FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: Indehaver af markedsføringstilladelsen og fremstiller [Se bilag I - Udfyldes nationalt] {Navn og adresse} <{tlf.}> <{fax}> <{e-mail}>
English: • Ketoconazole tablets (to treat Cushing's syndrome)
Danish: • Ketoconazol-tabletter (mod Cushings syndrom)
English: Due to the high inter-subject variability in haloperidol pharmacokinetics and the concentration-effect relationship, it is recommended to adjust the individual haloperidol decanoate dose based on the patient's response.
Danish: På grund af den store inter-individuelle variabilitet i haloperidols farmakokinetik og forholdet mellem koncentration og virkning anbefales det at justere den individuelle dosis af haloperidoldecanoat på basis af patientens respons.
English: Your doctor will discuss the risks and benefits of breast-feeding while you are using Haldol Decanoate.
Danish: Din læge vil tale med dig om risici og fordele ved at amme, mens du bruger Haldol Dekanoat.
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 serum-kreatinkinase.
English: No dose adjustment is recommended, but caution is advised when treating patients with renal impairment.
Danish: Dosisjustering anbefales ikke, men der skal udvises forsigtighed ved behandling af patienter med nedsat nyrefunktion.
English: Do not use Haldol Decanoate if:
Danish: Brug ikke Haldol Dekanoat, hvis:
English: In patients with first-episode schizophrenia treated with short-acting haloperidol formulations, 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, der behandles med korttidsvirkende haloperidolformuleringer, kan det terapeutiske respons opnås ved koncentrationer ned til 0,6 til 3,2 ng/ml baseret på målinger af D2-receptoroptagelse, og idet det antages, at et D2-receptor optagelsesniveau på 60 til 80 % er mest hensigtsmæssigt for at opnå terapeutisk respons og begrænse ekstrapyramidale symptomer.
English: In addition, the safety of haloperidol was evaluated in 284 haloperidol-treated patients who participated in 3 placebo-controlled clinical studies and in 1295 haloperidol-treated patients who participated in 16 double-blind active comparator-controlled clinical studies.
Danish: Derudover er sikkerheden af haloperidol vurderet hos 284 haloperidol-behandlede patienter, som deltog i 3 placebo-kontrollerede kliniske studier, og hos 1.295 haloperidol-behandlede patienter, som deltog i 16 dobbeltblinde studier med aktiv kontrol.
English: Haloperidol may antagonise the action of adrenaline and other sympathomimetic medicinal products (e.g. stimulants like amphetamines) and reverse the blood pressure-lowering effects of adrenergic-blocking medicinal products such as guanethidine.
Danish: Haloperidol kan antagonisere virkningen af adrenalin og andre sympatomimetiske midler (f.eks. stimulanser såsom amfetaminer) og ophæve den blodtrykssænkende virkning af adrenerge blokkere, som f.eks. guanethidin.
English: Haloperidol decanoate is an ester of haloperidol and decanoic acid, and as such, a depot antipsychotic belonging to the butyrophenones group.
Danish: Haloperidoldecanoat er en ester af haloperidol og decansyre og som sådan et antipsykotisk depotpræparat tilhørende butyrophenon-gruppen.
English: Measurement of haloperidol blood concentrations may be considered in individual cases.
Danish: Måling af haloperidolkoncentrationen i blodet kan overvejes individuelt.
English: • The most effective dose is expected to range between 25 and 75 mg.
Danish: • Den mest effektive dosis forventes at være mellem 25 og 75 mg.
English: Newborn infants exposed to antipsychotics (including haloperidol) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Danish: Nyfødte, der har været eksponeret for antipsykotika (inklusive haloperidol) under tredje trimester af graviditeten, har risiko for at få bivirkninger inklusive ekstrapyramidale og/eller seponeringssymptomer i varierende sværhedsgrad og varighed efter fødslen.
English: Dialysis is not recommended in the treatment of overdose because it removes only very small amounts of haloperidol (see section 5.2).
Danish: Dialyse anbefales ikke til behandling af overdosering, da kun meget små mængder haloperidol fjernes (se pkt.
English: • Indinavir, ritonavir or saquinavir (for human immunodeficiency virus or HIV)
Danish: • Indinavir, ritonavir eller saquinavir (mod humant immundefektvirus (HIV))
English: Dystonic symptoms can include, but are not limited to, torticollis, facial grimacing, trismus, tongue protrusion, and abnormal eye movements, including oculogyric crisis.
Danish: Dystoniske symptomer kan omfatte, men er ikke begrænset til, torticollis, ansigtsgrimasser, trismus, tungeprotrusion og unormale øjenbevægelser, herunder okulogyr krise.
English: Haloperidol inhibits the metabolism of tricyclic antidepressants (e.g. imipramine, desipramine), thereby increasing plasma concentrations of these medicinal products.
Danish: Haloperidol hæmmer metaboliseringen af tricykliske antidepressiva (f.eks. imipramin, desipramin), hvorved plasmakoncentrationen af disse lægemidler stiger.
English: There is insufficient information on the effects of haloperidol in breast-fed infants.
Danish: Der er utilstrækkelige oplysninger om virkningerne af haloperidol hos ammede spædbørn.
English: Haloperidol can increase the CNS depression produced by alcohol or CNS-depressant medicinal products, including hypnotics, sedatives or strong analgesics.
Danish: Haloperidol kan potensere CNS-depression forårsaget af alkohol eller CNS-supprimerende lægemidler, herunder hypnotika, sedativa og stærke analgetika.
English: Talk to your doctor if you have:
Danish: Tal med lægen, hvis du:
English: Haldol Decanoate contains the active substance haloperidol (as haloperidol decanoate).
Danish: Haldol Dekanoat indeholder det aktive stof haloperidol (som haloperidoldecanoat).
English: Belgium, France, Italy, Luxembourg, Netherlands: Haldol Decanoas Cyprus, Ireland, Malta, United Kingdom:
Danish: Belgien, Frankrig, Italien, Luxembourg, Holland:
English: • Lowering blood pressure (such as guanethidine and methyldopa)
Danish: • for højt blodtryk (såsom guanethidin og methyldopa)
English: Transition from oral haloperidol
Danish: Skift fra oral haloperidol
English: A serious problem called ‘neuroleptic malignant syndrome'.
Danish: Et alvorligt problem kaldet malignt neuroleptikasyndrom.
English: However, patients with severe renal impairment may require a lower initial dose, with subsequent adjustments at smaller increments and at longer intervals than in patients without renal impairment (see section 5.2).
Danish: Patienter med svært nedsat nyrefunktion kan imidlertid have behov for en lavere startdosis med efterfølgende justeringer i mindre trin og med længere mellemrum end hos patienter uden nedsat nyrefunktion (se pkt.
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 Decanoate dose be decreased as deemed necessary.
Danish: Det anbefales, at patienter, der tager haloperidol sammen med sådanne lægemidler, monitoreres nøje for symptomer på øgede eller forlængede farmakologiske virkninger af haloperidol, og at dosis af HALDOL Dekanoat om nødvendigt reduceres.
English: These tumours may be caused by prolonged dopamine D2 antagonism and hyperprolactinaemia.
Danish: Disse tumorer kan være forårsaget af langvarig dopamin-D2antagonisme og hyperprolaktinæmi.
English: As the initial dose of haloperidol decanoate is based on a multiple of the daily oral haloperidol dose, specific guidance on switching from other antipsychotics cannot be provided (see section 5.1).
Danish: Da den indledende dosis haloperidoldecanoat er baseret på et multiplum af den daglige orale haloperidoldosis, kan der ikke gives nogen specifik vejledning om skift fra andre antipsykotika (se pkt.
English: Haldol Decanoate is used in adults whose condition has previously been treated with haloperidol taken by mouth.
Danish: Haldol Dekanoat anvendes til voksne, som tidligere har fået behandling med haloperidol, der tages gennem munden.
English: Endocrine system concerns
Danish: Det endokrine system
English: • Depression (such as citalopram and escitalopram)
Danish: • depression (såsom citalopram og escitalopram)
English: Antipsychotic therapy in patients with hyperthyroidism must be used only with caution and must always be accompanied by therapy to achieve a euthyroid state.
Danish: Hos patienter med hypertyreoidisme skal antipsykotisk behandling altid anvendes med forsigtighed og ledsages af behandling for at opnå en eutyroid tilstand.
English: • The combined total dose of haloperidol from both formulations must not exceed the corresponding maximum oral haloperidol dose of 5 mg/day or the previously administered oral haloperidol dose in patients who have received long-term treatment with oral haloperidol.
Danish: • Den samlede totale dosis af haloperidol fra begge formuleringer må ikke overstige den tilsvarende maksimale orale haloperidoldosis på 5 mg/dag eller den tidligere administrerede orale haloperidoldosis hos patienter, som har modtaget langvarig behandling med oral haloperiodol.
English: Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma or concentrated albumin and vasopressor agents, such as dopamine or noradrenaline.
Danish: Hypotension og kredsløbskollaps kan modvirkes med intravenøs indgift af væske, plasma eller koncentreret albumin samt med vasopressorer såsom dopamin eller noradrenalin.
English: Adults • Your starting dose will normally be between 25 mg and 150 mg.
Danish: • Din startdosis vil normalt være mellem 25 mg og 150 mg.
English: Tell your doctor if you are taking:
Danish: Fortæl det til din læge, hvis du tager:
English: The possible increase in intraocular pressure must be considered when anticholinergic medicinal products, including antiparkinson medicinal products, are administered concomitantly with HALDOL Decanoate.
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 Dekanoat.
English: • Usually 4 weeks between injections.
Danish: • Det sædvanlige interval mellem injektionerne er 4 uger.
English: Antiparkinson medicinal products must be withdrawn very cautiously as extrapyramidal symptoms may emerge.
Danish: Antiparkinsonmidler skal seponeres meget forsigtigt, da der kan opstå ekstrapyramidale symptomer.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Danish: Der er blevet rapporteret agitation, hypertoni, hypotoni, tremor, døsighed, åndedrætsbesvær og problemer med at tage føde til sig.
English: Caution is recommended when haloperidol is administered to patients manifesting hypotension or orthostatic hypotension.
Danish: Det anbefales at udvise forsigtighed ved administration af haloperidol til patienter med hypotension eller ortostatisk hypotension.
English: Acute dystonia may occur during the first few days of treatment with haloperidol, but later onset as well as onset after dose increases has been reported.
Danish: Akut dystoni kan indtræde i løbet af de første par dage af behandlingen med haloperidol, men senere indtræden samt indtræden efter dosisøgning er rapporteret.
English: Less than 3% of the dose is excreted unchanged in the urine.
Danish: Mindre end 3 % af dosis udskilles uomdannet i urinen.
English: The major pathways are glucuronidation and ketone reduction.
Danish: De vigtigste metaboliseringsveje er glukuronidering og ketonreduktion.
English: For comatose patients, a patent airway must be established by use of an oropharyngeal airway or endotracheal tube.
Danish: Hos komatøse patienter skal der etableres frie luftveje ved hjælp af en orofaryngeal luftvej eller endotrakealtube.
English: • Abnormal muscle tension
Danish: • Unormal muskelspænding
English: • Pain (strong pain killers)
Danish: • smerter (stærke smertestillende midler)
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 Decanoate.
Danish: Din læge vil muligvis måle indholdet af kalium eller magnesium (eller andre salte (elektrolytter)) i dit blod før eller under behandlingen med Haldol Dekanoat.
English: Therefore, baseline and periodic electrolyte monitoring is recommended.
Danish: Det anbefales derfor at monitorere elektrolytter ved baseline og regelmæssigt under behandlingen.
English: After intramuscular injection, haloperidol decanoate is gradually released from muscle tissue and hydrolysed slowly into free haloperidol, which enters the systemic circulation.
Danish: Efter intramuskulær injektion frigives haloperidoldecanoat gradvist fra muskelvæv og hydrolyseres langsomt til frit haloperidol, som går over i det systemiske kredsløb.
English: • Itraconazole, posaconazole or voriconazole (for fungal infections)
Danish: • Itraconazol, posaconazol eller voriconazol (mod svampe-infektioner)
English: Tell your doctor straight away if you notice any of the serious side effects above.
Danish: Kontakt straks lægen, hvis du bemærker en eller flere af ovenstående alvorlige bivirkninger.
English: Certain medicines may affect the way that Haldol Decanoate works or may make heart problems more likely
Danish: Visse lægemidler kan påvirke virkningen af Haldol Dekanoat eller øge risikoen for hjerteproblemer
English: Even though impairment of renal function is not expected to affect haloperidol elimination to a clinically relevant extent, caution is advised in patients with renal impairment, and especially those with severe impairment, due to the long half-life of haloperidol and its reduced metabolite, and the possibility of accumulation (see section 4.2).
Danish: Selvom nedsat nyrefunktion ikke forventes at påvirke eliminationen af haloperidol i klinisk relevant grad, anbefales det at udvise forsigtighed hos patienter med nedsat nyrefunktion og især hos patienter med svært nedsat nyrefunktion pga. den lange halveringstid af haloperidol og dens reducerede metabolit samt risikoen for akkumulation (se pkt.
English: This must take into account the time after a change in dose to achieve a new steady state plasma concentration and the additional time to elicit a therapeutic response.
Danish: Tiden til at opnå en ny steady state-plasmakoncentration efter en dosisændring samt den yderligere tid til at fremkalde et terapeutisk respons skal tages i betragtning.
English: Antiparkinson medicinal products of the anticholinergic type may be prescribed as required to manage extrapyramidal symptoms, but it is recommended that they are not prescribed routinely as a preventive measure.
Danish: Antikolinerge lægemidler mod Parkinsons sygdom kan ordineres efter behov for at kontrollere ekstrapyramidale symptomer, men det frarådes at ordinere sådanne lægemidler rutinemæssigt som forebyggende behandling.
English: • Changes that show up in blood tests of the liver and other liver problems, such as: o Yellowing of the skin or whites of the eyes (jaundice) o Inflamed liver o Sudden liver failure
Danish: • Leverforandringer, der kan ses i blodprøver, og andre leverproblemer, såsom: o Gulfarvning af huden eller det hvide i øjnene (gulsot) o Leverbetændelse o Pludseligt leversvigt
English: • Before using the ampoule, roll it briefly between both hand palms to warm up the product.
Danish: • Inden brug skal ampullen rulles kortvarigt mellem håndfladerne for at opvarme præparatet.
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 mellem 1,6-1,7 gange højere end for patienter i placebogruppen.
English: • You have a low level of potassium in your blood, which has not been treated
Danish: • du har ubehandlet lavt kaliumindhold i blodet
English: If concomitant treatment with an antiparkinson medicinal product is required, it may have to be continued after stopping HALDOL Decanoate 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 Dekanoat, hvis antiparkinson-medicinen udskilles hurtigere end haloperidol, for at forhindre udvikling af ekstrapyramidale symptomer eller forværring af disse.
English: • It is recommended only to adjust the haloperidol decanoate dose if required (based on individual patient response) until an optimal therapeutic effect is obtained.
Danish: • Det anbefales kun at justere dosis af haloperidoldecanoat, hvis det er nødvendigt (baseret på det individuelle patientrespons), indtil der er opnået en optimal terapeutisk virkning.
English: Metabolic and nutritional disorders
Danish: Metabolisme og ernæring
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, har været rapporteret under behandling med antipsykotika.
English: • Problems having sex
Danish: • Seksuelle problemer
English: Transition from oral haloperidol • A low haloperidol decanoate dose of 12.5 to 25 mg is recommended.
Danish: Skift fra oral haloperidol • Det anbefales at anvende en lav dosis af haloperidoldecanoat på 12,5 til 25 mg.
English: Table 1: Haloperidol decanoate dose recommendations for adults aged 18 years and above
Danish: Tabel 1: Dosisanbefalinger for haloperidoldecanoat til voksne på 18 år og derover
English: Small amounts of haloperidol have been detected in plasma and urine of breast-fed newborns of mothers treated with haloperidol.
Danish: Der er påvist små mængder af haloperidol i plasma og urin hos nyfødte ammet af kvinder, som er i behandling med haloperidol.
English: The results are within the observed variability in haloperidol pharmacokinetics.
Danish: Resultaterne er inden for den observerede variabilitet i haloperidols farmakokinetik.
English: Akathisia Parkinsonism Masked facies Tremor Somnolence Sedation
Danish: Parkinsonisme Maskeansigt Tremor Døsighed Sedation
English: In rare cases the following symptoms were reported during the concomitant use of lithium and haloperidol: encephalopathy, extrapyramidal symptoms, tardive dyskinesia, neuroleptic malignant syndrome, acute brain syndrome and coma.
Danish: I sjældne tilfælde er følgende symptomer rapporteret ved samtidig brug af lithium og haloperidol: Encefalopati, ekstrapyramidale symptomer, tardiv dyskinesi, malignt neuroleptikasyndrom, akut hjernesyndrom og koma.
English: Observational studies comparing the stroke rate in elderly patients exposed to any antipsychotic to the stroke rate in those not exposed to such medicinal products found an increased stroke rate among exposed patients.
Danish: I observationsstudier, hvor forekomsten af apopleksi hos ældre patienter, der havde været eksponeret for et antipsykotikum, blev sammenlignet med forekomsten hos ældre patienter, der ikke havde været eksponeret for sådanne lægemidler, blev der set en øget forekomst af apopleksi hos de eksponerede patienter.
English: • Cancer (such as toremifene and vandetanib).
Danish: • kræft (såsom toremifen og vandetanib)
English: The cytochrome P450 enzyme system is also involved, particularly CYP3A4 and, to a lesser extent, CYP2D6.
Danish: CYP-enzymsystemet er også involveret, især CYP3A4 og i mindre grad CYP2D6.
English: prochlorperazine, promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine and ziprasidone)
Danish: promazin, sertindol, thiorizadin, trifluoperazin, triflupromazin og ziprasidon)
English: If you are not sure, talk to your doctor, pharmacist or nurse before being given Haldol Decanoate.
Danish: Hvis du er i tvivl, skal du tale med lægen, apotekspersonalet eller sundhedspersonalet, før du får Haldol Dekanoat.
English: Patients being considered for HALDOL Decanoate therapy must be initially treated with oral haloperidol to reduce the possibility of an unexpected adverse sensitivity to haloperidol.
Danish: Patienter, for hvem behandling med HALDOL Dekanoat overvejes, skal først behandles med oral haloperidol for at reducere risikoen for en uventet overfølsomhedsreaktion på haloperidol.
English: Administration of haloperidol decanoate as a depot intramuscular injection results in a slow and sustained release of free haloperidol.
Danish: Administration af haloperidoldecanoat som en intramuskulær depotinjektion resulterer i en langsom og forlænget frigivelse af frit haloperidol.
English: The risk of QTc prolongation increases with haloperidol dose and with haloperidol plasma concentrations.
Danish: Risikoen for QTc-forlængelse stiger med dosis og plasmakoncentrationen af haloperidol.
English: HALDOL Decanoate is indicated for the maintenance treatment of schizophrenia and schizoaffective disorder in adult patients currently stabilised with oral haloperidol (see section 5.1).
Danish: HALDOL Dekanoat er indiceret til vedligeholdelsesbehandling af skizofreni og skizoaffektive lidelser hos voksne patienter, der aktuelt er stabiliseret med oral haloperidol (se pkt.
English: A decision must be made whether to discontinue breastfeeding or to discontinue HALDOL Decanoate therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med HALDOL Dekanoat skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Haloperidol is metabolised by several routes (see section 5.2).
Danish: Haloperidol metaboliseres via adskillige veje (se pkt.
English: In clinical studies, patients were mostly reported to have received prior treatment with orally administered haloperidol before converting to haloperidol decanoate.
Danish: I kliniske studier havde patienterne oftest fået forudgående behandling med oralt haloperidol, før de skiftede til haloperidoldecanoat.
English: Rare cases of sudden death have been reported in psychiatric patients receiving antipsychotics, including haloperidol (see section 4.8).
Danish: Der er rapporteret om sjældne tilfælde af pludselig død hos psykiatriske patienter, der fik antipsykotika, herunder haloperidol (se pkt.
English: • Skin problems, such as: o Rash or itching o Increased sensitivity to sunlight o Flaking or peeling skin o Inflamed small blood vessels, leading to a skin rash with small red or purple bumps
Danish: • Hudproblemer såsom: o Udslæt eller kløe o Øget følsomhed over for sollys o Hudafskalning o Betændelse i de små blodkar med deraf følgende hududslæt med små røde eller lilla knuder
English: Angioedema Dermatitis exfoliative Leukocytoclastic vasculitis
Danish: Angioødem Eksfoliativ dermatitis Leukocytoklastisk vaskulitis