natgillin/translations-raw huggingface dataset:
CYP2D6 substrates include certain beta-blockers such as metoprolol, antipsychotics such as haloperidol, perphenazine and aripiprazole, antidepressants such as nortriptyline, imipramine, amitriptyline and desipramine, the chemotherapeutic tamoxifen, and the noradrenaline transporter inhibitor atomoxetine.
Supstrati CYP2D6 uključuju određene beta blokatore kao što je metoprolol, antipsihotike kao što su haloperidol, perfenazin i aripiprazol, antidepresive kao što su nortriptilin, imipramin, amitriptilin i desipramin, kemoterapijske lijekove tamoksifen i atomoksetin, inhibitor prijenosnika noradrenalina.
Your doctor will start your treatment with NUEDEXTA 15 mg/9 mg capsules which should be taken by you as follows:
Liječnik će započeti terapiju lijekom NUEDEXTA kapsulama 15 mg/9 mg, a morate ih uzimati ovako:
perphenazine, aripiprazole and chlorpromazine
perfenazin, aripiprazol i klorpromazin
Dextromethorphan has been shown to be a mild/moderate inhibitor of the OCT1 transporter in vitro.
Pokazalo se da je dekstrometorfan blagi/umjereni inhibitor prijenosnika OCT1 in vitro.
• you experience symptoms such as palpitations or fainting, which may be a sign of heart problems.
• ako osjetite simptome kao što su lupanje srca (palpitacije) ili nesvjesticu, što može biti znak tegoba sa srcem.
Liver enzyme inducers
Induktori jetrenih enzima
Combination with MAOIs is contraindicated (see section 4.3).
Kontraindicirana je kombinacija s MAOI (vidjeti dio 4.3).
The card should contain details to alert any HCP treating the patient that they are being treated with Nuedexta and of the potential for interaction once a patient is on treatment with Nuedexta and another treatment is added.
Ta kartica treba sadržavati pojedinosti kako bi svaki zdravstveni djelatnik koji liječi bolesnika bio upozoren na terapiju lijekom Nuedexta te na mogućnost interakcije kada se tekućoj terapiji lijekom Nuedexta doda dodatna terapija.
Shellac glaze (20% esterified) Propylene glycol Titanium dioxide (E171)
Tinta za označavanje šelak glazura (20% esterificirana) propilenglikol titanijev dioksid (E171)
• medicines used to treat HIV infection and AIDS, such as atazanavir, indinavir, nelfinavir,
• lijekovi za liječenje infekcije HIV-om te AIDS-a, kao što su atazanavir, indinavir, nelfinavir,
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).
Približno 1-10% bijelaca, 5-30% crnaca, 12-40% osoba arapskog podrijetla i 1% azijata pokazalo je povećanu metaboličku aktivnost prema supstratima CYP2D6 i klasificirani su kao ultrabrzi metabolizatori.
13 hard capsules
13 tvrdih kapsula
Neither dextromethorphan nor quinidine induced CYP1A2, CYP2B6 or CYP3A4 in human hepatocytes at concentrations up to 4.8 µM.
Ni dekstrometorfan ni kinidin nisu inducirali CYP1A2, CYP2B6 ili CYP3A4 u ljudskim hepatocitima pri koncentracijama do 4,8 µM.
Concomitant administration of medicines that inhibit CYP3A4 can be expected to increase plasma levels of quinidine, which could increase risk relating to QTc prolongation.
Može se očekivati da će istovremena primjena lijekova koji inhibiraju CYP3A4 povećati razine kinidina u plazmi, što bi moglo povećati rizik koji se odnosi na produljenje QTc intervala.
The mean plasma Cmax of quinidine following NUEDEXTA 15 mg / 9 mg twice daily in subjects with PBA was 1 to 3% of the therapeutic concentrations associated with antiarrhythmic efficacy (2 to 5 µg/mL).
Srednja vrijednost Cmax kinidina u plazmi nakon lijeka NUEDEXTA 15 mg/9 mg dvaput na dan u ispitanika s pseudobulbarnim afektom, iznosila je 1 do 3% terapijskih koncentracija povezanih s djelotvornošću antiaritmika (2 do 5 µg/mL).
This test dose is adequate to represent the steady state exposure in patients with CYP2D6 extensive metabolizer phenotype.
Ova testna doza odgovarajuće predstavlja izloženost u stanju dinamičke ravnoteže u bolesnika s fenotipom ekstenzivnih metabolizatora CYP2D6.
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.
Nakon primjene lijeka NUEDEXTA 23 mg/9 mg u 14 ekstenzivnih metabolizatora, poluživot eliminacije dekstrometorfana bio je 18,8 sati a poluživot eliminacije kinidina 9,6 sati.
Renal clearance involves both glomerular filtration and active tubular secretion, moderated by (pH-dependent) tubular reabsorption.
Klirens putem bubrega uključuje i glomerularnu filtraciju i aktivnu tubularnu sekreciju, ograničenu tubularnom reapsorpcijom (ovisnoj o pH).
Dose adjustment is not required in patients with a non-functional CYPD2D6 enzyme, referred to as poor metabolisers (PMs).
Prilagodba doze nije potrebna u bolesnika s nefunkcionalnim enzimom CYPD2D6, koji se nazivaju slabi metabolizatori.
The no effect dose in rabbits is 2 and 60 times higher than the RHD.
Doza bez učinka u kunića viša je 2 do 60 puta od doze preporučene u ljudi.
Erythema, Hyperhidrosis, Hypoaesthesia facial, Night sweats
Rijetko eritem, hiperhidroza, facijalna hipoestezija, noćna znojenja
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).
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).
Each hard capsule contains 109.2 mg of lactose (as monohydrate).
Jedna tvrda kapsula sadrži 109,2 mg laktoze (u obliku hidrata).
• certain medicines used to treat depression, including nortriptyline, desipramine, paroxetine imipramine and amitriptyline, nefazodone
• određeni lijekovi za liječenje depresije, uključujući nortriptilin, desipramin, paroksetin imipramin i amitriptilin, nefazodon
• medicines to treat epilepsy or fits, such as phenytoin, carbamazepine and phenobarbital
• lijekovi protiv epilepsije ili napadaja, kao što su fenitoin, karbamazepin i fenobarbital
• to give you a higher dose and to prescribe NUEDEXTA 23 mg/9 mg capsules to you.
• dati Vam višu dozu i propisati kapsule NUEDEXTA 23 mg/9 mg.
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.
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.
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.
Analiza populacijske farmakokinetike na temelju podataka za 109 ispitanika (75 muškaraca; 34 žene) nije pokazala vidljive spolne razlike s obzirom na farmakokinetiku dekstrometorfana / kinidina.
The tricyclic antidepressant desipramine is metabolized primarily by CYP2D6.
Triciklički antidepresiv desipramin metabolizira se prvenstveno putem CYP2D6.
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.
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.
Quinidine is excreted in human milk and it is unknown whether dextromethorphan is excreted in human milk.
Kinidin se u čovjeka izlučuje u majčino mlijeko, a nije poznato izlučuje li se dekstrometorfan u majčino mlijeko.
• redness of the skin (erythema), excessive sweating (hyperhidrosis), loss of sensation or numbness of the face, night sweats
• crvenilo kože (eritem), prekomjerno znojenje (hiperhidroza), gubitak osjetljivosti ili utrnulost lica, noćna znojenja
Fever may be a presenting symptom, and thrombocytopenia or other signs of hypersensitivity may also occur.
Početni simptom može biti vrućica, a mogu se pojaviti i trombocitopenija ili drugi znakovi preosjetljivosti.
• certain medicines for depression, called monoamine oxidase inhibitors (MAOIs- for example phenelzine and moklobemide).
• određeni lijekovi protiv depresije koji se nazivaju inhibitorima monoaminoksidaze (primjerice fenelzin i moklobemid).
Pack size: 13 capsules
Veličina pakiranja: 13 kapsula
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.
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.
• medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole
• lijekovi za liječenje gljivičnih infekcija, kao što su ketokonazol, itrakonazol, flukonazol
Concomitant administration of quinidine with digoxin, a P-glycoprotein substrate, results in serum digoxin levels that may be as much as doubled.
Istovremena primjena kinidina i digoksina, supstrata P-glikoproteina, rezultira serumskim razinama digoksina koje mogu biti čak dvostruke.
Patients receiving concomitant treatment with quinidine, quinine, or mefloquine (see section 4.5).
Bolesnici koji istovremeno primaju terapiju kinidinom, kininom ili meflokinom (vidjeti dio 4.5).
The selective serotonin reuptake inhibitor (SSRI) paroxetine is metabolized primarily by CYP2D6 and is also a potent CYP2D6 inhibitor.
Paroksetin, inhibitor selektivne ponovne pohrane serotonina (SSRI) metabolizira se prvenstveno putem CYP2D6 i također je snažan inhibitor CYP2D6.
Marketing Authorisation Holder and Manufacturer Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London
Nositelj odobrenja za stavljanje u promet gotovog lijeka i proizvođač Jenson Pharmaceutical Services Limited Carradine House, 237 Regents Park Road N3 3LF London
• to continue the treatment with NUEDEXTA 15 mg/9 mg capsules, or
• nastaviti liječenje kapsulama NUEDEXTA 15 mg/9 mg, ili
• Studies with Higher Dose Combinations of dextromethorphan / quinidine
• Ispitivanja s kombinacijama viših doza dekstrometorfan / kinidin
Dose adjustment is not required in patients with mild to moderate renal or hepatic impairment (see section 4.4).
Prilagodba doze nije potrebna u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega ili jetre (vidjeti dio 4.4).
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).
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).
Dextromethorphan can also be associated with hypersensitivity reactions, including uticaria, angioedema, and shortness of breath.
Također, dekstrometorfan može biti povezan s reakcijama preosjetljivosti, uključujući urtikariju, angioedem i nedostatak zraka.
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.
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.
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.
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.
The quinidine component is intended to inhibit CYP2D6 so that higher exposure to dextromethorphan can be achieved compared to when dextromethorphan is given alone.
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.
Capsule content Croscarmellose sodium Cellulose, microcrystalline Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate
Sadržaj kapsule karmelozanatrij, umrežena celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni laktoza hidrat magnezijev stearat
• certain medicines used to prevent blood clots in patients with heart conditions and at risk of stroke, such as ticagrelor and dabigatran-etexilate
• neki lijekovi za sprječavanje nastanka krvnih ugrušaka u bolesnika sa stanjima srca i pod rizikom od moždanog udara, kao što su tikagrelor i dabigatraneteksilat
Atrioventricular block first degree, Electrocardiogram QT prolonged
Manje često atrioventrikularni blok prvog stupnja, produljen QT interval na elektrokardiogramu
• 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).
• 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).
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.
Na temelju navoda iz literature, ne očekuju se interakcije lijekova kao rezultat inhibicije kinidina putem OATP1B1, OCT1, OCT2, OAT3, BSEP, MATE1 i MATE2-K.
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.
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.
• medicines containing quinidine, quinine, or mefloquine.
• lijekovi koji sadrže kinidin, kinin ili meflokin.
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.
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.
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.
≥65 godina, da bi se uvjerljivo odredilo ima li razlika u njihovom odgovoru s obzirom na djelotvornost i sigurnost lijeka.
The combination dose of dextromethorphan/quinidine increased steady state desipramine levels approximately 8-fold.
Kombinacija doze dekstrometorfan / kinidin povećala je razine desipramina u stanju dinamičke ravnoteže otprilike 8 puta.
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).
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).
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.
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.
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.
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.
Fertility In pre-clinical studies no effect on fertility was observed in male and female rats (see section 5.3).
U pretkliničkim ispitivanjima nisu opaženi učinci na plodnost u ženki i mužjaka štakora (vidjeti dio
Quinidine-associated thrombocytopenia usually, but not always, resolves within a few days of discontinuation of the sensitising medicinal product.
Obično, ali ne uvijek, trombocitopenija povezana s kinidinom nestaje unutar nekoliko dana nakon prekida davanja lijeka koji izaziva senzitizaciju.
• From Week 4 on:
• od 4. tjedna nadalje:
In the presence of quinidine, CYP3A4-dependent oxidative metabolism is believed to play a greater role in dextromethorphan elimination.
Smatra se da u prisustvu kinidina oksidacijski metabolizam ovisan o CYP3A4 ima veću ulogu u eliminaciji dekstrometorfana.
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.
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.
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.
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.
• Patient alert cards
• kartice s upozorenjima za bolesnika
• dizziness, headache, drowsiness
• omaglica, glavobolja, omamljenost
In vitro transporter interaction studies
Ispitivanja interakcije prijenosnika in vitro
• 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).
• 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).
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.
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.
The recommended starting dose is NUEDEXTA 15 mg/9 mg once daily.
Preporučena početna doza lijeka NUEDEXTA je 15 mg/9 mg jedanput na dan.
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.
Ostali učinci uključuju gubitak koordinacije pokreta (ataksija), nevoljne pokrete oka (nistagmus), prekomjernu kontrakciju mišića (distonija), zamućen vid i promjene u refleksima mišića.
Dextromethorphan is rapidly metabolized by CYP2D6 to its primary metabolite, dextrorphan, which is rapidly glucuronidated and renally eliminated.
Dekstrometorfan se brzo metabolizira s pomoću enzima CYP2D6 u svoj primarni metabolit dekstrorfan, koji se brzo glukuronizira i eliminira putem bubrega.
MARKETING AUTHORISATION HOLDER
ODOBRENJA ZA STAVLJANJE U PROMET
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.
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).
Patients receiving concomitant treatment with thioridazine, a medicinal product that both significantly prolongs QT interval and is primarily metabolized by CYP2D6.
Bolesnici koji istovremeno primaju terapiju tioridazinom, lijekom koji i značajno produljuje QT interval i primarno je metaboliziran enzimom CYP2D6.
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).
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).
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.
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.
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.
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.
Treatment should be discontinued if these symptoms occur.
Ako se pojave ovi simptomi, liječenje treba prekinuti.