone).
Danish: • Visse andre lægemidler (f.eks. bepridil, methadon).
English: Photosensitivity reaction Urticaria Pruritus Hyperhidrosis
Danish: Lysfølsomhedsreaktion Urticaria Pruritus Hyperhidrose
English: • Holding the lower ring, remove the whole oral syringe from the bottle (figure 3).
Danish: • Mens du holder på den nederste ring, skal du tage den orale sprøjte ud af flasken (figur 3).
English: • The amount of Haldol you take will then be adjusted until the doctor finds the dose that suits you best.
Danish: • Den mængde Haldol, som du tager, vil derefter blive justeret, indtil lægen finder den dosis, der passer bedst til dig.
English: The safety and efficacy of HALDOL oral solution in children below the ages defined in the indications have not been established.
Danish: HALDOL oral opløsnings sikkerhed og virkning hos børn yngre end den alder, der er defineret i indikationerne, er ikke klarlagt.
English: Austria, Belgium, Cyprus, France, Italy, Luxembourg, Netherlands, Portugal, Sweden, United Kingdom:
Danish: Østrig, Belgien, Cypern, Frankrig, Island, Italien, Luxembourg, Malta, Holland, Norge, Portugal, Rumænien, Sverige:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use only
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun til intramuskulær anvendelse Læs indlægssedlen inden brug.
English: Acute treatment of delirium when non-pharmacological treatments have failed
Danish: Akut behandling af delirium, når ikke-farmakologisk behandling har slået fejl
English: • Inflamed small blood vessels, leading to a skin rash with small red or purple bumps
Danish: • Betændelseslignende reaktion (inflammation) i de små blodkar med deraf følgende hududslæt med små røde eller lilla knuder
English: The safety and efficacy of HALDOL solution for injection in children and adolescents below 18 years of age have not been established.
Danish: Sikkerheden og virkningen af HALDOL injektionsvæske hos børn og unge under 18 år er ikke klarlagt.
English: • Cancer (such as toremifene and vandetanib).
Danish: • kræft (såsom toremifen og vandetanib).
English: Your doctor may advise you not to use Haldol while you are pregnant.
Danish: Lægen vil eventuelt anbefale, at du ikke bruger Haldol under graviditeten.
English: Neither presentation of HALDOL 2 mg/ml oral solution allows the whole range of recommended single doses to be measured.
Danish: Ingen af de to præsentationer af 2 mg/ml oral opløsning giver mulighed for at udmåle hele intervallet af anbefalede enkeltdoser.
English: Sudden death Face oedema Hypothermia
Danish: Pludselig død Ansigtsødem Hypotermi
English: Unless your doctor tells you otherwise, you should stop taking Haldol gradually.
Danish: Medmindre lægen fortæller noget andet, skal Haldol nedtrappes gradvist.
English: • Turn the bottle upside down over a spoon.
Danish: • Vend flasken med bunden opad over en ske.
English: • Swelling caused by fluid build up in the body.
Danish: • Hævelse som følge af væskeophobning i kroppen.
English: • Psychoses (such as fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine,
Danish: • psykoser (såsom fluphenazin, levomepromazin, perphenazin, pimozid, prochlorperazin,
English: • From postmarketing experience with haloperidol and haloperidol decanoate.
Danish: • Fra erfaring med haloperidol og haloperidoldecanoat efter markedsføring.
English: Talk to your doctor or pharmacist before taking Haldol if you are elderly, particularly if you have dementia.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Haldol, hvis du er ældre, især hvis du har demens.
English: • Persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated.
Danish: • Vedvarende, svær aggression hos børn og unge i alderen 6 til 17 år med autisme eller gennemgribende udviklingsforstyrrelser, når andre behandlinger har slået fejl eller ikke tolereres.
English: Your doctor may advise you not to take Haldol while you are pregnant.
Danish: Lægen vil eventuelt anbefale, at du ikke tager Haldol under graviditeten.
English: • Elderly people will normally start on half the lowest adult dose.
Danish: • Ældre mennesker får normalt en startdosis, der er halvt så stor som den laveste startdosis til voksne.
English: • Adjustments to the dose may be made every 1 to 7 days.
Danish: • Dosis kan justeres hver 1.-7. dag.
English: • Adjustments to the dose may be made every 1 to 3 days.
Danish: • Dosis kan justeres hver 1.-3. dag.
English: Caution is advised when HALDOL is used in combination with medicinal products known to cause electrolyte imbalance (see section 4.4).
Danish: Der skal udvises forsigtighed, hvis HALDOL anvendes i kombination med lægemidler, der vides at forårsage elektrolytforstyrrelser (se pkt.
English: If you forget to take Haldol
Danish: Hvis du har glemt at tage Haldol
English: The terminal elimination half-life of haloperidol is on average 24 hours (range of means 15 to 37 hours) after oral administration.
Danish: Haloperidols terminale eliminationshalveringstid efter oral administration er gennemsnitligt 24 timer (1537 timer).
English: • The recommended dose is 0.5 to 3 mg/day, administered orally in divided doses (2 to 3 times a day).
Danish: • De anbefalede dosis er 0,5-3 mg/dag oralt i delte doser (fordelt på 2 til 3 gange dagligt).
English: Treatment of persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated
Danish: Behandling af vedvarende, svær aggression hos børn og unge i alderen 6 til 17 år med autisme eller gennemgribende udviklingsforstyrrelser, når andre behandlinger har slået fejl eller ikke tolereres
English: Neither presentation of HALDOL 10 mg/ml oral solution allows the whole range of recommended single doses to be measured.
Danish: Ingen af de to præsentationer af 10 mg/ml oral opløsning giver mulighed for at udmåle hele intervallet af anbefalede enkeltdoser.
English: • Screw the oral syringe onto the bottle.
Danish: • Skru den orale sprøjte på flasken.
English: If you stop using Haldol
Danish: Hvis du holder op med at bruge Haldol
English: • Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer's dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others.
Danish: • Behandling af vedvarende aggression og psykotiske symptomer hos patienter med moderat til svær 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.
English: These have been reported in people taking antipsychotic medicines.
Danish: Der er rapporteret om sådanne blodpropper hos personer, der tager antipsykotiske lægemidler.
English: Since haloperidol is extensively metabolised in the liver, it is recommended to halve the initial dose, and adjust the dose with smaller increments and at longer intervals than in patients without hepatic impairment (see sections 4.4 and 5.2).
Danish: Eftersom haloperidol i vid udstrækning metaboliseres i leveren, anbefales det at halvere startdosis og justere dosis med mindre stigninger og længere intervaller end hos patienter uden nedsat leverfunktion (se pkt.
English: • Weight gain or loss
Danish: • Vægtstigning eller vægttab
English: You may need to be more closely monitored, and the amount of Haldol you are given may have to be altered.
Danish: Det kan være nødvendigt at holde dig under tættere overvågning eller at ændre din dosis af Haldol.
English: Do not use Haldol if:
Danish: Brug ikke Haldol:
English: Number of drops of HALDOL (dropper container)
Danish: Antal dråber HALDOL (dråbebeholder)
English: A high inter-subject variability in plasma concentrations was observed.
Danish: Der blev observeret en høj inter-individuel variabilitet i plasmakoncentrationerne.
English: However, if administered intravenously, continuous ECG monitoring must be performed for QTc interval prolongation and for ventricular arrhythmias.
Danish: Hvis injektionsvæsken imidlertid gives intravenøst, bør EKG monitoreres kontinuerligt for forlængelse af QTc-intervallet og ventrikulære arytmier.
English: Gradual withdrawal of haloperidol is advisable (see section 4.4).
Danish: Det tilrådes at nedtrappe behandlingen med haloperidol gradvist (se pkt.
English: Haldol contains the active substance haloperidol.
Danish: Haldol indeholder det aktive stof haloperidol.
English: Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer's dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others
Danish: Behandling af vedvarende aggression og psykotiske symptomer hos patienter med moderat til svær 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
English: The antidopaminergic effects of haloperidol on lactotropes in the anterior pituitary explain hyperprolactinaemia due to inhibition of dopamine-mediated tonic inhibition of prolactin secretion.
Danish: Haloperidols antidopaminerge virkning på laktotrope celler i hypofyseforlappen forklarer hyperprolanktinæmi (hæmning af den dopaminmedierede toniske hæmning af prolaktinsekretionen).
English: Bronchospasm Laryngeal oedema Laryngospasm
Danish: Larynxødem Larynxspasme
English: • The number of tablets you take will then be adjusted until the doctor finds the dose that suits you best.
Danish: • Det antal tabletter, du skal tage, vil derefter blive justeret, indtil lægen finder den dosis, der passer bedst til dig.
English: 2 mg/ml oral solution:
Danish: 2 mg/ml oral opløsning:
English: What you need to know before you take Haldol
Danish: Det skal du vide, før du begynder at tage Haldol
English: 10 mg/ml oral solution:
Danish: 10 mg/ml oral opløsning:
English: • Reported in clinical studies with haloperidol decanoate and relate to the active moiety.
Danish: • Rapporteret i kliniske studier med haloperidoldecanoat og relateret til den aktive lægemiddeldel.
English: • The need for continued treatment must be reassessed after 6 weeks.
Danish: • Behovet for fortsat behandling skal vurderes efter 6 uger.
English: If you are not sure, talk to your doctor or pharmacist before taking Haldol.
Danish: Hvis du er i tvivl, skal du tale med lægen eller apotekspersonalet, før du tager Haldol.
English: • The need for continued treatment must be reassessed after no more than 6 weeks.
Danish: • Behovet for fortsat behandling skal revurderes efter højst 6 uger.
English: Other medicines and Haldol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Haldol Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: • Problems breathing or feeding.
Danish: • vejrtrækningsproblemer eller spiseproblemer.
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.
Danish: Den reduktive metaboliseringsvej tegner sig imidlertid for ca. 23 % af biotransformationen, og tilbagekonvertering af den reducerede haloperidol-metabolit til haloperidol kan ikke fuldstændigt udelukkes.
English: • Lack of normal facial expression that sometimes looks like a mask.
Danish: • mangel på normal ansigtsmimik (maskeansigt).
English: For instructions on handling HALDOL solution for injection, see section 6.6.
Danish: For instruktioner om håndtering af HALDOL injektionsvæske, se pkt.
English: Trismus Muscle twitching
Danish: Trismus Muskeltrækninger
English: HALDOL and associated names (see Annex I) 1 mg tablets HALDOL and associated names (see Annex I) 2 mg tablets HALDOL and associated names (see Annex I) 4 mg tablets HALDOL and associated names (see Annex I) 5 mg tablets HALDOL and associated names (see Annex I) 10 mg tablets HALDOL and associated names (see Annex I) 20 mg tablets HALDOL and associated names (see Annex I) 2 mg/ml oral solution HALDOL and associated names (see Annex I) 10 mg/ml oral solution
Danish: HALDOL og relaterede navne (se bilag I) 1 mg tabletter HALDOL og relaterede navne (se bilag I) 2 mg tabletter HALDOL og relaterede navne (se bilag I) 4 mg tabletter HALDOL og relaterede navne (se bilag I) 5 mg tabletter HALDOL og relaterede navne (se bilag I) 10 mg tabletter HALDOL og relaterede navne (se bilag I) 20 mg tabletter HALDOL og relaterede navne (se bilag I) 2 mg/ml oral opløsning HALDOL og relaterede navne (se bilag I) 10 mg/ml oral opløsning
English: Tell your doctor straight away if you notice or suspect any of the following.
Danish: Fortæl det straks til lægen, hvis du bemærker eller har mistanke om noget af nedenstående.
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjældne (kan berøre op til 1 ud af 1.000 personer):
English: If you are not sure, talk to your doctor, pharmacist or nurse before being given Haldol.
Danish: Hvis du er i tvivl, skal du tale med lægen, apotekspersonalet eller sundhedspersonalet, før du får Haldol.
English: The active substance is haloperidol.
Danish: Aktivt stof: haloperidol.
English: Further doses may be administered and adjusted according to the patient's response (see sections 4.4 and 5.2).
Danish: Yderligere doser kan administreres og justeres i henhold til patientens respons (se pkt.
English: If you stop taking Haldol
Danish: Hvis du holder op med at tage Haldol
English: • Class III antiarrhythmics (e.g. amiodarone, dofetilide, dronedarone, ibutilide, sotalol).
Danish: • Klasse III-antiarytmika (f.eks. amiodaron, dofetilid, dronedaron, ibutilid, sotalol).
English: • Feeling agitated
Danish: • Føle sig oprevet
English: • Difficulty sleeping.
Danish: • søvnbesvær.
English: • Unscrew the oral syringe from the bottle by pushing the screw cap down while turning it anti-clockwise (figure 3).
Danish: • Skru den orale sprøjte af flasken ved at trykke skruelåget ned, mens du drejer det mod uret (figur 3).
English: A doctor or nurse will give this medicine to you, so it is unlikely that you will miss a dose or be given too much.
Danish: Hvis du har glemt en dosis eller har fået for meget Haldol Da du får dette lægemiddel af en læge eller sygeplejerske, er det ikke sandsynligt, at du glemmer en dosis eller får for meget.
English: What Haldol is and what it is used for What you need to know before you are given Haldol How to use Haldol
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Haldol Sådan skal du bruge Haldol Bivirkninger
English: • Treatment of moderate to severe manic episodes associated with bipolar I disorder.
Danish: • Behandling af moderate til svære maniske episoder i forbindelse med bipolar I-lidelse.
English: Do not take Haldol if you are taking certain medicines for:
Danish: Tag ikke Haldol, hvis du tager visse lægemidler mod:
English: Nonetheless, it is advised that in patients who are treated concomitantly with lithium and HALDOL, therapy must be stopped immediately if such symptoms occur.
Danish: Ikke desto mindre anbefales det at seponere behandlingen omgående, hvis sådanne symptomer opstår hos patienter i samtidig behandling med lithium og HALDOL.
English: Priapism Gynaecomastia
Danish: Priapisme Gynækomasti
English: Certain medicines may affect the way that Haldol works or may make heart problems more likely
Danish: Visse lægemidler kan påvirke virkningen af Haldol eller øge risikoen for hjerteproblemer Fortæl det til din læge, hvis du tager:
English: HALDOL and associated names (see Annex I) 1 mg tablets HALDOL and associated names (see Annex I) 2 mg tablets HALDOL and associated names (see Annex I) 4 mg tablets HALDOL and associated names (see Annex I) 5 mg tablets HALDOL and associated names (see Annex I) 10 mg tablets HALDOL and associated names (see Annex I) 20 mg tablets
Danish: HALDOL og relaterede navne (se bilag I) 1 mg tabletter HALDOL og relaterede navne (se bilag I) 2 mg tabletter HALDOL og relaterede navne (se bilag I) 4 mg tabletter HALDOL og relaterede navne (se bilag I) 5 mg tabletter HALDOL og relaterede navne (se bilag I) 10 mg tabletter HALDOL og relaterede navne (se bilag I) 20 mg tabletter
English: • 5 mg intramuscularly.
Danish: • 5 mg intramuskulært.
English: As a precautionary measure, it is preferable to avoid the use of HALDOL during pregnancy.
Danish: For en sikkerheds skyld bør HALDOL undgås under graviditet.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ DEN INDRE EMBALLAGE FLASKENS ETIKET
English: 8 drops
Danish: 8 dråber
English: Nervous system disorders
Danish: Nervesystemet Ekstrapyramidale forstyrrelser
English: Talk to your doctor before taking Haldol if you are taking any of these medicines.
Danish: Tal med lægen, før du tager Haldol, hvis du tager et eller flere af ovennævnte lægemidler.
English: 20 drops
Danish: 20 dråber
English: • Nausea and vomiting
Danish: • kvalme og opkastning
English: PHARMACEUTICAL FORM AND CONTENTS Oral solution [To be completed nationally]
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Oral opløsning [Udfyldes nationalt]
English: Combination treatment of postoperative nausea and vomiting when other medicinal products are ineffective or not tolerated
Danish: Kombinationsbehandling af postoperativ kvalme og opkastning, når andre lægemidler er virkningsløse eller ikke tolereres
English: • Combination treatment of postoperative nausea and vomiting when other medicinal products are ineffective or not tolerated.
Danish: • Kombinationsbehandling af postoperativ kvalme og opkastning, når andre lægemidler er virkningsløse eller ikke tolereres.
English: Package Leaflet for 10 mg/ml oral solution - bottle with oral syringe only: The HALDOL 10 mg/ml oral solution in a bottle with an oral syringe is intended to be used for doses of 5 mg haloperidol and above (equivalent to 0.5 ml and above).
Danish: Indlægsseddel til 10 mg/ml oral opløsning - kun flaske med oral sprøjte: HALDOL 10 mg/ml oral opløsning i en flaske med en oral sprøjte er beregnet til brug til doser på 5 mg haloperidol og derover (svarende til 0,5 ml og derover).
English: Photosensitivity reaction Urticaria Pruritus
Danish: Lysfølsomhedsreaktion Urticaria Pruritus
English: Haldol should not be used after the expiry date which is stated on the label and the carton.
Danish: Brug ikke Haldol efter den udløbsdato, der står på pakningen.
English: • Certain antidepressants (e.g. citalopram, escitalopram).
Danish: • Visse antidepressiva (f.eks. citalopram, escitalopram).
English: • 0.5 to 5 mg/day orally, as a single dose or in 2 divided doses.
Danish: • 0,5-5 mg/dag oralt som en enkelt dosis eller fordelt på 2 doser.
English: Do not throw away any medicines via wastewater <or household waste>.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: • Haldol is for oral use.
Danish: • Haldol tages gennem munden (oral anvendelse).
English: Reduced CYP2D6 enzyme activity may result in increased concentrations of haloperidol.
Danish: Reduceret CYP2D6-enzymaktivitet kan resultere i øgede haloperidol-koncentrationer.
English: Do not use Haldol if you are taking certain medicines for:
Danish: Du må ikke få Haldol, hvis du tager visse lægemidler mod:
English: • Class IA antiarrhythmics (e.g. disopyramide, quinidine).
Danish: • Klasse IA-antiarytmika (f.eks. disopyramid, kinidin).
English: HALDOL and associated names (see Annex I) 2 mg/ml oral solution HALDOL and associated names (see Annex I) 10 mg/ml oral solution
Danish: HALDOL og relaterede navne (se bilag I) 2 mg/ml oral opløsning HALDOL og relaterede navne (se bilag I) 10 mg/ml oral opløsning
English: • Sudden liver failure
Danish: • Pludseligt leversvigt
English: Treatment of moderate to severe manic episodes associated with bipolar I disorder
Danish: Behandling af moderate til svære maniske episoder i forbindelse med bipolar I-lidelse
English: • 2 to 5 mg intramuscularly.
Danish: • 2-5 mg intramuskulært.
English: • Certain medicinal products used in cancer (e.g. toremifene, vandetanib).
Danish: • Visse lægemidler mod cancer (f.eks. toremifen, vandetanib).
English: Treatment of tic disorders, including Tourette's syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed
Danish: Behandling af lidelser med tics, herunder Tourettes syndrom, hos børn og unge i alderen 10 til 17 år med svær sygdom, når pædagogisk, psykologisk og andre farmakologiske behandlinger har slået fejl
English: • 1 to 10 mg intramuscularly.
Danish: • 1-10 mg intramuskulært.
English: These measures will help protect the environment.
Danish: Dette kan forstærkes af alkohol.
English: Amenorrhoea Galactorrhoea Dysmenorrhoea Breast pain Breast discomfort
Danish: Amenoré Galaktoré Dysmenoré Brystsmerter Brystgener
English: The dose recommendations for HALDOL tablets are presented in Table 4.
Danish: Dosisanbefalingerne for HALDOL-tabletter er anført i tabel 4.
English: HALDOL and associated names (see Annex I) 5 mg/ml solution for injection
Danish: HALDOL og relaterede navne (se bilag I) 5 mg/ml injektionsvæske, opløsning