FrancophonIA/ELRC3.0 huggingface dataset:
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from NUEDEXTA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med NUEDEXTA skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where Nuedexta is marketed, at launch and after launch, all healthcare professionals who are expected to prescribe Nuedexta are provided with the following items:
Danish: Efter drøftelse og aftale med de nationale kompetente myndigheder i hver medlemsstat, hvor NUEDEXTA markedsføres, drager indehaveren af markedsføringstilladelsen omsorg for, at alle sundhedspersoner, der forventes at ordinere NUEDEXTA, ved lanceringen og efter lanceringen får udleveret en informationspakke med følgende elementer:
English: The treatment of cardiac effects (haemodynamically unstable polymorphic ventricular tachycardia (including torsades de pointes)) is either immediate cardioversion or immediate overdrive pacing.
Danish: Kardiale effekter (hæmodynamisk ustabil, polymorf ventrikulær takykardi (herunder torsade de pointes)), behandles med øjeblikkelig defibrillering eller øjeblikkelig anvendelse af pacemaker.
English: Quinidine inhibited CYP2D6 with a half maximal inhibitory concentration (IC50) of less than 0.05 µM.
Danish: Kinidin hæmmede CYP2D6 med en koncentrationen svarende til 50 % af maksimal hæmning (IC50) på under 0,05 µM.
English: • Co-administration of a strong CYP3A4 inhibitor
Danish: • koadministration af en potent CYP3A4-hæmmer
English: Dextromethorphan has been shown to be a mild/moderate inhibitor of the OCT1 transporter in vitro.
Danish: Dextromethorphan er påvist at være en svag til moderat hæmmer af OCT1-transportmekanismen in vitro.
English: When NUEDEXTA is used with other serotoninergic medicines, the risk of “serotonin syndrome” may be increased due to pharmacodynamic interaction.
Danish: Ved anvendelse af NUEDEXTA sammen med andre serotoninerge lægemidler kan risikoen for serotoninsyndrom øges som følge af farmakodynamisk interaktion.
English: The capsules can be taken either with or without food.
Danish: Kapslerne kan tages sammen med et måltid eller mellem måltiderne.
English: There is no relevant use of NUEDEXTA in the paediatric population for the symptomatic treatment of pseudobulbar affect.
Danish: Hos den pædiatriske population er der ingen relevant anvendelse af NUEDEXTA til symptomatisk behandling af pseudobulbær affekt.
English: Serious adverse reactions have been reported for NUEDEXTA; these are muscle spasticity, respiratory depression and decreased oxygen saturation in the blood.
Danish: Alvorlige bivirkninger indberettet for NUEDEXTA er muskelspasticitet, respirationsdepression og nedsat oxygenmætning af blodet.
English: As NUEDEXTA may cause harm to your unborn baby, its use is not recommended when you are pregnant or if you are a women of childbearing potential not using contraception.
Danish: Da NUEDEXTA kan medføre skade på det ufødte barn, frarådes det at bruge det, hvis du er gravid eller hvis du er en kvinde i den fødedygtige alder og ikke anvender svangerskabsforebyggelse.
English: • you experience symptoms such as palpitations or fainting, which may be a sign of heart problems.
Danish: • du har symptomer som hjertebanken eller besvimelse, der kan være tegn på hjerteproblemer
English: • weakness (asthenia), irritability
Danish: • svaghed (asteni), irritabilitet
English: Methods as to acidify the urine and dialysis are of no demonstrated benefit.
Danish: Der er ikke påvist gavnlig virkning af acidificering af urinen eller dialyse.
English: This test dose is adequate to represent the steady state exposure in patients with CYP2D6 extensive metabolizer phenotype.
Danish: Den anvendte testdosis er repræsentativ for steady state-eksponeringen hos patienter med fænotypen ekstensiv CYP2D6-metabolisator.
English: The tricyclic antidepressant desipramine is metabolized primarily by CYP2D6.
Danish: Det tricykliske antidepressivum desipramin metaboliseres primært af CYP2D6.
English: Pack size: 13 capsules
Danish: Pakningsstørrelse: 13 kapsler
English: Take care if you consume alcohol while you are taking NUEDEXTA as might increase the risk of side effects such as dizziness and sleepiness.
Danish: Vær forsigtig med alkoholindtagelse, mens du er i behandling med NUEDEXTA, da det kan øge risikoen for bivirkninger såsom svimmelhed og søvnighed.
English: • travel or motion sickness, ringing in the ears (tinnitus)
Danish: • køre- eller søsyge, ringen for ørerne (tinnitus)
English: Patients receiving concomitant treatment with thioridazine, a medicinal product that both significantly prolongs QT interval and is primarily metabolized by CYP2D6.
Danish: Patienter i samtidig behandling med thioridazin, et lægemiddel, der både signifikant forlænger QTintervallet og primært metaboliseres af CYP2D6.
English: If you forget to take NUEDEXTA
Danish: Hvis du har glemt at tage NUEDEXTA
English: When initiating treatment with NUEDEXTA in patients at risk of QT prolongation, electrocardiographic (ECG) evaluation of the QT interval should be conducted at baseline and at 2 hours after the first dose administered in the fasted state (approximates to quinidine Tmax).
Danish: Hos patienter med risiko for QT-forlængelse bør der ved indledningen af behandlingen med NUEDEXTA foretages EKG-bestemmelse af QT-intervallet ved baseline og to timer efter den første administrerede fastende dosis (omtrent svarende til Tmax for kinidin).
English: The maximum daily dose from week 4 onwards is NUEDEXTA 23 mg/9 mg, twice daily.
Danish: Den maksimale dagsdosis fra uge 4 er NUEDEXTA, 23 mg/9 mg, to gange dagligt.
English: • to continue the treatment with NUEDEXTA 15 mg/9 mg capsules, or
Danish: • at fortsætte behandlingen med NUEDEXTA, kapsler, 15 mg/9 mg, eller
English: • gall stones, increased bilirubin levels in the blood, abnormal liver function test
Danish: • galdesten, forhøjet bilirubin i blodet, abnorm leverfunktionsprøve
English: Your doctor will start your treatment with NUEDEXTA 15 mg/9 mg capsules which should be taken by you as follows:
Danish: Lægen sætter dig i behandling med NUEDEXTA, kapsler, 15 mg/9 mg, som du skal tage således:
English: Capsule content Croscarmellose sodium Cellulose, microcrystalline Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate
Danish: Kapselindhold Croscarmellosenatrium Cellulose, mikrokrystallinsk Silica, kolloid vandfri Lactosemonohydrat Magnesiumstearat
English: If concomitant treatment with strong or moderate CYP3A4 inhibitors is considered necessary, it is recommended that electrocardiographic (ECG) evaluation of the QT interval be carried out before NUEDEXTA is administered and at appropriate time point(s) subsequently.
Danish: Ved behov for samtidig behandling med stærke eller moderate CYP3A4-hæmmere anbefales EKG-bestemmelse af QT-intervallet før administration af NUEDEXTA og på et eller flere passende tidspunkter efterfølgende.
English: Most cases remit when quinidine is withdrawn.
Danish: I de fleste tilfælde ses remission ved seponering af kinidin.
English: CYP2D6 substrates include certain beta-blockers such as metoprolol, antipsychotics such as haloperidol, perphenazine and aripiprazole, antidepressants such as nortriptyline, imipramine, amitriptyline and desipramine, the chemotherapeutic tamoxifen, and the noradrenaline transporter inhibitor atomoxetine.
Danish: CYP2D6-substrater omfatter visse betablokkere såsom metoprolol, antipsykotika såsom haloperidol, perphenazin and aripiprazol, antidepressiva såsom nortriptylin, imipramin, amitriptylin og desipramin, det kemoterapeutiske middel tamoxifen og noradrenalintransporthæmmeren atomoxetin.
English: The maximum mean (95% upper confidence bound) differences from placebo after baseline-correction were 10.2 (14.6) and 18.4 (22.7) ms following dextromethorphan/quinidine doses of 23 mg /26 mg and 46 mg /53 mg, respectively.
Danish: Den gennemsnitlige maksimale (øvre grænse af 95 % sikkerhedsintervallet) forskel fra placebo efter baseline-korrektion var 10,2 (14,6) og 18,4 (22,7) ms efter dextromethorphan/kinidin i en dosering af henholdsvis 23 mg/26 mg og 46 mg/53 mg.
English: Ten patients discontinued study treatment due to ADRs, one of these patients due to a serious ADR (worsening muscle spasticity).
Danish: Ti patienter fik seponeret behandlingen på grund af bivirkninger, som i ét tilfælde var alvorlig (forværring af muskelspasticitet).
English: A population pharmacokinetic analysis of 170 subjects (148 subjects <65 years old and 22 subjects ≥65 years old) administered dextromethorphan 23 mg / quinidine 26 mg revealed similar pharmacokinetics in subjects <65 years and those ≥65 years of age.
Danish: Populationsfarmakokinetisk analyse af 170 personer (148 personer <65 år og 22 personer ≥65 år), som fik dextromethorphan 23 mg/kinidin 26 mg, viser samme farmakokinetik hos personer <65 år og ≥65 år.
English: Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy.
Danish: Hos patienter i kinidinbehandling er beskrevet hepatitis, herunder granulomatøs hepatitis, sædvanligvis i de første uger af behandlingen.
English: • medicines to treat epilepsy or fits, such as phenytoin, carbamazepine and phenobarbital
Danish: • lægemidler til behandling af epilepsi eller anfald, såsom fenytoin, karbamazepin og phenobarbital
English: Quinidine plasma concentrations are proportional to quinidine dose.
Danish: Plasmakoncentrationerne af kinidin er proportionale med kinidindosis.
English: Patients taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the preceding 14 days due to the risk of serious and possibly fatal drug interactions, including serotonin syndrome.
Danish: Patienter, der får monoaminoxidasehæmmere (MAO-hæmmere) eller har fået MAO-hæmmere inden for de foregående 14 dage, idet der er risiko for alvorlig og muligvis fatal lægemiddelinteraktion, herunder serotoninsyndrom.
English: The efficacy of dextromethorphan/quinidine for the treatment of PBA was demonstrated in three randomised, controlled, double-blind, multicentre clinical trials in PBA subjects with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).
Danish: Virkningen af dextromethorphan/kinidin til behandling af PBA blev påvist i tre randomiserede, kontrollerede, dobbeltblindede kliniske multicenterundersøgelser hos patienter med PBA og underliggende amyotrofisk lateralsklerose (ALS) eller multipel sklerose (MS).
English: While therapeutic doses of quinidine for treatment of cardiac arrhythmia or malaria are generally ≥10fold higher than the dose of quinidine in this medicinal product, potentially fatal cardiac arrhythmia, including torsades de pointes, can occur at quinidine exposures that are possible from NUEDEXTA overdose.
Danish: Skønt de terapeutiske doser af kinidin til behandling af hjertearytmier og malaria generelt er ≥10 gange højere end kinidindosis i NUEDEXTA, kan overdosering med NUEDEXTA medføre potentielt fatal hjertearytmi med torsade de pointes som følge af kinidineksponeringen.
English: The higher dose of quinidine used in these studies would have resulted in approximately a 1.6 fold greater exposure to of dextromethorphan than with NUEDEXTA 23 mg/ 9 mg.
Danish: Den højere dosis af kinidin i disse undersøgelser forventedes at resultere i en ca. 1,6 gange større dextromethorphan-eksponering end med NUEDEXTA, 23 mg/9 mg.
English: • you have problems with your liver or kidney.
Danish: • du har lever- eller nyreproblemer.
English: The no effect dose in rabbits is 2 and 60 times higher than the RHD.
Danish: Nuleffektdosis hos kaniner er henholdsvis 2 og 60 gange højere end den anbefalede dosis til mennesker.
English: The quinidine in NUEDEXTA inhibits CYP2D6 in patients in whom CYP2D6 is not otherwise genetically absent or of low activity (“CYP2D6 Poor Metabolisers” see “Pharmacogenomics” in section 5.2).
Danish: Kinidinet i NUEDEXTA hæmmer CYP2D6 hos patienter, hos hvem CYP2D6 ikke i forvejen mangler genetisk eller har lav aktivitet (“dårlige CYP2D6-metabolisatorer”, se farmakogenomik i pkt.
English: Caution should be exercised if patients are treated with concomitant selective serotonin reuptake inhibitors (SSRIs).
Danish: Forsigtighed bør udvises ved sideløbende behandling med serotoningenoptagshæmmere (SSRI).
English: Neither dextromethorphan nor quinidine induced CYP1A2, CYP2B6 or CYP3A4 in human hepatocytes at concentrations up to 4.8 µM.
Danish: Hverken dextromethorphan eller kinidin inducerede CYP1A2, CYP2B6 eller CYP3A4 i humane hepatocytter i koncentrationer op til 4,8 µM.
English: Mean changes in QTcF were 6.8 ms for NUEDEXTA 23 mg/ 9 mg and 9.1 ms for the reference positive control (moxifloxacin).
Danish: Den gennemsnitlige ændring i QTcF var 6,8 ms for NUEDEXTA 23 mg/9 mg, og 9,1 ms for det aktive kontrolstof (moxifloxacin).
English: The risk of thrombocytopenia in association with the lower dose of quinidine in NUEDEXTA is unknown.
Danish: Risikoen for trombocytopeni i forbindelse med den lavere dosis af kinidin i NUEDEXTA kendes ikke.
English: Do not stop taking this medicine without speaking to your doctor first, even if you begin to feel better.
Danish: Du må ikke holde op med at tage NUEDEXTA uden at have spurgt lægen, selv om du har fået det bedre.
English: • Patient alert cards
Danish: • patientadvarselskort
English: The mean plasma Cmax of quinidine following NUEDEXTA 15 mg / 9 mg twice daily in subjects with PBA was 1 to 3% of the therapeutic concentrations associated with antiarrhythmic efficacy (2 to 5 µg/mL).
Danish: Den gennemsnitlige Cmax af kinidin i plasma efter NUEDEXTA, 15 mg/9 mg, to gange dagligt hos patienter med PBA var 1 til 3 % af de terapeutiske antiarytmiske koncentrationer (2 til 5 µg/ml).
English: Dextromethorphan is rapidly metabolized by CYP2D6 to its primary metabolite, dextrorphan, which is rapidly glucuronidated and renally eliminated.
Danish: Dextromethorphan metaboliseres hurtigt af CYP2D6 til den primære metabolit dextrorphan, der hurtigt glukuronideres og udskilles renalt.
English: If you stop taking NUEDEXTA
Danish: Hvis du holder op med at bruge NUEDEXTA
English: • you experience symptoms such as bruising, bleeding under the skin, nosebleeds and/or bleeding gums, as this may be a sign of low levels of blood cells called platelets (thrombocytopenia).
Danish: • du får symptomer såsom blå mærker, blødning under huden, næseblødning og/eller eller blødende gummer, da dette kan det være tegn på for lavt indhold af blodplader (trombocytopeni)
English: The most common adverse reactions were mild to moderate nausea, dizziness, and headache.
Danish: De hyppigste bivirkninger var let til moderat kvalme, svimmelhed og hovedpine.
English: Tricyclic antidepressants (TCAs e.g. desipramine, nortriptyline, imipramine, amitriptyline) are metabolised by CYP2D6 and therefore are also subject to pharmacokinetic interaction with quinidine.
Danish: Tricykliske antidepressiva (f.eks. desipramin, nortriptylin, imipramin, amitriptylin) metaboliseres af CYP2D6 og er derfor underkastet farmakokinetisk interaktion med kinidin.
English: The adverse reactions considered at least possibly related to treatment with NUEDEXTA in the placebo-controlled and the open-label extension phase of the above mentioned clinical study are listed below by body system organ class and frequency.
Danish: Nedenfor er opstillet de bivirkninger i den placebokontrollerede og den åbne forlængede fase af ovennævnte kliniske undersøgelse, der i det mindste har mulig sammenhæng med NUEDEXTA, inddelt efter systemorganklasse og hyppighed.
English: Marketing Authorisation Holder and Manufacturer Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London
Danish: Indehaver af markedsføringstilladelsen og fremstiller Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London
English: Quinidine is an inhibitor of P-glycoprotein.
Danish: Kinidin hæmmer P-glykoprotein.
English: • Epistaxis, Pharyngolaryngeal pain, Respiratory depression, Rhinorrhoea, Yawning
Danish: • Epistaxis, faryngolaryngeale smerter, respirationsdepression, rhinorré, gaben
English: • Drug-drug interactions including involvement of CYP2D6 substrates and inhibitors
Danish: • lægemiddelinteraktioner, herunder medvirken af CYP2D6-substrater og -hæmmere
English: To access capsules:
Danish: Udtagning af kapslerne:
English: They include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil.
Danish: Disse omfatter, men ikke er ikke begrænset til, atazanavir, clarithromycin, indinavir, itraconazol, ketoconazol, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazol, fosamprenavir, grapefrugtjuice og verapamil.
English: Non-specific symptoms, such as light-headedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia.
Danish: Uspecifikke symptomer såsom svimmelhed, kulderystelser, feber, kvalme og opkastning kan gå forud for eller ledsage trombocytopeni.
English: Concomitant administration of medicines that inhibit CYP3A4 can be expected to increase plasma levels of quinidine, which could increase risk relating to QTc prolongation.
Danish: Samtidig anvendelse af lægemidler, der hæmmer CYP3A4, kan forventes at øge plasmakoncentrationen af kinidin med risiko for QTc-forlængelse.
English: • Educational material for Healthcare Professionals (HCPs)
Danish: • uddannelsesmateriale til sundhedspersoner
English: Quinidine is a potent inhibitor of CYP2D6.
Danish: Kinidin er en potent hæmmer af CYP2D6.
English: Patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes ventricular tachycardia (see section 4.4).
Danish: Patienter med forlænget QT-interval, kongenit langt QT-syndrom eller anamnese med tegn på torsade de pointes ventrikulær takykardi (se pkt.
English: Concomitant administration of quinidine with digoxin, a P-glycoprotein substrate, results in serum digoxin levels that may be as much as doubled.
Danish: Anvendelse af kinidin sammen med digoxin, der er et substrat for Pglykoprotein, medfører op til en fordobling af serum-digoxin.
English: Dose adjustment is not required in patients with a non-functional CYPD2D6 enzyme, referred to as poor metabolisers (PMs).
Danish: Der kræves ikke dosisjustering hos patienter med ikke-fungerende CYPD2D6-enzym (såkaldt dårlige metabolisatorer (PM).
English: Quinidine is metabolised by CYP3A4.
Danish: Kinidin metaboliseres af CYP3A4.
English: • Bruxism, Confusional state, Depressed mood, Depression, Disorientation, Early morning awakening, Flat affect, Hallucination, Impulsive behaviour, Indifference, Insomnia, Restlessness, Sleep disorder
Danish: • Bruksisme, konfusionstilstand, nedtrykthed, depression, desorientering, opvågnen tidligt om morgenen, affektaffladning, hallucinationer, impulsiv adfærd, indifferens, søvnløshed, rastløshed, søvnforstyrrelser
English: NUEDEXTA should be discontinued immediately if thrombocytopenia occurs, unless the thrombocytopenia is clearly not drug-related.
Danish: Ved trombocytopeni bør NUEDEXTA straks seponeres, medmindre trombocytopenien klart ikke er lægemiddelrelateret.
English: • medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole
Danish: • lægemidler mod svampeinfektioner såsom ketoconazol, itraconazol og fluconazol
English: Potent CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John's wort/Hypericum perforatum) may accelerate the metabolism of quinidine, resulting in lower plasma concentrations and hence decreased inhibition of CYP2D6.
Danish: Potente CYP3A4-induktorer (f.eks. rifampicin, fenytoin, phenobarbital, karbamazepin, perikum (Hypericum perforatum)) kan fremskynde metaboliseringen af kinidin og nedsætte dets plasmakoncentration, hvorved hæmningen CYP2D6 mindskes.
English: The selective serotonin reuptake inhibitor (SSRI) paroxetine is metabolized primarily by CYP2D6 and is also a potent CYP2D6 inhibitor.
Danish: Den selektive serotoningenoptagshæmmer (SSRI) paroxetin metaboliseres primært af CYP2D6 og er samtidig en potent CYP2D6-hæmmer.
English: In this placebo-controlled 12-week study, 326 PBA subjects with underlying ALS or MS were randomized to receive NUEDEXTA 15 mg / 9 mg, (n=107), NUEDEXTA 23 mg / 9 mg (n=110), or placebo (n=109) for 12 weeks.
Danish: I denne placebokontrollerede undersøgelse blev 326 patienter med PBA med underliggende ALS eller MS randomiseret til NUEDEXTA, 15 mg/9 mg (n=107), NUEDEXTA, 23 mg/9 mg (n=110) eller placebo (n=109) i 12 uger.
English: During development of this medicinal product, dose combinations of dextromethorphan/quinidine containing up to 6-times higher dextromethorphan dose and 12-times higher quinidine dose were studied.
Danish: Under udviklingen af dette lægemiddel blev kombinationer af dextromethorphan og kinidin undersøgt med op til 6 gange højere dosis af dextromethorphan og 12 gange højere dosis af kinidin.
English: Following repeated doses of NUEDEXTA 23 mg / 9 mg and NUEDEXTA 15 mg / 9 mg, maximal plasma concentrations (Cmax) of dextromethorphan are reached approximately 3 to 4 hours after dosing and maximal plasma concentrations of quinidine are reached approximately 2 hours after dosing.
Danish: Efter gentagne doser af NUEDEXTA, 23 mg/9 mg og NUEDEXTA, 15 mg/9 mg, nås maksimal plasmakoncentration (Cmax) af dextromethorphan ca. 3-4 timer efter dosering, og maksimal plasmakoncentration af kinidin ca. 2 timer efter dosering.
English: In the presence of quinidine, CYP3A4-dependent oxidative metabolism is believed to play a greater role in dextromethorphan elimination.
Danish: I tilstedeværelse af kinidin antages den CYP3A4afhængige oxidative metabolisering at spille en øget rolle i udskillelsen af dextromethorphan.
English: Squeeze and hold at tabs above and below () Pull out card to the right ( )
Danish: Tag fat om fligene over og under ().
English: The quinidine component is intended to inhibit CYP2D6 so that higher exposure to dextromethorphan can be achieved compared to when dextromethorphan is given alone.
Danish: Hensigten med kinidinkomponenten er at hæmme CYP2D6, så der opnås højere eksponering for dextromethorphan end med dextromethorphan alene.
English: • Studies with Higher Dose Combinations of dextromethorphan / quinidine
Danish: • Undersøgelser med kombinationer af dextromethorphan/kinidin i højere dosering
English: • to give you a higher dose and to prescribe NUEDEXTA 23 mg/9 mg capsules to you.
Danish: • at give dig en højere dosis og ordinere NUEDEXTA, kapsler, 23 mg/9 mg.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du får bivirkninger, skal du sige det til lægen eller på apoteket.
English: • double vision, blurred vision
Danish: • dobbeltsyn, sløret syn
English: What you need to know before you take NUEDEXTA
Danish: Det skal du vide, før du begynder at tage NUEDEXTA
English: Dextromethorphan can also be associated with hypersensitivity reactions, including uticaria, angioedema, and shortness of breath.
Danish: Dextromethorphan kan desuden være forbundet med hypersensitivitetsreaktioner, herunder urticaria, angioødem og dyspnø.
English: Approximately 1-10% of individuals of Caucasian descent, 5-30% of Black African descent, 12-40% of Arab descent and 1% of Asian descent exhibit increased metabolic activity for CYP2D6 substrates and are classified as Ultra-rapid Metabolizer (UMs).
Danish: Ca. 1-10 % af personer af kaukasisk race, 5-30 % af personer af sort afrikanske race, 12-40 % af personer af arabisk oprindelse og 1 % af personer af asiatisk oprindelse har øget metabolisk aktivitet over for substrater for CYP2D6 og klassificeres som ultrahurtige metabolisatorer (UM).