FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP agreed that Durogesic can be used in adults to treat severe long-term pain that requires continuous treatment with opioid medicines, whether or not the pain is caused by cancer.
Danish: CHMP vedtog, at Durogesic kan anvendes hos voksne til behandling af svære langvarige smerter, der kræver uafbrudt behandling med opioide lægemidler, uanset om smerterne skyldes kræft.
English: Durogesic must not be used to relieve severe short-term pain or pain resulting from an operation.
Danish: Durogesic må ikke anvendes til lindring af svære kortvarige smerter eller smerter efter operation.
English: Durogesic can also be used to treat severe long-term pain in children from 2 years of age who are already being treated with opioids.
Danish: Durogesic kan desuden bruges til behandling af langvarige smerter hos børn fra 2 års-alderen, som i forvejen er i behandling med opioider.
English: Durogesic is a medicine used to relieve severe long-term pain in adults and children from 2 years of age.
Danish: Durogesic er et lægemiddel til lindring af svære, langvarige smerter hos voksne og børn fra 2 årsalderen.
English: Tables to work out the appropriate dose of Durogesic when switching from other opioids taken by mouth or given by injection have been included in the harmonised SmPC.
Danish: Det harmoniserede produktresumé indeholder tabeller til beregning af den korrekte dosis af Durogesic ved skift fra andre opioide lægemidler, der tages gennem munden eller gives ved injektion.
English: However, adult patients who cannot take opioids by mouth and for whom Durogesic is considered the only option could be given the patch with the lowest dose.
Danish: Dog kan voksne patienter bruge plastret med den laveste dosis, hvis de ikke kan tage opioide lægemidler gennem munden, eller hvis Durogesic anses for at være den eneste mulighed.
English: Durogesic patches release enough fentanyl to be fatal if not used appropriately, especially for a child; sufficient fentanyl remains in the patch to cause severe effects even after it has been used.
Danish: Durogesic depotplastre frigiver tilstrækkeligt fentanyl til at være livsfarlige, hvis de ikke anvendes rigtigt, navnlig for et barn.
English: Durogesic was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1.
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh) fandt, at der er behov for harmonisering for Durogesic1.
English: This list is not exhaustive.
Danish: Denne liste er ikke udtømmende.
English: Most of these symptoms were reversible.
Danish: De fleste af disse symptomer var reversible.
English: Your doctor will decide how to treat this
Danish: Lægen vil beslutte, hvordan dette skal behandles
English: These illnesses may make you:
Danish: Disse sygdomme kan få dig til at:
English: Treatment is supportive.
Danish: Behandlingen er understøttende.
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Østrig:
English: • You are less aware of things around you or your reactions become unusually slow
Danish: • du er mindre opmærksom på ting omkring dig, eller dine reaktioner bliver usædvanligt langsomme
English: The manifestations may be permanent in some patients.
Danish: Manifestationerne kan være permanente hos nogle patienter.
English: This medicine must not be used if any of the above applies to you.
Danish: Dette lægemiddel må ikke bruges, hvis noget af ovenstående gælder for dig.
English: This is most likely to occur within the first few weeks of treatment.
Danish: Der er størst sandsynlighed for dette i de første par uger af behandlingen.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Danish: Dette produktresumé er resultatet af referralproceduren, som denne afgørelse fra Kommissionen vedrører.
English: Patients must always be maintained on the lowest effective dose.
Danish: Patienten skal altid holdes på laveste effektive dosis.
English: Adults aged 18 years and above
Danish: Voksne på 18 år og derover
English: Iceland, Norway, Sweden:
Danish: Island, Norge, Sverige:
English: Consequently, it is recommended that newborn infants be monitored carefully.
Danish: Det anbefales derfor at nyfødte overvåges nøje.
English: Severe allergic reaction that may include:
Danish: Alvorlig allergisk reaktion, som kan omfatte:
English: Problems with the heart:
Danish: Problemer med hjertet:
English: Respiratory depression may necessitate artificial respiration.
Danish: Respirationsdepression kan kræve kunstig respiration.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres efter behov af de relevante myndigheder i medlemsstaten i samarbejde med referencemedlemsstaten i henhold til de procedurer, der er fastsat i afsnit III, kapitel 4 i direktiv 2001/83/EF.
English: Hyperthermia is often an early sign of this syndrome.
Danish: Hypertermi er ofte et tidligt tegn på dette syndrom.
English: You may need urgent medical treatment.
Danish: Du kan have behov for øjeblikkelig lægebehandling.
English: Hypertension rather than hypotension is also possible.
Danish: Hypertension snarere end hypotension er også mulig.
English: cannot be estimated from the available data.
Danish: kan ikke estimeres ud fra forhåndenværende data.
English: How much medicine will you be given
Danish: Så meget medicin vil du få
English: Males and younger age groups are at higher risk of experiencing such reactions.
Danish: Mænd og yngre aldersgrupper har højere risiko for sådanne reaktioner.
English: The frequency is unknown.
Danish: Hyppigheden er ukendt.
English: An increased risk cannot be excluded for other patient populations.
Danish: Det kan ikke udelukkes, at risikoen er øget hos andre patientpopulationer.
English: • You will not be given more than 300 mg every 4 weeks.
Danish: • Du vil ikke få mere end 300 mg hver 4. uge.
English: • Severe allergic reactions (adrenaline)
Danish: • alvorlige allergiske reaktioner (adrenalin)
English: It remains unclear whether this represents a distinct clinical entity.
Danish: Det er uvist, om dette udgør en bestemt klinisk helhed.
English: • Feel unusually suspicious (paranoia)
Danish: • føle dig usædvanligt mistroisk (paranoia)
English: • Being unable to move
Danish: • manglede evne til at bevæge sig
English: As the administration of volumes greater than 3 ml is uncomfortable for the patient, such large volumes are not recommended.
Danish: Da administration af voluminer over 3 ml er ubehagelige for patienten, frarådes sådanne store voluminer.
English: • Feel very aggressive, hostile or violent.
Danish: • føle dig meget aggressiv, fjendtlig eller voldelig
English: The exact frequency of these problems is unknown.
Danish: Den præcise hyppighed af disse problemer er ukendt.
English: A baseline ECG is recommended before treatment.
Danish: Et baseline-EKG anbefales inden behandlingen.
English: It is recommended to alternate between the two gluteal muscles.
Danish: Det anbefales at veksle mellem de to sædemuskler.
English: It can also cause severe allergic reactions and blood clots.
Danish: Det kan også forårsage alvorlige allergiske reaktioner og blodpropper.
English: • You have a type of dementia called ‘Lewy body dementia'
Danish: • du har en type demens, der kaldes ”Lewy Body demens”
English: See ‘Look out for serious side effects' in section 4.
Danish: Se afsnittet ”Vær opmærksom på alvorlige bivirkninger” i afsnit 4.
English: It is recommended that ECG and vital signs be monitored, and that monitoring continues until the ECG is normal.
Danish: Det anbefales at monitorere EKG og vitale tegn og at fortsætte monitoreringen, indtil EKG er normaliseret.
English: Pregnancy - if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice.
Danish: Graviditet - Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds.
English: Very common: ≥1/10 Common:
Danish: Meget almindelig: ≥ 1/10 Almindelig:
English: • See, hear, feel or smell things that are not there (hallucinations)
Danish: • se, høre, føle eller lugte ting, der ikke findes (hallucinationer)
English: This means you should be careful how much alcohol you drink.
Danish: Du skal derfor være forsigtig med at drikke alkohol.
English: • Your age
Danish: • din alder
English: venlafaxine.
Danish: venlafaxin.
English: Sudden deaths have occurred in patients using this medicine, but the exact frequency of these deaths is unknown.
Danish: Der er set pludselig død hos patienter i behandling med dette lægemiddel, men den præcise hyppighed af disse dødsfald er ikke kendt.
English: Mean haloperidol plasma protein binding in adults is approximately 88 to 92%.
Danish: Den gennemsnitlige proteinbinding af haloperidol hos voksne er cirka 88 til 92 %.
English: On average, concentrations in this range would be obtained with doses of 1 to 4 mg daily.
Danish: Gennemsnitligt kan koncentrationer i dette område opnås med doser på 1 til 4 mg dagligt.
English: • High or low body temperature
Danish: • Høj eller lav kropstemperatur
English: • Feel confused (delirium)
Danish: • føle dig forvirret (delirium)
English: Tell your doctor straight away and stop taking both medicines if you get:
Danish: Fortæl det straks til lægen, og stop med at tage begge lægemidler, hvis du oplever:
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Danish: Hos patienter, der udvikler disse symptomer, kan det være skadeligt at øge dosis.
English: These include mental health problems (such as schizophrenia).
Danish: Det gælder blandt andet mentale lidelser (såsom skizofreni).
English: This belongs to a group of medicines called ‘antipsychotics'.
Danish: Det tilhører en gruppe lægemidler, der kaldes antipsykotika.
English: • Difficulty or being unable to open the mouth
Danish: • Besvær med eller manglende evne til at åbne munden
English: It is used for illnesses affecting the way you think, feel or behave.
Danish: Det anvendes mod sygdomme, der påvirker tanker, følelser eller adfærd.
English: There is a high inter-subject variability for plasma protein binding.
Danish: Der er en høj interindividuel variabilitet i plasmaproteinbindingen.
English: • You have Parkinson's disease
Danish: • du har Parkinsons sygdom
English: It is administered as a deep intramuscular injection in the gluteal region.
Danish: Det administreres som en dyb intramuskulær injektion i glutealregionen.
English: These intravenous doses, which prolonged QTc, did not cause arrhythmias.
Danish: Disse intravenøse doser, der forlængede QTc, forårsagede ikke arytmier.
English: • How you have reacted to haloperidol in the past
Danish: • hvordan du har reageret på haloperidol tidligere
English: Depression Insomnia
Danish: Depression Insomni
English: Talk to your doctor if you have any questions about this.
Danish: Kontakt lægen, hvis du har spørgsmål om dette.
English: • You have heart failure or recently had a heart attack
Danish: • du har hjertesvigt eller har haft et hjerteanfald for nylig
English: The following problems may occur in newborn babies of mothers that use Haldol Decanoate in the last 3 months of their pregnancy (the last trimester):
Danish: Følgende problemer kan opstå hos nyfødte, hvis mødre har fået Haldol Dekanoat i de sidste 3 måneder af graviditeten (sidste trimester):
English: Steady state plasma levels are reached within 2 to 4 months in patients receiving monthly injections.
Danish: Steady state-plasmaniveauer nås efter 2-4 måneder hos patienter, der får månedlige indsprøjtninger.
English: • Upward movement of the eyes or fast eye movements that you cannot control
Danish: • Opadgående bevægelser af øjet eller hurtige øjenbevægelser, som du ikke kan kontrollere
English: Patients with depression
Danish: Patienter med depression
English: It is recommended that patients be advised not to drive or operate machines during treatment, until their susceptibility is known.
Danish: Det anbefales at informere patienterne om ikke at føre motorkøretøj eller betjene maskiner, før deres følsomhed er klarlagt.
English: • A maximum dose of 300 mg every 4 weeks must not be exceeded because the safety concerns outweigh the clinical benefits of treatment.
Danish: • Den maksimale dosis må ikke overstige 300 mg hver 4. uge, fordi sikkerhedsproblemerne vejer tungere end de kliniske fordele ved behandlingen.
English: Your doctor will adjust the dose to suit you, and may also give you a type of haloperidol that you take by mouth.
Danish: Din læge vil tilpasse dosis til dine behov og vil eventuelt også give dig en type haloperidol, som du skal tage gennem munden.
English: • Persistent and painful erection of the penis
Danish: • Langvarig og smertefuld rejsning af penis
English: Your doctor will decide how much Haldol Decanoate you need and for how long.
Danish: Din læge beslutter, hvor meget Haldol Dekanoat du skal have og i hvor lang tid.
English: The plasma concentrations rise gradually, usually peaking within 3 to 9 days after injection.
Danish: Plasmakoncentrationen stiger gradvist og når som regel det maksimale niveau 3 til 9 dage efter injektionen.
English: The syndrome may be masked when treatment is reinstituted, when the dose is increased or when a switch is made to a different antipsychotic.
Danish: Syndromet kan maskeres, når behandlingen genoptages, når dosis øges, eller når der skiftes til et andet antipsykotikum.
English: • Feel very excited, agitated, enthusiastic, impulsive or hyperactive
Danish: • føle dig opstemt, urolig, entusiastisk, impulsiv eller hyperaktiv
English: Class effects of antipsychotics
Danish: Klasseeffekter for antipsykotika
English: A doctor or nurse will give this medicine to you, so it is unlikely that you will be given too much.
Danish: Da du får dette lægemiddel af en læge eller sygeplejerske, er det usandsynligt, at du får for meget.
English: The risk of these events appears to increase with high doses, high plasma concentrations, in predisposed patients or with parenteral use, particularly intravenous administration.
Danish: Risikoen for disse hændelser synes at være øget ved høje doser, høje plasmakoncentrationer, hos prædisponerede patienter og ved parenteral anvendelse, især intravenøs administration.
English: • Changes in menstrual cycle (periods), such as no periods, or long, heavy, painful periods
Danish: • Ændringer i menstruationscyklus, såsom manglende menstruation eller langvarige, kraftige og smertefulde menstruationer
English: Treatment initiation and dose titration must be carried out under close clinical supervision.
Danish: Indledning af behandling og dosistitrering skal udføres under tæt klinisk overvågning.
English: • Progressive supranuclear palsy.
Danish: • Progressiv supranukleær parese.
English: • You will only be given a higher dose than 75 mg every 4 weeks if your doctor decides it is safe to do so.
Danish: • Du vil kun få en højere dosis end 75 mg hver 4. uge, hvis din læge beslutter, at det er sikkert.
English: It is for intramuscular use, and is given as an injection deep into a muscle.
Danish: Det er til intramuskulær anvendelse, hvilket betyder, at det gives som en indsprøjtning dybt ind i en muskel.
English: In extreme cases, the patient would appear comatose with respiratory depression and hypotension that could be severe enough to produce a shock-like state.
Danish: I ekstreme tilfælde kan patienten virke komatøs med respirationsdepression og hypotension i så svær grad, at det fremkalder en shock-lignende tilstand.
English: • Serious mental health problem, such as believing things that are not true (delusions) or seeing, feeling, hearing or smelling things that are not there (hallucinations)
Danish: • Alvorlige mentale problemer, såsom at tro på ting, der ikke findes (vrangforestillinger), eller se, føle, høre eller lugte ting, som ikke er der (hallucinationer)
English: This association may be stronger for haloperidol than for atypical antipsychotic medicinal products, is most pronounced in the first 30 days after the start of treatment, and persists for at least 6 months.
Danish: Denne association kan være mere udtalt for haloperidol end for atypiske antipsykotika, er mest udtalt i de første 30 dage efter behandlingsstart og varer ved i mindst 6 måneder.
English: • Difficulty getting and keeping an erection (impotence)
Danish: • Problemer med at få og opretholde rejsning (impotens)
English: The following side effects have also been reported, but their exact frequency is unknown:
Danish: Der er også indberettet følgende bivirkninger, men den præcise hyppighed af disse bivirkninger er ikke kendt:
English: • It is recommended to assess the individual benefit-risk when considering doses above 200 mg every 4 weeks.
Danish: • Det anbefales, at det individuelle benefit/risk-forhold vurderes, hvis det overvejes at anvende doser over 200 mg hver 4. uge.
English: • Uncertain mechanism - buspirone.
Danish: • Uvis mekanisme - buspiron.
English: Increased mortality in elderly people with dementia
Danish: Øget dødelighed hos ældre med demens
English: The relationship between dose and plasma haloperidol level is approximately linear for doses below 450 mg.
Danish: Forholdet mellem dosis og plasmaniveauet af haloperidol er omtrent lineært for doser under 450 mg.
English: Problems controlling movements of the body or limbs (extrapyramidal disorder), such as:
Danish: Problemer med at kontrollere kropsbevægelser (ekstrapyramidale forstyrrelser), såsom:
English: Haldol Decanoate will be given by a doctor or nurse.
Danish: Du vil få Haldol Dekanoat af en læge eller sygeplejerske.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of local tolerability, repeat dose toxicity and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af lokal tolerabilitet, toksicitet efter gentagne doser og genotoksicitet.
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: A moderate amount of data on pregnant women (more than 400 pregnancy outcomes) indicate no malformative or foeto/ neonatal toxicity of haloperidol.
Danish: En moderat mængde data fra gravide kvinder (mere end 400 fødsler) indikerer ingen haloperidolrelaterede misdannelser eller føtal/neonatal toksicitet.
English: Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Danish: Selvom dødsårsagen varierede, var de fleste dødsfald tilsyneladende af enten kardiovaskulær karakter (f.eks. hjertesvigt, pludselig død) eller infektiøs karakter (f.eks. pneumoni).
English: This increase may be higher with all butyrophenones, including haloperidol.
Danish: Denne øgede risiko kan være højere med alle butyrophenoner, herunder haloperidol.
English: • Breast problems, such as: o Pain or discomfort o Unexpected production of breast milk o Enlarged breasts in men
Danish: • Brystproblemer såsom: o Smerter eller ubehag o Uventet produktion af brystmælk o Brystforstørrelse hos mænd
English: Annex III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: Bilag III PRODUKTRESUMÉ, MÆRKNING OG INDLÆGSSEDDEL
English: A single dose of Haldol Decanoate will normally last for 4 weeks.
Danish: En enkelt dosis Haldol Dekanoat varer normalt i 4 uger.
English: Haloperidol plasma concentrations in elderly patients were higher than in younger adults administered the same dose.
Danish: Plasmakoncentration af haloperidol var højere hos ældre patienter end hos yngre voksne, der fik administreret den samme dosis.
English: • Uncorrected hypokalaemia.
Danish: • Ukorrigeret hypokaliæmi.
English: Elderly people and people with dementia
Danish: Ældre og personer med demens
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 inter-individuelle variabilitet (variationskoefficient, %) i haloperidol-clearance blev estimeret til 44 % i en populationsfarmakokinetisk analyse af patienter med skizofreni.
English: After intravenous haloperidol administration, 21% of the dose was eliminated in the faeces and 33% in the urine.
Danish: Efter intravenøs administration af haloperidol blev 21 % af dosis elimineret i fæces og 33 % i urin.
English: Haloperidol is rapidly distributed to various tissues and organs, as indicated by the large volume of distribution (mean values 8 to 21 l/kg after intravenous dosing).
Danish: Haloperidol fordeles hurtigt til forskellige væv og organer, hvilket det store distributionsvolumen vidner om (gennemsnitsværdier på 8 til 21 l/kg efter intravenøs administration).
English: Although no clear association with the administration of antipsychotics and human breast tumours has been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.
Danish: Selvom der ikke er påvist nogen klar forbindelse mellem administration af antipsykotika og humane brysttumorer i kliniske og epidemiologiske studier, skal der udvises forsigtighed hos patienter med en relevant anamnese.
English: • Low blood pressure, or feel dizzy upon sitting up or standing up
Danish: • har lavt blodtryk eller føler dig svimmel, når du sætter dig op eller rejser dig op
English: Special monitoring may be needed if you are using lithium and Haldol Decanoate at the same time.
Danish: Du kan have brug for særlig overvågning, hvis du bruger lithium og Haldol Dekanoat på samme tid.
English: If you get any of these effects, you may be given an additional medicine.
Danish: Hvis du får en eller flere af disse bivirkninger, vil du eventuelt få yderligere medicin.
English: Effect of haloperidol on other medicinal products
Danish: Haloperidols virkning på andre lægemidler
English: Do not drive or use any tools or machines without discussing this with your doctor first.
Danish: Du må ikke føre motorkøretøj eller betjene maskiner, før du har drøftet det med din læge.
English: This is because small amounts of the medicine may pass into the mother's milk and on to the baby.
Danish: Små mængder af medicinen kan nemlig gå over i mælken og dermed overføres til barnet.
English: The risk of ventricular arrhythmias, possibly associated with QTc prolongation, must be considered.
Danish: Risikoen for ventrikulære arytmier, muligvis forbundet med QTc-forlængelse, skal tages i betragtning.
English: Therapeutic concentrations
Danish: Terapeutiske koncentrationer
English: • A slow heart beat, heart disease or anyone in your close family has died suddenly of heart problems
Danish: • har langsomme hjerteslag, hjertesygdom, eller hvis nogen i din nærmeste familie pludseligt er døde som følge af hjerteproblemer
English: • A low level of potassium or magnesium (or other ‘electrolyte') in your blood.
Danish: • har lavt niveau af kalium eller magnesium (eller andre salte (elektrolytter)) i blodet.
English: It also crosses the placenta and is excreted in breast milk.
Danish: Det passerer også placenta og udskilles i human mælk.
English: In cases of severe extrapyramidal reactions, it is recommended that an antiparkinson medicinal product be administered, and continued for several weeks.
Danish: I tilfælde af svære ekstrapyramidale reaktioner anbefales administration af et antiparkinsonmiddel, som fortsættes i flere uger.
English: Treatment of severe arrhythmias with appropriate anti-arrhythmic measures is recommended.
Danish: Det anbefales at behandle svær arytmi med passende antiarytmiske tiltag.