FrancophonIA/ELRC3.0 huggingface dataset:
English: You should not drink grapefruit juice or eat grapefruits while you are taking NUEDEXTA as this can increase the likelihood of serious side effects.
Slovenian: Zdravilo NUEDEXTA skupaj s hrano, pijačo in alkoholom Ko jemljete zdravilo NUEDEXTA, ne smete piti soka grenivke ali jesti grenivk, saj bi s tem lahko povečali verjetnost za pojav resnih neželenih učinkov.
English: The quinidine component is not expected to contribute to the effectiveness of NUEDEXTA in PMs, but adverse reactions of the quinidine component are still possible.
Slovenian: Kinidinska komponenta naj ne bi prispevala k učinkovitosti zdravila NUEDEXTA pri osebah s slabo presnovo, kljub temu pa so možni neželeni učinki kinidinske komponente.
English: NUEDEXTA is used for the treatment of pseudobulbar affect (PBA) in adults.
Slovenian: Zdravilo NUEDEXTA se uporablja za zdravljenje psevdobulbarne paralize (PBP) pri odraslih.
English: The effect of NUEDEXTA 23 mg / 9 mg (for 7 consecutive doses) on QTc prolongation was evaluated in a randomised, double-blind (except for moxifloxacin), placebo- and positive-controlled (400 mg moxifloxacin) crossover thorough QT study in 50 fasted normal healthy men and women with CYP2D6 extensive metabolizer (EM) genotype.
Slovenian: Učinek zdravila NUEDEXTA 23 mg/9 mg (pri 7 zaporednih odmerkih) na podaljšanje intervala QTc je bil ocenjen v randomizirani, dvojno slepi (z izjemo moksifloksacina), s placebom in pozitivno kontrolo nadzorovani (400 mg moksifloksacina), navzkrižni izčrpni študiji intervala QT pri 50 teščih normalnih zdravih moških in ženskah z genotipom izčrpne presnove CYP2D6.
English: Dextromethorphan did not inhibit (<20% inhibition) any of the tested isoenzymes: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4 in human liver microsomes at concentrations up to 5 µM.
Slovenian: Dekstrometorfan ni zaviral (< 20-odstotno zaviranje) nobenega od testiranih izoencimov: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A4 na mikrosomih človeških jeter v koncentracijah do 5 µM.
English: Following single and repeated combination doses of NUEDEXTA 23 mg / 9 mg, subjects had an approximately 20-fold increase in dextromethorphan exposure compared to subjects given dextromethorphan without quinidine.
Slovenian: Po enkratnih in večkratnih kombiniranih odmerkih zdravila NUEDEXTA 23 mg/9 mg se je pri preskušancih izpostavljenost dekstrometorfanu povečala približno za 20-krat v primerjavi s preskušanci, ki so prejeli dekstrometorfan brez kinidina.
English: PBA is a neurological condition characterized by involuntary and uncontrollable episodes of laughing and/or crying, which don't match your emotional state or mood.
Slovenian: PBP je nevrološka bolezen, za katero so značilne nehotene in nekontrolirane epizode smejanja in/ali joka, ki ne ustrezajo vašemu čustvenemu stanju ali razpoloženju.
English: Symptoms of serotonin syndrome include altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor.
Slovenian: Simptomi serotoninskega simptoma vključujejo spremenjeno duševno stanje, hipertenzijo, nemir, mioklonus, hipertermijo, hiperrefleksijo, diaforezo, drgetanje in tremor.
English: A population pharmacokinetic analysis of race with 109 subjects (21 Caucasian; 71 Hispanic; 18 Black) revealed no apparent racial differences in the pharmacokinetics of dextromethorphan/quinidine.
Slovenian: Farmakokinetična analiza populacije po rasi, ki je proučevala 109 bolnikov (21 belcev; 71 bolnikov hispanskega porekla; 18 temnopoltih), ni pokazala očitnih razlik po rasi pri farmakokinetiki dekstrometorfana/kinidina.
English: Two additional phase III studies were conducted using a higher dose combination of dextromethorphan 23 mg/quinidine 26 mg.
Slovenian: Opravili so dve dodatni študiji III. faze, v katerih so uporabili večji odmerek kombinacije dekstrometorfana 23 mg/kinidina 26 mg.
English: • decreased appetite
Slovenian: • zmanjšan tek
English: Dose adjustment is not required in patients with mild to moderate renal or hepatic impairment (see section 4.4).
Slovenian: Pri bolnikih z blago do zmerno ledvično ali jetrno okvaro prilagajanje odmerka ni potrebno (glejte poglavje 4.4).
English: 13 hard capsules
Slovenian: 13 trdih kapsul
English: Quinidine is metabolised by CYP3A4.
Slovenian: Kinidin se presnavlja z encimom CYP3A4.
English: Atrioventricular block first degree, Electrocardiogram QT prolonged
Slovenian: Srčne bolezni občasni atrioventrikularni blok prve stopnje, podaljšanje intervala QT na elektrokardiogramu redki
English: The most commonly reported side effects are gastrointestinal disorders (such as diarrhoea, nausea), nervous system disorders (such as dizziness, headache, somnolence) and fatigue.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so bili gastrointestinalne motnje (kot sta diareja in navzea), bolezni živčevja (kot so omotica, glavobol, somnolenca) in utrujenost.
English: Each bottle consists of high density polyethylene (HDPE) with a child resistant polypropylene cap and contains 60 hard capsules.
Slovenian: Plastenka je izdelana iz polietilena visoke gostote (HDPE) s pokrovčkom iz polipropilena, ki je varen za otroke, in vsebuje 60 trdih kapsul.
English: The effects of supra-therapeutic doses of dextromethorphan /quinidine (23 mg /26 mg and 46 mg / 53 mg, for 7 consecutive doses) on QTc prolongation were evaluated in a randomised, placebocontrolled, double-blind, crossover design with an additional open-label positive control (400 mg moxifloxacin) arm in 36 healthy volunteers.
Slovenian: Učinki odmerkov dekstrometorfana/kinidina, ki so bili večji od terapevtskih odmerkov (23 mg/26 mg in 46 mg/53 mg v 7 zaporednih odmerkih), na podaljšanje intervala QTc so bili ocenjeni v randomizirani, s placebom nadzorovani, dvojno slepi, navzkrižni študiji z dodatnim odprtim krakom za pozitivno kontrolo (400 mg moksifloksacina) pri 36 zdravih prostovoljcih.
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
Slovenian: • motnje ravnotežja, nenormalna koordinacija, težave z govorom (disartrija), motnje gibanja, zbadanje/mravljinčenje ali odrevenelost (parestezija), izguba občutka in nadzora spodnjih okončin (parapareza), sedacija
English: Plasma concentrations of quinidine increased 20-30% when memantine was added.
Slovenian: Ob dodajanju memantina se je koncentracija kinidina v plazmi povečala za 20-30 %.
English: Dextromethorphan / quinidine has not been studied in patients with severe renal impairment.
Slovenian: Dekstrometorfana/kinidina niso proučevali pri bolnikih s hudo okvaro ledvic.
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.
Slovenian: Kinidin zavira presnovo dekstrometorfana, zato so lahko neželeni učinki prevelikega odmerjanja zdravila NUEDEXTA hujši in vztrajnejši kot pri prevelikem odmerjanju samo dekstrometorfana.
English: 60% of subjects had underlying ALS and 40% of subjects had underlying MS. All subjects had clinically relevant PBA symptoms, quantified as CNS-LS score of 13 or more.
Slovenian: Vsi preskušanci so imeli klinično pomembne simptome PBP, kvantificirane na lestvici CNS-LS kot rezultat 13 ali več.
English: When taking two capsules within 24 hours, you should leave about 12 hours between doses.
Slovenian: Če jemljete po dve kapsuli v obdobju 24 ur, naj med odmerkoma mine približno 12 ur.
English: • anxiety
Slovenian: • utrujenost
English: How to take NUEDEXTA
Slovenian: Kako jemati zdravilo NUEDEXTA
English: NUEDEXTA should be discontinued immediately if thrombocytopenia occurs, unless the thrombocytopenia is clearly not drug-related.
Slovenian: Če se pojavi trombocitopenija, je treba zdravljenje z zdravilom NUEDEXTA takoj prekiniti, razen če je jasno, da trombocitopenija ni povezana z zdravilom.
English: perphenazine, aripiprazole and chlorpromazine
Slovenian: haloperidol, perfenazin, aripiprazol in klorpromazin;
English: The concomitant use of thioridazine is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba tioridazina je kontraindicirana (glejte poglavje 4.3).
English: Mean baseline daily PBA episode rates (calculated from the total number of episodes reported for up to 7 pre-treatment days) were 4.7 in the NUEDEXTA 23 mg/9 mg group, 6.8 in the NUEDEXTA 15 mg/9 mg group, and 4.5 in the placebo group.
Slovenian: Povprečne dnevne stopnje epizod PBP od izhodišča (izračunane iz skupnega števila epizod, o katerih so poročali do 7 dni pred zdravljenjem) so bile 4,7 v skupini z zdravilom NUEDEXTA 23 mg/9 mg, 6,8 v skupini z zdravilom NUEDEXTA 15 mg/9 mg in 4,5 v skupini s placebom.
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.
Slovenian: Bolnik mora 21 dni jemati po eno kapsulo zdravila NUEDEXTA 15 mg/9 mg dvakrat na dan, eno zjutraj in eno zvečer z 12-urnim presledkom.
English: Tell your doctor immediately if you notice any of the following:
Slovenian: Če opazite kar koli od naslednjega, takoj obvestite svojega zdravnika:
English: Eligible patients had a diagnosis of PBA defined by episodes of involuntary, uncontrollable emotional expressions of laughing and/or crying that are incongruous or disproportionate to their emotional state or mood.
Slovenian: Primerni bolniki so imeli diagnozo PBP, opredeljeno z epizodami nehotenega čustvenega izražanja s smehom in/ali jokom, ki ga ni mogoče nadzorovati ter je neskladno ali nesorazmerno z dejanskim čustvenim stanjem ali razpoloženjem.
English: Based on the results of transporter inhibition studies drug-drug interactions related to dextromethorphan inhibition of P-gp, OATP1B1, OATP1B3, OCT2, OAT1, OAT3 or BSEP are not expected during treatment withNUEDEXTA.
Slovenian: Študije medsebojnega delovanja s prenašalci in vitro Na podlagi rezultatov študij medsebojnega delovanja s prenašalci, se medsebojno delovanje zdravil, povezano z zaviranjem P-glikoproteina, OATP1B1, OATP1B3, OCT2, OAT1, OAT3 in BSEP, ki bi ga povzročal dekstrometorfan, pri zdravljenju z zdravilom NUEDEXTA ne pričakuje.
English: Other signs and symptoms of overdose may include vomiting, diarrhoea, tinnitus, high-frequency hearing loss, vertigo, blurred vision, diplopia, photophobia, headache, confusion, and delirium.
Slovenian: Drugi znaki in simptomi prevelikega odmerjanja so lahko bruhanje, diareja, tinitus, izguba sluha za visoke frekvence, vertigo, zamegljen vid, diplopija, fotofobija, glavobol, konfuznost in delirij.
English: Caution is required when administering NUEDEXTA in combination with flecainide, chlorpromazine and haloperidol.
Slovenian: Če se zdravilo NUEDEXTA daje sočasno s flekainidom, klorpromazinom in haloperidolom, je potrebna previdnost.
English: Do not take NUEDEXTA
Slovenian: Ne jemljite zdravila NUEDEXTA:
English: The maximum mean (95% upper confidence bound) differences from placebo after baseline-correction were 10.2 (14.6) and 18.4 (22.7) ms following dextromethorphan/quinidine doses of 23 mg /26 mg and 46 mg /53 mg, respectively.
Slovenian: Največje povprečne (95odstotna zgornja meja zaupanja) razlike v primerjavi s placebom po korekciji glede na izhodišče so bile 10,2 (14,6) in 18,4 (22,7) ms po odmerkih dekstrometorfana/kinidina 23 mg/26 mg in 46 mg/53 mg. Odmerki, večji od terapevtskih, zadovoljivo predstavljajo dvig izpostavljenost kinidinu zaradi medsebojnih delovanj zdravil in motenj delovanja organov.
English: The p-value for NUEDEXTA 23 mg /9 mg vs placebo was p=0.0002 and for NUEDEXTA 15 mg /9 mg vs placebo was p=0.008.
Slovenian: P-vrednost za zdravilo NUEDEXTA 23 mg/9 mg v primerjavi s placebom je znašala p = 0,0002, za zdravilo NUEDEXTA 15 mg/9 mg v primerjavi s placebom pa je znašala p = 0,008.
English: Mean baseline CNS-LS scores were 19.8 in the NUEDEXTA 23 mg /9 mg group, 21.0 in the NUEDEXTA 15 mg /9 mg group, and 19.9 in the placebo group.
Slovenian: Povprečni rezultat na lestvici CNS-LS, merjen od izhodišča, je bil 19,8 v skupini z zdravilom NUEDEXTA 23 mg/9 mg, 21,0 v skupini z zdravilom NUEDEXTA 15 mg/9 mg in 19,9 v skupini s placebom.
English: • abnormal faeces, indigestion, inflammation of the lining of the stomach (gastritis), numbness and abnormal sensation in the mouth, rectal pain, dry tongue
Slovenian: • nenormalen iztrebek, prebavne motnje, vnetje želodčne sluznice (gastritis), odrevenelost in nenormalen občutek v ustih, bolečina v danki, suh jezik
English: Dose adjustment is not required in patients with increased CYP2D6 activity, referred to as ultra-rapid metabolisers (UMs), see section 5.2.
Slovenian: Pri bolnikih s povečano dejavnostjo encima CYP2D6, tj. ultrahitrih metabolizatorjih (UM), odmerka ni treba prilagajati; glejte poglavje 5.2.
English: OUTER CARTON - NUEDEXTA 15 mg/9 mg capsules: PACK OF 13 CAPSULES
Slovenian: ZUNANJA OVOJNINA - NUEDEXTA 15 mg/9 mg kapsule: PAKIRANJE 13 KAPSUL
English: • Quinidine increases the amount of dextromethorphan in your body, by blocking the breakdown of dextromethorphan by the liver.
Slovenian: • dekstrometorfan deluje na možgane; • kinidin povečuje količino dekstrometorfana v telesu, tako da zavira razgradnjo dekstrometorfana v jetrih.
English: • St John's wort, a herbal medicine used to treat depression
Slovenian: • šentjanževka, zdravilo rastlinskega izvora, ki ga uporabljamo za zdravljenje depresije;
English: Concomitant use of NUEDEXTA and TCAs is not recommended (see section 4.4).
Slovenian: Sočasna uporaba zdravila NUEDEXTA in tricikličnih antidepresivov ni priporočljiva (glejte poglavje 4.4).
English: Other adverse reactions include ataxia, nystagmus, dystonia, blurred vision, and changes in muscle reflexes.
Slovenian: Drugi neželeni učinki so ataksija, nistagmus, distonija, zamegljen vid in spremembe mišičnih refleksov.
English: • musculoskeletal stiffness, muscle pain (myalgia), neck pain, pain in the limbs
Slovenian: • skeletno-mišična togost, mišična bolečina (mialgija), bolečina v vratu, bolečina v udih
English: • you develop symptoms of an allergic reaction such as swelling of the throat or tongue, difficulty breathing, dizziness, fever, rash, or hives after taking this medicine.
Slovenian: • po uporabi tega zdravila opazite simptome alergijske reakcije, kot so otekanje grla ali jezika, težave z dihanjem, omotica, vročina, izpuščaj ali koprivnica;
English: • NUEDEXTA 23 mg/9 mg is a brick red gelatin capsule, size 1, with “DMQ / 30-10” printed in white ink on the capsule and three white bands around the circumference.
Slovenian: • Kapsula NUEDEXTA 23 mg/9 mg je opečnato rdeča želatinasta kapsula velikosti 1 z belo oznako »DMQ / 30-10« in tremi belimi obroči okoli oboda.
English: 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.
Slovenian: Kartica mora vsebovati podatke, ki opozorijo vsakega zdravstvenega delavca, ki zdravi bolnika, da bolnik prejema zdravljenje z zdravilom NUEDEXTA.
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).
Slovenian: Povprečni rezultati na lestvici CNS-LS, izraženi z metodo najmanjših kvadratov, so se ob koncu zdravljenja v primerjavi s placebom znižali v obeh skupinah zdravljenja (znižanje za 8,2 točke v skupini z zdravilom NUEDEXTA 23 mg/9mg, znižanje za 7,5 točke v skupini z zdravilom NUEDEXTA 15 mg/9 mg, znižanje za 5,7 točke v skupini s placebom).
English: • nose bleeds, throat pain, excessively slow or shallow breathing (respiratory depression), runny nose, yawning
Slovenian: • krvavitve iz nosu, bolečine v grlu, prepočasno ali plitko dihanje (respiratorna depresija), izcedek iz nosu, zehanje
English: The selective serotonin reuptake inhibitor (SSRI) paroxetine is metabolized primarily by CYP2D6 and is also a potent CYP2D6 inhibitor.
Slovenian: Paroksetin (zaviralec in substrat encima CYP2D6) Selektivni zaviralec ponovnega privzema serotonina (SSRI), paroksetin, se primarno presnavlja z encimom CYP2D6 in je prav tako močan zaviralec encima CYP2D6.
English: Symptoms of serotonin syndrome include agitation, high blood pressure, restlessness, muscle spasms and twitching, high body temperature, excessive sweating, shivering, and tremor.
Slovenian: Simptomi serotoninskega sindroma vključujejo agitacijo, visok krvni tlak, nemir, mišične krče in trzanje, visoko telesno temperaturo, prekomerno potenje, tresavico in tremor;
English: In a study of a combination dose of dextromethorphan 23 mg / quinidine 26 mg twice daily in 12 subjects with mild (CLCR 50-80 mL/min) or moderate (CLCR 30-50 mL/min) renal impairment (6 each) compared to 9 healthy subjects (matched in gender, age, and weight range to impaired subjects), subjects showed little difference in quinidine or dextromethorphan pharmacokinetics compared to healthy subjects.
Slovenian: V študiji kombiniranega odmerka dekstrometorfana 23 mg/kinidina 26 mg dvakrat dnevno pri 12 bolnikih z blago (CLCR 50-80 ml/min) ali zmerno (CLCR 30-50 ml/min) okvaro ledvic (6 bolnikov za vsako), kjer so bolnike primerjali z 9 zdravimi preskušanci (ki so bili po spolu, starosti in obsegu telesne mase primerljivi z bolniki), so pri bolnikih opazili majhne razlike v farmakokinetiki kinidina in dekstrometorfana v primerjavi z zdravimi preskušanci.
English: Dose adjustment is therefore not required in mild or moderate renal impairment.
Slovenian: Pri blagi ali zmerni okvari ledvic zato prilagajanje odmerka ni potrebno.
English: • common (≥1/100 to <1/10)
Slovenian: • pogosti (≥1/100 do <1/10);
English: Combination with MAOIs is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba z zaviralci MAO je kontraindicirana (glejte poglavje 4.3).
English: The quinidine component of NUEDEXTA serves to selectively inhibit CYP2D6-dependent oxidative metabolism of dextromethorphan, thus increasing dextromethorphan plasma concentrations.
Slovenian: Kinidinska komponenta zdravila NUEDEXTA selektivno zavira oksidativno presnovo dekstrometorfana, odvisno od CYP2D6, ter na ta način povečuje plazemske koncentracije dekstrometorfana.
English: Patients with a history of quinidine-, quinine-, mefloquine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome (see section 4.4).
Slovenian: Bolniki z anamnezo trombocitopenije, hepatitisa, depresije kostnega mozga ali lupusu podobnega sindroma, ki so jih povzročili kinidin, kinin ali meflokin (glejte poglavje 4.4).
English: In a study of a combination dose of dextromethorphan 23 mg / quinidine 26 mg twice daily in 12 subjects with mild or moderate hepatic impairment (as indicated by the Child-Pugh method; 6 each) compared to 9 healthy subjects (matched in gender, age, and weight range to impaired subjects), subjects with moderate hepatic impairment showed similar dextromethorphan AUC and Cmax and clearance compared to healthy subjects.
Slovenian: V študiji kombiniranega odmerka dekstrometorfana 23 mg/kinidina 26 mg dvakrat dnevno pri 12 bolnikih z blago ali zmerno okvaro jeter (6 bolnikov za vsako po metodi Child-Pugh), kjer so bolnike primerjali z 9 zdravimi preskušanci (ki so bili po spolu, starosti in obsegu telesne mase primerljivi z bolniki), so pri bolnikih z zmerno okvaro jeter opazili podobne vrednosti AUC in Cmax dekstrometorfana in očistka v primerjavi z zdravimi preskušanci.
English: Concomitant use of CYP2D6 substrates/inhibitors
Slovenian: Sočasna uporaba substratov/zaviralcev CYP2D6
English: Neither dextromethorphan alone nor dextromethorphan/quinidine has been evaluated in patients with severe hepatic impairment.
Slovenian: Dekstrometorfan samostojno in dekstrometorfan/kinidin pri bolnikih s hudo okvaro jeter nista bila ocenjena.
English: NUEDEXTA may cause dizziness (see section 4.8).
Slovenian: Zdravilo NUEDEXTA lahko povzroči omotico (glejte poglavje 4.8).
English: Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used to increase the systemic bioavailability of dextromethorphan.
Slovenian: Kinidinijev sulfat je specifični zaviralec oksidativne presnove, odvisne od encima CYP2D6, in se uporablja za povečanje sistemske biološke uporabnosti dekstrometorfana.
English: • Epistaxis, Pharyngolaryngeal pain, Respiratory depression, Rhinorrhoea, Yawning
Slovenian: • epistaksa, bolečina v grlu in žrelu, respiratorna depresija, rinoreja, zehanje
English: • abdominal pain, constipation, dry mouth, wind (flatulence), stomach discomfort, vomiting
Slovenian: • bolečina v trebuhu, zaprtost, suha usta, vetrovi (flatulenca), neugodje v želodcu, bruhanje
English: The patient should take one NUEDEXTA 15 mg/9 mg capsule once daily, in the morning, for the initial 7 days.
Slovenian: Bolnik mora v prvih 7 dnevih jemati po eno kapsulo zdravila NUEDEXTA 15 mg/9 mg enkrat na dan, zjutraj.
English: • Patient alert cards
Slovenian: • kartice z opozorili za bolnika.
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko prinajveč 1 od 10 bolnikov)
English: • medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole
Slovenian: • zdravila, ki jih uporabljamo za zdravljenje glivičnih obolenj, kot npr. ketokonazol, itrakonazol,
English: CYP3A4 inhibitors
Slovenian: Zaviralci encima CYP3A4
English: Erythema, Hyperhidrosis, Hypoaesthesia facial, Night sweats
Slovenian: Bolezni kože in podkožja eritem, hiperhidroza, obrazna hipoestezija, nočno potenje
English: NUEDEXTA contains lactose.
Slovenian: Zdravilo NUEDEXTA vsebuje laktozo.
English: • uncommon (≥1/1,000 to <1/100)
Slovenian: • občasni (≥1/1.000 do <1/100);
English: Quinidine did not inhibit (<30% inhibition) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, or CYP3A4 in human microsomes at concentrations up to 5 µM.
Slovenian: Kinidin ni zaviral (< 30-odstotno zaviranje) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1 ali
English: Symptoms of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, increased heart rate, hyperexcitability, and toxic psychosis.
Slovenian: Simptomi prevelikega odmerjanja dekstrometorfana so navzea, bruhanje, stupor, koma, respiratorna depresija, epileptični napadi, povišan srčni utrip, čezmerna vzdražljivost in toksična psihoza.
English: Brick red gelatin capsule, size 1, with “DMQ / 30-10” printed in white ink on the capsule and three white bands around the circumference.
Slovenian: Opečnato rdeča želatinasta kapsula velikosti 1 z belo oznako „DMQ / 30-10“ in tremi belimi obroči okoli oboda.
English: • NUEDEXTA 15 mg/9 mg is a brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
Slovenian: • Kapsula NUEDEXTA 15 mg/9 mg je opečnato rdeča želatinasta kapsula velikosti 1 z belo oznako »DMQ / 20-10«.
English: • medicines used to treat various heart conditions, such as diltiazem, verapamil, digoxin,
Slovenian: • zdravila, ki jih uporabljamo za zdravljenje različnih srčnih obolenj, npr. diltiazem, verapamil,
English: • medicines used to treat bacterial infections, including tuberculosis, containing clarithromycin,
Slovenian: • zdravila, ki jih uporabljamo za zdravljenje bakterijskih okužb, vključno s tuberkulozo, in ki vsebujejo klaritromicin, telitromicin, eritromicin in rifampicin;
English: Concomitant medicinal products that both prolong the QT interval and are primarily metabolised by CYP2D6 (see below) are of particular potential concern.
Slovenian: Morebitno nevarnost lahko predstavlja predvsem sočasno jemanje zdravil, ki podaljšajo interval QT in se primarno presnavljajo z encimom CYP2D6 (glejte spodaj).