natgillin/translations-raw huggingface dataset:
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.
Po dajanju kombiniranega zdravila ostaja vezava na beljakovine v osnovi enaka kot po dajanju posameznih sestavin; na beljakovine se veže približno 60-70 % dekstrometorfana in 80-89 % kinidina.
Take your next dose at the usual time and make sure that approximately 12 hours passes between two doses.
Vzemite naslednji odmerek ob običajnem času in počakajte, da med odmerkoma mine približno 12 ur.
NUEDEXTA may be taken without regard to meals as food does not affect the exposure of dextromethorphan and quinidine significantly.
Zdravilo NUEDEXTA je mogoče jemati ne glede na obroke, saj hrana ne vpliva bistveno na izpostavljenost dekstrometorfanu in kinidinu.
• very rare (<1/10,000)
• zelo redki (<1/10.000).
Patients taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the preceding 14 days due to the risk of serious and possibly fatal drug interactions, including serotonin syndrome.
Bolniki, ki jemljejo zaviralce monoamin-oksidaze (MAOI) ali so jemali zaviralce MAO v preteklih 14 dneh, zaradi tveganja resnih in morebitno smrtnih interakcij med zdravili, vključno s serotoninskim sindromom.
As NUEDEXTA may cause harm to your unborn baby, its use is not recommended when you are pregnant or if you are a women of childbearing potential not using contraception.
Ker lahko zdravilo NUEDEXTA škoduje vašemu nerojenemu otroku, njegova uporaba ni priporočljiva, ko ste noseči ali če ste ženska v rodni dobi, ki ne uporablja kontracepcije.
Efficacy has only been studied in patients with underlying Amyotrophic Lateral Sclerosis or Multiple Sclerosis (see section 5.1).
Učinkovitost so proučevali samo pri bolnikih, pri katerih je bila osnovna bolezen amiotrofična lateralna skleroza ali multipla skleroza (glejte poglavje 5.1).
• you experience symptoms such as palpitations or fainting, which may be a sign of heart problems.
• se pri vas pojavljajo simptomi, kot so palpitacije ali omedlevica, ki so lahko znak težav s srcem;
Studies in animals (rats and rabbits) have shown developmental toxicity, including teratogenicity and embryolethality (see section 5.3).
Študije na živalih (podganah in kuncih) so pokazale toksičnost za razvoj, vključno s teratogenostjo in smrtnostjo pri zarodkih (glejte poglavje 5.3).
The 12-week open-label phase of the study (during which all subjects received NUEDEXTA 23 mg / 9 mg) showed persistence of the effect observed in the placebo controlled period.
12-tedenska odprta faza študije (v kateri so vsi preskušanci prejemali zdravilo NUEDEXTA 23 mg/9 mg) je pokazala ohranjanje učinka, ki so ga opazili v obdobju, nadzorovanim s placebom.
The first was a 4-week study in PBA subjects with underlying ALS, and the second was a 12-week study in subjects with underlying MS.
Prva študija je bila 4-tedenska študija s preskušanci, ki so imeli PBP in osnovno bolezen ALS, druga pa je bila 12-tedenska študija s preskušanci, ki so imeli osnovno bolezen MS.
To evaluate long-term data, 253 subjects who completed the double-blind study phase had the option of entering an open-label extension phase, receiving NUEDEXTA 23 mg /9 mg for another 84 days.
Za oceno dolgoročnih podatkov je imelo 253 preskušancev, ki je zaključilo fazo dvojno slepe študije, možnost vstopa v odprto podaljšano fazo, v kateri so prejemali zdravilo NUEDEXTA 23 mg/9 mg še 84 dni.
Strong and moderate CYP3A4 inhibitors should be avoided during treatment with NUEDEXTA.
Močnim in zmernim zaviralcem CYP3A4 se je treba med zdravljenjem z zdravilom NUEDEXTA izogibati.
It should not be used if immunemediated thrombocytopenia from structurally related active substances including quinine and mefloquine is suspected, as cross-sensitivity can occur.
Zdravilo se ne sme uporabiti, če obstaja sum na imunsko trombocitopenijo, ki je posledica strukturno sorodnih zdravilnih učinkovin, vključno s kininom in meflokinom, saj se lahko pojavi navzkrižna občutljivost.
Drugs that delay elimination of quinidine (cimetidine, carbonic anhydrase inhibitors, thiazide diuretics) should be withdrawn unless absolutely required.
Uporabo zdravil, ki upočasnijo izločanje kinidina (cimetidin, zaviralci karbonske anhidraze, tiazidni diuretiki), je treba prekiniti, razen če je ta nujna.
• double vision, blurred vision
• dvojni vid, zamegljen vid
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte z zdravnikom.
Both dextromethorphan and memantine are antagonists of the N-methyl-D-aspartate (NMDA) receptor which could theoretically result in an additive effect at NMDA receptors and potentially an increased incidence of adverse reactions.
Dekstrometorfan in memantin sta antagonista receptorjev N-metil-D-aspartata (NMDA), kar lahko teoretično povzroči aditivni učinek na receptorjih NMDA in morebitno povečano pojavnost neželenih učinkov.
• atomoxetine, used to treat attention-deficit hyperactivity disorder (ADHD)
• atomoksetin, ki ga uporabljamo za zdravljenje motnje pomanjkanja pozornosti (ADHD);
Quinidine is an inhibitor of P-glycoprotein.
Kinidin je zaviralec P-glikoproteina.
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.
Če se pri bolniku pojavijo simptomi, ki lahko kažejo na pojav srčnih aritmij, npr. sinkopa ali palpitacije, je treba jemanje zdravila NUEDEXTA prekiniti in opraviti dodatno oceno bolnika.
Caution should be exercised if patients are treated with concomitant selective serotonin reuptake inhibitors (SSRIs).
Pri bolnikih, ki se sočasno zdravijo s selektivnimi zaviralci ponovnega privzema serotonina (SSRI), je potrebna previdnost.
• Educational material for Healthcare Professionals (HCPs)
• izobraževalni material za zdravstvene delavce;
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 metabolit je 3-hidroksikinidin, ki naj bi bil vsaj pol toliko farmakološko aktiven kot kinidin glede učinkov na srce, npr. na podaljšanje intervala QT.
• if you take a medicine called thioridazine, which is used for mental illness but can also affect the heart.
• če jemljete zdravilo, imenovano tioridazin, ki ga uporabljamo za zdravljenje duševnih bolezni, lahko pa vpliva tudi na srce;
What you need to know before you take NUEDEXTA
Kaj morate vedeti, preden boste vzeli zdravilo NUEDEXTA
Mild to moderate hepatic impairment had little effect on quinidine pharmacokinetics.
Blaga do zmerna okvara jeter je imela majhen vpliv na farmakokinetiko kinidina.
LVH and LVD are more likely to be present in patients with chronic hypertension, known coronary artery disease or history of stroke.
LVH in LVD bosta verjetneje prisotna pri bolnikih s kronično hipertenzijo, potrjeno koronarno boleznijo ali možgansko kapjo v anamnezi.
• if you have a history of a liver disease (hepatitis) caused by quinidine
• če ste v preteklosti imeli bolezen jeter (hepatitis), ki jo je povzročil kinidin;
A population pharmacokinetic analysis revealed similar pharmacokinetics in patients <65 years and those ≥65 years of age (see section 5.2).
Farmakokinetična analiza populacije je pokazala podobno farmakokinetiko pri bolnikih, starih < 65 let, in bolnikih, starih ≥ 65 let (glejte poglavje 5.2).
Patients with moderate hepatic impairment showed an increased frequency of adverse reactions.
Pri bolnikih z zmerno okvaro jeter so opazili povečano pogostnost neželenih učinkov.
Lactose warning
Opozorilo o laktozi
Use in older persons No special dose adjustment of NUEDEXTA is required in older patients.
Uporaba pri starejših osebah Pri starejših bolnikih niso potrebna posebna prilagajanja odmerkov zdravila NUEDEXTA.
Quinidine inhibited CYP2D6 with a half maximal inhibitory concentration (IC50) of less than 0.05 µM.
Kinidin je zaviral CYP2D6 pri polovični najvišji koncentraciji zaviranja (IC50) manj kot 0,05 µM.
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.
Uporaba aktivnega oglja v običajnem odmerku 1 g/kg, ki se daje vsakih 2-6 ur v obliki mešanice z 8 ml/kg pitne vode, lahko izboljša sistemsko izločanje kinidina; ta ukrep ni primeren, če je prisoten ileus.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redkimi dednimi težavami, kot so intoleranca za galaktozo, laponska oblika zmanjšane aktivnosti laktaze ali malabsorpcija glukoze/galaktoze, tega zdravila ne smejo jemati.
If any of the above occur, stop taking the capsules and tell your doctor immediately
Če opazite katerega koli od zgornjih neželenih učinkov, prenehajte jemati kapsule in takoj obvestite svojega zdravnika.
Your doctor will start your treatment with NUEDEXTA 15 mg/9 mg capsules which should be taken by you as follows:
Vaš zdravnik bo uvedel zdravljenje z zdravilom NUEDEXTA 15 mg/9 mg kapsule, ki jih morate jemati, kot sledi:
Renal clearance involves both glomerular filtration and active tubular secretion, moderated by (pH-dependent) tubular reabsorption.
Ledvični očistek vključuje glomerulno filtracijo in aktivno tubulno sekrecijo, ki ju znižuje (od pH odvisna) tubulna reabsorpcija.
Serious adverse reactions have been reported for NUEDEXTA; these are muscle spasticity, respiratory depression and decreased oxygen saturation in the blood.
Pri zdravilu NUEDEXTA so poročali o resnih neželenih učinkih; ti so mišična spastičnost, respiratorna depresija in zmanjšana nasičenost s kisikom v krvi.
Dextromethorphan may increase the risk of serotonin syndrome, and this risk is increased by overdose, particularly if taken with other serotonergic agents, SSRIs or tricyclic antidepressants.
Dekstrometorfan lahko poveča tveganje za serotoninski sindrom, to tveganje pa se pri prevelikem odmerjanju še poveča, predvsem v kombinaciji z drugimi serotoninergičnimi učinkovinami, zaviralci SSRI ali tricikličnimi antidepresivi.
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.
Zato pri bolnikih z blago in zmerno jetrno okvaro prilagajanje odmerka ni potrebno, čeprav je treba razmisliti o dodatnem spremljanju za neželene reakcije pri bolnikih z zmerno jetrno okvaro.
As this medicinal product may cause foetal harm, it is not recommended during pregnancy and in women of childbearing potential not using contraception.
Ker lahko to zdravilo poškoduje plod, njegova uporaba ni priporočljiva med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
• 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).
• če ste v preteklosti imeli bolezen, imenovano lupusu podoben sindrom, ki ga je povzročil kinidin (ta lahko povzroči bolečine v sklepih, kožni izpuščaj, pretirano občutljivost kože na sonce in splošno slabo počutje);
Dextromethorphan is a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist.
Dekstrometorfan je agonist receptorjev sigma-1 in nekompetitivni antagonist receptorjev NMDA.
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.
Zdravilom, ki so odvisna od presnove z encimom CYP2D6, predvsem zdravilom s sorazmerno ozkim terapevtskim indeksom, se je treba med zdravljenjem z zdravilom NUEDEXTA navadno izogibati, o čemer je treba obvestiti tudi bolnika.
In addition, the maintenance of the clinical effect of NUEDEXTA in the patient should be regularly monitored in the long-term against its tolerability, in order to ascertain the continued benefit of the product.
Poleg tega je treba zaradi morebitne tolerance redno in dolgoročno spremljati vzdrževanje kliničnega učinka zdravila NUEDEXTA pri bolniku, s čimer se potrdi nenehna korist zdravila.
Approximately 30% of study participants carried diagnoses other than ALS and MS, including stroke, traumatic brain injury, Parkinson's disease, Alzheimer's disease and other dementia, primary lateral sclerosis, progressive bulbar palsy, and progressive supranuclear palsy.
Približno 30 % udeležencev študije je imelo diagnozo, ki ni bila ALS ali MS, vključno z možgansko kapjo, travmatsko poškodbo možganov, Parkinsonovo boleznijo, Alzheimerjevo boleznijo in drugimi demencami, primarno lateralno sklerozo, progresivno bulbarno paralizo in progresivno supranuklearno paralizo.
The frequency of PBA episodes as measured by “Count of Episodes” in both NUEDEXTA treatment groups decreased significantly throughout the course of the study by an incremental reduction of 47% and 49% relative to placebo, respectively (p <0.0001 for both comparisons).
Pogostnost epizod PBP, merjena s številom epizod v obeh skupinah, zdravljenih z zdravilom NUEDEXTA, je v času študije pomembno upadla s postopnim zmanjšanjem za 47 % in 49 % v primerjavi s placebom (p < 0,0001 za obe primerjavi).
Other P-gp substrates for which a dose reduction may be considered include ticagrelor and dabigatran-etexilate.
Druga substrata P-glikoproteina, pri katerih bo morda treba razmisliti o zmanjšanju odmerka, sta tikagrelor in dabigatran eteksilat.
In both studies the primary outcome measure, CNS-LS, and the secondary outcome measure, “count of episodes of laughing and crying”, were statistically significantly decreased by the dextromethorphan/quinidine combination.
V obeh študijah sta bila merilo primarnega izida, CNS-LS, in merilo sekundarnega izida, število epizod smejanja in joka, statistično pomembno nižja ob uporabi kombinacije dekstrometorfana/kinidina.
Digoxin and other P-glycoprotein substrates
Digoksin in drugi substrati P-glikoproteina
• travel or motion sickness, ringing in the ears (tinnitus)
• potovalna bolezen ali kinetoza, zvenenje v ušesih (tinitus)
• if you are taking, or have taken during the last two weeks, certain medicines for depression called monoamine oxidase inhibitors (MAOIs), such as phenelzine and moclobemide.
• če jemljete ali če ste v zadnjih dveh tednih jemali določena zdravila proti depresiji, imenovana zaviralci monoamin-oksidaze (MAOI), kakršna sta npr. fenelzin in moklobemid.
• The other ingredients are croscarmellose sodium, cellulose microcrystalline, silica colloidal, lactose monohydrate, magnesium stearate and gelatin, titanium dioxide (E171), red iron oxide (E172), printing ink (shellac glaze, propylene glycol, titanium dioxide (E171)).
• Druge sestavine so premreženi natrijev karmelozat, mikrokristalna celuloza, koloidni silicijev dioksid, laktoza monohidrat, magnezijev stearat in želatina, titanov dioksid (E171), rdeči železov oksid (E172), črnilo za tisk (glazura šelaka, propilenglikol, titanov dioksid (E171)).
Each hard capsule contains 119.1 mg of lactose (as monohydrate).
Ena trda kapsula vsebuje 119,1 mg laktoze (v obliki monohidrata).
If concomitant treatment with strong or moderate CYP3A4 inhibitors is considered necessary, it is recommended that electrocardiographic (ECG) evaluation of the QT interval be carried out before NUEDEXTA is administered and at appropriate time point(s) subsequently.
Če je sočasno zdravljenje z močnimi ali zmernimi zaviralci CYP3A4 nujno, je priporočljivo, da se pred uporabo zdravila NUEDEXTA in pozneje ob ustreznih časovnih točkah opravi elektrokardiografska (EKG) ocena intervala QT.
This may lead to lower, potentially subtherapeutic plasma concentrations of dextromethorphan and decreased efficacy of NUEDEXTA.
To lahko povzroči zmanjšane, morebitno nezadostno terapevtske koncentracije dekstrometorfana v plazmi in zmanjšano učinkovitost zdravila NUEDEXTA.
Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy.
Pri bolnikih, ki so prejemali kinidin, so poročali o hepatitisu, vključno z granulomatoznim hepatitisom, ki se je navadno pojavil v prvih tednih zdravljenja.
Take care if you consume alcohol while you are taking NUEDEXTA as might increase the risk of side effects such as dizziness and sleepiness.
Bodite previdni, če pijete alkohol, ko jemljete zdravilo NUEDEXTA, saj lahko poveča tveganje za pojav neželenih učinkov, kot sta omotica in zaspanost.
Evaluation and treatment of overdose is based on experience with the individual components, dextromethorphan and quinidine.
Ocena in zdravljenje prevelikega odmerjanja temeljita na izkušnjah s posameznima učinkovinama, dekstrometorfanom in kinidinom.
Cardiac effects
Učinki na srce
Dextromethorphan may increase the risk of serotonin syndrome (see Warnings and precautions and Possible side effects).
Dekstrometorfan lahko poveča tveganje za serotoninski sindrom (glejte poglavji Opozorila in previdnostni ukrepi in Možni neželeni učinki).
Through its binding to the NMDA, sigma-1, SERT and 5-HT1B/D receptors, dextromethorphan is thought to have a modulatory effect on neurotransmission involving glutamate, monoamines (including serotonin), as well as ion channel function.
Zaradi vezave na receptorje NMDA, sigma-1, SERT in 5-HT1B/D menijo, da ima dekstrometorfan modulacijski učinek na prenos živčnih prenašalcev, ki vključuje glutamat in monoamine (vključno s serotoninom),in delovanje ionskih kanalčkov.
Dextromethorphan is a low-affinity uncompetitive NMDA antagonist and sigma-1 receptor agonist that has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence.
Dekstrometorfan je nekompetitivni antagonist NMDA z majhno afiniteto in agonist receptorja sigma1, katerega potencial za zlorabo, toleranco ali telesno odvisnost se ni sistematično proučeval na živalih ali pri ljudeh.
Do not use this medicine after the expiry date which is stated on the bottle, blister and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki na plastenki, pretisnem omotu in škatli poleg oznake „Uporabno do“.
• From Week 4 on:
• Od 4. tedna naprej:
How to store NUEDEXTA Contents of the pack and other information
Shranjevanje zdravila NUEDEXTA Vsebina pakiranja in dodatne informacije
Treatment with an MAOI should not be initiated until at least 14 days after stopping NUEDEXTA (see section 4.5).
Zdravljenje z zaviralci MAO se sme začeti šele, ko je od prekinitve jemanja zdravila NUEDEXTA preteklo vsaj 14 dni (glejte poglavje 4.5).
• 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)
• če ste imeli v preteklosti nizke ravni krvnih celic zaradi kinidina, kinina ali meflokina (to lahko povzroči večjo nagnjenost h krvavitvam in modricam kot običajno);
• Drug misuse and abuse
• neprimerno uporabo in zlorabo zdravil.
Ten patients discontinued study treatment due to ADRs, one of these patients due to a serious ADR (worsening muscle spasticity).
Deset bolnikov je študijo prekinilo zaradi neželenih učinkov, eden od njih zaradi resnega neželenega učinka (vedno hujša mišična spastičnost).
Plasma digoxin concentrations should be closely monitored in patients taking NUEDEXTA concomitantly, and the digoxin dose reduced, as necessary.
Koncentracije digoksina v plazmi je treba pozorno spremljati pri bolnikih, ki sočasno jemljejo zdravilo NUEDEXTA, in po potrebi zmanjšati odmerek digoksina.
The educational material for HCPs should assist them in the collection and assessment of relevant patient's details on pre-existing co-morbidities and concomitant medications prior to initiating Nuedexta therapy.
Izobraževalni material bo zdravstvenim delavcem pomagal pri zbiranju in ocenjevanju potrebnih podatkov bolnika o obstoječih sočasnih boleznih in sočasno uporabljanih zdravilih pred uvedbo zdravljenja z zdravilom NUEDEXTA.
There are currently limited data on the magnitude of the effect of CYP3A4 inhibitors on the pharmacokinetic parameters of quinidine and its metabolites, including the potential for accumulation at steady state.
Trenutno so podatki o obsegu učinka zaviralcev CYP3A4 na farmakokinetične parametre kinidina in njegove metabolite omejeni, vključno s potencialom za kopičenje v stanju dinamičnega ravnovesja.
Each hard capsule contains 109.2 mg of lactose (as monohydrate).
Ena trda kapsula vsebuje 109,2 mg laktoze (v obliki monohidrata).
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).
To vključuje bolnike z nepravilnostmi intervala QT v družinski anamnezi, bolnike, ki sočasno jemljejo zdravila, ki podaljšajo interval QT, in bolnike s hipertrofijo levega prekata (LVH) in/ali disfunkcijo levega prekata (LVD).
Patients with complete atrioventricular (AV) block without implanted pacemakers, or in patients who are at high risk of complete AV block (see section 4.4).
Bolniki s kompletnim atrioventrikularnim (AV) blokom brez vsajenega srčnega spodbujevalnika ali bolniki z velikim tveganjem za kompletni AV-blok (glejte poglavje 4.4).
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).
Če je sočasna uporaba substrata encima CYP2D6 nujna, je treba odmerek substrata CYP2D6 ustrezno zmanjšati skladno s farmakokinetiko zadevnega substrata (glejte poglavje 4.5).
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.
Varnost zdravila NUEDEXTA so proučevali v 12-tedenski dvojno slepi, randomizirani, s placebom nadzorovani, multicentrični študiji pri 326 bolnikih s PBP in osnovno boleznijo ALS (60 %) ali MS (40 %) ter sledilni odprti podaljšani fazi s podskupino bolnikov v tej študiji (253 bolnikov), ki je trajala dodatnih 84 dni.
• certain medicines used to prevent blood clots in patients with heart conditions and at risk of stroke, such as ticagrelor and dabigatran-etexilate
• določena zdravila, ki jih uporabljamo za preprečevanje krvnih strdkov pri bolnikih s srčnimi obolenji in tveganjem za kap, npr. tikagrelor in dabigatran eteksilat;
• thioridazine, a medicine used in the treatment of schizophrenia and psychosis, that may affect the heart,
• tioridazin, zdravilo, ki ga uporabljamo za zdravljenje shizofrenije in psihoze, ki lahko vpliva na srce;
The adverse reactions considered at least possibly related to treatment with NUEDEXTA in the placebo-controlled and the open-label extension phase of the above mentioned clinical study are listed below by body system organ class and frequency.
Neželeni učinki, ki so bili v s placebom nadzorovani in odprti podaljšani fazi zgoraj omenjene študije vsaj morebitno povezani z zdravljenjem z zdravilom NUEDEXTA, so navedeni spodaj glede na organski sistem in pogostnost.
Mean changes in QTcF were 6.8 ms for NUEDEXTA 23 mg/ 9 mg and 9.1 ms for the reference positive control (moxifloxacin).
Povprečne spremembe v QTcF so znašale 6,8 ms za zdravilo NUEDEXTA 23 mg/9 mg in 9,1 ms za referenčno pozitivno kontrolo (moksifloksacin).
• very common (≥1/10)
• zelo pogosti (≥1/10);
When taking two capsules within 24 hours, the recommended dose interval is 12 hours.
Če je treba v 24 urah vzeti dve kapsuli, je priporočeni presledek med odmerkoma 12 ur.