natgillin/translations-raw huggingface dataset:
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: 
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:
Kardiale effekter (hæmodynamisk ustabil, polymorf ventrikulær takykardi (herunder torsade de pointes)), behandles med øjeblikkelig defibrillering eller øjeblikkelig anvendelse af pacemaker. 
The treatment of cardiac effects (haemodynamically unstable polymorphic ventricular tachycardia (including torsades de pointes)) is either immediate cardioversion or immediate overdrive pacing.
Kinidin hæmmede CYP2D6 med en koncentrationen svarende til 50 % af maksimal hæmning (IC50) på under 0,05 µM. 
Quinidine inhibited CYP2D6 with a half maximal inhibitory concentration (IC50) of less than 0.05 µM.
• koadministration af en potent CYP3A4-hæmmer 
• Co-administration of a strong CYP3A4 inhibitor
Dextromethorphan er påvist at være en svag til moderat hæmmer af OCT1-transportmekanismen in vitro. 
Dextromethorphan has been shown to be a mild/moderate inhibitor of the OCT1 transporter in vitro.
Ved anvendelse af NUEDEXTA sammen med andre serotoninerge lægemidler kan risikoen for serotoninsyndrom øges som følge af farmakodynamisk interaktion. 
When NUEDEXTA is used with other serotoninergic medicines, the risk of “serotonin syndrome” may be increased due to pharmacodynamic interaction.
Kapslerne kan tages sammen med et måltid eller mellem måltiderne. 
The capsules can be taken either with or without food.
Hos den pædiatriske population er der ingen relevant anvendelse af NUEDEXTA til symptomatisk behandling af pseudobulbær affekt. 
There is no relevant use of NUEDEXTA in the paediatric population for the symptomatic treatment of pseudobulbar affect.
Alvorlige bivirkninger indberettet for NUEDEXTA er muskelspasticitet, respirationsdepression og nedsat oxygenmætning af blodet. 
Serious adverse reactions have been reported for NUEDEXTA; these are muscle spasticity, respiratory depression and decreased oxygen saturation in the blood.
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. 
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.
• du har symptomer som hjertebanken eller besvimelse, der kan være tegn på hjerteproblemer 
• you experience symptoms such as palpitations or fainting, which may be a sign of heart problems.
• svaghed (asteni), irritabilitet 
• weakness (asthenia), irritability
Der er ikke påvist gavnlig virkning af acidificering af urinen eller dialyse. 
Methods as to acidify the urine and dialysis are of no demonstrated benefit.
Den anvendte testdosis er repræsentativ for steady state-eksponeringen hos patienter med fænotypen ekstensiv CYP2D6-metabolisator. 
This test dose is adequate to represent the steady state exposure in patients with CYP2D6 extensive metabolizer phenotype.
Det tricykliske antidepressivum desipramin metaboliseres primært af CYP2D6. 
The tricyclic antidepressant desipramine is metabolized primarily by CYP2D6.
Pakningsstørrelse: 13 kapsler 
Pack size: 13 capsules
Vær forsigtig med alkoholindtagelse, mens du er i behandling med NUEDEXTA, da det kan øge risikoen for bivirkninger såsom svimmelhed og søvnighed. 
Take care if you consume alcohol while you are taking NUEDEXTA as might increase the risk of side effects such as dizziness and sleepiness.
• køre- eller søsyge, ringen for ørerne (tinnitus) 
• travel or motion sickness, ringing in the ears (tinnitus)
Patienter i samtidig behandling med thioridazin, et lægemiddel, der både signifikant forlænger QTintervallet og primært metaboliseres af CYP2D6. 
Patients receiving concomitant treatment with thioridazine, a medicinal product that both significantly prolongs QT interval and is primarily metabolized by CYP2D6.
Hvis du har glemt at tage NUEDEXTA 
If you forget to take NUEDEXTA
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). 
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).
Den maksimale dagsdosis fra uge 4 er NUEDEXTA, 23 mg/9 mg, to gange dagligt. 
The maximum daily dose from week 4 onwards is NUEDEXTA 23 mg/9 mg, twice daily.
• at fortsætte behandlingen med NUEDEXTA, kapsler, 15 mg/9 mg, eller 
• to continue the treatment with NUEDEXTA 15 mg/9 mg capsules, or
• galdesten, forhøjet bilirubin i blodet, abnorm leverfunktionsprøve 
• gall stones, increased bilirubin levels in the blood, abnormal liver function test
Lægen sætter dig i behandling med NUEDEXTA, kapsler, 15 mg/9 mg, som du skal tage således: 
Your doctor will start your treatment with NUEDEXTA 15 mg/9 mg capsules which should be taken by you as follows:
Kapselindhold Croscarmellosenatrium Cellulose, mikrokrystallinsk Silica, kolloid vandfri Lactosemonohydrat Magnesiumstearat 
Capsule content Croscarmellose sodium Cellulose, microcrystalline Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate
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. 
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.
I de fleste tilfælde ses remission ved seponering af kinidin. 
Most cases remit when quinidine is withdrawn.
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. 
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.
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. 
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.
Ti patienter fik seponeret behandlingen på grund af bivirkninger, som i ét tilfælde var alvorlig (forværring af muskelspasticitet). 
Ten patients discontinued study treatment due to ADRs, one of these patients due to a serious ADR (worsening muscle spasticity).
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. 
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.
Hos patienter i kinidinbehandling er beskrevet hepatitis, herunder granulomatøs hepatitis, sædvanligvis i de første uger af behandlingen. 
Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy.
• lægemidler til behandling af epilepsi eller anfald, såsom fenytoin, karbamazepin og phenobarbital 
• medicines to treat epilepsy or fits, such as phenytoin, carbamazepine and phenobarbital
Plasmakoncentrationerne af kinidin er proportionale med kinidindosis. 
Quinidine plasma concentrations are proportional to quinidine dose.
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. 
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.
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). 
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).
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. 
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.
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. 
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.
• du har lever- eller nyreproblemer. 
• you have problems with your liver or kidney.
Nuleffektdosis hos kaniner er henholdsvis 2 og 60 gange højere end den anbefalede dosis til mennesker. 
The no effect dose in rabbits is 2 and 60 times higher than the RHD.
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. 
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).
Forsigtighed bør udvises ved sideløbende behandling med serotoningenoptagshæmmere (SSRI). 
Caution should be exercised if patients are treated with concomitant selective serotonin reuptake inhibitors (SSRIs).
Hverken dextromethorphan eller kinidin inducerede CYP1A2, CYP2B6 eller CYP3A4 i humane hepatocytter i koncentrationer op til 4,8 µM. 
Neither dextromethorphan nor quinidine induced CYP1A2, CYP2B6 or CYP3A4 in human hepatocytes at concentrations up to 4.8 µM.
Den gennemsnitlige ændring i QTcF var 6,8 ms for NUEDEXTA 23 mg/9 mg, og 9,1 ms for det aktive kontrolstof (moxifloxacin). 
Mean changes in QTcF were 6.8 ms for NUEDEXTA 23 mg/ 9 mg and 9.1 ms for the reference positive control (moxifloxacin).
Risikoen for trombocytopeni i forbindelse med den lavere dosis af kinidin i NUEDEXTA kendes ikke. 
The risk of thrombocytopenia in association with the lower dose of quinidine in NUEDEXTA is unknown.
Du må ikke holde op med at tage NUEDEXTA uden at have spurgt lægen, selv om du har fået det bedre. 
Do not stop taking this medicine without speaking to your doctor first, even if you begin to feel better.
• patientadvarselskort 
• Patient alert cards
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). 
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).
Dextromethorphan metaboliseres hurtigt af CYP2D6 til den primære metabolit dextrorphan, der hurtigt glukuronideres og udskilles renalt. 
Dextromethorphan is rapidly metabolized by CYP2D6 to its primary metabolite, dextrorphan, which is rapidly glucuronidated and renally eliminated.
Hvis du holder op med at bruge NUEDEXTA 
If you stop taking NUEDEXTA
• 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) 
• 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).
De hyppigste bivirkninger var let til moderat kvalme, svimmelhed og hovedpine. 
The most common adverse reactions were mild to moderate nausea, dizziness, and headache.
Tricykliske antidepressiva (f.eks. desipramin, nortriptylin, imipramin, amitriptylin) metaboliseres af CYP2D6 og er derfor underkastet farmakokinetisk interaktion med kinidin. 
Tricyclic antidepressants (TCAs e.g. desipramine, nortriptyline, imipramine, amitriptyline) are metabolised by CYP2D6 and therefore are also subject to pharmacokinetic interaction with quinidine.
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. 
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.
Indehaver af markedsføringstilladelsen og fremstiller Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London 
Marketing Authorisation Holder and Manufacturer Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London
Kinidin hæmmer P-glykoprotein. 
Quinidine is an inhibitor of P-glycoprotein.
• Epistaxis, faryngolaryngeale smerter, respirationsdepression, rhinorré, gaben 
• Epistaxis, Pharyngolaryngeal pain, Respiratory depression, Rhinorrhoea, Yawning
• lægemiddelinteraktioner, herunder medvirken af CYP2D6-substrater og -hæmmere 
• Drug-drug interactions including involvement of CYP2D6 substrates and inhibitors
Udtagning af kapslerne: 
To access capsules:
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. 
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.
Uspecifikke symptomer såsom svimmelhed, kulderystelser, feber, kvalme og opkastning kan gå forud for eller ledsage trombocytopeni. 
Non-specific symptoms, such as light-headedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia.
Samtidig anvendelse af lægemidler, der hæmmer CYP3A4, kan forventes at øge plasmakoncentrationen af kinidin med risiko for QTc-forlængelse. 
Concomitant administration of medicines that inhibit CYP3A4 can be expected to increase plasma levels of quinidine, which could increase risk relating to QTc prolongation.
• uddannelsesmateriale til sundhedspersoner 
• Educational material for Healthcare Professionals (HCPs)
Kinidin er en potent hæmmer af CYP2D6. 
Quinidine is a potent inhibitor of CYP2D6.
Patienter med forlænget QT-interval, kongenit langt QT-syndrom eller anamnese med tegn på torsade de pointes ventrikulær takykardi (se pkt. 
Patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes ventricular tachycardia (see section 4.4).
Anvendelse af kinidin sammen med digoxin, der er et substrat for Pglykoprotein, medfører op til en fordobling af serum-digoxin. 
Concomitant administration of quinidine with digoxin, a P-glycoprotein substrate, results in serum digoxin levels that may be as much as doubled.
Der kræves ikke dosisjustering hos patienter med ikke-fungerende CYPD2D6-enzym (såkaldt dårlige metabolisatorer (PM). 
Dose adjustment is not required in patients with a non-functional CYPD2D6 enzyme, referred to as poor metabolisers (PMs).
Kinidin metaboliseres af CYP3A4. 
Quinidine is metabolised by CYP3A4.
• Bruksisme, konfusionstilstand, nedtrykthed, depression, desorientering, opvågnen tidligt om morgenen, affektaffladning, hallucinationer, impulsiv adfærd, indifferens, søvnløshed, rastløshed, søvnforstyrrelser 
• Bruxism, Confusional state, Depressed mood, Depression, Disorientation, Early morning awakening, Flat affect, Hallucination, Impulsive behaviour, Indifference, Insomnia, Restlessness, Sleep disorder
Ved trombocytopeni bør NUEDEXTA straks seponeres, medmindre trombocytopenien klart ikke er lægemiddelrelateret. 
NUEDEXTA should be discontinued immediately if thrombocytopenia occurs, unless the thrombocytopenia is clearly not drug-related.
• lægemidler mod svampeinfektioner såsom ketoconazol, itraconazol og fluconazol 
• medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole
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. 
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.
Den selektive serotoningenoptagshæmmer (SSRI) paroxetin metaboliseres primært af CYP2D6 og er samtidig en potent CYP2D6-hæmmer. 
The selective serotonin reuptake inhibitor (SSRI) paroxetine is metabolized primarily by CYP2D6 and is also a potent CYP2D6 inhibitor.
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. 
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.
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. 
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.
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. 
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.
I tilstedeværelse af kinidin antages den CYP3A4afhængige oxidative metabolisering at spille en øget rolle i udskillelsen af dextromethorphan. 
In the presence of quinidine, CYP3A4-dependent oxidative metabolism is believed to play a greater role in dextromethorphan elimination.
Tag fat om fligene over og under (). 
Squeeze and hold at tabs above and below () Pull out card to the right ( )
Hensigten med kinidinkomponenten er at hæmme CYP2D6, så der opnås højere eksponering for dextromethorphan end med dextromethorphan alene. 
The quinidine component is intended to inhibit CYP2D6 so that higher exposure to dextromethorphan can be achieved compared to when dextromethorphan is given alone.
• Undersøgelser med kombinationer af dextromethorphan/kinidin i højere dosering 
• Studies with Higher Dose Combinations of dextromethorphan / quinidine
• at give dig en højere dosis og ordinere NUEDEXTA, kapsler, 23 mg/9 mg. 
• to give you a higher dose and to prescribe NUEDEXTA 23 mg/9 mg capsules to you.
Hvis du får bivirkninger, skal du sige det til lægen eller på apoteket. 
If you get any side effects, talk to your doctor or pharmacist.
• dobbeltsyn, sløret syn 
• double vision, blurred vision
Det skal du vide, før du begynder at tage NUEDEXTA 
What you need to know before you take NUEDEXTA
Dextromethorphan kan desuden være forbundet med hypersensitivitetsreaktioner, herunder urticaria, angioødem og dyspnø. 
Dextromethorphan can also be associated with hypersensitivity reactions, including uticaria, angioedema, and shortness of breath.
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). 
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).
I de embryoføtale toksicitetsundersøgelser og udviklingstoksicitetsundersøgelserne (rotter og kaniner) med dextromethorphanhydrobromid/kinidinsulfat sås abnormiteter ved mellemste og højeste dosis med nedsat ossifikation fra laveste dosis hos rotter; denne dosis er henholdsvis 1 og 50 gange den humane dosis på 30/18 mg dagligt, beregnet som mg/m2. 
In embryo-fetal and developmental toxicity studies (rats and rabbits) with dextromethorphan hydrobromide/quinidine sulfate, abnormalities were observed at mid and high dose with reduced ossification from the lowest dose in rats which is approximately 1 and 50 times the human dose of 30/18 mg/day on a mg/m basis, respectively.
NUEDEXTA er indiceret til symptomatisk behandling af pseudobulbær affekt (PBA) hos voksne (se pkt. 
NUEDEXTA is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults (see section 4.4).
Når der tages to kapsler inden for 24 timer, anbefales et dosisinterval på 12 timer. 
When taking two capsules within 24 hours, the recommended dose interval is 12 hours.
• du får symptomer såsom gulfarvning af hud eller øjne, mørk urin, kvalme eller opkastning, nedsat appetit, mavesmerter og feber, da dette kan være tegn på lægemiddelforårsaget leverbetændelse (hepatitis) 
• you experience symptoms, such as yellowing of the skin or eyes, dark urine, nausea or vomiting, loss of appetite, abdominal pain, and fever, as this may be a sign of drug-induced hepatitis (liver inflammation).
NUEDEXTA anvendes til behandling af pseudobulbær affekt (PBA) hos voksne. 
NUEDEXTA is used for the treatment of pseudobulbar affect (PBA) in adults.
Beskrivelse. 
Description:
Den anbefalede begyndelsesdosis af NUEDEXTA er 15 mg/9 mg én gang dagligt. 
The recommended starting dose is NUEDEXTA 15 mg/9 mg once daily.