natgillin/translations-raw huggingface dataset:
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).
Simptomi predoziranja kinidinom uključuju nepravilne otkucaje srca i nizak krvni tlak, a mogu također uključivati povraćanje, proljev, zvonjenje u ušima, gubitak sluha za visoke frekvencije, vrtoglavicu, zamućen vid, dvostruke slike, povećanu osjetljivost očiju na svjetlo, glavobolju, smetenost i delirij (karakteriziranu gubitkom pozornosti, lošim pamćenjem, dezorijentiranošću, oštećenim govorom).
• 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
• poremećaj ravnoteže, poremećena koordinacija, otežan govor (dizartrija), disfunkcija kretanja, bockanje i peckanje / trnci ili utrnulost (parestezija), gubitak osjeta ili funkcije nogu (parapareza), sedacija
If you stop taking NUEDEXTA
Ako prestanete uzimati lijek NUEDEXTA
Quinidine increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6 (CYP2D6), which catalyses a major biotransformation pathway for dextromethorphan.
Kinidin povećava plazmatske razine dekstrometorfana kompeticijskom inihibicijom citokroma P450 2D6 (CYP2D6), koji katalizira glavni put biotransformacije dekstrometorfana.
NUEDEXTA may cause dizziness (see section 4.8).
NUEDEXTA može prouzročiti omaglicu (vidjeti dio 4.8).
If you forget to take NUEDEXTA
Ako ste zaboravili uzeti lijek NUEDEXTA
Caution should be exercised if patients are treated with concomitant selective serotonin reuptake inhibitors (SSRIs).
Ako su bolesnici istovremeno liječeni inhibitorima selektivne ponovne pohrane serotonina (SSRI), potrebno je postupati oprezno.
To access capsules:
Vađenje kapsule:
NUEDEXTA contains lactose.
NUEDEXTA sadrži laktozu.
• Myocardial infarction, Palpitations, Ventricular extrasystoles
Rijetko infarkt miokarda, palpitacije, ventrikularne ekstrasistole
NUEDEXTA can help reduce how often you have episodes of PBA.
NUEDEXTA Vam može pomoći smanjiti učestalost epizoda pseudobulbarnog afekta.
Symptoms of serotonin syndrome include altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor.
Simptomi serotoninskog sindroma uključuju promijenjeni mentalni status, hipertenziju, nemir, mioklonus, hipertermiju, hiperrefleksiju, dijaforezu, drhtanje i tremor.
• Drug-drug interactions including involvement of CYP2D6 substrates and inhibitors
• interakcije lijekova koje uključuju supstrate i inhibitore CYP2D6
When taking two capsules within 24 hours, you should leave about 12 hours between doses.
Kada uzimate dvije kapsule unutar 24 sata, između doza morate napraviti razmak od otprilike 12 sati.
After administration of the combination product, protein binding remains essentially the same as that after administration of the individual components; dextromethorphan is approximately 60-70% protein bound, and quinidine is approximately 80-89% protein bound.
Dekstrometorfan se veže na proteine približno 60-70%, a kinidin približno 80-89%.
NUEDEXTA contains lactose
NUEDEXTA sadrži laktozu
Balance disorder, Coordination abnormal, Dysarthria, Motor dysfunction, Paraesthesia, Paraparesis, Sedation
Rijetko poremećaj ravnoteže, abnormalna koordinacija, disartrija, motorička disfunkcija, parestezija, parapareza, sedacija
NUEDEXTA has the potential to cause QTc prolongation and hence torsades de pointes-type ventricular tachycardia.
NUEDEXTA može izazvati produljenje QTc intervala, a time i ventrikularnu tahikardiju torsades de pointes.
• Off-label use
• uporabu izvan odobrenih indikacija
Common side effects (may affect up to 1 in 10 people)
Česte nuspojave (mogu se javiti u do 1 od 10 osoba)
The patient should take one NUEDEXTA 15 mg/9 mg capsule once daily, in the morning, for the initial 7 days.
Bolesnik treba uzeti jednu kapsulu NUEDEXTA 15 mg/9 mg jedanput na dan, ujutro, prvih 7 dana.
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.
Nakon jedne i ponovljenih kombiniranih doza lijeka NUEDEXTA 23 mg/9 mg, ispitanici su pokazali približno 20 puta veću izloženost dekstrometorfanu u usporedbi s ispitanicima koji su primili dekstrometorfan bez kinidina.
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.
P-vrijednost za lijek NUEDEXTA 23 mg/9 mg naspram placebu bila je p=0,0002, a za lijek NUEDEXTA 15 mg/9 mg naspram placebu p=0,008.
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.
Prosječne stope dnevnih epizoda pseudobulbarnog afekta na početku (izračunatih iz ukupnog broja epizoda zabilježenih u do 7 dana prije liječenja) bile su 4,7 u skupini NUEDEXTA 23 mg/9 mg, 6,8 u skupini NUEDEXTA 15 mg/9 mg i 4,5 u skupini koja je primala placebo.
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.
Analiza populacijske farmakokinetike u odnosu na rasnu pripadnost provedena na 109 ispitanika (21 bijelac; 71 latinoamerikanac; 18 crnaca) nije pokazala vidljive razlike s obzirom na farmakokinetiku dekstrometorfana / kinidina.
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.
Učinak lijeka NUEDEXTA 23 mg/9 mg (u 7 uzastopnih doza) na produljenje QTc intervala procijenjen je u randomiziranom dvostruko slijepom ispitivanju (osim za moksifloksacin), kontroliranom placebom i pozitivnom kontrolom (400 mg moksifloksacin) sveobuhvatnom ukriženom ispitivanju QT intervala provedenom natašte u 50 normalnih zdravih muškaraca i žena s genotipom ekstenzivnih metabolizatora CYP2D6.
Patients with moderate hepatic impairment showed an increased frequency of adverse reactions.
Bolesnici s umjerenim oštećenjem funkcije jetre pokazali su povećanu učestalost nuspojava.
Concomitant use of NUEDEXTA and TCAs is not recommended (see section 4.4).
Ne preporučuje se istovremena uporaba lijeka NUEDEXTA i tricikličkih antidepresiva (vidjeti dio 4.4).
Plasma concentrations of quinidine increased 20-30% when memantine was added.
Dodatkom memantina, koncentracija kinidina u plazmi povećala se za 20-30%.
Patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes ventricular tachycardia (see section 4.4).
Bolesnici s produljenim QT intervalom, sindromom prirođeno produljenog QT intervala ili anamnezom koja upućuje na ventrikularnu tahikardiju torsades de pointes (vidjeti dio 4.4).
• Bruxism, Confusional state, Depressed mood, Depression, Disorientation, Early morning awakening, Flat affect, Hallucination, Impulsive behaviour, Indifference, Insomnia, Restlessness, Sleep disorder
Rijetko bruksizam, stanje konfuzije, depresivno raspoloženje, depresija, dezorijentiranost, rano buđenje, zaravnjen afekt, halucinacije, impulzivno ponašanje, ravnodušnost, nesanica, nemir, poremećaj spavanja
Treatment with NUEDEXTA may therefore result in elevated plasma levels and accumulation of co-administered medicinal products that undergo extensive CYP2D6 metabolism.
Terapija NUEDEXTOM stoga može rezultirati povišenim plazmatskim razinama istovremeno primijenjenih lijekova koji se opsežno metaboliziraju putem CYP2D6.
The risk of thrombocytopenia in association with the lower dose of quinidine in NUEDEXTA is unknown.
Rizik od trombocitopenije povezan s nižom dozom kinidina, kakvu sadrži NUEDEXTA, nije poznat.
• very common (≥1/10)
• vrlo često (≥1/10)
• Drug misuse and abuse
• pogrešnu primjenu i zloporabu lijeka
• 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.
• ako nakon uzimanja ovog lijeka razvijete simptome alergijske reakcije, kao što su oticanje grla ili jezika, otežano disanje, omaglica, vrućica, osip ili koprivnjača.
Other adverse reactions include ataxia, nystagmus, dystonia, blurred vision, and changes in muscle reflexes.
Druge nuspojave uključuju ataksiju, nistagmus, distoniju, zamućen vid i promjene u refleksima mišića.
Plasma digoxin concentrations should be closely monitored in patients taking NUEDEXTA concomitantly, and the digoxin dose reduced, as necessary.
U bolesnika koji istovremeno uzimaju NUEDEXTU, koncentracije plazmatskog digoksina treba pomno nadzirati, a dozu digoksina smanjiti prema potrebi.
If the clinical response with NUEDEXTA 15 mg/9 mg is adequate, the dose taken in weeks 2-4 should be continued.
Ako je s lijekom NUEDEXTA 15 mg/9 mg postignut odgovarajući klinički odgovor, treba nastaviti s dozom koju je bolesnik uzimao od 2. do 4. tjedna.
Patients with a history of quinidine-, quinine-, mefloquine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome (see section 4.4).
Bolesnici s trombocitopenijom izazvanom kinidinom, kininom, meflokinom, bolesnici s hepatitisom, depresijom koštane srži ili sindromom poput lupusa u anamnezi (vidjeti dio 4.4).
Neither dextromethorphan alone nor dextromethorphan/quinidine has been evaluated in patients with severe hepatic impairment.
Ni sam dekstrometorfan ni kombinacija dekstrometorfan / kinidin nisu bili procijenjeni u bolesnika s teškim oštećenjem funkcije jetre.
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.
Učinci supraterapijskih doza dekstrometorfana / kinidina (23 mg / 26 mg i 46 mg / 53 mg, za 7 uzastopnih doza) na produljenje QTc intervala procijenjeni su u 36 zdravih dobrovoljaca u randomiziranom, placebom kontroliranom dvostruko slijepom ispitivanju s ukrižavanjem lijeka uz dodatnu otvorenu pozitivnu kontrolnu skupinu (400 mg moksifloksacina).
The concomitant use of thioridazine is contraindicated (see section 4.3).
Kontraindicirana je istovremena uporaba tioridazina (vidjeti dio 4.3).
Uncommon side effects (may affect up to 1 in 100 people)
Manje česte nuspojave (mogu se javiti u do 1 od 100 osoba)
Quinidine did not inhibit (<30% inhibition) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, or CYP3A4 in human microsomes at concentrations up to 5 µM.
Kinidin u koncentracijama do 5 µM nije inhibirao (<30% inhibicije) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1 ili CYP3A4 u ljudskim mikrosomima.
The most common adverse reactions were mild to moderate nausea, dizziness, and headache.
Najčešće nuspojave bile su blaga do umjerena mučnina, omaglica i glavobolja.
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.
Interakcije lijekova s desipraminom i paroksetinom ispitivane su u kontroliranim kliničkim ispitivanjima s kombiniranom dozom dekstrometorfana / kinidina (dekstrometorfan 23 mg / kinidin 26 mg) višom nego što je u ovom lijeku; rezultati ispitivanja opisani su u narednim odlomcima.
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.
Srednje vrijednosti početnih rezultata na ljestvici CNS-LS iznosile su 19,8 u skupini NUEDEXTA 23 mg/9 mg, 21,0 u skupini NUEDEXTA 15 m/9 mg i 19,9 u skupini koja je primala placebo.
NUEDEXTA is used for the treatment of pseudobulbar affect (PBA) in adults.
NUEDEXTA se primjenjuje za liječenje pseudobulbarnog afekta u odraslih.
• distorted sense of taste (dysgeusia), sleepiness (hypersomnia), muscle spasticity, fainting
• promijenjen osjet okusa (disgeuzija), pospanost (hipersomnija), mišićna ukočenost, nesvjestica
NUEDEXTA should be discontinued immediately if thrombocytopenia occurs, unless the thrombocytopenia is clearly not drug-related.
Ako se pojavi trombocitopenija, terapiju NUEDEXTOM treba odmah prekinuti, osim kad je jasno da trombocitopenija nije povezana s lijekom.
Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used to increase the systemic bioavailability of dextromethorphan.
Kinidin sulfat specifični je inhibitor oksidacijskog metabolizma ovisnog o CYP2D6, koji služi za povećanje sistemske bioraspoloživosti dekstrometorfana.
• musculoskeletal stiffness, muscle pain (myalgia), neck pain, pain in the limbs
• mišićno-koštana ukočenost, bol u mišićima (mialgija), bol u vratu, bol u udovima
• gall stones, increased bilirubin levels in the blood, abnormal liver function test
• žučni kamenci, povišene razine bilirubina u krvi, poremećeni nalazi jetrene funkcije
Thioridazine, a CYP2D6 substrates that also prolong the QT interval is contraindicated (see section 4.3).
Kontraindiciran je tioridazin, supstrat CYP2D6 koji također produljuje QT interval (vidjeti dio 4.3).
The quinidine component of NUEDEXTA serves to selectively inhibit CYP2D6-dependent oxidative metabolism of dextromethorphan, thus increasing dextromethorphan plasma concentrations.
Komponenta kinidina u NUEDEXTI služi za selektivnu inhibiciju oksidacijskog metabolizma dekstrometorfana ovisnog o CYP2D6, čime se povećavaju koncentracije dekstrometorfana u plazmi.
The most commonly reported adverse reactions are gastrointestinal disorders (such as diarrhoea, nausea), nervous system disorders (such as dizziness, headache, somnolence) and fatigue.
Najčešće prijavljivane nuspojave bile su gastrointestinalni poremećaji (kao što su proljev, mučnina). poremećaji živčanog sustava (kao što su omaglica, glavobolja, somnolencija) i umor.
Concomitant use of flecainide, chlorpromazine or haloperidol, CYP2D6 substrates that also prolong QT interval, requires caution (see section 4.4).
Oprez zahtijeva istovremena upotreba flekainida, klorpromazina ili haloperidola, supstrata CYP2D6 koji također produljuju QT interval (vidjeti dio 4.4).
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.
Dekstrometorfan u koncentracijama do 5 µM nije inhibirao (<20% inhibicije) nijedan od ispitanih izoenzima: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ili CYP3A4 u mikrosomima ljudske jetre.
• Co-administration of a strong CYP3A4 inhibitor
• istovremenu primjenu snažnog inhibitora CYP3A4
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.
Pseudobulbarni afekt je posljedica neurološke bolesti koja utječe na mozak, ili ozljede mozga, a definira se na temelju pojave epizoda nevoljnih izražavanja emocija, koje se ne mogu kontrolirati; smijeha i/ili plača koji nisu u skladu ili su u nerazmjeru s bolesnikovim emocionalnim stanjem ili raspoloženjem.
OUTER CARTON - NUEDEXTA 15 mg/9 mg capsules: PACK OF 13 CAPSULES
KUTIJA - NUEDEXTA 15 mg/9 mg kapsule: PAKIRANJE OD 13 KAPSULA
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.
Na temelju ispitivanja inhibicije prijenosnika, tijekom liječenja NUEDEXTOM ne očekuju se interakcije lijekova u odnosu na inhibiciju dekstrometorfana povezanu s P-gp, OATP1B1, OATP1B3, OCT2, OAT1, OAT3 ili BSEP.
• Epistaxis, Pharyngolaryngeal pain, Respiratory depression, Rhinorrhoea, Yawning
Rijetko epistaksa, faringolaringealna bol, depresija disanja, rinoreja, zijevanje
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.
Stoga u bolesnika s blagim i umjerenim oštećenjem funkcije jetre nije potrebna prilagodba doze, ali u bolesnika s umjerenim oštećenjem funkcije jetre potrebno je voditi računa o dodatnom nadzoru zbog mogućih nuspojava.
Dose adjustment is therefore not required in mild or moderate renal impairment.
Stoga prilagodba doze nije potrebna u bolesnika s blagim ili umjerenim oštećenjem bubrega.
Gastric lavage may be of use.
Može biti korisna lavaža želuca.
Brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
Ciglasto-crvena želatinska kapsula, veličine 1, s oznakom „DMQ / 20-10“ otisnutom bijelom tintom na kapsuli.
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.
U ispitivanju kombinirane doze dekstrometorfana 23 mg / kinidina 26 mg dvaput na dan u 12 ispitanika s blagim ili umjerenim oštećenjem funkcije jetre (kako je pokazala Child-Pugh metoda; po 6 ispitanika za svako oštećenje) u usporedbi s 9 zdravih ispitanika (usklađenih s ispitanicima s oštećenjem po spolu, dobi i rasponu tjelesne težine), ispitanici s umjerenim oštećenjem funkcije jetre pokazali su slične vrijednosti dekstrometorfana za AUC i Cmax te klirens u usporedbi sa zdravim ispitanicima.
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.
NUEDEXTA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima Bolesnike treba upozoriti na moguće učinke na središnji živčani sustav, kao što su somnolencija, omaglica i sinkopa ili oštećen vid (vidjeti dio 4.8) te im savjetovati da ne upravljaju vozilima i ne rukuju strojevima, ako se u njih pojave ti simptomi.
Other signs and symptoms of overdose may include vomiting, diarrhoea, tinnitus, high-frequency hearing loss, vertigo, blurred vision, diplopia, photophobia, headache, confusion, and delirium.
Drugi znakovi i simptomi predoziranja mogu uključivati povraćanje, proljev, tinitus, gubitak sluha za visoke frekvencije, vrtoglavicu, zamućen vid, diplopiju, fotofobiju, glavobolju, konfuziju i delirij.
Two additional phase III studies were conducted using a higher dose combination of dextromethorphan 23 mg/quinidine 26 mg.
Provedena su dva dodatna ispitivanja faze III s višom kombiniranom dozom dekstrometorfana 23 mg / kinidina 26 mg.
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
Nedostatak sposobnosti za metabolizaciju supstrata CYP2D6 uglavnom ima približno 7-8% bijelaca, 3-6% crnaca, 2-3% osoba arapskog podrijetla i 1-2% azijata pa su klasificirani kao slabi metabolizatori.
• you have a history of drug abuse.
• ako ste u prošlosti uzimali droge.
Cardiac effects
Učinci na srce
In patients with severe hepatic impairment (Child-Pugh C) or severe renal impairment (Creatinine Clearance < 30 mL/min/1.73m
U bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C) ili teškim oštećenjem funkcije bubrega (klirens kreatinina <30 ml/min/1,73m2), potencijalne rizike povezane s primjenom ovog lijeka treba procijeniti u odnosu na medicinsku potrebu (vidjeti dio 5.2).
60% of subjects had underlying ALS and 40% of subjects had underlying MS. All subjects had clinically relevant PBA symptoms, quantified as CNS-LS score of 13 or more.
Svi ispitanici imali su klinički relevantne simptome pseudobulbarnog afekta, izražene kao rezultat na ljestvici CNS-LS od 13 ili više.
• nose bleeds, throat pain, excessively slow or shallow breathing (respiratory depression), runny nose, yawning
• krvarenje iz nosa, bol u grlu, prekomjerno sporo ili plitko disanje (depresija disanja), curenje nosa, zijevanje
Quinidine is metabolized by CYP3A4.
Kinidin se metabolizira putem enzima CYP3A4.
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.
Pseudobulbarni afekt je neurološko stanje koje obilježavaju nevoljne epizode smijeha i/ili plača koje ne možete kontrolirati, a one ne odgovaraju Vašem emocionalnom stanju ili raspoloženju.
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.
U ispitivanju kombinirane doze dekstrometorfana 23 mg / kinidina 26 mg dvaput na dan u 12 ispitanika s blagim (CLCR 50-80 ml/min) ili umjerenim (CLCR 30-50 ml/min) oštećenjem funkcije bubrega (za svako oštećenje 6 ispitanika) u usporedbi s 9 zdravih ispitanika (usklađenih po spolu, dobi i rasponu tjelesne težine s ispitanicima s oštećenjem), ispitanici su pokazali malu razliku u farmakokinetici kinidina ili dekstrometorfana u usporedbi sa zdravim ispitanicima.
Patients with renal and hepatic impairment
Bolesnici s oštećenjem funkcije bubrega i jetre
• rare (≥1/10,000 to <1/1,000)
• rijetko (≥1/10 000 i <1/1000)
Quinidine is metabolised by CYP3A4.
Kinidin se metabolizira enzimom CYP3A4.
How to take NUEDEXTA
Kako uzimati lijek NUEDEXTA
• common (≥1/100 to <1/10)
• često (≥1/100 i <1/10)
Uncommon Anxiety
Manje često anksioznost
• medicines used to treat various heart conditions, such as diltiazem, verapamil, digoxin,
• lijekovi za liječenje raznih srčanih stanja, kao što su diltiazem, verapamil, digoksin, flekainid i beta blokatori (kao što je metoprolol)
Anorexia
Rijetko anoreksija
The potential for dextromethorphan and quinidine to inhibit or induce cytochrome P450 in vitro were evaluated in human microsomes.
Potencijal dekstrometorfana i kinidina da inhibiraju ili induciraju citokrom
CYP2D6 genotype
Genotip CYP2D6
Brick red gelatin capsule, size 1, with “DMQ / 30-10” printed in white ink on the capsule and three white bands around the circumference.
Ciglasto-crvena želatinska kapsula, veličine 1, s oznakom „DMQ / 30-10“ otisnutom bijelom tintom na kapsuli i tri bijele pruge oko tijela kapsule.
NUEDEXTA 23 mg/9 mg hard capsules
NUEDEXTA 23 mg/9 mg tvrde kapsule
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.
Podobni bolesnici bili su oni s dijagnozom pseudobulbarnog afekta definiranom epizodama nevoljnih emocionalnih ekspresija smijeha i/ili plača koje nisu mogli kontrolirati, a koje su u raskoraku ili nerazmjeru s njihovim emocionalnim stanjem ili raspoloženjem.
NUEDEXTA 15 mg/9 mg hard capsules
NUEDEXTA 15 mg/9 mg tvrde kapsule