FrancophonIA/ELRC3.0 huggingface dataset:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Danish: D BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • if you have a history of a liver disease (hepatitis) caused by quinidine
Danish: • hvis du tidligere har haft leversygdom (hepatitis) forårsaget af kinidin
English: However, cases of dextromethorphan abuse have been reported, predominately in adolescents.
Danish: Misbrug af dextromethorphan er dog beskrevet, hovedsagelig hos unge.
English: This may lead to lower, potentially subtherapeutic plasma concentrations of dextromethorphan and decreased efficacy of NUEDEXTA.
Danish: Dette kan medføre lavere, potentielt subterapeutiske plasmakoncentrationer af dextromethorphan og nedsat virkning af NUEDEXTA.
English: Due to the possibility of dextromethorphan abuse, physicians should evaluate patients for a history of drug abuse, and observe such patients closely for signs of misuse or abuse (e.g. development of tolerance, increases in dose, drug-seeking behaviour).
Danish: På grund af muligheden for misbrug af dextromethorphan bør patienten vurderes for stofmisbrug i anamnesen, og sådanne patienter bør nøje overvåges for misbrugstegn (f.eks. udvikling af tolerans, dosisstigning, stofsøgende adfærd).
English: • Dextromethorphan acts on the brain.
Danish: • Dextromethorphan virker på hjernen.
English: • From Week 4 on:
Danish: • Fra uge 4:
English: Strong and moderate CYP3A4 inhibitors should be avoided during treatment with NUEDEXTA.
Danish: Stærke og moderate CYP3A4-hæmmere bør undgås under behandling med NUEDEXTA.
English: In such UM patients, dextromethorphan is rapidly metabolised, leading to lower, potentially subtherapeutic concentrations.
Danish: Hos sådanne UM-patienter metaboliseres dextromethorphan hurtigt, hvilket medfører lavere, potentielt subterapeutiske koncentrationer.
English: This includes any side effects not listed in this leaflet.
Danish: Dette gælder også bivirkninger, der ikke fremgår af denne indlægsseddel.
English: • heart problems, such as slow, fast or irregular heart beat, or altered results during an electrocardiogram (ECG - QT prolongation)
Danish: • hjerteproblemer såsom langsom, hurtig eller uregelmæssig hjerterytme eller forandringer på elektrokardiogrammet (EKG - QT-forlængelse)
English: The major metabolite is 3-hydroxyquinidine, which is considered to be at least half as pharmacologically active as quinidine with respect to cardiac effects such as QT prolongation.
Danish: Den vigtigste metabolit er 3-hydroxyquinidin, der anses for at have mindst halvt så stor farmakologisk aktivitet som kinidin hvad angår kardiale virkninger såsom QT-forlængelse.
English: NUEDEXTA can help reduce how often you have episodes of PBA.
Danish: NUEDEXTA kan medvirke til at mindske antallet af episoder med PBA.
English: Cardiac effects
Danish: Kardiale effekter
English: Your doctor will monitor you closely for signs of NUEDEXTA misuse or abuse.
Danish: Lægen vil overvåge dig nøje for tegn på misbrug af NUEDEXTA.
English: There are currently limited data on the magnitude of the effect of CYP3A4 inhibitors on the pharmacokinetic parameters of quinidine and its metabolites, including the potential for accumulation at steady state.
Danish: På nuværende tidspunkt foreligger der begrænsede oplysninger om størrelsen af CYP3A4-hæmmeres indvirkning på de farmakokinetiske parametre af kinidin og dets metabolitter, herunder potentialet for akkumulering i steady state.
English: Evaluation and treatment of overdose is based on experience with the individual components, dextromethorphan and quinidine.
Danish: Vurdering og behandling af overdosering er baseret på erfaringerne med enkeltkomponenterne dextromethorphan og kinidin.
English: Digoxin and other P-glycoprotein substrates
Danish: Digoxin og andre P-glykoproteinsubstrater
English: Patients with complete atrioventricular (AV) block without implanted pacemakers, or in patients who are at high risk of complete AV block (see section 4.4).
Danish: Patienter med totalt atrioventrikulært (AV) blok uden implanteret pacemaker og patienter med høj risiko for totalt AV-blok (se pkt.
English: Drug abuse and dependence
Danish: Stofmisbrug og afhængighed
English: • loss of appetite (anorexia)
Danish: • nedsat appetit (anoreksi)
English: The frequency of PBA episodes as measured by “Count of Episodes” in both NUEDEXTA treatment groups decreased significantly throughout the course of the study by an incremental reduction of 47% and 49% relative to placebo, respectively (p <0.0001 for both comparisons).
Danish: Hyppigheden af PBA-episoder, målt som “antal episoder” i de to NUEDEXTA-behandlingsgrupper, aftog væsentligt i løbet af undersøgelsen med en reduktion på henholdsvis 47 % og 49 % i forhold til placebo (p <0,0001 for begge sammenligninger ).
English: • if you are allergic to dextromethorphan, quinidine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for dextromethorphan, kinidin eller et af de øvrige indholdsstoffer i NUEDEXTA (angivet i afsnit 6)
English: • Cardiac effects (QT prolongation) including pre-existing cardiovascular conditions and clinically significant electrolyte imbalances
Danish: • kardiale effekter (QT-forlængelse), herunder præeksisterende kardiovaskulær sygdom og klinisk vigtige elektrolytforstyrrelser
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • if you take a medicine called thioridazine, which is used for mental illness but can also affect the heart.
Danish: • hvis du får lægemidlet thioridazin, der anvendes til psykiske sygdomme, men også kan påvirke hjertet
English: Plasma concentrations of quinidine increased 20-30% when memantine was added.
Danish: Plasmakoncentrationerne af kinidin steg med 20-30 % ved tillægsbehandling med memantin.
English: Dextromethorphan hydrobromide is the pharmacologically active ingredient that acts on the central nervous system (CNS).
Danish: Dextromethorphanhydrobromid er det farmakologisk aktive indholdsstof, der virker på centralnervesystemet (CNS).
English: • sexual dysfunction
Danish: • seksuel funktionsforstyrrelse
English: In all studies, the efficacy endpoints were “Count of episodes of laughing and crying” (PBA episodes) and subject scores on the Center for Neurologic Studies - Lability Scale (CNS-LS), a validated 7-item, self-administered questionnaire that provides a quantitative measure of the frequency and severity of PBA. CNS-LS scores range from a minimum of 7 (no symptoms) to a maximum of 35.
Danish: I alle undersøgelserne var endepunkterne for virkning “antal episoder med latter og gråd” (PBAepisoder) og deltagernes score på Center for Neurologic Studies - Lability Scale (CNS-LS), der er et valideret 7-punkts selvadministreret spørgeskema, som giver et kvantitativt mål for hyppigheden og sværheden af PBA. CNS-LS-score går fra en mindsteværdi på 7 (ingen symptomer) til en maksimumværdi på 35.
English: NUEDEXTA has no or negligible influence on the ability to drive and use machines.
Danish: NUEDEXTA påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: • thioridazine, a medicine used in the treatment of schizophrenia and psychosis, that may affect the heart,
Danish: • thioridazin, et lægemiddel, der anvendes til behandling af skizofreni og psykose og som kan påvirke hjertet
English: Hypokalemia and hypomagnesemia should be corrected prior to initiation of therapy, and serum potassium and serum magnesium levels should be monitored during treatment if clinically indicated.
Danish: Inden påbegyndelse af behandlingen bør hypokaliæmi og hypomagnesiæmi korrigeres, og under behandlingen bør serumkalium og serummagnesium overvåges, hvis det er klinisk indiceret.
English: • tamoxifen, used to treat or prevent some cancers
Danish: • tamoxifen, der anvendes til behandling af visse kræftformer
English: In addition, the maintenance of the clinical effect of NUEDEXTA in the patient should be regularly monitored in the long-term against its tolerability, in order to ascertain the continued benefit of the product.
Danish: Desuden bør den fortsatte kliniske virkning af NUEDEXTA regelmæssigt og langsigtet følges og sammenholdes med dets tolerabilitet for at sikre, at behandlingen fortsat har klinisk fordel.
English: Drugs that delay elimination of quinidine (cimetidine, carbonic anhydrase inhibitors, thiazide diuretics) should be withdrawn unless absolutely required.
Danish: Midler, der forsinker udskillelsen af kinidin (cimetidin, carboanhydrasehæmmere, thiaziddiuretika) bør seponeres, medmindre de er absolut nødvendige.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere information om dette lægemiddel på Det europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu
English: The maximum mean (95% upper confidence bound) difference from placebo after baseline correction was 10.2 (12.6) ms.
Danish: Den maksimale gennemsnitsforskel (øvre grænse af 95 % sikkerhedsintervallet) i forhold til placebo efter korrektion fra baseline var 10,2 (12,6) ms.
English: • diarrhoea, nausea
Danish: • diarré, kvalme
English: Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.
Danish: Der bør træffes foranstaltninger til at mindske risikoen for fald, navnlig ved motoriske forstyrrelser, der påvirker gangen, eller ved fald i anamnesen.
English: This medicinal product does not require any special storage conditions.
Danish: Ingen særlige krav til opbevaringsforhold.
English: Uncommon Motion sickness, Tinnitus
Danish: Ikke almindelig Transportsyge, tinnitus
English: Quinidine-associated thrombocytopenia usually, but not always, resolves within a few days of discontinuation of the sensitising medicinal product.
Danish: Kinidinrelateret trombocytopeni svinder sædvanligvis, men ikke altid, få dage efter seponering af det sensibiliserende lægemiddel.
English: • Myocardial infarction, Palpitations, Ventricular extrasystoles
Danish: • Myokardieinfarkt, palpitationer, ventrikulære ekstrasystoler
English: ECG should be re-evaluated if risk factors for QTc prolongation change significantly during treatment with NUEDEXTA.
Danish: Fornyet EKG-vurdering bør foretages ved væsentlige ændringer i risikofaktorerne for QTcforlængelse under behandlingen med NUEDEXTA.
English: In the event of inadequate clinical response, see recommended dose titration schedule.
Danish: Ved inadækvat klinisk respons henvises til den anbefalede dosistitreringsplan.
English: A population pharmacokinetic analysis revealed similar pharmacokinetics in patients <65 years and those ≥65 years of age (see section 5.2).
Danish: En populationsfarmakokinetisk analyse viste samme farmakokinetik hos patienter <65 og ≥65 år (se pkt.
English: To evaluate long-term data, 253 subjects who completed the double-blind study phase had the option of entering an open-label extension phase, receiving NUEDEXTA 23 mg /9 mg for another 84 days.
Danish: For at der kunne genereres langsigtede data fik 253 patienter, der fuldførte undersøgelsens dobbeltblindede fase, mulighed for at indgå i en åben forlængelsesfase, hvor de fik NUEDEXTA, 23 mg/9 mg, i endnu 84 dage.
English: It is not known whether the active substances of NUEDEXTA are expressed into human milk.
Danish: Det vides ikke, om de aktive stoffer i NUEDEXTA udskilles i modermælk.
English: Blister of a PVC based clear film with aluminium foil seal.
Danish: Blister af klar PVC-baseret film lukket med alufolie.
English: Through its binding to the NMDA, sigma-1, SERT and 5-HT1B/D receptors, dextromethorphan is thought to have a modulatory effect on neurotransmission involving glutamate, monoamines (including serotonin), as well as ion channel function.
Danish: Gennem sin binding til NMDA-, sigma-1-, SERT- og 5-HT1B/D-receptorerne menes dextromethorphan at have en modulerende virkning på neurotransmission, hvori der indgår glutamat og monoaminer (herunder serotonin) samt på ionkanalfunktionen.
English: Dextromethorphan may increase the risk of serotonin syndrome (see Warnings and precautions and Possible side effects).
Danish: Dextromethorphan kan øge risikoen for serotoninsyndrom (se Advarsler og forsigtighedsregler og Bivirkninger).
English: NUEDEXTA has the potential to cause QTc prolongation and hence torsades de pointes-type ventricular tachycardia.
Danish: NUEDEXTA har potentiale for at forårsage QTc-forlængelse og dermed ventrikulær takykardi af torsade de pointes-typen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with NUEDEXTA in all subsets of the paediatric population in PBA (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af undersøgelser med NUEDEXTA i alle undergrupper af den pædiatriske population ved PBA (se pkt.
English: The potential for dextromethorphan and quinidine to inhibit or induce cytochrome P450 in vitro were evaluated in human microsomes.
Danish: Potentialet af dextromethorphan og kinidin for in vitro-hæmning eller -induktion af cytokrom P450 blev vurderet i humane mikrosomer.
English: The capsule should be taken orally (by mouth) either with or without food at about the same time each day.
Danish: Kapslen skal indtages oralt (gennem munden) på omtrent samme klokkeslæt hver dag, enten sammen med et måltid eller mellem måltiderne.
English: • medicines to reduce pain and/or cough, such as codeine and hydrocodone
Danish: • lægemidler mod smerter og/eller hoste, såsom kodein og hydrocodon
English: The pharmacokinetics of dextromethorphan/quinidine have not been investigated systematically in elderly subjects (aged >65 years) although such subjects were included in the clinical programme (14% ≥65 years, 2% ≥75 years).
Danish: Farmakokinetikken af dextromethorphan/kinidin er ikke systematisk undersøgt hos ældre (over 65 år), skønt der i de kliniske program indgik et antal ældre (14 % ≥65 år, 2 % ≥75 år).
English: The card should contain details to alert any HCP treating the patient that they are being treated with Nuedexta and of the potential for interaction once a patient is on treatment with Nuedexta and another treatment is added.
Danish: Kortet skal indeholde oplysninger til det behandlende sundhedsfaglige personale om, at patienten er i behandling med NUEDEXTA og om risikoen for interaktion, når en patient behandles med NUEDEXTA, og en anden behandling tilføjes.
English: Dextromethorphan is a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist.
Danish: Dextromethorphan er en sigma-1-receptoragonist og en ikke-kompetitiv NMDA-receptorantagonist.
English: Plasma digoxin concentrations should be closely monitored in patients taking NUEDEXTA concomitantly, and the digoxin dose reduced, as necessary.
Danish: Plasmakoncentrationen af digoxin bør overvåges tæt hos patienter i samtidig behandling med NUEDEXTA, og digoxindosis om nødvendigt reduceres.
English: No more than 2 capsules should be taken in any 24-hour period, with 12 hours between each dose.
Danish: Der bør ikke tages mere end to kapsler i løbet af en 24-timers periode, og der skal gå 12 timer mellem hver dosis.
English: NUEDEXTA should be discontinued if hepatitis occurs unless it is clearly not treatment related.
Danish: Ved hepatitis bør NUEDEXTA seponeres, medmindre den klart ikke er behandlingsrelateret.
English: Treatment with an MAOI should not be initiated until at least 14 days after stopping NUEDEXTA (see section 4.5).
Danish: Behandling med en MAO-hæmmer bør ikke indledes, før der er gået mindst 14 dage efter ophør af behandlingen med NUEDEXTA (se pkt.
English: Mild to moderate hepatic impairment had little effect on quinidine pharmacokinetics.
Danish: Let til moderat nedsat leverfunktion havde ringe indvirkning på farmakokinetikken af kinidin.
English: Each hard capsule contains 119.1 mg of lactose (as monohydrate).
Danish: Hver hård kapsel indeholder 119,1 mg lactose (som monohydrat).
English: NUEDEXTA may be taken without regard to meals as food does not affect the exposure of dextromethorphan and quinidine significantly.
Danish: NUEDEXTA kan tages uafhængigt af måltider, da fødeindtagelse ikke nævneværdigt påvirker eksponeringen for dextromethorphan og kinidin.
English: • medicines used to treat schizophrenia and other psychotic disorders, such as haloperidol,
Danish: • lægemidler til behandling af skizofreni og andre psykotiske sygdomme, såsom haloperidol,
English: Approximately 30% of study participants carried diagnoses other than ALS and MS, including stroke, traumatic brain injury, Parkinson's disease, Alzheimer's disease and other dementia, primary lateral sclerosis, progressive bulbar palsy, and progressive supranuclear palsy.
Danish: Ca. 30 % af undersøgelsens deltagere havde andre diagnoser end ALS eller MS, herunder apopleksi, traumatisk hjerneskade, Parkinsons sygdom, Alzheimers sygdom og anden form for demens, primær lateralsklerose, progressiv bulbær parese og progressiv supranukleær parese.
English: Dextromethorphan is a low-affinity uncompetitive NMDA antagonist and sigma-1 receptor agonist that has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence.
Danish: Dextromethorphan er en ikke-kompetitiv NMDA-antagonist med lav affinitet og er en sigma-1receptoragonist, hvis potentiale for misbrug, tolerans og fysisk afhængighed ikke er systematisk undersøgt hos dyr eller mennesker.
English: The educational material for HCPs should assist them in the collection and assessment of relevant patient's details on pre-existing co-morbidities and concomitant medications prior to initiating Nuedexta therapy.
Danish: Uddannelsesmaterialet for det sundhedsfaglige personale skal bistå dem med at indhente og vurdere relevante oplysninger om patienten vedrørende præeksisterende komorbiditet og samtidig medicinering, før behandlingen med NUEDEXTA påbegyndes.
English: Caution should be used when this medicinal product is taken in combination with alcohol or other centrally acting medicinal products that might increase the risk of adverse reactions such as somnolence and dizziness.
Danish: Forsigtighed bør udvises ved kombination af dette lægemiddel med alkohol eller andre centralt virkende lægemidler, som kan øge risikoen for bivirkninger såsom somnolens og svimmelhed.
English: Fever may be a presenting symptom, and thrombocytopenia or other signs of hypersensitivity may also occur.
Danish: Feber kan være et første symptom, og der kan desuden forekomme trombocytopeni og andre tegn på hypersensitivitet.
English: Do not use this medicine after the expiry date which is stated on the bottle, blister and carton after EXP.
Danish: Brug ikke NUEDEXTA efter den udløbsdato, der står på flasken, blisterpakningen og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: No other drug interactions with CYP2D6 substrates have been systematically investigated.
Danish: Der er ikke foretaget andre systematiske undersøgelser af lægemiddelinteraktioner med CYP2D6substrater.
English: The 12-week open-label phase of the study (during which all subjects received NUEDEXTA 23 mg / 9 mg) showed persistence of the effect observed in the placebo controlled period.
Danish: Den 12-ugers åbne fase af undersøgelsen (hvor alle patienterne fik NUEDEXTA, 23 mg/9 mg) viste vedholdende virkning svarende til den, der var iagttaget i den placebokontrollerede periode.
English: Likewise, this medicinal product should not be restarted in sensitised patients, because more rapid and more severe thrombocytopenia than the original episode can occur.
Danish: Hos sensibiliserede patienter bør behandlingen med dette lægemiddel ikke genoptages, da der er risiko for hurtigere indsættende og sværere trombocytopeni end ved den oprindelige episode.
English: Each hard capsule contains 109.2 mg of lactose (as monohydrate).
Danish: Hver hård kapsel indeholder 109,2 mg lactose (som monohydrat).
English: Other antiarrhythmics with Class I (procainamide) or Class III activities should (if possible) be avoided.
Danish: Om muligt bør det undgås at anvende andre antiarytmika med aktivitet svarende til klasse I (prokainamid) eller klasse III.
English: • very rare (<1/10,000)
Danish: • meget sjælden (<1/10 000)
English: Titanium dioxide (E171) Red iron oxide (E172)
Danish: Titaniumdioxid (E171)
English: The exact mechanism by which dextromethorphan exerts therapeutic effects in patients with pseudobulbar affect is unknown.
Danish: Den nøjagtige mekanisme bag dextromethorphans terapeutiske virkning hos patienter med pseudobulbær affekt kendes ikke.
English: Efficacy has only been studied in patients with underlying Amyotrophic Lateral Sclerosis or Multiple Sclerosis (see section 5.1).
Danish: Virkningen er kun undersøgt hos patienter med underliggende amyotrofisk lateralsklerose eller multipel sklerose (se pkt.
English: The safety of NUEDEXTA was investigated in a double-blind, randomized, placebo-controlled, multicenter study over 12 weeks in 326 PBA patients with underlying ALS (60%) or MS (40%) and in a follow-up open-label extension phase with a patient subgroup of this study (253 patients) for an additional 84 days.
Danish: Sikkerheden af NUEDEXTA blev undersøgt i en dobbeltblindet, randomiseret, placebokontrolleret 12 ugers multicenterundersøgelse hos 326 patienter med PBA med underliggende ALS (60 %) eller multipel sklerose (40 %) samt i en opfølgende åben udvidelsesfase med en undergruppe fra denne undersøgelse (253 patienter) af yderligere 84 dages varighed.
English: Pack size: 60 capsules
Danish: Pakningsstørrelse: 60 kapsler
English: • certain medicines used to prevent blood clots in patients with heart conditions and at risk of stroke, such as ticagrelor and dabigatran-etexilate
Danish: • visse lægemidler, der anvendes til behandling af blodpropper hos patienter med hjertesygdom og risiko for slagtilfælde, såsom ticagrelor og dabigatranetexilat
English: • The other ingredients are croscarmellose sodium, cellulose microcrystalline, silica colloidal, lactose monohydrate, magnesium stearate and gelatin, titanium dioxide (E171), red iron oxide (E172), printing ink (shellac glaze, propylene glycol, titanium dioxide (E171)).
Danish: • De øvrige indholdsstoffer er croscarmellosenatrium, cellulose mikrokrystallinsk, silica kolloid, lactosemonohydrat, magnesiumstearat og gelatine, titaniumdioxid (E171), jernoxid rød (E172), trykfarve (shellacglasering, propylenglycol, titaniumdioxid (E171)).
English: • From the eighth day of treatment onwards: two capsules per day, one in the morning and one in the evening, 12 hours apart.
Danish: • Fra den 8. og følgende behandlingsdage: to kapsler dagligt, en om morgenen og en om aftenen,
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen udfører de lægemiddelovervågningsaktiviteter og -tiltag, der er fastsat i den vedtagne risikostyringsplan, som fremgår af modul 1.8.2 af markedsføringstilladelsen, samt alle efterfølgende vedtagne ajourføringer af risikostyringsplanen.
English: Quinidine at higher doses than in NUEDEXTA can cause immune-mediated thrombocytopenia that can be severe or fatal.
Danish: Kinidin i doser højere end i NUEDEXTA kan forårsage immunmedieret trombocytopeni, som kan være af svær grad eller fatal.
English: The supratherapeutic doses are adequate to represent quinidine exposure increases due to drug-drug interactions and organ dysfunctions.
Danish: De supraterapeutiske doser er repræsentative for forhøjet kinidineksponering ved lægemiddelinteraktioner og organdysfunktion.
English: Atrioventricular block first degree, Electrocardiogram QT prolonged
Danish: Atrioventrikulært blok af første grad, QT-forlængelse på EKG