FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: S obzirom na taj učinak na CYP2D6, akumulacija glavne tvari lijeka i/ili nemogućnost stvaranja aktivnog metabolita mogu utjecati na sigurnost i/ili djelotvornost lijeka koji se uzima istovremeno s NUEDEXTOM koju metabolizira CYP2D6 (vidjeti dio 4.5).
English: Each hard capsule contains 109.2 mg of lactose (as monohydrate).
Croatian: Jedna tvrda kapsula sadrži 109,2 mg laktoze (u obliku hidrata).
English: • certain medicines used to treat depression, including nortriptyline, desipramine, paroxetine imipramine and amitriptyline, nefazodone
Croatian: • određeni lijekovi za liječenje depresije, uključujući nortriptilin, desipramin, paroksetin imipramin i amitriptilin, nefazodon
English: • medicines to treat epilepsy or fits, such as phenytoin, carbamazepine and phenobarbital
Croatian: • lijekovi protiv epilepsije ili napadaja, kao što su fenitoin, karbamazepin i fenobarbital
English: • to give you a higher dose and to prescribe NUEDEXTA 23 mg/9 mg capsules to you.
Croatian: • dati Vam višu dozu i propisati kapsule NUEDEXTA 23 mg/9 mg.
English: 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.
Croatian: Snažni induktori CYP3A4 (npr. rifampicin, fenitoin, fenobarbital, karbamazepin, gospina trava / Hypericum perforatum) mogu ubrzati metabolizam kinidina, rezultirajući nižim koncentracijama u plazmi te otuda smanjenom inhibicijom CYP2D6.
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.
Croatian: Analiza populacijske farmakokinetike na temelju podataka za 109 ispitanika (75 muškaraca; 34 žene) nije pokazala vidljive spolne razlike s obzirom na farmakokinetiku dekstrometorfana / kinidina.
English: The tricyclic antidepressant desipramine is metabolized primarily by CYP2D6.
Croatian: Triciklički antidepresiv desipramin metabolizira se prvenstveno putem CYP2D6.
English: 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.
Croatian: Nakon ponavljanih doza NUEDEXTA 23 mg/9 mg i NUEDEXTA 15 mg/9 mg, maksimalna koncentracija dekstrometorfana u plazmi (Cmax) dosegnuta je otprilike 3 do 4 sata poslije doze, a maksimalne koncentracije kinidina u plazmi dosegnute su otprilike 2 sata poslije doze.
English: Quinidine is excreted in human milk and it is unknown whether dextromethorphan is excreted in human milk.
Croatian: Kinidin se u čovjeka izlučuje u majčino mlijeko, a nije poznato izlučuje li se dekstrometorfan u majčino mlijeko.
English: • redness of the skin (erythema), excessive sweating (hyperhidrosis), loss of sensation or numbness of the face, night sweats
Croatian: • crvenilo kože (eritem), prekomjerno znojenje (hiperhidroza), gubitak osjetljivosti ili utrnulost lica, noćna znojenja
English: Fever may be a presenting symptom, and thrombocytopenia or other signs of hypersensitivity may also occur.
Croatian: Početni simptom može biti vrućica, a mogu se pojaviti i trombocitopenija ili drugi znakovi preosjetljivosti.
English: • certain medicines for depression, called monoamine oxidase inhibitors (MAOIs- for example phenelzine and moklobemide).
Croatian: • određeni lijekovi protiv depresije koji se nazivaju inhibitorima monoaminoksidaze (primjerice fenelzin i moklobemid).
English: Pack size: 13 capsules
Croatian: Veličina pakiranja: 13 kapsula
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.
Croatian: U ekstenzivnih metabolizatora, srednje vrijednosti za Cmax i AUC0-12 dekstrometorfana i dekstrorfana povećale su se kada su se doze dekstrometorfana povećale s 15 mg na 23 mg a srednje vrijednosti Cmax i AUC0-12 kinidina bile su slične.
English: • medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole
Croatian: • lijekovi za liječenje gljivičnih infekcija, kao što su ketokonazol, itrakonazol, flukonazol
English: Concomitant administration of quinidine with digoxin, a P-glycoprotein substrate, results in serum digoxin levels that may be as much as doubled.
Croatian: Istovremena primjena kinidina i digoksina, supstrata P-glikoproteina, rezultira serumskim razinama digoksina koje mogu biti čak dvostruke.
English: Patients receiving concomitant treatment with quinidine, quinine, or mefloquine (see section 4.5).
Croatian: Bolesnici koji istovremeno primaju terapiju kinidinom, kininom ili meflokinom (vidjeti dio 4.5).
English: The selective serotonin reuptake inhibitor (SSRI) paroxetine is metabolized primarily by CYP2D6 and is also a potent CYP2D6 inhibitor.
Croatian: Paroksetin, inhibitor selektivne ponovne pohrane serotonina (SSRI) metabolizira se prvenstveno putem CYP2D6 i također je snažan inhibitor CYP2D6.
English: Marketing Authorisation Holder and Manufacturer Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London
Croatian: Nositelj odobrenja za stavljanje u promet gotovog lijeka i proizvođač Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London
English: • to continue the treatment with NUEDEXTA 15 mg/9 mg capsules, or
Croatian: • nastaviti liječenje kapsulama NUEDEXTA 15 mg/9 mg, ili
English: • Studies with Higher Dose Combinations of dextromethorphan / quinidine
Croatian: • Ispitivanja s kombinacijama viših doza dekstrometorfan / kinidin
English: Dose adjustment is not required in patients with mild to moderate renal or hepatic impairment (see section 4.4).
Croatian: Prilagodba doze nije potrebna u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega ili jetre (vidjeti dio 4.4).
English: The efficacy of dextromethorphan/quinidine for the treatment of PBA was demonstrated in three randomised, controlled, double-blind, multicentre clinical trials in PBA subjects with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS).
Croatian: Djelotvornost dekstrometorfana / kinidina u liječenju pseudobulbarnog afekta dokazana je u tri randomizirana, kontrolirana, dvostruko slijepa, multicentrična klinička ispitivanja u ispitanika s pseudobulbarnim afektom u kojih su temeljne bolesti bile amiotrofna lateralna skleroza (ALS) ili multipla skleroza (MS).
English: Dextromethorphan can also be associated with hypersensitivity reactions, including uticaria, angioedema, and shortness of breath.
Croatian: Također, dekstrometorfan može biti povezan s reakcijama preosjetljivosti, uključujući urtikariju, angioedem i nedostatak zraka.
English: The safety of NUEDEXTA was investigated in a double-blind, randomized, placebo-controlled, multicenter study over 12 weeks in 326 PBA patients with underlying ALS (60%) or MS (40%) and in a follow-up open-label extension phase with a patient subgroup of this study (253 patients) for an additional 84 days.
Croatian: Sigurnost lijeka NUEDEXTA ispitivana je tijekom 12 tjedana u dvostruko slijepom, randomiziranom, placebom kontroliranom multicentričnom ispitivanju provedenom u 326 bolesnika s pseudobulbarnim afektom kod kojih su temeljne bolesti bile amiotrofna lateralna skleroza (60%) ili multipla skleroza (40%), te u otvorenoj fazi produžetka praćenja s podskupinom bolesnika iz tog ispitivanja (253 bolesnika) dodatna 84 dana.
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.
Croatian: U ispitivanjima embriofetalne i razvojne toksičnosti (štakori i kunići) s dekstrometorfan hidrobromidom / kinidin sulfatom, abnormalnosti su opažene pri srednjoj i visokoj dozi uz smanjenu osifikaciju pri najnižoj dozi u štakora, što je približno 1 i 50 puta više od doze u ljudi od 30/18 mg na dan izraženo na bazi mg/m2.
English: The quinidine component is intended to inhibit CYP2D6 so that higher exposure to dextromethorphan can be achieved compared to when dextromethorphan is given alone.
Croatian: Komponenta kinidina namijenjena je za inhibiciju CYP2D6 tako da se može postići viša izloženost dekstrometorfanu u usporedbi s izloženošću postignutom kada se dekstrometorfan daje sam.
English: Capsule content Croscarmellose sodium Cellulose, microcrystalline Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate
Croatian: Sadržaj kapsule karmelozanatrij, umrežena celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni laktoza hidrat magnezijev stearat
English: • certain medicines used to prevent blood clots in patients with heart conditions and at risk of stroke, such as ticagrelor and dabigatran-etexilate
Croatian: • neki lijekovi za sprječavanje nastanka krvnih ugrušaka u bolesnika sa stanjima srca i pod rizikom od moždanog udara, kao što su tikagrelor i dabigatraneteksilat
English: Atrioventricular block first degree, Electrocardiogram QT prolonged
Croatian: Manje često atrioventrikularni blok prvog stupnja, produljen QT interval na elektrokardiogramu
English: • you experience symptoms such as bruising, bleeding under the skin, nosebleeds and/or bleeding gums, as this may be a sign of low levels of blood cells called platelets (thrombocytopenia).
Croatian: • ako Vam se pojave simptomi kao što su nastanak modrica, krvarenje ispod kože, krvarenje iz nosa i/ili iz desni, jer to može biti znak malog broja krvnih stanica koji se nazivaju trombociti (trombocitopenija).
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.
Croatian: Na temelju navoda iz literature, ne očekuju se interakcije lijekova kao rezultat inhibicije kinidina putem OATP1B1, OCT1, OCT2, OAT3, BSEP, MATE1 i MATE2-K.
English: 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.
Croatian: U postupku razvoja ovog lijeka, ispitivane su kombinacije doza dekstrometorfan / kinidin koje su sadržavale do 6 puta više doze dekstrometorfana i 12 puta više doze kinidina.
English: • medicines containing quinidine, quinine, or mefloquine.
Croatian: • lijekovi koji sadrže kinidin, kinin ili meflokin.
English: In all studies, the efficacy endpoints were “Count of episodes of laughing and crying” (PBA episodes) and subject scores on the Center for Neurologic Studies - Lability Scale (CNS-LS), a validated 7-item, self-administered questionnaire that provides a quantitative measure of the frequency and severity of PBA. CNS-LS scores range from a minimum of 7 (no symptoms) to a maximum of 35.
Croatian: U svim ispitivanjima ishod djelotvornosti bio je „broj epizoda smijeha i plača“ (epizode pseudobulbarnog afekta) i ispitanikovi rezultati na ljestvici labilnosti Centra za neurološka ispitivanja (Center for Neurologic Studies - Lability Scale, CNS-LS), validiranog samoocjenskog upitnika od 7 čestica koji kvantitativno mjeri učestalost i težinu pseudobulbarnog afekta.
English: Clinical studies did not include a sufficient number of patients aged ≥65 years to conclusively determine whether they respond differently in terms of efficacy and safety.
Croatian: ≥65 godina, da bi se uvjerljivo odredilo ima li razlika u njihovom odgovoru s obzirom na djelotvornost i sigurnost lijeka.
English: The combination dose of dextromethorphan/quinidine increased steady state desipramine levels approximately 8-fold.
Croatian: Kombinacija doze dekstrometorfan / kinidin povećala je razine desipramina u stanju dinamičke ravnoteže otprilike 8 puta.
English: When initiating treatment with NUEDEXTA in patients at risk of QT prolongation, electrocardiographic (ECG) evaluation of the QT interval should be conducted at baseline and at 2 hours after the first dose administered in the fasted state (approximates to quinidine Tmax).
Croatian: Kada se započinje terapija NUEDEXTOM u bolesnika s rizikom od produljenja QT intervala, potrebno je elektrokardiografski procijeniti (EKG) QT interval na početku te 2 sata nakon prve doze primijenjene natašte (slično vrijednosti Tmax kinidina).
English: The major metabolite is 3-hydroxyquinidine, which is considered to be at least half as pharmacologically active as quinidine with respect to cardiac effects such as QT prolongation.
Croatian: Glavni je metabolit 3-hidroksikinidin, koji se s obzirom na učinke na srčanu aktivnost kao što je produljenje QT intervala, smatra barem upola farmakološki aktivnim u usporedbi s kinidinom.
English: A 12 month open-label safety study, also using the higher dose combination of dextromethorphan 23 mg /quinidine 26 mg, included 553 subjects with PBA associated with thirty-four different neurological conditions.
Croatian: Otvoreno sigurnosno ispitivanje u trajanju od 12 mjeseci, također s višom kombiniranom dozom dekstrometorfana 23 mg / kinidina 26 mg, uključilo je 553 ispitanika s pseudobulbarnim afektom povezanim s trideset i četiri različita neurološka stanja.
English: Fertility In pre-clinical studies no effect on fertility was observed in male and female rats (see section 5.3).
Croatian: U pretkliničkim ispitivanjima nisu opaženi učinci na plodnost u ženki i mužjaka štakora (vidjeti dio
English: Quinidine-associated thrombocytopenia usually, but not always, resolves within a few days of discontinuation of the sensitising medicinal product.
Croatian: Obično, ali ne uvijek, trombocitopenija povezana s kinidinom nestaje unutar nekoliko dana nakon prekida davanja lijeka koji izaziva senzitizaciju.
English: • From Week 4 on:
Croatian: • od 4. tjedna nadalje:
English: In the presence of quinidine, CYP3A4-dependent oxidative metabolism is believed to play a greater role in dextromethorphan elimination.
Croatian: Smatra se da u prisustvu kinidina oksidacijski metabolizam ovisan o CYP3A4 ima veću ulogu u eliminaciji dekstrometorfana.
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.
Croatian: Bolesnik treba uzeti jednu kapsulu NUEDEXTA 15 mg/9 mg, dva puta na dan, jednu ujutro i jednu navečer, s razmakom od 12 sati, tijekom 21 dana.
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.
Croatian: Ako s lijekom NUEDEXTA 15 mg/9 mg nije postignut odgovarajući klinički odgovor, potrebno je propisati NUEDEXTA 23 mg/9 mg, uzima se dvaput na dan, jedna ujutro i jedna navečer, s razmakom od 12 sati.
English: • Patient alert cards
Croatian: • kartice s upozorenjima za bolesnika
English: • dizziness, headache, drowsiness
Croatian: • omaglica, glavobolja, omamljenost
English: In vitro transporter interaction studies
Croatian: Ispitivanja interakcije prijenosnika in vitro
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).
Croatian: • ako Vam se pojave simptomi kao što su žutilo kože ili očiju, tamna mokraća, mučnina ili povraćanje, gubitak apetita, bol u trbuhu i vrućica, jer to može biti znak žutice izazvane lijekom (upala jetre).
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.
Croatian: Preživljenje mladunaca i njihova težina bili su neznatno smanjeni u odnosu na najnižu dozu, što je odgovaralo približno 1 i 50 puta više od doze u ljudi koja iznosi 30/18 mg/kg izraženo na bazi mg/m2, za dekstrometorfan hidrobromid i kinidin sulfat.
English: The recommended starting dose is NUEDEXTA 15 mg/9 mg once daily.
Croatian: Preporučena početna doza lijeka NUEDEXTA je 15 mg/9 mg jedanput na dan.
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.
Croatian: Ostali učinci uključuju gubitak koordinacije pokreta (ataksija), nevoljne pokrete oka (nistagmus), prekomjernu kontrakciju mišića (distonija), zamućen vid i promjene u refleksima mišića.
English: Dextromethorphan is rapidly metabolized by CYP2D6 to its primary metabolite, dextrorphan, which is rapidly glucuronidated and renally eliminated.
Croatian: Dekstrometorfan se brzo metabolizira s pomoću enzima CYP2D6 u svoj primarni metabolit dekstrorfan, koji se brzo glukuronizira i eliminira putem bubrega.
English: MARKETING AUTHORISATION HOLDER
Croatian: ODOBRENJA ZA STAVLJANJE U PROMET
English: 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.
Croatian: U tom placebom kontroliranom ispitivanju koje je trajalo 12 tjedana, 326 ispitanika s pseudobulbarnim afektom te ALS ili MS kao temeljnim bolestima, randomizirano je u skupine koje su 12 tjedana primale lijek NUEDEXTA 15 mg/9 mg, (n=107), NUEDEXTA 23 mg/9 mg (n=110) ili placebo (n=109).
English: Patients receiving concomitant treatment with thioridazine, a medicinal product that both significantly prolongs QT interval and is primarily metabolized by CYP2D6.
Croatian: Bolesnici koji istovremeno primaju terapiju tioridazinom, lijekom koji i značajno produljuje QT interval i primarno je metaboliziran enzimom CYP2D6.
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).
Croatian: Srednje vrijednost najmanjih kvadrata rezultata ljestvice CNS-LS bile su značajno smanjene na kraju liječenja u obje skupine u usporedbi s placebom (smanjenje za 8,2 točke za NUEDEXTU 23 mg/9 mg, smanjenje za 7,5 točaka za NUEDEXTA 15 mg/9 mg, smanjenje za 5,7 točaka za placebo).
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.
Croatian: Odmah obavijestite liječnika ako osjetite teške simptome uključujući agitaciju (uzbuđenost), visoki krvni tlak, nemir, mišićne grčeve i trzanje, visoku tjelesnu temperaturu, prekomjerno znojenje, drhtanje i tremor.
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.
Croatian: Metabolizam dekstrometorfana inhibira kinidin, tako da nuspojave/štetne reakcije predoziranja zbog lijeka NUEDEXTA mogu biti teže ili ustrajnije nego one nastale kao posljedica predoziranja samo dekstrometorfanom.
English: Treatment should be discontinued if these symptoms occur.
Croatian: Ako se pojave ovi simptomi, liječenje treba prekinuti.
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).
Croatian: 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).
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
Croatian: • poremećaj ravnoteže, poremećena koordinacija, otežan govor (dizartrija), disfunkcija kretanja, bockanje i peckanje / trnci ili utrnulost (parestezija), gubitak osjeta ili funkcije nogu (parapareza), sedacija
English: If you stop taking NUEDEXTA
Croatian: Ako prestanete uzimati lijek NUEDEXTA
English: Quinidine increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6 (CYP2D6), which catalyses a major biotransformation pathway for dextromethorphan.
Croatian: Kinidin povećava plazmatske razine dekstrometorfana kompeticijskom inihibicijom citokroma P450 2D6 (CYP2D6), koji katalizira glavni put biotransformacije dekstrometorfana.
English: NUEDEXTA may cause dizziness (see section 4.8).
Croatian: NUEDEXTA može prouzročiti omaglicu (vidjeti dio 4.8).
English: If you forget to take NUEDEXTA
Croatian: Ako ste zaboravili uzeti lijek NUEDEXTA
English: Caution should be exercised if patients are treated with concomitant selective serotonin reuptake inhibitors (SSRIs).
Croatian: Ako su bolesnici istovremeno liječeni inhibitorima selektivne ponovne pohrane serotonina (SSRI), potrebno je postupati oprezno.
English: To access capsules:
Croatian: Vađenje kapsule:
English: NUEDEXTA contains lactose.
Croatian: NUEDEXTA sadrži laktozu.
English: • Myocardial infarction, Palpitations, Ventricular extrasystoles
Croatian: Rijetko infarkt miokarda, palpitacije, ventrikularne ekstrasistole
English: NUEDEXTA can help reduce how often you have episodes of PBA.
Croatian: NUEDEXTA Vam može pomoći smanjiti učestalost epizoda pseudobulbarnog afekta.
English: Symptoms of serotonin syndrome include altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor.
Croatian: Simptomi serotoninskog sindroma uključuju promijenjeni mentalni status, hipertenziju, nemir, mioklonus, hipertermiju, hiperrefleksiju, dijaforezu, drhtanje i tremor.
English: • Drug-drug interactions including involvement of CYP2D6 substrates and inhibitors
Croatian: • interakcije lijekova koje uključuju supstrate i inhibitore CYP2D6
English: When taking two capsules within 24 hours, you should leave about 12 hours between doses.
Croatian: Kada uzimate dvije kapsule unutar 24 sata, između doza morate napraviti razmak od otprilike 12 sati.
English: 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.
Croatian: Dekstrometorfan se veže na proteine približno 60-70%, a kinidin približno 80-89%.
English: NUEDEXTA contains lactose
Croatian: NUEDEXTA sadrži laktozu
English: Balance disorder, Coordination abnormal, Dysarthria, Motor dysfunction, Paraesthesia, Paraparesis, Sedation
Croatian: Rijetko poremećaj ravnoteže, abnormalna koordinacija, disartrija, motorička disfunkcija, parestezija, parapareza, sedacija
English: NUEDEXTA has the potential to cause QTc prolongation and hence torsades de pointes-type ventricular tachycardia.
Croatian: NUEDEXTA može izazvati produljenje QTc intervala, a time i ventrikularnu tahikardiju torsades de pointes.
English: • Off-label use
Croatian: • uporabu izvan odobrenih indikacija