natgillin/translations-raw huggingface dataset:
• Bruxism, Confusional state, Depressed mood, Depression, Disorientation, Early morning awakening, Flat affect, Hallucination, Impulsive behaviour, Indifference, Insomnia, Restlessness, Sleep disorder
• bruksizem, konfuznost, depresivno razpoloženje, depresija, dezorientiranost, zbujanje zgodaj zjutraj, apatičnost, halucinacije, impulzivno vedenje, indiferentnost, nespečnost, nemir, motnje spanja
• to give you a higher dose and to prescribe NUEDEXTA 23 mg/9 mg capsules to you.
• za dvig odmerka in vam bo predpisal zdravilo NUEDEXTA 23 mg/9 mg kapsule.
Pack size: 13 capsules
Velikost pakiranja: 13 kapsul
• Myocardial infarction, Palpitations, Ventricular extrasystoles
• miokardni infarkt, palpitacije, prekatne ekstrasistole
If you stop taking NUEDEXTA
Če ste prenehali jemati zdravilo NUEDEXTA
The potential for dextromethorphan and quinidine to inhibit or induce cytochrome P450 in vitro were evaluated in human microsomes.
Študije medsebojnega delovanja s CYP P450 in vitro Potencial dekstrometorfana in kinidina za zaviranje ali indukcijo citokroma P450 in vitro je bil ocenjen na človeških mikrosomih.
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 % posameznikov kavkazijskega porekla, 5-30 % posameznikov afriškega črnega porekla, 12-40 % posameznikov arabskega porekla in 1 % posameznikov azijskega porekla izkazuje povišano presnovno dejavnost za substrate CYP2D6, zato so označeni kot osebe z izjemno hitro presnovo.
They include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil.
Ti med drugim vključujejo atazanavir, klaritromicin, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromicin, amprenavir, aprepitant, diltiazem, eritromicin, flukonazol, fosamprenavir, sok grenivke in verapamil.
• distorted sense of taste (dysgeusia), sleepiness (hypersomnia), muscle spasticity, fainting
• moten čut za okus (disgevzija), zaspanost (hipersomnija), mišična spastičnost, omedlevica
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.
Pri osebah z obsežno presnovo so se vrednosti Cmax in AUC0-12 dekstrometorfana in dekstrorfana povišale s povišanjem odmerkov dekstrometorfana s 15 mg na 23 mg, povprečne vrednosti Cmax in AUC0-12 kinidina pa so bile podobne.
Dextromethorphan is rapidly metabolized by CYP2D6 to its primary metabolite, dextrorphan, which is rapidly glucuronidated and renally eliminated.
Dekstrometorfan se hitro presnavlja s CYP2D6 v svoj osnovni metabolit, dekstrorfan, ki se hitro spremeni v glukuronid in izloči prek ledvic.
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.
V tej 12-tedenski študiji, nadzorovani s placebom, so randomizirali 326 preskušancev s PBP in z amiotrofično lateralno sklerozo (ALS) ali multiplo sklerozo (MS) kot osnovno boleznijo, tako da so 12 tednov prejemali zdravilo NUEDEXTA 15 mg/9 mg, (n=107), NUEDEXTA 23 mg/9 mg (n=110) ali placebo (n=109).
ECG should be re-evaluated if risk factors for QTc prolongation change significantly during treatment with NUEDEXTA.
Če se dejavniki tveganja za podaljšanje intervala QTc med zdravljenjem z zdravilom NUEDEXTA znatno spremenijo, je treba ponovno oceniti EKG.
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.
Drugi učinki vključujejo izgubo koordiniranega gibanja (ataksija), nehotene očesne premike (nistagmus), prekomerno krčenje mišic (distonija), zamegljen vid in spremembe mišičnih refleksov.
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.
V študijah embriofetalne in razvojne toksičnosti (pri podganah in kuncih) z dekstrometorfanijevim bromidom/kinidinijevim sulfatom so opazili anomalije pri srednjem in visokem odmerku z zmanjšano osifikacijo od najnižjega odmerka pri podganah, kar je približno 1-kratnik in 50-kratnik odmerka za človeka 30/18 mg/dan na podlagi mg/m2.
NUEDEXTA has the potential to cause QTc prolongation and hence torsades de pointes-type ventricular tachycardia.
Zdravilo NUEDEXTA lahko podaljša interval QTc in posledično povzroči ventrikularno tahikardijo tipa torsades de pointes.
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.
Po dajanju zdravila NUEDEXTA 23 mg/9 mg 14 osebam z obsežno presnovo je bil razpolovni čas izločanja dekstrometorfana 18,8 ure, razpolovni čas izločanja kinidina pa je bil 9,6 ure.
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.
Če je klinični odziv z zdravilom NUEDEXTA 15 mg/9 mg nezadosten, je treba predpisati zdravilo NUEDEXTA 23 mg/9 mg, ki ga mora bolnik jemati dvakrat na dan, po eno kapsulo zjutraj in eno zvečer z 12-urnim presledkom.
The most common adverse reactions were mild to moderate nausea, dizziness, and headache.
Najpogostejši neželeni učinki so bili blaga do zmerna navzea, omotica in glavobol.
Dextromethorphan hydrobromide is the pharmacologically active ingredient that acts on the central nervous system (CNS).
Dekstrometorfanijev bromid je farmakološko aktivna zdravilna učinkovina, ki deluje na osrednje živčevje.
Quinidine increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6 (CYP2D6), which catalyses a major biotransformation pathway for dextromethorphan.
Kinidin poviša ravni dekstrometorfana v plazmi, tako da kompetitivno zavira citokrom P450 2D6 (CPY2D6), ki katalizira glavno pot biotransformacije dekstrometorfana.
• chest discomfort, chest pain, chills, feeling hot, gait disturbance (difficulty walking), flu-like illness, fever, decreased oxygen levels in the blood
• neugodje v prsnem košu, bolečina v prsnem košu, mrzlica, občutek vročine, motnje hoje (težave pri hoji), gripi podobna bolezen, vročina, znižane ravni kisika v krvi
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.
Preživetje mladičev in telesna masa mladičev sta bila nekoliko zmanjšana pri najnižjem odmerku, ki ustreza približno 1-kratniku in 50-kratniku odmerka za ljudi v višini 30/18 mg/kg na podlagi mg/m za dekstrometorfan bromid oziroma kinidin sulfat.
Fertility In pre-clinical studies no effect on fertility was observed in male and female rats (see section 5.3).
V predkliničnih študijah na podganjih samcih in samicah niso opazili nobenega učinka na plodnost (glejte poglavje 5.3).
• Co-administration of a strong CYP3A4 inhibitor
• sočasnim dajanjem močnega zaviralca CYP3A4;
Talk to your doctor before and after taking NUEDEXTA if:
Pred začetkom jemanja zdravila NUEDEXTA in po njem se posvetujte z zdravnikom, če:
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 podlagi podatkov iz literature medsebojnega delovanja zdravil kot posledice zaviranja OATP1B1, OCT1, OCT2, OAT3, BSEP, MATE1 in MATE2-K, ki bi ga povzročal kinidin, ni pričakovati.
In the presence of quinidine, CYP3A4-dependent oxidative metabolism is believed to play a greater role in dextromethorphan elimination.
Predvideva se, da ima v prisotnosti kinidina oksidativna presnova, odvisna od CYP3A4, večjo vlogo pri izločanju dekstrometorfana.
What NUEDEXTA looks like and contents of the pack
Izgled zdravila NUEDEXTA in vsebina pakiranja
Dextromethorphan can also be associated with hypersensitivity reactions, including uticaria, angioedema, and shortness of breath.
Dekstrometorfan je lahko povezan tudi s preobčutljivostnimi reakcijami, vključno z urtikarijo, angioedemom in zasoplostjo.
• medicines containing quinidine, quinine, or mefloquine.
• zdravila, ki vsebujejo kinidin, kinin ali meflokin.
Symptoms of quinidine overdose include irregular heartbeat and low blood pressure, and may also include vomiting, diarrhoea, ringing in the ears, high-frequency hearing loss, vertigo, blurred vision, double vision, increased sensitivity of the eyes to light, headache, confusion, and delirium (characterised by loss of attention, poor memory, disorientation, impaired speech).
Simptomi prevelikega odmerjanja kinidina so nereden srčni ritem in nizek krvni tlak, vključujejo pa lahko tudi bruhanje, drisko, zvenenje v ušesih, izgubo sluha za visoke frekvence, vrtoglavico, zamegljen vid, dvojni vid, povečano občutljivost oči za svetlobo, glavobol, zmedenost in delirij (za katerega je značilno pomanjkanje pozornosti, slab spomin, dezorientiranost in otežen govor).
Fever may be a presenting symptom, and thrombocytopenia or other signs of hypersensitivity may also occur.
Na to lahko kaže povišana telesna temperatura, pojavijo pa se lahko tudi trombocitopenija ali drugi znaki preobčutljivosti.
You should not drink grapefruit juice or eat grapefruits while you are taking NUEDEXTA as this can increase the likelihood of serious side effects.
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.
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.
Kinidinska komponenta naj ne bi prispevala k učinkovitosti zdravila NUEDEXTA pri osebah s slabo presnovo, kljub temu pa so možni neželeni učinki kinidinske komponente.
NUEDEXTA is used for the treatment of pseudobulbar affect (PBA) in adults.
Zdravilo NUEDEXTA se uporablja za zdravljenje psevdobulbarne paralize (PBP) pri odraslih.
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.
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.
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.
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.
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.
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.
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.
PBP je nevrološka bolezen, za katero so značilne nehotene in nekontrolirane epizode smejanja in/ali joka, ki ne ustrezajo vašemu čustvenemu stanju ali razpoloženju.
Symptoms of serotonin syndrome include altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor.
Simptomi serotoninskega simptoma vključujejo spremenjeno duševno stanje, hipertenzijo, nemir, mioklonus, hipertermijo, hiperrefleksijo, diaforezo, drgetanje in tremor.
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.
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.
Two additional phase III studies were conducted using a higher dose combination of dextromethorphan 23 mg/quinidine 26 mg.
Opravili so dve dodatni študiji III. faze, v katerih so uporabili večji odmerek kombinacije dekstrometorfana 23 mg/kinidina 26 mg.
• decreased appetite
• zmanjšan tek
Dose adjustment is not required in patients with mild to moderate renal or hepatic impairment (see section 4.4).
Pri bolnikih z blago do zmerno ledvično ali jetrno okvaro prilagajanje odmerka ni potrebno (glejte poglavje 4.4).
13 hard capsules
13 trdih kapsul
Quinidine is metabolised by CYP3A4.
Kinidin se presnavlja z encimom CYP3A4.
Atrioventricular block first degree, Electrocardiogram QT prolonged
Srčne bolezni občasni atrioventrikularni blok prve stopnje, podaljšanje intervala QT na elektrokardiogramu redki
The most commonly reported side effects are gastrointestinal disorders (such as diarrhoea, nausea), nervous system disorders (such as dizziness, headache, somnolence) and fatigue.
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.
Each bottle consists of high density polyethylene (HDPE) with a child resistant polypropylene cap and contains 60 hard capsules.
Plastenka je izdelana iz polietilena visoke gostote (HDPE) s pokrovčkom iz polipropilena, ki je varen za otroke, in vsebuje 60 trdih kapsul.
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.
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.
• 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
• motnje ravnotežja, nenormalna koordinacija, težave z govorom (disartrija), motnje gibanja, zbadanje/mravljinčenje ali odrevenelost (parestezija), izguba občutka in nadzora spodnjih okončin (parapareza), sedacija
Plasma concentrations of quinidine increased 20-30% when memantine was added.
Ob dodajanju memantina se je koncentracija kinidina v plazmi povečala za 20-30 %.
Dextromethorphan / quinidine has not been studied in patients with severe renal impairment.
Dekstrometorfana/kinidina niso proučevali pri bolnikih s hudo okvaro ledvic.
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.
Kinidin zavira presnovo dekstrometorfana, zato so lahko neželeni učinki prevelikega odmerjanja zdravila NUEDEXTA hujši in vztrajnejši kot pri prevelikem odmerjanju samo dekstrometorfana.
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.
Vsi preskušanci so imeli klinično pomembne simptome PBP, kvantificirane na lestvici CNS-LS kot rezultat 13 ali več.
When taking two capsules within 24 hours, you should leave about 12 hours between doses.
Če jemljete po dve kapsuli v obdobju 24 ur, naj med odmerkoma mine približno 12 ur.
• anxiety
• utrujenost
How to take NUEDEXTA
Kako jemati zdravilo NUEDEXTA
NUEDEXTA should be discontinued immediately if thrombocytopenia occurs, unless the thrombocytopenia is clearly not drug-related.
Če se pojavi trombocitopenija, je treba zdravljenje z zdravilom NUEDEXTA takoj prekiniti, razen če je jasno, da trombocitopenija ni povezana z zdravilom.
perphenazine, aripiprazole and chlorpromazine
haloperidol, perfenazin, aripiprazol in klorpromazin;
The concomitant use of thioridazine is contraindicated (see section 4.3).
Sočasna uporaba tioridazina je kontraindicirana (glejte poglavje 4.3).
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.
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.
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.
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.
Tell your doctor immediately if you notice any of the following:
Če opazite kar koli od naslednjega, takoj obvestite svojega zdravnika:
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.
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.
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.
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.
Other signs and symptoms of overdose may include vomiting, diarrhoea, tinnitus, high-frequency hearing loss, vertigo, blurred vision, diplopia, photophobia, headache, confusion, and delirium.
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.
Caution is required when administering NUEDEXTA in combination with flecainide, chlorpromazine and haloperidol.
Če se zdravilo NUEDEXTA daje sočasno s flekainidom, klorpromazinom in haloperidolom, je potrebna previdnost.
Do not take NUEDEXTA
Ne jemljite zdravila NUEDEXTA:
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.
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.
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.
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.
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.
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.
• abnormal faeces, indigestion, inflammation of the lining of the stomach (gastritis), numbness and abnormal sensation in the mouth, rectal pain, dry tongue
• nenormalen iztrebek, prebavne motnje, vnetje želodčne sluznice (gastritis), odrevenelost in nenormalen občutek v ustih, bolečina v danki, suh jezik
Dose adjustment is not required in patients with increased CYP2D6 activity, referred to as ultra-rapid metabolisers (UMs), see section 5.2.
Pri bolnikih s povečano dejavnostjo encima CYP2D6, tj. ultrahitrih metabolizatorjih (UM), odmerka ni treba prilagajati; glejte poglavje 5.2.
OUTER CARTON - NUEDEXTA 15 mg/9 mg capsules: PACK OF 13 CAPSULES
ZUNANJA OVOJNINA - NUEDEXTA 15 mg/9 mg kapsule: PAKIRANJE 13 KAPSUL
• Quinidine increases the amount of dextromethorphan in your body, by blocking the breakdown of dextromethorphan by the liver.
• dekstrometorfan deluje na možgane; • kinidin povečuje količino dekstrometorfana v telesu, tako da zavira razgradnjo dekstrometorfana v jetrih.
• St John's wort, a herbal medicine used to treat depression
• šentjanževka, zdravilo rastlinskega izvora, ki ga uporabljamo za zdravljenje depresije;
Concomitant use of NUEDEXTA and TCAs is not recommended (see section 4.4).
Sočasna uporaba zdravila NUEDEXTA in tricikličnih antidepresivov ni priporočljiva (glejte poglavje 4.4).
Other adverse reactions include ataxia, nystagmus, dystonia, blurred vision, and changes in muscle reflexes.
Drugi neželeni učinki so ataksija, nistagmus, distonija, zamegljen vid in spremembe mišičnih refleksov.
• musculoskeletal stiffness, muscle pain (myalgia), neck pain, pain in the limbs
• skeletno-mišična togost, mišična bolečina (mialgija), bolečina v vratu, bolečina v udih
• 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.
• po uporabi tega zdravila opazite simptome alergijske reakcije, kot so otekanje grla ali jezika, težave z dihanjem, omotica, vročina, izpuščaj ali koprivnica;
• 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.
• 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.
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.
Kartica mora vsebovati podatke, ki opozorijo vsakega zdravstvenega delavca, ki zdravi bolnika, da bolnik prejema zdravljenje z zdravilom NUEDEXTA.