FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: NUEDEXTA is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults (see section 4.4).
Danish: NUEDEXTA er indiceret til symptomatisk behandling af pseudobulbær affekt (PBA) hos voksne (se pkt.
English: When taking two capsules within 24 hours, the recommended dose interval is 12 hours.
Danish: Når der tages to kapsler inden for 24 timer, anbefales et dosisinterval på 12 timer.
English: • 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).
Danish: • 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)
English: NUEDEXTA is used for the treatment of pseudobulbar affect (PBA) in adults.
Danish: NUEDEXTA anvendes til behandling af pseudobulbær affekt (PBA) hos voksne.
English: Description:
Danish: Beskrivelse.
English: The recommended starting dose is NUEDEXTA 15 mg/9 mg once daily.
Danish: Den anbefalede begyndelsesdosis af NUEDEXTA er 15 mg/9 mg én gang dagligt.
English: Neither dextromethorphan alone nor dextromethorphan/quinidine has been evaluated in patients with severe hepatic impairment.
Danish: Hverken dextromethorphan alene eller dextromethorphan/kinidin er vurderet hos patienter med svært nedsat leverfunktion.
English: Fertility In pre-clinical studies no effect on fertility was observed in male and female rats (see section 5.3).
Danish: Fertilitet I de prækliniske undersøgelser sås ingen virkning på fertiliteten hos han- eller hunrotter (se pkt.
English: 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.
Danish: Andre virkninger er nedsat evne til at koordinere bevægelser (ataksi), ufrivillige øjenbevægelser (nystagmus), muskelspændinger (dystoni), sløret syn og ændrede muskelreflekser.
English: • Serotonin syndrome
Danish: • serotoninsyndrom
English: Quinidine increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6 (CYP2D6), which catalyses a major biotransformation pathway for dextromethorphan.
Danish: Kinidin øger plasmakoncentrationerne af dextromethorphan ved kompetitiv hæmning af cytokrom P450 2D6 (CYP2D6), der katalyserer en af de vigtigste biotransformationsveje for dextromethorphan.
English: 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.
Danish: 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.
English: Treatment of dextromethorphan overdose should be directed at symptomatic and supportive measures.
Danish: Ved overdosering med dextromethorphan er behandlingen symptomatisk og støttende.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: Treatment should be discontinued if these symptoms occur.
Danish: Ved sådanne symptomer bør behandlingen seponeres.
English: • 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)
Danish: • 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)
English: 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.
Danish: En populationsfarmakokinetisk analyse af data fra 109 personer (75 mænd og 34 kvinder) viste ingen åbenbare kønsforskelle i farmakokinetikken af dextromethorphan/kinidin.
English: 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.
Danish: 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.
English: Reproductive system and breast disorders General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet
English: As this medicinal product may cause foetal harm, it is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Da NUEDEXTA kan medføre fosterbeskadigelse, bør det ikke anvendes under graviditet eller hos kvinder i den fertile alder, som ikke anvender kontraception.
English: 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.
Danish: 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.
English: Dose adjustment is not required in patients with increased CYP2D6 activity, referred to as ultra-rapid metabolisers (UMs), see section 5.2.
Danish: Der kræves heller ikke dosisjustering hos patienter med forhøjet CYP2D6aktivitet, såkaldt ultrahurtige metabolisatorer (UM), se pkt.
English: 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.
Danish: Litteraturdata giver ikke grundlag for at forvente lægemiddelinteraktioner som følge af kinidinbetinget hæmning af OATP1B1, OCT1, OCT2, OAT3, BSEP, MATE1 eller MATE2-K.
English: You should not drink grapefruit juice or eat grapefruits while you are taking NUEDEXTA as this can increase the likelihood of serious side effects.
Danish: Brug af NUEDEXTA sammen med mad, drikke og alkohol Undgå grapefrugtjuice og grapefrugt, mens du får NUEDEXTA, da dette øger risikoen for alvorlige bivirkninger.
English: • if you are already taking medicines containing quinidine, quinine, or mefloquine.
Danish: • hvis du i forvejen får lægemidler indeholdende kinidin, kinin eller mefloquin.
English: Interaction with NUEDEXTA may result in an increased effect on QT interval (see sections 4.4 and 4.5).
Danish: Interaktion med NUEDEXTA kan medføre øget påvirkning af QT-intervallet (se pkt.
English: 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.
Danish: 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.
English: It should not be used if immunemediated thrombocytopenia from structurally related active substances including quinine and mefloquine is suspected, as cross-sensitivity can occur.
Danish: Ved mistanke om immunmedieret trombocytopeni forårsaget af strukturelt beslægtede aktive stoffer, herunder kinin og mefloquin, bør NUEDEXTA ikke anvendes, da krydsallergi kan forekomme.
English: 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.
Danish: 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.
English: The concomitant use of thioridazine is contraindicated (see section 4.3).
Danish: Samtidig anvendelse af thioridazin er kontraindiceret (se pkt.
English: 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).
Danish: 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).
English: 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.
Danish: Ved symptomer tydende på hjertearytmi, f.eks. synkope eller palpitationer, bør NUEDEXTA seponeres, indtil patienten er nærmere udredt.
English: • 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).
Danish: • hvis du har haft lupuslignende syndrom forårsaget af kinidin (kan medføre ledsmerter, hududslæt, overfølsomhed af huden over for sol, og almindelig utilpashed)
English: • redness of the skin (erythema), excessive sweating (hyperhidrosis), loss of sensation or numbness of the face, night sweats
Danish: • rødme af huden (erytem), svedtendens (hyperhidrose), nedsat følesans eller følelsesløshed i ansigtet, nattesved
English: • 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
Danish: • balanceforstyrrelse, abnorm koordination, talevanskeligheder (dysartri), bevægelsesforstyrrelser, prikken og stikken/snurren eller følelsesløshed (paræstesi), manglende følesans eller funktion i benene (paraparese), sløvhed
English: Patients with a history of quinidine-, quinine-, mefloquine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome (see section 4.4).
Danish: Patienter med kinidin, kinin- eller mefloqininduceret trombocytopeni, hepatitis, knoglemarvsdepression eller lupuslignende syndrom i anamnesen (se pkt.
English: • Summary of Product Characteristics (SmPC)
Danish: • produktresumé (SPC)
English: 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.
Danish: Kun for NUEDEXTA, 15 mg/9 m: Blister af klar, PVC-baseret film, lukket med alufolie.
English: Patients with moderate hepatic impairment showed an increased frequency of adverse reactions.
Danish: Patienter med moderat leverfunktionsnedsættelse havde øget bivirkningsfrekvens.
English: The pharmacokinetics of dextromethorphan/quinidine in paediatric patients has not been studied (see section 5.1).
Danish: Pædiatrisk population Farmakokinetikken af dextromethorphan/kinidin hos pædiatriske patienter er ikke undersøgt (se pkt.
English: These are medicines used to treat malaria or heart rhythm problems,
Danish: Disse lægemidler anvendes til behandling af malaria eller forstyrrelser i hjerterytmen,
English: Balance disorder, Coordination abnormal, Dysarthria, Motor dysfunction, Paraesthesia, Paraparesis, Sedation
Danish: Balanceforstyrrelser, koordinationsforstyrrelser, dysartri, motoriske forstyrrelser, paræstesi, paraparese, sedation
English: Patients receiving concomitant treatment with quinidine, quinine, or mefloquine (see section 4.5).
Danish: Patienter i samtidig behandling med kinidin, kinin eller mefloquin (se pkt.
English: • heart attack (myocardial infarction), heart palpitations
Danish: • hjerteanfald (myokardieinfarkt), hjertebanken
English: 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).
Danish: Ved behov for sideløbende anvendelse af lægemidler, som er CYP2D6-substrater, skal dosis heraf nedsættes i henhold til deres farmakokinetik (se pkt.
English: • medicines used to prevent nausea and vomiting during chemotherapy and after surgery, such as aprepitant
Danish: • lægemidler til forebyggelse af kvalme og opkastning under kemoterapi og efter operationer,
English: 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).
Danish: 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.
English: If the clinical response with NUEDEXTA 15 mg/9 mg is adequate, the dose taken in weeks 2-4 should be continued.
Danish: Ved adækvat klinisk respons med NUEDEXTA, 15 mg/9 mg, fortsættes med samme dosering som i uge 2-4.
English: 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.
Danish: 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.
English: • medicines containing quinidine, quinine, or mefloquine.
Danish: • lægemidler indeholdende kinidin, kinin eller mefloquin.
English: These are medicines used to treat malaria or heart rhythm problems.
Danish: Disse lægemidler anvendes til behandling af malaria eller forstyrrelser i hjerterytmen
English: 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.
Danish: Hos dårlige metabolisatorer forventes kinidinkomponenten ikke at bidrage til virkningen af NUEDEXTA, men bivirkninger af kinidinkomponenten er alligevel mulige.
English: 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.
Danish: 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.
English: • certain medicines used to treat depression, including nortriptyline, desipramine, paroxetine imipramine and amitriptyline, nefazodone
Danish: • visse lægemidler mod depression, herunder nortriptylin, desipramin, paroxetin, imipramin,
English: 60 hard capsules
Danish: Indeholder 60 hårde kapsler.
English: The quinidine component of NUEDEXTA serves to selectively inhibit CYP2D6-dependent oxidative metabolism of dextromethorphan, thus increasing dextromethorphan plasma concentrations.
Danish: Kinidinkomponenten i NUEDEXTA tjener til selektivt at hæmme den CYP2D6-afhængige oxidative metabolisering af dextromethorphan og derved øge plasmakoncentrationen af dextromethorphan.
English: 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.
Danish: 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.
English: Treatment with NUEDEXTA may therefore result in elevated plasma levels and accumulation of co-administered medicinal products that undergo extensive CYP2D6 metabolism.
Danish: NUEDEXTA kan derfor medføre forhøjet plasmakoncentration og akkumulering af samtidigt anvendte lægemidler, der vidtgående metaboliseres af CYP2D6.
English: 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.
Danish: 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.
English: Shellac glaze (20% esterified) Propylene glycol Titanium dioxide (E171)
Danish: Shellacglasering (20 % esterificeret) Propylenglycol
English: Other signs and symptoms of overdose may include vomiting, diarrhoea, tinnitus, high-frequency hearing loss, vertigo, blurred vision, diplopia, photophobia, headache, confusion, and delirium.
Danish: Andre tegn og symptomer på overdosis kan være opkastning, diarré, tinnitus, høretab ved høje frekvenser, vertigo, sløret syn, diplopi, fotofobi, hovedpine, konfusion og delirium.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (forekommer hos indtil 1 ud af 10 behandlede):
English: What NUEDEXTA contains
Danish: NUEDEXTA indeholder:
English: Quinidine did not inhibit (<30% inhibition) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, or CYP3A4 in human microsomes at concentrations up to 5 µM.
Danish: Kinidin hæmmede ikke (<30 % hæmning) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1 eller CYP3A4 i humane mikrosomer ved en koncentration op 5 µM.
English: Dextromethorphan / quinidine has not been studied in patients with severe renal impairment.
Danish: Dextromethorphan/kinidin er ikke undersøgt hos patienter med svært nedsat nyrefunktion.
English: 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.
Danish: 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.
English: 13 hard capsules
Danish: Indeholder 13 hårde kapsler.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Dette lægemiddel bør ikke anvendes hos patienter med sjældne arvelige lidelser såsom galaktoseintolerans eller Lapp-laktasemangel (glukose/galaktosemalabsorption).
English: 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.
Danish: 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.
English: CYP2D6 substrates
Danish: CYP2D6-substrater
English: Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used to increase the systemic bioavailability of dextromethorphan.
Danish: Kinidinsulfat er en specifik hæmmer af CYP2D6-afhængig oxidativ metabolisering og anvendes til at øge den systemiske biotilgængelighed af dextromethorphan.
English: • musculoskeletal stiffness, muscle pain (myalgia), neck pain, pain in the limbs
Danish: • muskelstivhed, muskelsmerter (myalgi), nakkesmerter, smerter i lemmerne
English: Dose adjustment is not required in patients with mild to moderate renal or hepatic impairment (see section 4.4).
Danish: Der kræves ikke dosisjustering hos patienter med let til moderat nedsat nyre- eller leverfunktion (se pkt.
English: The patient should take one NUEDEXTA 15 mg/9 mg capsule once daily, in the morning, for the initial 7 days.
Danish: Patienten skal tage én kapsel af NUEDEXTA, 15 mg/9 mg, én gang dagligt om morgenen i de første 7 dage.
English: Thioridazine, a CYP2D6 substrates that also prolong the QT interval is contraindicated (see section 4.3).
Danish: Thioridazin er kontraindiceret, da det er et CYP2D6-substrat, der ligeledes forlænger QT-intervallet (se pkt.
English: Concomitant use of flecainide, chlorpromazine or haloperidol, CYP2D6 substrates that also prolong QT interval, requires caution (see section 4.4).
Danish: Forsigtighed bør udvises ved samtidig anvendelse af flecainid, chlorpromazin og haloperidol, som er CYP2D6-substrater, der ligeledes forlænger QT-intervallet (se pkt.
English: • rare (≥1/10,000 to <1/1,000)
Danish: • sjælden (≥1/10 000 til <1/1 000)
English: 4.3 Special warnings and precautions for use
Danish: 4.5 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Symptoms of serotonin syndrome include altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor.
Danish: Symptomer på serotoninsyndrom er ændret mental status, hypertension, rastløshed, myokloni, hypertermi, hyperrefleksi, diaforese, kulderystelser og tremor.
English: • distorted sense of taste (dysgeusia), sleepiness (hypersomnia), muscle spasticity, fainting
Danish: • forkerte smagsindtryk (dysgeusi), søvnighed (hypersomni), muskelkramper (spasticitet),
English: Brick red gelatin capsule, size 1, with “DMQ / 30-10” printed in white ink on the capsule and three white bands around the circumference.
Danish: Rødbrune gelatinekapsler, størrelse 1, med påskriften “DMQ/30-10” med hvid trykfarve på kapslen og tre hvide bånd langs omkredsen.
English: 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.
Danish: 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).