natgillin/translations-raw huggingface dataset:
Hverken dextromethorphan alene eller dextromethorphan/kinidin er vurderet hos patienter med svært nedsat leverfunktion. 
Neither dextromethorphan alone nor dextromethorphan/quinidine has been evaluated in patients with severe hepatic impairment.
Fertilitet I de prækliniske undersøgelser sås ingen virkning på fertiliteten hos han- eller hunrotter (se pkt. 
Fertility In pre-clinical studies no effect on fertility was observed in male and female rats (see section 5.3).
Andre virkninger er nedsat evne til at koordinere bevægelser (ataksi), ufrivillige øjenbevægelser (nystagmus), muskelspændinger (dystoni), sløret syn og ændrede muskelreflekser. 
Other effects include loss of coordinated movement (ataxia), involuntary eye movements (nystagmus), over contraction of the muscles (dystonia), blurred vision, and changes in muscle reflexes.
• serotoninsyndrom 
• Serotonin syndrome
Kinidin øger plasmakoncentrationerne af dextromethorphan ved kompetitiv hæmning af cytokrom P450 2D6 (CYP2D6), der katalyserer en af de vigtigste biotransformationsveje for dextromethorphan. 
Quinidine increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6 (CYP2D6), which catalyses a major biotransformation pathway for dextromethorphan.
Metaboliseringen af dextromethorphan hæmmes af kinidin, hvorfor virkningerne af overdosering med NUEDEXTA kan være sværere eller mere persisterende end ved en overdosis af dextromethorphan alene. 
Metabolism of dextromethorphan is inhibited by quinidine, such that adverse reactions of overdose due to NUEDEXTA might be more severe or more persistent compared to overdose of dextromethorphan alone.
Ved overdosering med dextromethorphan er behandlingen symptomatisk og støttende. 
Treatment of dextromethorphan overdose should be directed at symptomatic and supportive measures.
Ved behandling med NUEDEXTA bør det sædvanligvis undgås at anvende lægemidler, der er afhængige af CYP2D6metabolisering, navnlig lægemidler med forholdsvis smalt terapeutisk indeks,, og patienterne skal instrueres herom. 
Medicinal products that are dependent on CYP2D6 metabolism, especially those with a relatively narrow therapeutic index, should generally be avoided during treatment with NUEDEXTA, and patients must be instructed accordingly.
Ca. 7-8 % af personer af kaukasisk race, 3-6 % af personer af sort afrikansk race, 2-3 % af personer af arabisk oprindelse og 1-2 % af personer af asiatisk oprindelse mangler evnen til at metabolisere substrater for CYP2D6 og klassificeres som dårlige metabolisatorer (PM). 
Approximately 7-8% of individuals of Caucasian descent, 3-6% of Black African descent, 2-3% of Arab descent and 1-2% of Asian descent generally lack the capacity to metabolize CYP2D6 substrates and are classified as Poor Metabolizer (PMs).
Ved sådanne symptomer bør behandlingen seponeres. 
Treatment should be discontinued if these symptoms occur.
• hvis du tidligere har haft for lavt indhold af blodceller forårsaget af kinidin, kinin eller mefloquin (kan vise sig ved unormal tendens til blødning eller blå mærker) 
• if you have a history of low levels of blood cells caused by quinidine, quinine or mefloquine (this can cause a tendency to bleed or bruise more easily than normal)
En populationsfarmakokinetisk analyse af data fra 109 personer (75 mænd og 34 kvinder) viste ingen åbenbare kønsforskelle i farmakokinetikken af dextromethorphan/kinidin. 
A population pharmacokinetic analysis based on data from 109 subjects (75 male; 34 female) showed no apparent gender differences in the pharmacokinetics of dextromethorphan/quinidine.
Patienten skal tage én kapsel af NUEDEXTA, 15 mg/9 mg, to gange dagligt, én om morgenen og én om aftenen, med 12-timers mellemrum, i 21 dage. 
The patient should take one NUEDEXTA 15 mg/9 mg capsule, two times per day, one in the morning and one in the evening, 12-hours apart, for 21 days.
Almene symptomer og reaktioner på administrationsstedet 
Reproductive system and breast disorders General disorders and administration site conditions
Da NUEDEXTA kan medføre fosterbeskadigelse, bør det ikke anvendes under graviditet eller hos kvinder i den fertile alder, som ikke anvender kontraception. 
As this medicinal product may cause foetal harm, it is not recommended during pregnancy and in women of childbearing potential not using contraception.
Efter administration af NUEDEXTA, 23 mg/9 mg, til 14 ekstensive metabolisatorer var eliminationshalveringstiden 18,8 timer for dextromethorphan og 9,6 timer for kinidin. 
After administration of NUEDEXTA 23 mg/9 mg to 14 extensive metabolizers, the elimination halflife of dextromethorphan was 18.8 hours and the elimination half-life of quinidine was 9.6 hours.
Der kræves heller ikke dosisjustering hos patienter med forhøjet CYP2D6aktivitet, såkaldt ultrahurtige metabolisatorer (UM), se pkt. 
Dose adjustment is not required in patients with increased CYP2D6 activity, referred to as ultra-rapid metabolisers (UMs), see section 5.2.
Litteraturdata giver ikke grundlag for at forvente lægemiddelinteraktioner som følge af kinidinbetinget hæmning af OATP1B1, OCT1, OCT2, OAT3, BSEP, MATE1 eller MATE2-K. 
Based on literature citations, drug-drug interactions as a result of quinidine inhibition of OATP1B1, OCT1, OCT2, OAT3, BSEP, MATE1, and MATE2-K are not expected.
Brug af NUEDEXTA sammen med mad, drikke og alkohol Undgå grapefrugtjuice og grapefrugt, mens du får NUEDEXTA, da dette øger risikoen for alvorlige bivirkninger. 
You should not drink grapefruit juice or eat grapefruits while you are taking NUEDEXTA as this can increase the likelihood of serious side effects.
• hvis du i forvejen får lægemidler indeholdende kinidin, kinin eller mefloquin. 
• if you are already taking medicines containing quinidine, quinine, or mefloquine.
Interaktion med NUEDEXTA kan medføre øget påvirkning af QT-intervallet (se pkt. 
Interaction with NUEDEXTA may result in an increased effect on QT interval (see sections 4.4 and 4.5).
Ungernes overlevelse og vægt var let nedsat fra den laveste dosis svarende til henholdsvis ca. 1 og 50 gange den humane dosis på 30/18 mg dagligt, beregnet som mg/m for dextromethorphanhydrobromid og kinidinsulfat. 
Pup survival and pup weight were slightly decreased from the lowest dose corresponding approximately to 1and 50 times the human dose of 30/18 mg/kg on a mg/m2 basis, for dextromethorphan hydrobromide and quinidine sulfate, respectively.
Ved mistanke om immunmedieret trombocytopeni forårsaget af strukturelt beslægtede aktive stoffer, herunder kinin og mefloquin, bør NUEDEXTA ikke anvendes, da krydsallergi kan forekomme. 
It should not be used if immunemediated thrombocytopenia from structurally related active substances including quinine and mefloquine is suspected, as cross-sensitivity can occur.
Aktivt kul i sædvanlig dosis på 1 g/kg, indgivet hver 2. til 6. time opslæmmet i postevand, 8 ml/kg, kan øge den systemiske udskillelse af kinidin. 
Administration of activated charcoal in conventional dose of 1 g/kg, administered every 2 to 6 hours as a slurry with 8 mL/kg of tap water may enhance the systemic elimination of quinidine; this measures should be avoided if an ileus is present.
Samtidig anvendelse af thioridazin er kontraindiceret (se pkt. 
The concomitant use of thioridazine is contraindicated (see section 4.3).
Mindste middelkvadrat af CNS-LS-score var væsentligt reduceret ved behandlingens slutning i begge behandlingsgrupper i forhold til placebo (8,2 point mindre for NUEDEXTA, 23 mg/9 mg og 7,5 point mindre for NUEDEXTA, 15 mg/9 mg mod 5,7 point mindre for placebo). 
The least-squares mean CNS-LS scores were significantly reduced at the end of treatment in both treatment groups compared to placebo (8.2 point reduction for NUEDEXTA 23 mg /9 mg, 7.5 point reduction for NUEDEXTA 15 mg /9 mg, 5.7 point reduction for placebo).
Ved symptomer tydende på hjertearytmi, f.eks. synkope eller palpitationer, bør NUEDEXTA seponeres, indtil patienten er nærmere udredt. 
If patients experience symptoms that could indicate the occurrence of cardiac arrhythmias, e.g. syncope or palpitations, NUEDEXTA should be discontinued pending further evaluation of the patient.
• hvis du har haft lupuslignende syndrom forårsaget af kinidin (kan medføre ledsmerter, hududslæt, overfølsomhed af huden over for sol, og almindelig utilpashed) 
• if you have a history of a condition called lupus-like syndrome caused by quinidine (this can cause joint pains, skin rash, excessive skin sensitivity to sun and overall feeling of sickness).
• rødme af huden (erytem), svedtendens (hyperhidrose), nedsat følesans eller følelsesløshed i ansigtet, nattesved 
• redness of the skin (erythema), excessive sweating (hyperhidrosis), loss of sensation or numbness of the face, night sweats
• balanceforstyrrelse, abnorm koordination, talevanskeligheder (dysartri), bevægelsesforstyrrelser, prikken og stikken/snurren eller følelsesløshed (paræstesi), manglende følesans eller funktion i benene (paraparese), sløvhed 
• balance disorder, abnormal coordination, speech difficulties (dysarthria), movement dysfunction, pins and needles / tingling or numbness (paraesthesia), loss of feeling or function in the lower limbs (paraparesis), sedation
Patienter med kinidin, kinin- eller mefloqininduceret trombocytopeni, hepatitis, knoglemarvsdepression eller lupuslignende syndrom i anamnesen (se pkt. 
Patients with a history of quinidine-, quinine-, mefloquine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome (see section 4.4).
• produktresumé (SPC) 
• Summary of Product Characteristics (SmPC)
Kun for NUEDEXTA, 15 mg/9 m: Blister af klar, PVC-baseret film, lukket med alufolie. 
Only for NUEDEXTA 15 mg/9 mg: Blister packs consist of a PVC based clear film with aluminium foil seal and contains 13 hard capsules.
Patienter med moderat leverfunktionsnedsættelse havde øget bivirkningsfrekvens. 
Patients with moderate hepatic impairment showed an increased frequency of adverse reactions.
Pædiatrisk population Farmakokinetikken af dextromethorphan/kinidin hos pædiatriske patienter er ikke undersøgt (se pkt. 
The pharmacokinetics of dextromethorphan/quinidine in paediatric patients has not been studied (see section 5.1).
Disse lægemidler anvendes til behandling af malaria eller forstyrrelser i hjerterytmen, 
These are medicines used to treat malaria or heart rhythm problems,
Balanceforstyrrelser, koordinationsforstyrrelser, dysartri, motoriske forstyrrelser, paræstesi, paraparese, sedation 
Balance disorder, Coordination abnormal, Dysarthria, Motor dysfunction, Paraesthesia, Paraparesis, Sedation
Patienter i samtidig behandling med kinidin, kinin eller mefloquin (se pkt. 
Patients receiving concomitant treatment with quinidine, quinine, or mefloquine (see section 4.5).
• hjerteanfald (myokardieinfarkt), hjertebanken 
• heart attack (myocardial infarction), heart palpitations
Ved behov for sideløbende anvendelse af lægemidler, som er CYP2D6-substrater, skal dosis heraf nedsættes i henhold til deres farmakokinetik (se pkt. 
When concomitant use of a CYP2D6 substrate drug is considered necessary, the dose of the CYP2D6 substrate should be reduced as appropriate according to the pharmacokinetics of the substrate involved (see section 4.5).
• lægemidler til forebyggelse af kvalme og opkastning under kemoterapi og efter operationer, 
• medicines used to prevent nausea and vomiting during chemotherapy and after surgery, such as aprepitant
Dette gælder således for patienter med unormalt QT i anamnesen, ved samtidig behandling med lægemidler, der forlænger QT-intervallet, og ved hypertrofi og/eller dysfunktion af venstre ventrikel. 
This includes patients with a family history of QT abnormality, concomitant medicinal products that prolong the QT interval, and patients with left ventricular hypertrophy (LVH) and/or left ventricular dysfunction (LVD).
Ved adækvat klinisk respons med NUEDEXTA, 15 mg/9 mg, fortsættes med samme dosering som i uge 2-4. 
If the clinical response with NUEDEXTA 15 mg/9 mg is adequate, the dose taken in weeks 2-4 should be continued.
Dextromethorphan hæmmede ikke (<20 % hæmning) nogen af de testede isoenzymer: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 eller CYP3A4 i humane levermikrosomer ved en koncentration op til 5 µM. 
Dextromethorphan did not inhibit (<20% inhibition) any of the tested isoenzymes: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4 in human liver microsomes at concentrations up to 5 µM.
• lægemidler indeholdende kinidin, kinin eller mefloquin. 
• medicines containing quinidine, quinine, or mefloquine.
Disse lægemidler anvendes til behandling af malaria eller forstyrrelser i hjerterytmen 
These are medicines used to treat malaria or heart rhythm problems.
Hos dårlige metabolisatorer forventes kinidinkomponenten ikke at bidrage til virkningen af NUEDEXTA, men bivirkninger af kinidinkomponenten er alligevel mulige. 
The quinidine component is not expected to contribute to the effectiveness of NUEDEXTA in PMs, but adverse reactions of the quinidine component are still possible.
Den gennemsnitlige CNS-LS-score ved baseline var 19,8 i gruppen på NUEDEXTA, 23 mg/9 mg, 21,0 i gruppen på NUEDEXTA, 15 mg/9 mg, og 19,9 i placebogruppen. 
Mean baseline CNS-LS scores were 19.8 in the NUEDEXTA 23 mg /9 mg group, 21.0 in the NUEDEXTA 15 mg /9 mg group, and 19.9 in the placebo group.
• visse lægemidler mod depression, herunder nortriptylin, desipramin, paroxetin, imipramin, 
• certain medicines used to treat depression, including nortriptyline, desipramine, paroxetine imipramine and amitriptyline, nefazodone
Indeholder 60 hårde kapsler. 
60 hard capsules
Kinidinkomponenten i NUEDEXTA tjener til selektivt at hæmme den CYP2D6-afhængige oxidative metabolisering af dextromethorphan og derved øge plasmakoncentrationen af dextromethorphan. 
The quinidine component of NUEDEXTA serves to selectively inhibit CYP2D6-dependent oxidative metabolism of dextromethorphan, thus increasing dextromethorphan plasma concentrations.
Den gennemsnitlige daglige frekvens af PBA-episoder (beregnet af det totale antal indberettede episoder i op til 7 dage før behandlingen) var 4,7 i gruppen på NUEDEXTA, 23 mg/9 mg, 6,8 i gruppen på NUEDEXTA, 15 mg/9 mg, og 4,5 i placebogruppen. 
Mean baseline daily PBA episode rates (calculated from the total number of episodes reported for up to 7 pre-treatment days) were 4.7 in the NUEDEXTA 23 mg/9 mg group, 6.8 in the NUEDEXTA 15 mg/9 mg group, and 4.5 in the placebo group.
NUEDEXTA kan derfor medføre forhøjet plasmakoncentration og akkumulering af samtidigt anvendte lægemidler, der vidtgående metaboliseres af CYP2D6. 
Treatment with NUEDEXTA may therefore result in elevated plasma levels and accumulation of co-administered medicinal products that undergo extensive CYP2D6 metabolism.
En populationsfarmakokinetisk analyse af etnisk baggrund hos 109 personer (21 af kaukasisk race, 71 af latinamerikansk oprindelse, 18 sorte) viste ingen åbenbare etnisk betingede forskelle i farmakokinetikken af dextromethorphan/kinidin. 
A population pharmacokinetic analysis of race with 109 subjects (21 Caucasian; 71 Hispanic; 18 Black) revealed no apparent racial differences in the pharmacokinetics of dextromethorphan/quinidine.
Shellacglasering (20 % esterificeret) Propylenglycol 
Shellac glaze (20% esterified) Propylene glycol Titanium dioxide (E171)
Andre tegn og symptomer på overdosis kan være opkastning, diarré, tinnitus, høretab ved høje frekvenser, vertigo, sløret syn, diplopi, fotofobi, hovedpine, konfusion og delirium. 
Other signs and symptoms of overdose may include vomiting, diarrhoea, tinnitus, high-frequency hearing loss, vertigo, blurred vision, diplopia, photophobia, headache, confusion, and delirium.
Almindelige bivirkninger (forekommer hos indtil 1 ud af 10 behandlede): 
Common side effects (may affect up to 1 in 10 people)
NUEDEXTA indeholder: 
What NUEDEXTA contains
Kinidin hæmmede ikke (<30 % hæmning) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1 eller CYP3A4 i humane mikrosomer ved en koncentration op 5 µM. 
Quinidine did not inhibit (<30% inhibition) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, or CYP3A4 in human microsomes at concentrations up to 5 µM.
Dextromethorphan/kinidin er ikke undersøgt hos patienter med svært nedsat nyrefunktion. 
Dextromethorphan / quinidine has not been studied in patients with severe renal impairment.
Virkningerne på QTc-forlængelse af supraterapeutiske doser af dextromethorphan/kinidin (23 mg/26 mg og 46 mg/53 mg i syv på hinanden følgende doser) blev vurderet i en randomiseret, placebokontrolleret, dobbeltblindet overkrydsningsundersøgelse med en supplerende åben arm med aktivt sammenligningsstof (400 mg moxifloxacin) hos 36 raske forsøgspersoner. 
The effects of supra-therapeutic doses of dextromethorphan /quinidine (23 mg /26 mg and 46 mg / 53 mg, for 7 consecutive doses) on QTc prolongation were evaluated in a randomised, placebocontrolled, double-blind, crossover design with an additional open-label positive control (400 mg moxifloxacin) arm in 36 healthy volunteers.
Indeholder 13 hårde kapsler. 
13 hard capsules
Dette lægemiddel bør ikke anvendes hos patienter med sjældne arvelige lidelser såsom galaktoseintolerans eller Lapp-laktasemangel (glukose/galaktosemalabsorption). 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Hos ekstensive metabolisatorer steg gennemsnitsværdierne af Cmax og AUC0-12 for dextromethorphan og dextrorphan, når dosis af dextromethorphan øgedes fra 15 mg til 23 mg, mens gennemsnitsværdierne af Cmax og AUC0-12 for kinidin var uændrede. 
In extensive metabolizers, mean Cmax and AUC0-12 values of dextromethorphan and dextrorphan increased as doses of dextromethorphan increased from 15 mg to 23 mg and mean Cmax and AUC0-12 values of quinidine were similar.
CYP2D6-substrater 
CYP2D6 substrates
Kinidinsulfat er en specifik hæmmer af CYP2D6-afhængig oxidativ metabolisering og anvendes til at øge den systemiske biotilgængelighed af dextromethorphan. 
Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used to increase the systemic bioavailability of dextromethorphan.
• muskelstivhed, muskelsmerter (myalgi), nakkesmerter, smerter i lemmerne 
• musculoskeletal stiffness, muscle pain (myalgia), neck pain, pain in the limbs
Der kræves ikke dosisjustering hos patienter med let til moderat nedsat nyre- eller leverfunktion (se pkt. 
Dose adjustment is not required in patients with mild to moderate renal or hepatic impairment (see section 4.4).
Patienten skal tage én kapsel af NUEDEXTA, 15 mg/9 mg, én gang dagligt om morgenen i de første 7 dage. 
The patient should take one NUEDEXTA 15 mg/9 mg capsule once daily, in the morning, for the initial 7 days.
Thioridazin er kontraindiceret, da det er et CYP2D6-substrat, der ligeledes forlænger QT-intervallet (se pkt. 
Thioridazine, a CYP2D6 substrates that also prolong the QT interval is contraindicated (see section 4.3).
Forsigtighed bør udvises ved samtidig anvendelse af flecainid, chlorpromazin og haloperidol, som er CYP2D6-substrater, der ligeledes forlænger QT-intervallet (se pkt. 
Concomitant use of flecainide, chlorpromazine or haloperidol, CYP2D6 substrates that also prolong QT interval, requires caution (see section 4.4).
• sjælden (≥1/10 000 til <1/1 000) 
• rare (≥1/10,000 to <1/1,000)
4.5 Særlige advarsler og forsigtighedsregler vedrørende brugen 
4.3 Special warnings and precautions for use
Symptomer på serotoninsyndrom er ændret mental status, hypertension, rastløshed, myokloni, hypertermi, hyperrefleksi, diaforese, kulderystelser og tremor. 
Symptoms of serotonin syndrome include altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor.
• forkerte smagsindtryk (dysgeusi), søvnighed (hypersomni), muskelkramper (spasticitet), 
• distorted sense of taste (dysgeusia), sleepiness (hypersomnia), muscle spasticity, fainting
Rødbrune gelatinekapsler, størrelse 1, med påskriften “DMQ/30-10” med hvid trykfarve på kapslen og tre hvide bånd langs omkredsen. 
Brick red gelatin capsule, size 1, with “DMQ / 30-10” printed in white ink on the capsule and three white bands around the circumference.
Virkningen af NUEDEXTA, 23 mg/9 mg (syv på hinanden følgende doser) på QTc-forlængelse blev vurderet i en omfattende randomiseret, dobbeltblindet (undtagen for moxifloxacin), QToverkrydsningsundersøgelse med placebokontrol og aktivt sammenligningsstof (400 mg moxifloxacin) hos 50 fastende, normale, raske mænd og kvinder med genotypen ekstensiv metabolisator (EM). 
The effect of NUEDEXTA 23 mg / 9 mg (for 7 consecutive doses) on QTc prolongation was evaluated in a randomised, double-blind (except for moxifloxacin), placebo- and positive-controlled (400 mg moxifloxacin) crossover thorough QT study in 50 fasted normal healthy men and women with CYP2D6 extensive metabolizer (EM) genotype.
For NUEDEXTA 23 mg/9 mg, var p=0,0002 for sammenligning med placebo, og for NUEDEXTA, 15 mg/9 mg, var p=0,008 for sammenligning med placebo. 
The p-value for NUEDEXTA 23 mg /9 mg vs placebo was p=0.0002 and for NUEDEXTA 15 mg /9 mg vs placebo was p=0.008.
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne er anført i pkt. 
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
På grund af risikoen for serotoninsyndrom må NUEDEXTA ikke anvendes sammen med monoaminoxidasehæmmere (MAO-hæmmere) såsom phenelzin eller moclobemid, eller hvis patienten har fået MAO-hæmmere inden for de foregående 14 dage (se pkt. 
NUEDEXTA must not be used with monoamine oxidase inhibitors (MAOIs), such as phenelzine and moklobemide, or in patients who have taken MAOIs within the preceding 14 days due to the risk of serotonin syndrome (see section 4.3).
• almindelig (≥ 1/100 til < 1/10), 
• common (≥1/100 to <1/10)
De hyppigst indberettede bivirkninger er gastrointestinale gener (såsom diarré og kvalme), symptomer fra nervesystemet (såsom svimmelhed, hovedpine og somnolens) og træthed. 
The most commonly reported side effects are gastrointestinal disorders (such as diarrhoea, nausea), nervous system disorders (such as dizziness, headache, somnolence) and fatigue.
Hvis du holder op med at tage NUEDEXTA, skal der gå mindst 14 dage, før du begynder at få en MAO-hæmmer. 
Do not take NUEDEXTA if you have taken these antidepressants during the last two weeks and allow at least 14 days after stopping NUEDEXTA before starting an MAOI.
NUEDEXTA indeholder lactose 
NUEDEXTA contains lactose
Efter enkelt og gentagen dosering af NUEDEXTA, 23 mg/9 mg, var deltagernes eksponering for dextromethorphan ca. 20 gange større end hos dem, der fik dextromethorphan uden kinidin. 
Following single and repeated combination doses of NUEDEXTA 23 mg / 9 mg, subjects had an approximately 20-fold increase in dextromethorphan exposure compared to subjects given dextromethorphan without quinidine.
Fortæl det straks til lægen, hvis du får svære symptomer, herunder uro, for højt blodtryk, rastløshed, muskeltrækninger og sitren, forhøjet legemstemperatur, stærk svedtendens, kulderystelser eller rysten. 
Tell your doctor immediately if you experience severe symptoms including agitation, high blood pressure, restlessness, muscle spasms and twitching, high body temperature, excessive sweating, shivering, and tremor.
Almindelig Svimmelhed, hovedpine, somnolens 
Common Dizziness, Headache, Somnolence
In vitro-interaktionsundersøgelser for transportmekanismer Undersøgelserne af transporthæmning giver ikke grundlag for at forvente lægemiddelinteraktioner som følge af dextromethorphan-betinget hæmning af P-gp, OATP1B1, OATP1B3, OCT2, OAT1, OAT3 eller BSEP ved behandling med NUEDEXTA. 
Based on the results of transporter inhibition studies drug-drug interactions related to dextromethorphan inhibition of P-gp, OATP1B1, OATP1B3, OCT2, OAT1, OAT3 or BSEP are not expected during treatment withNUEDEXTA.
Brug ikke NUEDEXTA 
Do not take NUEDEXTA