FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne er anført i pkt.
English: 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).
Danish: 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.
English: • common (≥1/100 to <1/10)
Danish: • almindelig (≥ 1/100 til < 1/10),
English: The most commonly reported side effects are gastrointestinal disorders (such as diarrhoea, nausea), nervous system disorders (such as dizziness, headache, somnolence) and fatigue.
Danish: De hyppigst indberettede bivirkninger er gastrointestinale gener (såsom diarré og kvalme), symptomer fra nervesystemet (såsom svimmelhed, hovedpine og somnolens) og træthed.
English: 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.
Danish: Hvis du holder op med at tage NUEDEXTA, skal der gå mindst 14 dage, før du begynder at få en MAO-hæmmer.
English: NUEDEXTA contains lactose
Danish: NUEDEXTA indeholder lactose
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Common Dizziness, Headache, Somnolence
Danish: Almindelig Svimmelhed, hovedpine, somnolens
English: 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.
Danish: 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.
English: Do not take NUEDEXTA
Danish: Brug ikke NUEDEXTA
English: PBA is a consequence of neurological diseases affecting the brain, or brain, injury and is defined by episodes of involuntary, uncontrollable emotional expressions of laughing and/or crying that are incongruous or disproportionate to the patient's emotional state or mood.
Danish: PBA er en følge af neurologiske sygdomme i hjernen eller hjernetraumer og er kendetegnet ved episoder med involuntære, ukontrollerbare følelsesudbrud med latter og/eller gråd uden sammenhæng eller ude af proportioner med patientens emotionelle tilstand eller sindsstemning.
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ualmindelige bivirkninger: (forekommer hos indtil 1 ud af 100 behandlede):
English: Hard capsule
Danish: Kapsler, hårde.
English: Patients should be warned about the potential for CNS-related effects like somnolence, dizziness and syncope or impaired vision (see section 4.8), and advised not to drive or operate machinery if these symptoms occur.
Danish: Patienterne skal advares om potentialet for CNS-relaterede virkninger såsom somnolens, svimmelhed, synkope og nedsat syn (se pkt.
English: Other adverse reactions include ataxia, nystagmus, dystonia, blurred vision, and changes in muscle reflexes.
Danish: Andre bivirkninger er ataksi, nystagmus, dystoni, sløret syn og ændrede muskelreflekser.
English: If the clinical response with NUEDEXTA 15 mg/9 mg is inadequate, NUEDEXTA 23 mg/9 mg should be prescribed, taken two times per day, one in the morning and one in the evening, 12 hours apart.
Danish: Ved inadækvat klinisk respons med NUEDEXTA, 15 mg/9 mg, ordineres NUEDEXTA, 23 mg/9 mg, to gange dagligt, én om morgenen og én om aftenen med 12-timers mellemrum.
English: Eligible patients had a diagnosis of PBA defined by episodes of involuntary, uncontrollable emotional expressions of laughing and/or crying that are incongruous or disproportionate to their emotional state or mood.
Danish: Egnede patienter fik fastlagt diagnosen PBA ved episoder med involuntære, ukontrollerbare følelsesudbrud med latter og/eller gråd uden sammenhæng eller ude af proportioner med patientens emotionelle tilstand eller sindsstemning.
English: NUEDEXTA contains lactose.
Danish: NUEDEXTA indeholder lactose.
English: Brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
Danish: Rødbrune gelatinekapsler, størrelse 1, med påskriften “DMQ/20-10” med hvid trykfarve på kapslen.
English: In patients with severe hepatic impairment (Child-Pugh C) or severe renal impairment (Creatinine Clearance < 30 mL/min/1.73m
Danish: Hos patienter med svært nedsat leverfunktion (Child-Pugh C) eller svært nedsat nyrefunktion (kreatininclearance < 30 ml/min/1,73 m2) bør de potentielle risici ved lægemidlets anvendelse afvejes mod det medicinske behov (se pkt.
English: NUEDEXTA may cause dizziness (see section 4.8).
Danish: NUEDEXTA kan forårsage svimmelhed (se pkt.
English: • you develop symptoms of an allergic reaction such as swelling of the throat or tongue, difficulty breathing, dizziness, fever, rash, or hives after taking this medicine.
Danish: • du efter at have taget dette lægemiddel får symptomer på en allergisk reaktion såsom hævelse i halsen eller af tungen, vejrtrækningsbesvær, svimmelhed, feber, udslæt eller nældefeber
English: PBA is a neurological condition characterized by involuntary and uncontrollable episodes of laughing and/or crying, which don't match your emotional state or mood.
Danish: PBA er en neurologisk sygdom kendetegnet af ufrivillige og ukontrollerbare episoder med latter og gråd, som ikke svarer til følelser eller sindsstemning hos den pågældende.
English: Given the pharmacodynamic and pharmacokinetic interactions, concomitant use of NUEDEXTA and TCAs is not recommended due to the elevated risk of serotonin syndrome (see section 4.5).
Danish: Samtidig brug af NUEDEXTA og tricykliske antidepressiva frarådes på grund af den farmakodynamiske og farmakokinetiske interaktion og den forhøjede risiko for serotoninsyndrom (se pkt.
English: Therefore, dosage adjustment is not required in patients with mild and moderate hepatic impairment, although additional monitoring for adverse reactions should be considered in patients with moderate hepatic impairment.
Danish: Hos patienter med let til moderat nedsat leverfunktion kræves derfor ingen dosisjustering, men øget overvågning for bivirkninger bør overvejes.
English: The combination dose of dextromethorphan/quinidine increased steady state desipramine levels approximately 8-fold.
Danish: Dextromethorphan/kinidin i denne dosis øgede steady state-koncentrationen af desipramin til ca. den 8-dobbelte.
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjælden (forekommer hos indtil 1 ud af 1 000 behandlede):
English: How to take NUEDEXTA
Danish: Sådan skal du tage NUEDEXTA
English: • St John's wort, a herbal medicine used to treat depression
Danish: • perikum (et naturlægemiddel, der anvendes til behandling af depression)
English: • abnormal faeces, indigestion, inflammation of the lining of the stomach (gastritis), numbness and abnormal sensation in the mouth, rectal pain, dry tongue
Danish: • unormal afføring, fordøjelsesbesvær, irritation af maveslimhinden (gastritis), følelsesløshed og abnorm følesans i munden, smerter fra endetarmen, mundtørhed
English: • medicines used to treat HIV infection and AIDS, such as atazanavir, indinavir, nelfinavir,
Danish: • lægemidler mod hiv-smitte og aids såsom atazanavir, indinavir, nelfinavir, ritonavir, saquinavir,
English: Paroxetine (CYP2D6 inhibitor and substrate)
Danish: Paroxetin (CYP2D6-hæmmer og -substrat)
English: Chest discomfort, Chest pain, Chills, Feeling hot, Gait disturbance, Influenza like illness, Pyrexia, Oxygen
Danish: Ubehag i brystet, brystsmerter, kulderystelser, varmefølelse, gangforstyrrelser, influenzalignende sygdom, pyreksi, nedsat oxygenmætning
English: Desipramine (CYP2D6 substrate)
Danish: Desipramin (CYP2D6-substrat)
English: • dizziness, headache, drowsiness
Danish: • svimmelhed, hovedpine, døsighed
English: Concomitant medicinal products that both prolong the QT interval and are primarily metabolised by CYP2D6 (see below) are of particular potential concern.
Danish: Særlig risiko foreligger ved behandling med lægemidler, som både forlænger QT-intervallet og primært metaboliseres af CYP2D6 (se nedenfor).
English: Concomitant use of CYP2D6 substrates/inhibitors
Danish: Samtidig anvendelse af CYP2D6-substrater/-inhibitorer.
English: When taking two capsules within 24 hours, you should leave about 12 hours between doses.
Danish: Når du får to kapsler inden for 24 timer, skal der gå ca. 12 timer mellem hver.
English: LVH and LVD are more likely to be present in patients with chronic hypertension, known coronary artery disease or history of stroke.
Danish: Hypertrofi og dysfunktion af venstre ventrikel forekommer oftere hos patienter med kronisk hypertension, kendt koronararteriesygdom eller anamnese med apopleksi.
English: In a study of a combination dose of dextromethorphan 23 mg / quinidine 26 mg twice daily in 12 subjects with mild (CLCR 50-80 mL/min) or moderate (CLCR 30-50 mL/min) renal impairment (6 each) compared to 9 healthy subjects (matched in gender, age, and weight range to impaired subjects), subjects showed little difference in quinidine or dextromethorphan pharmacokinetics compared to healthy subjects.
Danish: I en undersøgelse, hvor der blev givet en kombineret dosis af dextromethorphan 23 mg/kinidin 26 mg to gange dagligt til 12 personer med let (kreatininclearance 50-80 ml/min) eller moderat (kreatininclearance 30-50 ml/min) nyrefunktionsnedsættelse (6 af hver), sås ringe forskel i farmakokinetikken af kinidin og dextromethorphan i forhold til 9 raske sammenligningspersoner (matchede i køn, alder og vægt).
English: • chest discomfort, chest pain, chills, feeling hot, gait disturbance (difficulty walking), flu-like illness, fever, decreased oxygen levels in the blood
Danish: • ubehag i brystet, brystsmerter, kulderystelser, varmefølelse, gangforstyrrelser, influenzalignende sygdom, feber, nedsat iltmætning i blodet
English: Patients should be monitored for worsening clinical condition in myasthenia gravis and other conditions that may be adversely affected by anticholinergic effects.
Danish: Ved myasthenia gravis og andre sygdomme, der kan forværres ved antikolinerg påvirkning, bør den kliniske tilstand overvåges.
English: • if you are taking, or have taken during the last two weeks, certain medicines for depression called monoamine oxidase inhibitors (MAOIs), such as phenelzine and moclobemide.
Danish: • hvis du er i behandling med MAO-hæmmere (lægemidler mod depression), f.eks. phenelzin eller moclobemid, eller har været det inden for de seneste 14 dage.
English: Adverse reactions of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, tachycardia, hyperexcitability, and toxic psychosis.
Danish: Bivirkningerne ved overdosering med dextromethorphan er kvalme, opkastning, stupor, koma, respirationsdepression, krampeanfald, takykardi, hyperexcitabilitet og toksisk psykose.
English: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap. Each bottle is packed in a carton.
Danish: Flaske af HD-polyethylen (HDPE) med børnesikret låg af polypropylen.
English: Drug interactions with desipramine and paroxetine have been studied in controlled clinical trials with a higher dose combination of dextromethorphan/quinidine (dextromethorphan 23 mg/ quinidine 26 mg) than in this medicinal product; study results are described below.
Danish: Lægemiddelinteraktioner med desipramin og paroxetin har været genstand for kontrollerede kliniske undersøgelser med kombinationen af dextromethorphan og kinidin i en højere dosis (dextromethorphan 23 mg/kinidin 26 mg) end i dette lægemiddel.
English: • uncommon (≥1/1,000 to <1/100)
Danish: • ikke almindelig (≥1/1 000 til <1/100)
English: (syncope), fall
Danish: besvimelse (synkope), faldtendens
English: In a study of a combination dose of dextromethorphan 23 mg / quinidine 26 mg twice daily in 12 subjects with mild or moderate hepatic impairment (as indicated by the Child-Pugh method; 6 each) compared to 9 healthy subjects (matched in gender, age, and weight range to impaired subjects), subjects with moderate hepatic impairment showed similar dextromethorphan AUC and Cmax and clearance compared to healthy subjects.
Danish: I en undersøgelse, hvor der blev givet en kombineret dosis af dextromethorphan 23 mg/kinidin 26 mg to gange dagligt til 12 personer med let eller moderat nedsat leverfunktion (i henhold til Child-Pughmetoden; 6 af hver), var AUC, Cmax og clearance af dextromethorphan den samme som hos 9 raske sammenligningspersoner (matchede i køn, alder og vægt).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med NUEDEXTA Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin, har gjort det for nylig eller påtænker at gøre det.
English: Erythema, Hyperhidrosis, Hypoaesthesia facial, Night sweats
Danish: Erytem, hyperhidrose, facial hypæstesi, erytem, nattesved
English: In the case of pro-drugs whose actions are mediated by the CYP2D6-produced metabolites (for example, codeine and hydrocodone, whose analgesic and antitussive effects appear to be mediated by morphine and hydromorphone, respectively), efficacy may be substantially reduced by NUEDEXTA due to inhibition of CYP2D6 and hence impaired formation of the active metabolite.
Danish: For pro-drugs, hvis virkning medieres af metabolitter frembragt af CYP2D6, kan NUEDEXTA væsentligt forringe virkningen ved at hæmme CYP2D6 og mindske dannelsen af den aktive metabolit.
English: Two additional phase III studies were conducted using a higher dose combination of dextromethorphan 23 mg/quinidine 26 mg.
Danish: Der blev udført to yderligere fase III-undersøgelser med en højere dosering: dextromethorphan 23 mg/kinidin 26 mg.
English: Symptoms of quinidine overdose include irregular heartbeat and low blood pressure, and may also include vomiting, diarrhoea, ringing in the ears, high-frequency hearing loss, vertigo, blurred vision, double vision, increased sensitivity of the eyes to light, headache, confusion, and delirium (characterised by loss of attention, poor memory, disorientation, impaired speech).
Danish: Desuden kan det medføre opkastning, diarré, ringen for ørerne, høretab ved høje toner, svimmelhed, sløret syn, dobbeltsyn, øget lysfølsomhed af øjnene, hovedpine, omtågethed og delirium (karakteriseret ved svækket opmærksomhed, dårlig hukommelse, desorientering og talevanskeligheder).
English: Diplopia, Vision blurred
Danish: Diplopi, sløret syn
English: See leaflet for further information.
Danish: Yderligere oplysninger herom fremgår af indlægssedlen.
English: Patients with renal and hepatic impairment
Danish: Patienter med nedsat nyre- eller leverfunktion
English: Combination with MAOIs is contraindicated (see section 4.3).
Danish: Samtidig anvendelse af MAO-hæmmere er kontraindiceret (se pkt.
English: • medicines used to treat bacterial infections, including tuberculosis, containing clarithromycin,
Danish: • lægemidler, der anvendes til behandling af bakterielle infektioner, herunder tuberkulose, og som indeholder clarithromycin, telithromycin, erythromycin eller rifampicin
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Ikke almindelig Udslæt
English: Dextromethorphan may increase the risk of serotonin syndrome, and this risk is increased by overdose, particularly if taken with other serotonergic agents, SSRIs or tricyclic antidepressants.
Danish: Risikoen øges ved overdosering, navnlig ved indtagelse sammen med andre serotonerge lægemidler, SSRI eller tricykliske antidepressiva.
English: If you have taken more capsules than you should, speak to your doctor immediately.
Danish: Hvis du har taget for mange NUEDEXTA tabletter Kontakt straks lægen, hvis du har taget for mange kapsler.
English: Dose adjustment is therefore not required in mild or moderate renal impairment.
Danish: Der er derfor ikke behov for dosisjustering for patienter med let til moderat nedsat nyrefunktion.
English: Symptoms of serotonin syndrome include agitation, high blood pressure, restlessness, muscle spasms and twitching, high body temperature, excessive sweating, shivering, and tremor.
Danish: Symptomerne på serotoninsyndrom er uro, for højt blodtryk, rastløshed, muskelspasmer, sitren og rysten, forhøjet temperatur, svedtendens, kulderystelser og rysten.
English: Uncommon Dysgeusia, Hypersomnia, Muscle spasticity, Syncope, Fall
Danish: Dysgeusi, hypersomni, muskelspasticitet, synkope, faldtendens
English: Uncommon Decreased appetite
Danish: Metabolisme og ernæring Ikke almindelig Nedsat appetit
English: • NUEDEXTA 15 mg/9 mg is a brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
Danish: • NUEDEXTA, 15 mg/9 mg, er rødbrune gelatinekapsler, størrelse 1, med påskriften “DMQ/20
English: INFORMATION IN BRAILLE NUEDEXTA 23 mg/9 mg
Danish: NUEDEXTA, 23 mg/9 mg
English: Before treatment with Nuedexta is initiated patients must be fully evaluated to confirm the diagnosis of PBA. Central to the diagnosis are the presence of an underlying neurological condition known to cause PBA, and confirmation that the episodes of emotional expression do not reflect the patient's emotional state or mood.
Danish: Afgørende for diagnosen er tilstedeværelsen af en underliggende neurologisk sygdom, der vides at medføre PBA, og bekræftelse af, at episoderne med emotionelle udbrud er uden sammenhæng eller ude af proportioner med patientens emotionelle tilstand eller sindsstemning.
English: Because of this effect on CYP2D6, accumulation of parent drug substances and/or failure of active metabolite formation may affect the safety and/or the efficacy of medicinal products used concomitantly with NUEDEXTA that are metabolised by CYP2D6 (see section 4.5).
Danish: Dette kan påvirke sikkerhed og/eller virkning af lægemidler, der anvendes sammen med NUEDEXTA og metaboliseres af CYP2D6 (se pkt.
English: INFORMATION IN BRAILLE NUEDEXTA 15 mg/9 mg
Danish: NUEDEXTA, 15 mg/9 mg
English: NUEDEXTA 15 mg/9 mg hard capsules NUEDEXTA 23 mg/9 mg hard capsules dextromethorphan / quinidine
Danish: NUEDEXTA, kapsler, hårde, 15 mg/9 mg NUEDEXTA, kapsler, hårde, 23 mg/9 mg dextromethorphan/kinidin
English: • fatigue
Danish: • træthed
English: • very common (≥1/10)
Danish: • meget almindelig (>1/10)
English: Both dextromethorphan and memantine are antagonists of the N-methyl-D-aspartate (NMDA) receptor which could theoretically result in an additive effect at NMDA receptors and potentially an increased incidence of adverse reactions.
Danish: Både dextromethorphan og memantin er antagonister til N-methyl-D-aspartat- (NMDA-) receptoren.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: • certain medicines for depression, called monoamine oxidase inhibitors (MAOIs- for example phenelzine and moklobemide).
Danish: • visse lægemidler mod depression, der kaldes monoaminoxidasehæmmere (MAO-hæmmere),
English: Common Diarrhoea, Nausea Abdominal pain, Constipation, Dry mouth, Flatulence, Stomach discomfort, Vomiting
Danish: Abdominalsmerter, konstipation, mundtørhed, flatulens, ubehag i maven, opkastning
English: ritonavir, saquinavir, amprenavir, fosamprenavir
Danish: Muskelstivhed, myalgi, nakkesmerter, ekstremitetssmerter
English: BLISTER SLEEVE (13 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
Danish: HYLSTER TIL BLISTER (13 kapsler, hårde) - NUEDEXTA, kapsler, 15 mg/9 mg
English: • medicines used to treat various heart conditions, such as diltiazem, verapamil, digoxin,
Danish: • lægemidler, mod forskellige hjertesygdomme, således diltiazem, verapamil, digoxin, flecainid og betablokkere (såsom metoprolol)
English: • teeth grinding (bruxism), confusion, depressed mood, depression, disorientation (e.g. difficulty sensing time, direction, and recognition of people and places), early morning awakening,
Danish: • tænderskæren (bruksisme), omtågethed, nedtrykthed, depression, desorientering (f.eks. vanskelighed ved at opfatte tidspunkt og retning eller genkende personer og steder), opvågnen tidligt om morgenen, nedsat følelsesudtryk (affektaffladning), sansebedrag (hallucinationer), pludselige indskydelser (impulsiv adfærd), ligegyldighed, søvnløshed (insomni), rastløshed, søvnforstyrrelser
English: NUEDEXTA 15 mg/9 mg hard capsules dextromethorphan / quinidine
Danish: NUEDEXTA, kapsler, hårde, 15 mg/9 mg dextromethorphan/kinidin
English: Driving and using machines NUEDEXTA may cause dizziness.
Danish: NUEDEXTA kan medføre svimmelhed.
English: NUEDEXTA 23 mg/9 mg hard capsules dextromethorphan / quinidine
Danish: NUEDEXTA, kapsler, hårde, 23 mg/9 mg dextromethorphan/kinidin
English: Plasma concentrations of dextromethorphan and dextrorphan are proportional to dextromethorphan dose in the presence of a fixed dose of quinidine such as that contained in NUEDEXTA.
Danish: I tilstedeværelse af en fast dosis kinidin således som den, der er indeholdt i NUEDEXTA, er plasmakoncentrationerne af dextromethorphan og dextrorphan proportionale med dextromethorphandosis.
English: Quinidine at higher doses has also been associated with a lupus-like syndrome involving polyarthritis, sometimes with a positive antinuclear antibody test. Other associations include rash, bronchospasm, lymphadenopathy, haemolytic anaemia, vasculitis, uveitis, angioedema, agranulocytosis, the sicca syndrome, myalgia, elevation in serum levels of skeletal-muscle enzymes, and pneumonitis.
Danish: Andre tilknyttede symptomer er udslæt, bronkospasme, lymfadenopati, hæmolytisk anæmi, vaskulitis, uveitis, angioødem, agranulocytose, siccasyndrom, myalgi, forhøjet serumkoncentration af skeletmuskelenzymer og pneumonitis.
English: OUTER CARTON - NUEDEXTA 15 mg/9 mg capsules: PACK OF 13 CAPSULES
Danish: YDERKARTON - NUEDEXTA, kapsler, hårde, 15 mg/9 mg INDEHOLDER 13 KAPSLER
English: Symptoms of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, increased heart rate, hyperexcitability, and toxic psychosis.
Danish: Symptomerne på overdosering med dextromethorphan er kvalme, opkastning, sløvhed, bevidstløshed, nedsat vejrtrækning, krampeanfald, øget hjerterytme, irritabilitet og psykose som følge af giftpåvirkning.
English: Each NUEDEXTA 23 mg/9 mg capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 23.11 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Danish: Hver kapsel NUEDEXTA, 23 mg/9 mg, indeholder dextromethorphanhydrobromidmonohydrat svarende til 23,11 mg dextromethorphan og kinidinsulfatdihydrat svarende til 8,69 mg kinidin.