natgillin/translations-raw huggingface dataset:
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.
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.