FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: Other P-gp substrates for which a dose reduction may be considered include ticagrelor and dabigatran-etexilate.
Slovenian: Druga substrata P-glikoproteina, pri katerih bo morda treba razmisliti o zmanjšanju odmerka, sta tikagrelor in dabigatran eteksilat.
English: 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.
Slovenian: 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.
English: Digoxin and other P-glycoprotein substrates
Slovenian: Digoksin in drugi substrati P-glikoproteina
English: • travel or motion sickness, ringing in the ears (tinnitus)
Slovenian: • potovalna bolezen ali kinetoza, zvenenje v ušesih (tinitus)
English: • 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.
Slovenian: • 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.
English: • 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)).
Slovenian: • 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)).
English: Each hard capsule contains 119.1 mg of lactose (as monohydrate).
Slovenian: Ena trda kapsula vsebuje 119,1 mg laktoze (v obliki monohidrata).
English: 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.
Slovenian: 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.
English: United Kingdom
Slovenian: VELIKA BRITANIJA
English: This may lead to lower, potentially subtherapeutic plasma concentrations of dextromethorphan and decreased efficacy of NUEDEXTA.
Slovenian: To lahko povzroči zmanjšane, morebitno nezadostno terapevtske koncentracije dekstrometorfana v plazmi in zmanjšano učinkovitost zdravila NUEDEXTA.
English: Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy.
Slovenian: Pri bolnikih, ki so prejemali kinidin, so poročali o hepatitisu, vključno z granulomatoznim hepatitisom, ki se je navadno pojavil v prvih tednih zdravljenja.
English: Take care if you consume alcohol while you are taking NUEDEXTA as might increase the risk of side effects such as dizziness and sleepiness.
Slovenian: Bodite previdni, če pijete alkohol, ko jemljete zdravilo NUEDEXTA, saj lahko poveča tveganje za pojav neželenih učinkov, kot sta omotica in zaspanost.
English: Evaluation and treatment of overdose is based on experience with the individual components, dextromethorphan and quinidine.
Slovenian: Ocena in zdravljenje prevelikega odmerjanja temeljita na izkušnjah s posameznima učinkovinama, dekstrometorfanom in kinidinom.
English: Cardiac effects
Slovenian: Učinki na srce
English: Dextromethorphan may increase the risk of serotonin syndrome (see Warnings and precautions and Possible side effects).
Slovenian: Dekstrometorfan lahko poveča tveganje za serotoninski sindrom (glejte poglavji Opozorila in previdnostni ukrepi in Možni neželeni učinki).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Do not use this medicine after the expiry date which is stated on the bottle, blister and carton after EXP.
Slovenian: 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“.
English: • From Week 4 on:
Slovenian: • Od 4. tedna naprej:
English: How to store NUEDEXTA Contents of the pack and other information
Slovenian: Shranjevanje zdravila NUEDEXTA Vsebina pakiranja in dodatne informacije
English: Treatment with an MAOI should not be initiated until at least 14 days after stopping NUEDEXTA (see section 4.5).
Slovenian: Zdravljenje z zaviralci MAO se sme začeti šele, ko je od prekinitve jemanja zdravila NUEDEXTA preteklo vsaj 14 dni (glejte poglavje 4.5).
English: • 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)
Slovenian: • 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);
English: • Drug misuse and abuse
Slovenian: • neprimerno uporabo in zlorabo zdravil.
English: Ten patients discontinued study treatment due to ADRs, one of these patients due to a serious ADR (worsening muscle spasticity).
Slovenian: Deset bolnikov je študijo prekinilo zaradi neželenih učinkov, eden od njih zaradi resnega neželenega učinka (vedno hujša mišična spastičnost).
English: Plasma digoxin concentrations should be closely monitored in patients taking NUEDEXTA concomitantly, and the digoxin dose reduced, as necessary.
Slovenian: Koncentracije digoksina v plazmi je treba pozorno spremljati pri bolnikih, ki sočasno jemljejo zdravilo NUEDEXTA, in po potrebi zmanjšati odmerek digoksina.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Each hard capsule contains 109.2 mg of lactose (as monohydrate).
Slovenian: Ena trda kapsula vsebuje 109,2 mg laktoze (v obliki monohidrata).
English: 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).
Slovenian: 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).
English: 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).
Slovenian: Bolniki s kompletnim atrioventrikularnim (AV) blokom brez vsajenega srčnega spodbujevalnika ali bolniki z velikim tveganjem za kompletni AV-blok (glejte poglavje 4.4).
English: 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).
Slovenian: Če je sočasna uporaba substrata encima CYP2D6 nujna, je treba odmerek substrata CYP2D6 ustrezno zmanjšati skladno s farmakokinetiko zadevnega substrata (glejte poglavje 4.5).
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.
Slovenian: 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.
English: • certain medicines used to prevent blood clots in patients with heart conditions and at risk of stroke, such as ticagrelor and dabigatran-etexilate
Slovenian: • določena zdravila, ki jih uporabljamo za preprečevanje krvnih strdkov pri bolnikih s srčnimi obolenji in tveganjem za kap, npr. tikagrelor in dabigatran eteksilat;
English: • thioridazine, a medicine used in the treatment of schizophrenia and psychosis, that may affect the heart,
Slovenian: • tioridazin, zdravilo, ki ga uporabljamo za zdravljenje shizofrenije in psihoze, ki lahko vpliva na srce;
English: 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.
Slovenian: 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.
English: Mean changes in QTcF were 6.8 ms for NUEDEXTA 23 mg/ 9 mg and 9.1 ms for the reference positive control (moxifloxacin).
Slovenian: 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).
English: • very common (≥1/10)
Slovenian: • zelo pogosti (≥1/10);
English: When taking two capsules within 24 hours, the recommended dose interval is 12 hours.
Slovenian: Če je treba v 24 urah vzeti dve kapsuli, je priporočeni presledek med odmerkoma 12 ur.
English: Shellac glaze (20% esterified) Propylene glycol Titanium dioxide (E171)
Slovenian: Črnilo za tisk glazura šelaka (20-odstotno esterificirana) propilenglikol titanov dioksid (E171)
English: What NUEDEXTA is and what it is used for What you need to know before you take NUEDEXTA How to take NUEDEXTA
Slovenian: Kaj je zdravilo NUEDEXTA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo NUEDEXTA Kako jemati zdravilo NUEDEXTA Možni neželeni učinki
English: • you have a condition called myasthenia gravis (an autoimmune neuromuscular disease that causes muscle weakness and fatigability).
Slovenian: • imate bolezen, imenovano miastenija gravis (avtoimunska živčno-mišična bolezen, ki povzroča šibkost mišic in mišično utrujenost);
English: • medicines used to prevent nausea and vomiting during chemotherapy and after surgery, such as aprepitant
Slovenian: • zdravila, ki jih uporabljamo za preprečevanje navzee in bruhanja med kemoterapijo in po operacijah, npr. aprepitant;
English: While therapeutic doses of quinidine for treatment of cardiac arrhythmia or malaria are generally ≥10fold higher than the dose of quinidine in this medicinal product, potentially fatal cardiac arrhythmia, including torsades de pointes, can occur at quinidine exposures that are possible from NUEDEXTA overdose.
Slovenian: Medtem ko so terapevtski odmerki kinidina za zdravljenje srčne aritmije ali malarije navadno ≥ 10krat večji kot odmerek kinidina v tem zdravilu, se lahko pri izpostavljenosti kinidinu, ki je mogoča pri prevelikem odmerjanju zdravila NUEDEXTA, pojavi morebitno smrtna srčna aritmija, vključno s tipom torsades de pointes.
English: Liver enzyme inducers
Slovenian: Induktorji jetrnih encimov
English: In such UM patients, dextromethorphan is rapidly metabolised, leading to lower, potentially subtherapeutic concentrations.
Slovenian: Pri takšnih bolnikih z izjemno hitro presnovo se dekstrometorfan hitro presnavlja, kar povzroča zmanjšane, morebitno nezadostne terapevtske koncentracije.
English: • gall stones, increased bilirubin levels in the blood, abnormal liver function test
Slovenian: • žolčni kamni, povečane ravni bilirubina v krvi, nenormalni rezultati jetrnega delovanja
English: The higher dose of quinidine used in these studies would have resulted in approximately a 1.6 fold greater exposure to of dextromethorphan than with NUEDEXTA 23 mg/ 9 mg.
Slovenian: Večji odmerek kinidina, uporabljen v teh študijah, naj bi povzročil približno 1,6-krat večjo izpostavljenost dekstrometorfanu kot odmerek zdravila NUEDEXTA 23 mg/9 mg.
English: Quinidine is excreted in human milk and it is unknown whether dextromethorphan is excreted in human milk.
Slovenian: Kinidin se izloča v materino mleko, ni pa znano, ali se dekstrometorfan prav tako izloča v materino mleko.
English: The pharmacokinetics of dextromethorphan/quinidine in paediatric patients has not been studied (see section 5.1).
Slovenian: Farmakokinetika dekstrometorfana/kinidina ni bila proučevana pri pediatričnih bolnikih (glejte poglavje 5.1).
English: NUEDEXTA must not be used with monoamine oxidase inhibitors (MAOIs), such as phenelzine and moklobemide, or in patients who have taken MAOIs within the preceding 14 days due to the risk of serotonin syndrome (see section 4.3).
Slovenian: Zdravilo NUEDEXTA se ne sme uporabljati v kombinaciji z zaviralci monoamin-oksidaze (MAOI), kot sta fenelzin in moklobemid, ali pri bolnikih, ki so v zadnjih 14 dneh jemali zaviralce MAO, saj obstaja tveganje za serotoninski sindrom (glejte poglavje 4.3).
English: Given the pharmacodynamic and pharmacokinetic interactions, concomitant use of NUEDEXTA and TCAs is not recommended due to the elevated risk of serotonin syndrome (see section 4.5).
Slovenian: Z vidika farmakodinamičnih in farmakokinetičnih interakcij sočasna uporaba zdravila NUEDEXTA in tricikličnih antidepresivov ni priporočljiva zaradi povečanega tveganja za serotoninski sindrom (glejte poglavje 4.5).
English: Concomitant administration of medicines that inhibit CYP3A4 can be expected to increase plasma levels of quinidine, which could increase risk relating to QTc prolongation.
Slovenian: Sočasna uporaba zdravil, ki zavirajo encim CYP3A4, lahko pričakovano poviša ravni kinidina v plazmi, kar lahko poveča tveganje, povezano s podaljšanjem intervala QTc.
English: • Drug-drug interactions including involvement of CYP2D6 substrates and inhibitors
Slovenian: • medsebojnim delovanjem zdravil, vključno z vključevanjem substratov in zaviralcev CYP2D6;
English: Treatment should be discontinued if these symptoms occur.
Slovenian: Če se pojavijo ti simptomi, je treba zdravljenje prekiniti.
English: There are no or limited amount of data from the use of NUEDEXTA in pregnant women.
Slovenian: Podatkov o uporabi zdravila NUEDEXTA pri nosečnicah ni ali pa so omejeni.
English: 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).
Slovenian: kinidina v plazmi po jemanju zdravila NUEDEXTA 15 mg/9 mg dvakrat dnevno je bila pri preskušancih s PBP 1 do 3 % terapevtskih koncentracij, povezanih z antiaritmično učinkovitostjo (2 do 5 µg/ml).
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.
Slovenian: 12-mesečna odprta študija varnosti, v kateri so prav tako uporabili večji odmerek kombinacije dekstrometorfana 23 mg/kinidina 26 mg, je vključevala 553 preskušancev s PBP, povezano s štiriintridesetimi različnimi nevrološkimi boleznimi.
English: Pack size: 60 capsules
Slovenian: Velikost pakiranja: 60 kapsul
English: If the clinical response with NUEDEXTA 15 mg/9 mg is adequate, the dose taken in weeks 2-4 should be continued.
Slovenian: Če je klinični odziv z zdravilom NUEDEXTA 15 mg/9 mg zadosten, je treba nadaljevati z odmerkom, ki ga je bolnik jemal med 2.-4. tednom.
English: Capsule content Croscarmellose sodium Cellulose, microcrystalline Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate
Slovenian: Vsebina kapsule natrijev karmelozat mikrokristalna celuloza koloidni brezvodni silicijev dioksid laktoza monohidrat magnezijev stearat
English: Quinidine at higher doses than in NUEDEXTA can cause immune-mediated thrombocytopenia that can be severe or fatal.
Slovenian: Kinidin lahko v večjih odmerkih, kot jih vsebuje zdravilo NUEDEXTA, povzroči imunsko trombocitopenijo, ki je lahko huda ali smrtna.
English: NUEDEXTA is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults (see section 4.4).
Slovenian: Zdravilo NUEDEXTA je indicirano za simptomatsko zdravljenje psevdobulbarne paralize (PBP) pri odraslih (glejte poglavje 4.4).
English: The effect of the combination on the patient's QTc interval should be evaluated with pre- and post-dose ECGs.
Slovenian: Učinek te kombinacije na bolnikov interval QTc je treba pred odmerjanjem in po njem oceniti z EKG.
English: A population pharmacokinetic analysis of 170 subjects (148 subjects <65 years old and 22 subjects ≥65 years old) administered dextromethorphan 23 mg / quinidine 26 mg revealed similar pharmacokinetics in subjects <65 years and those ≥65 years of age.
Slovenian: Farmakokinetična analiza populacije pri 170 bolnikih (148 bolnikov < 65 let in 22 bolnikov ≥ 65 let), ki so prejemali dekstrometorfan 23 mg/kinidin 26 mg, je pokazala podobno farmakokinetiko pri bolnikih, starih < 65 let, in bolnikih, starih ≥ 65 let.
English: Jenson Pharmaceutical Services Limited
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Jenson Pharmaceutical Services Limited
English: Quinidine is a potent inhibitor of CYP2D6.
Slovenian: Kinidin je močan zaviralec encima CYP2D6.
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).
Slovenian: Zaradi tega učinka na encim CYP2D6 lahko kopičenje primarnih snovi v zdravilu in/ali odsotnost tvorbe aktivnih presnovkov vpliva na varnost in/ali učinkovitost zdravil, ki se uporabljajo sočasno z zdravilom NUEDEXTA in jih presnavlja encim CYP2D6 (glejte poglavje 4.5).
English: 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.
Slovenian: Substrati encima CYP2D6 vključujejo nekatere beta-adrenergične antagoniste, kot je metoprolol, antipsihotike, kot so haloperidol, perfenazin in aripiprazol, antidepresive, kot so nortriptilin, imipramin, amitriptilin ter dezipramin, kemoterapevtik tamoksifen in zaviralec prenašalca noradrenalina, atomoksetin.
English: There is no relevant use of NUEDEXTA in the paediatric population for the symptomatic treatment of pseudobulbar affect.
Slovenian: Zdravilo NUEDEXTA ni primerno za uporabo pri pediatrični populaciji za simptomatsko zdravljenje psevdobulbarne paralize.
English: • Studies with Higher Dose Combinations of dextromethorphan / quinidine
Slovenian: • Študije z večjim odmerkom kombinacije dekstrometorfana/kinidina
English: Quinidine-associated thrombocytopenia usually, but not always, resolves within a few days of discontinuation of the sensitising medicinal product.
Slovenian: Trombocitopenija, povezana s kinidinom, navadno (vendar ne vedno) izzveni v nekaj dneh po prekinitvi jemanja zdravila, ki povzroča preobčutljivost.
English: In the case of pro-drugs whose actions are mediated by the CYP2D6-produced metabolites (for example, codeine and hydrocodone, whose analgesic and antitussive effects appear to be mediated by morphine and hydromorphone, respectively), efficacy may be substantially reduced by NUEDEXTA due to inhibition of CYP2D6 and hence impaired formation of the active metabolite.
Slovenian: Pri predzdravilih, katerih delovanje je odvisno od presnovkov, ki jih tvori encim CYP2D6 (na primer kodeina in hidrokodona, pri katerih se zdi, da sta analgetični in antitusični učinek odvisna od morfina oziroma hidromorfona), lahko zdravilo NUEDEXTA zmanjša učinek zaradi zaviranja encima CYP2D6 in posledično poslabšane tvorbe aktivnega presnovka.
English: Most cases remit when quinidine is withdrawn.
Slovenian: Pri večini primerov po prekinitvi kinidina pride do izboljšanja.
English: Patients receiving concomitant treatment with quinidine, quinine, or mefloquine (see section 4.5).
Slovenian: Bolniki, ki se sočasno zdravijo s kinidinom, kininom ali meflokinom (glejte poglavje 4.5).
English: NUEDEXTA should be discontinued if hepatitis occurs unless it is clearly not treatment related.
Slovenian: Če se pojavi hepatitis, je treba jemanje zdravila NUEDEXTA prekiniti, razen če je jasno, da hepatitis ni povezan z zdravljenjem.
English: • weakness (asthenia), irritability
Slovenian: • šibkost (astenija), razdražljivost
English: • certain medicines for depression, called monoamine oxidase inhibitors (MAOIs- for example phenelzine and moklobemide).
Slovenian: • določena zdravila za depresijo, imenovana zaviralci monoamin-oksidaze (MAOI, npr. fenelzin in moklobemid).
English: Concomitant use of flecainide, chlorpromazine or haloperidol, CYP2D6 substrates that also prolong QT interval, requires caution (see section 4.4).
Slovenian: Pri sočasni uporabi flekainida, klorpromazina ali haloperidola, substratov encima CYP2D6, ki prav tako podaljšajo interval QT, je potrebna previdnost (glejte poglavje 4.4).
English: The quinidine in NUEDEXTA inhibits CYP2D6 in patients in whom CYP2D6 is not otherwise genetically absent or of low activity (“CYP2D6 Poor Metabolisers” see “Pharmacogenomics” in section 5.2).
Slovenian: Kinidin v zdravilu NUEDEXTA zavira encim CYP2D6 pri bolnikih, pri katerih encim CYP2D6 ni genetsko odsoten ali nima počasne dejavnosti („Počasni metabolizatorji encima CYP2D6“, glejte „Farmakogenomika“ v poglavju 5.2).
English: The no effect dose in rabbits is 2 and 60 times higher than the RHD.
Slovenian: Odmerek brez učinka pri kuncih je približno 2-krat in 60