FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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: • Lidelser med tics, herunder Tourettes syndrom, hos børn og unge i alderen 10 til 17 år med svære grader af sygdommen, når pædagogisk, psykologisk og anden farmakologisk behandling har slået fejl.
English: HALDOL should be used with caution in patients who are known poor metabolisers of cytochrome P450 (CYP) 2D6 and who are coadministered a CYP3A4 inhibitor.
Danish: Patienter med betydeligt nedsat CYP2D6-aktivitet - poor CYP2D6-metabolisers HALDOL skal anvendes med forsigtighed hos patienter, som vides at være poor CYP2D6-metabolisers og som samtidig får en CYP3A4-hæmmer.
English: 4 drops
Danish: 4 dråber
English: Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder
Danish: Behandling af akut psykomotorisk agitation i forbindelse med psykose eller maniske episoder ved bipolar I-lidelse
English: It is rare in people taking Haldol (may affect up to 1 in 1,000 people).
Danish: Det forekommer sjældent hos personer, der får Haldol (kan berøre op til 1 ud af 1.000 personer).
English: The maximum dose is 5 mg/day.
Danish: Den maksimale døgndosis er 5 mg.
English: Therefore, dose adjustment and caution is advised in patients with hepatic impairment (see sections 4.2 and 4.4).
Danish: Derfor tilrådes dosisjustering og forsigtighed hos patienter med nedsat leverfunktion (se pkt.
English: 10 drops
Danish: 10 dråber
English: • Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate.
Danish: • Hurtig kontrol af svær akut psykomotorisk agitation i forbindelse med psykose eller maniske episoder ved bipolar I-lidelse, når behandling med orale midler ikke er egnet.
English: • Treatment of tic disorders, including Tourette's syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed.
Danish: • Behandling af lidelser med tics, herunder Tourettes syndrom, hos patienter med svære grader af sygdommen, når pædagogisk, psykologisk og anden farmakologisk behandling har slået fejl.
English: What Haldol contains The active substance is haloperidol.
Danish: Haldol indeholder: Aktivt stof: haloperidol.
English: The dose recommendations for HALDOL tablets are presented in Table 1.
Danish: Dosisanbefalingerne for HALDOL-tabletter er anført i tabel 1.
English: 6 drops
Danish: 6 dråber
English: Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated, and oral therapy is not appropriate
Danish: Behandling af lette til moderate grader af Huntingtons chorea, når andre lægemidler er virkningsløse eller ikke tolereres, og behandling med orale midler ikke er egnet
English: How to use Haldol
Danish: Sådan skal du bruge Haldol
English: • 1 to 10 mg/day orally, as a single dose or in 2 to 3 divided doses.
Danish: • 1-10 mg/dag oralt som en enkelt dosis eller fordelt på 2 til 3 doser.
English: • Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder.
Danish: • Behandling af akut psykomotorisk agitation i forbindelse med psykose eller maniske episoder ved bipolar I-lidelse.
English: Talk to your doctor or nurse before being given Haldol if you are taking any of these medicines.
Danish: Tal med lægen eller sundhedspersonalet, før du får Haldol, hvis du tager et eller flere af ovennævnte lægemidler.
English: A decrease in CYP2D6 enzyme activity may result in increased haloperidol concentrations.
Danish: Et fald i CYP2D6enzymaktivitet kan resultere i øget haloperidol-koncentration.
English: • Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated.
Danish: • Behandling af lette til moderate grader af Huntingtons chorea, når andre lægemidler ikke er effektive eller ikke tolereres.
English: Treatment of tic disorders, including Tourette's syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed
Danish: Behandling af lidelser med tics, herunder Tourettes syndrom, hos patienter med svære grader af sygdommen, når pædagogisk, psykologisk og anden farmakologisk behandling har slået fejl
English: The HALDOL 2 mg/ml oral solution in a bottle with an oral syringe is intended to be used for single doses of 0.5 mg haloperidol and above (equivalent to 0.25 ml and above).
Danish: HALDOL 2 mg/ml oral opløsning i en flaske med en oral sprøjte er beregnet til brug ved enkeltdoser på 0,5 mg haloperidol og derover (svarende til 0,25 ml og derover).
English: • The dose will then be adjusted until the doctor finds the dose that suits you best.
Danish: • Dosis justeres så, indtil lægen finder den bedst egnede dosis.
English: Your doctor may have to change your dose of Haldol if you are taking any of these medicines.
Danish: Hvis du tager et eller flere af disse lægemidler, vil lægen eventuelt ændre din dosis af Haldol.
English: • Single or combination prophylaxis in patients at moderate to high risk of postoperative nausea and vomiting, when other medicinal products are ineffective or not tolerated.
Danish: • Profylakse (monoterapi eller kombinationsbehandling) hos patienter med moderat til høj risiko for postoperativ kvalme og opkastning, når andre lægemidler er virkningsløse eller ikke tolereres.
English: • 2 to 10 mg/day orally, as a single dose or in 2 divided doses.
Danish: • 2-10 mg/dag oralt, som en enkelt dosis eller fordelt på 2 doser.
English: 5 drops
Danish: 5 dråber
English: • Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated, and oral therapy is not appropriate.
Danish: • Behandling af lette til moderate grader af Huntingtons chorea, når andre lægemidler er virkningsløse eller ikke tolereres, og behandling med orale midler ikke er egnet.
English: • Remove the cap from the bottle by pushing the screw cap down while turning it anti-clockwise (figure 1).
Danish: • Tag låget af flasken ved at trykke skruelåget ned, mens du drejer det mod uret (figur 1).
English: Weight increased Weight decreased
Danish: Vægtstigning Vægtreduktion
English: • 1 to 2 mg intramuscularly.
Danish: • 1-2 mg intramuskulært.
English: Treatment of mild to moderate chorea in Huntington's disease, when other medicinal products are ineffective or not tolerated
Danish: Behandling af lette til moderate grader af Huntingtons chorea, når andre lægemidler ikke er effektive eller ikke tolereres
English: How to take Haldol
Danish: Sådan skal du tage Haldol
English: Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate
Danish: Hurtig kontrol af svær akut psykomotorisk agitation i forbindelse med psykose eller maniske episoder ved bipolar I-lidelse, når behandling med orale midler ikke er egnet.
English: Following intramuscular administration, haloperidol is completely absorbed.
Danish: Haloperidol absorberes fuldstændigt efter intramuskulær administration.
English: The HALDOL 10 mg/ml oral solution in a bottle with an oral syringe is intended to be used for single doses of 5 mg haloperidol and above (equivalent to 0.5 ml and above).
Danish: HALDOL 10 mg/ml oral opløsning i en flaske med en oral sprøjte er beregnet til brug ved enkeltdoser på 5 mg haloperidol og derover (svarende til 0,5 ml og derover).
English: Single or combination prophylaxis in patients at moderate to high risk of postoperative nausea and vomiting, when other medicinal products are ineffective or not tolerated
Danish: Profylakse (monoterapi eller kombinationsbehandling) hos patienter med moderat til høj risiko for postoperativ kvalme og opkastning, når andre lægemidler er virkningsløse eller ikke tolereres
English: • Serious mental health problem, such as believing things that are not true (delusions) or seeing,
Danish: • Alvorlige mentale problemer, såsom vrangforestillinger (at tro på ting, der ikke findes) eller hallucinationer (at se, føle, høre eller lugte ting, som ikke er der)
English: These are very common in people using Haldol (may affect more than 1 in 10 people).
Danish: Disse bivirkninger er meget almindelige hos personer i behandling med Haldol (kan berøre flere end 1 ud af 10 personer).
English: Ventricular fibrillation Torsade de pointes Ventricular tachycardia Extrasystoles
Danish: Ventrikulær takykardi Ekstrasystoler
English: These medicines may make heart problems more likely, so talk to your doctor if you are taking any of these and do not take Haldol (see ‘Do not take Haldol if').
Danish: Hvis du tager et eller flere af disse lægemidler, skal du tale med lægen og undlade at tage Haldol (se ”Tag ikke Haldol, hvis”).
English: As haloperidol is metabolised by the liver, dose adjustment and caution is advised in patients with hepatic impairment (see sections 4.2 and 5.2).
Danish: Eftersom haloperidol metaboliseres i leveren, tilrådes det at justere dosis og at udvise forsigtighed hos patienter med nedsat leverfunktion (se pkt.
English: The HALDOL 10 mg/ml oral solution in a dropper container is intended to be used for single doses up to 10 mg haloperidol (20 drops).
Danish: HALDOL 10 mg/ml opløsning i dråbebeholder er beregnet til brug ved enkeltdoser på op til 10 mg haloperidol (20 dråber).
English: • Certain antimalarials (e.g. halofantrine).
Danish: • Visse midler mod malaria (f.eks. halofantrin).
English: These medicines may make heart problems more likely, so talk to your doctor if you are taking any of these and do not use Haldol (see ‘Do not use Haldol if').
Danish: Hvis du bruger et eller flere af disse lægemidler skal du tale med lægen, og undlade at bruge Haldol (se ”Brug ikke Haldol”).
English: • The recommended doses are 0.5 to 3 mg/day in children and adolescents aged 10 to 17 years,
Danish: • Den anbefalede dosis til børn og unge i alderen 10 til 17 år er 0,5-3 mg/dag oralt i delte doser
English: Package Leaflet for 10 mg/ml oral solution - bottle with oral syringe only:
Danish: Indlægsseddel til 10 mg/ml oral opløsning - kun flaske med oral sprøjte:
English: • Certain antifungals (e.g. pentamidine).
Danish: • Visse antimykotika (f.eks. pentamidin).
English: The dose recommendations for HALDOL solution for injection are presented in Table 1.
Danish: Dosisanbefalingerne for HALDOL injektionsvæske er anført i tabel 1.
English: The HALDOL 2 mg/ml oral solution in a dropper container is intended to be used for single doses up to 2 mg haloperidol (equivalent to 20 drops).
Danish: HALDOL 2 mg/ml opløsning i dråbebeholder er beregnet til brug ved enkeltdoser på op til 2 mg haloperidol (svarende til 20 dråber).
English: Package Leaflet for 2 mg/ml oral solution - bottle with oral syringe only:
Danish: Indlægsseddel til 2 mg/ml oral opløsning - kun flaske med oral sprøjte:
English: ≥1/1,000 to <1/100
Danish: ≥1/100 til <1/10 Ikke almindelig: ≥1/1.000 til <1/100
English: The dose recommendations for HALDOL oral solution are presented in Table 4.
Danish: Dosisanbefalingerne for HALDOL oral opløsning er anført i tabel 4.
English: The number of drops or quantity (ml) required to achieve a given single dose using HALDOL 10 mg/ml oral solution is presented in Table 3.
Danish: Antallet af dråber eller mængden (i ml), der skal bruges for at opnå en given enkeltdosis ved brug af HALDOL 10 mg/ml oral opløsning, er angivet i tabel 3.
English: The dose recommendations for HALDOL oral solution are presented in Table 1.
Danish: Dosisanbefalingerne for HALDOL oral opløsning er anført i tabel 1.
English: The number of drops or quantity (ml) required to achieve a given single dose using HALDOL 2 mg/ml oral solution is presented in Table 2.
Danish: Antallet af dråber eller mængden (i ml), der skal bruges for at opnå en given enkeltdosis ved brug af HALDOL 2 mg/ml oral opløsning, er angivet i tabel 2.
English: Conversion table for HALDOL 10 mg/ml oral solution mg haloperidol ml HALDOL (bottle with oral syringe)
Danish: Konverteringstabel for HALDOL 10 mg/ml oral opløsning mg haloperidol ml HALDOL (flaske med oral sprøjte)
English: Cardiac arrest (the heart stops beating) has also occurred in people taking antipsychotic medicines.
Danish: Der er også forekommet hjertestop hos personer i behandling med antipsykotiske lægemidler.
English: Conversion table for HALDOL 2 mg/ml oral solution mg haloperidol ml HALDOL (bottle with oral syringe)
Danish: Konverteringstabel for HALDOL 2 mg/ml oral opløsning mg haloperidol ml HALDOL (flaske med oral sprøjte)
English: Contents of the pack and other information What Haldol contains The active substance is haloperidol.
Danish: Pakningsstørrelser og yderligere oplysninger Haldol indeholder:
English: As haloperidol is metabolised by the liver, half the initial dose and caution is advised in patients with hepatic impairment (see sections 4.2 and 5.2).
Danish: Eftersom haloperidol metaboliseres i leveren, bør startdosis halveres, og der bør udvises forsigtighed hos patienter med nedsat leverfunktion (se pkt.
English: • Remove the cap from the bottle by pushing down on the cap while turning it anti-clockwise (figure 1).
Danish: • Tag låget af flasken ved at trykke ned på låget, mens du drejer det mod uret (figur 1).
English: • Difficulty sleeping
Danish: • Føle sig søvnig
English: Therefore, half the initial dose and caution is advised in patients with hepatic impairment (see sections 4.2 and 4.4).
Danish: Derfor tilrådes det at halvere startdosis og at udvise forsigtighed hos patienter med nedsat leverfunktion (se pkt.
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 5 mg/ml solution for injection [See Annex I - To be completed nationally]
Danish: HALDOL og relaterede navne (se bilag I) 5 mg/ml injektionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: 2 drops
Danish: 2 dråber
English: • Fits (seizures)
Danish: • kløende udslæt (nældefeber)
English: 3 drops
Danish: 3 dråber
English: Conversion table for HALDOL 10 mg/ml oral solution mg haloperidol
Danish: Konverteringstabel for HALDOL 10 mg/ml oral opløsning mg haloperidol
English: administered orally in divided doses (2 to 3 times a day).
Danish: (fordelt på 2-3 doser).
English: Excipient
Danish: Udslæt
English: An allergic reaction is uncommon in people taking Haldol (may affect up to 1 in 100 people).
Danish: Allergiske reaktioner er ikke almindelige hos personer, der tager Haldol (kan berøre op til 1 ud af 100 personer).
English: Conversion table for HALDOL 2 mg/ml oral solution mg haloperidol
Danish: Konverteringstabel for HALDOL 2 mg/ml oral opløsning mg haloperidol
English: • Remove the cap from the bottle by pushing down on the cap while turning it anti-clockwise.
Danish: • Tag låget af flasken ved at trykke ned på låget, mens du drejer det mod uret.
English: Acute hepatic failure
Danish: Akut leversvigt Kolestase
English: Heart problems are uncommon in people taking Haldol (may affect up to 1 in 100 people).
Danish: Hjerteproblemer er ikke almindelige hos personer, der tager Haldol (kan berøre op til 1 ud af 100 personer).
English: Package Leaflet for 10 mg/ml oral solution - dropper container only:
Danish: Indlægsseddel til 10 mg/ml oral opløsning - kun dråbebeholder:
English: How to store Haldol
Danish: Sådan får du Haldol
English: Constipation Dry mouth Salivary hypersecretion
Danish: Forstoppelse Tør mund Hypersalivation
English: Liver function test abnormal
Danish: Unormale leverfunktionst est
English: Treatment with HALDOL solution for injection must be discontinued as soon as clinically indicated and, if further treatment is needed, oral haloperidol should be initiated at a 1:1 dose conversion rate followed by dose adjustment according to clinical response.
Danish: Såfremt der er behov for yderligere behandling, bør oral haloperidol iværksættes med en dosis- konverteringsratio på
English: An allergic reaction is uncommon in people using Haldol (may affect up to 1 in 100 people).
Danish: Allergiske reaktioner er ikke almindelige hos personer, der får Haldol (kan berøre op til 1 ud af 100 personer).
English: The quantity (ml) required to achieve a given single dose using HALDOL 10 mg/ml oral solution is presented below.
Danish: Den mængde (ml), der skal bruges for at opnå en given enkeltdosis ved brug af HALDOL 10 mg/ml oral opløsning, er angivet nedenfor.
English: The number of drops required to achieve a given single dose using HALDOL 10 mg/ml oral solution is presented below.
Danish: Antallet af dråber, der skal bruges for at opnå en given enkeltdosis ved brug af HALDOL 10 mg/ml oral opløsning, er angivet nedenfor.
English: The quantity (ml) required to achieve a given single dose using HALDOL 2 mg/ml oral solution is presented below.
Danish: Den mængde (ml), der skal bruges for at opnå en given enkeltdosis ved brug af HALDOL 2 mg/ml oral opløsning, er angivet nedenfor.
English: The number of drops required to achieve a given single dose using HALDOL 2 mg/ml oral solution is presented below.
Danish: Antallet af dråber, der skal bruges for at opnå en given enkeltdosis ved brug af HALDOL 2 mg/ml oral opløsning, er angivet nedenfor.
English: Cholestasis
Danish: Brudniveau
English: Package Leaflet for 2 mg/ml oral solution - dropper container only:
Danish: Indlægsseddel til 2 mg/ml oral opløsning - kun dråbebeholder:
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 5 mg/ml solution for injection [See Annex I - To be completed nationally] haloperidol
Danish: HALDOL og relaterede navne (se bilag I) 5 mg/ml injektionsvæske, opløsning [Se bilag I - Udfyldes nationalt] haloperidol
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 10 mg/ml oral solution [See Annex I - To be completed nationally] haloperidol
Danish: HALDOL og relaterede navne (se bilag I) 10 mg/ml oral opløsning [Se bilag I - Udfyldes nationalt] haloperidol
English: If you miss a dose or have too much Haldol
Danish: Hvis du har taget for meget Haldol
English: Tablet [To be completed nationally]
Danish: Hjælpestof [Udfyldes nationalt]
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 2 mg/ml oral solution [See Annex I - To be completed nationally] haloperidol
Danish: HALDOL og relaterede navne (se bilag I) 2 mg/ml oral opløsning [Se bilag I - Udfyldes nationalt] haloperidol
English: (ml).
Danish: (gulsot)
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 20 mg tablets [See Annex I - To be completed nationally] haloperidol
Danish: HALDOL og relaterede navne (se bilag I) 20 mg tabletter [Se bilag I - Udfyldes nationalt] haloperidol
English: Treatment of schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated
Danish: Tabel 4: Dosisanbefalinger for haloperidol til den pædiatriske population Behandling af skizofreni hos unge i alderen 13 til 17 år, når andre farmakologiske behandlinger har slået fejl eller ikke tolereres
English: Table 3: Conversion table for HALDOL 10 mg/ml oral solution mg haloperidol Number of drops of HALDOL (dropper container)
Danish: Tabel 3: Konverteringstabel for HALDOL 10 mg/ml oral opløsning mg haloperidol
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 2 mg tablets [See Annex I - To be completed nationally] haloperidol
Danish: LÆGEMIDLETS NAVN og relaterede navne (se bilag I) 2 mg tabletter [Se bilag I - Udfyldes nationalt] haloperidol
English: Table 2: Conversion table for HALDOL 2 mg/ml oral solution mg haloperidol Number of drops of HALDOL (dropper container)
Danish: Tabel 2: Konverteringstabel for HALDOL 2 mg/ml oral opløsning mg haloperidol
English: Treatment withdrawal
Danish: Behandling med
English: Renal impairment
Danish: Hypertermi Ødem
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 10 mg tablets [See Annex I - To be completed nationally] haloperidol
Danish: HALDOL og relaterede navne (se bilag I) 10 mg tabletter [Se bilag I - Udfyldes nationalt] haloperidol
English: • Empty the contents onto a spoon.
Danish: • Tøm indholdet ned i en ske.
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 5 mg tablets [See Annex I - To be completed nationally] haloperidol
Danish: HALDOL og relaterede navne (se bilag I) 5 mg tabletter [Se bilag I - Udfyldes nationalt] haloperidol
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 1 mg tablets [See Annex I - To be completed nationally] haloperidol
Danish: HALDOL og relaterede navne (se bilag I) 1 mg tabletter [Se bilag I - Udfyldes nationalt] haloperidol
English: Breastfeeding
Danish: Kramper
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 4 mg tablets [See Annex I - To be completed nationally] haloperidol
Danish: HALDOL og relaterede navne (se bilag I) 4 mg tabletter [Se bilag I - Udfyldes nationalt] haloperidol
English: PACKAGE LEAFLET
Danish: • Hudafskalning
English: <Other sources of information> <Detailed information on this medicine is available on the website of {MS/Agency}>
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelssen.dk.
English: 4 drops mg haloperidol Number of drops of HALDOL (dropper container)
Danish: 4 dråber mg haloperidol
English: In addition, there was no reason why the medicine would work in one group of patients and not in others.
Danish: Endvidere var det ikke begrundet, hvorfor lægemidlet skulle virke hos én gruppe af patienter og ikke hos andre.
English: The company that applied for authorisation is AB Science.
Danish: Den virksomhed, der har indgivet ansøgningen, er AB Science.
English: It had requested a re-examination of the opinion but later withdrew its request.
Danish: AB Science havde anmodet om en revurdering af udtalelsen, men har senere trukket denne anmodning tilbage.
English: Furthermore, an inspection at two of the study sites showed deficiencies in the way the study was conducted, which cast doubt on the integrity of the data.
Danish: En inspektion på to af forsøgscentrene viste desuden mangler i den måde, hvorpå studiet blev gennemført, hvorfor dataenes integritet kunne betvivles.
English: Alsitek is a medicine that contains the active substance masitinib.
Danish: Alsitek er et lægemiddel, der indeholder det aktive stof masitinib.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i et klinisk studie eller i et program for anvendelse med særlig udleveringstilladelse og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der behandler dig.
English: Although a positive effect on symptoms was seen in the group of patients whose disease worsened at a normal rate compared with those whose disease worsened rapidly, the CHMP considered that this way of classifying patients was arbitrary and did not reflect clinical practice.
Danish: Selvom der sås en positiv effekt på symptomerne i den gruppe patienter, hvis sygdom forværredes i normalt tempo, sammenholdt med de patienter, hvis sygdom forværredes hurtigt, vurderede CHMP, at denne måde at klassificere patienterne på var vilkårlig og ikke afspejlede klinisk praksis.
English: What is Alsitek?
Danish: Hvad er Alsitek?
English: What was Alsitek expected to be used for?
Danish: Hvad forventedes Alsitek anvendt til?
English: Refusal of the marketing authorisation for Alsitek (masitinib) EMA/207380/2018
Danish: Afslag på ansøgningen om markedsføringstilladelse for Alsitek (masitinib) EMA/207380/2018