natgillin/translations-raw huggingface dataset:
The exact mechanism by which dextromethorphan exerts therapeutic effects in patients with pseudobulbar affect is unknown. 
Točni mehanizam kojim dekstrometorfan ostvaruje terapijski učinak u bolesnika s pseudobulbarnim afektom nije poznat.
• very rare (<1/10,000) 
• vrlo rijetko (<1/10 000)
Serious adverse reactions have been reported for NUEDEXTA; these are muscle spasticity, respiratory depression and decreased oxygen saturation in the blood. 
Za lijek NUEDEXTA prijavljene su ozbiljne nuspojave; to su mišićna spastičnost, depresija disanja i smanjena zasićenost krvi kisikom.
Ten patients discontinued study treatment due to ADRs, one of these patients due to a serious ADR (worsening muscle spasticity). 
Deset bolesnika prekinulo je liječenje u sklopu ispitivanja zbog nuspojava na lijek, jedan od tih bolesnika zbog ozbiljne nuspojave na lijek (pogoršanje mišićne spastičnosti).
Use in older persons No special dose adjustment of NUEDEXTA is required in older patients. 
U starijih bolesnika nije potrebna posebna prilagodba doze lijeka NUEDEXTA.
• Quinidine increases the amount of dextromethorphan in your body, by blocking the breakdown of dextromethorphan by the liver. 
• Kinidin povećava količinu dekstrometorfana u Vašem tijelu time što blokira razgradnju dekstrometorfana u jetri.
Approximately 74% were Caucasian, 4% were Black, 1% were Asian and 19% were of Hispanic origin. 
Otprilike njih 74% bili su bijelci, 4% crnci, 1% ispitanika bili su azijati a 19% latinoameričkog podrijetla.
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. 
Bolesnici koji uzimaju inhibitore monoaminoksidaze (MAOI) ili koji su uzimali MAOI unutar 14 proteklih dana zbog opasnosti od ozbiljne i možda smrtonosne interakcije lijekova, uključujući serotoninski sindrom.
• Dextromethorphan acts on the brain. 
• Dekstrometorfan djeluje na mozak.
Blister of a PVC based clear film with aluminium foil seal. 
Blister s prozirnim filmom na PVC podlozi, zatvoren aluminijskom folijom.
Drug abuse and dependence 
Zloporaba lijeka i ovisnost
• excessively slow or shallow breathing (respiratory depression) and/or turning blue. 
• prekomjerno sporo ili plitko disanje (depresija disanja) i/ili pojava plave boje kože.
• thioridazine, a medicine used in the treatment of schizophrenia and psychosis, that may affect the heart, 
• tioridazin, lijek koji se koristi u liječenju shizofrenije i psihoze, a može utjecati na srce,
The patient alert card should be provided to all patients with instructions to carry it on them at all times. 
Karticu s upozorenjima za bolesnika trebali bi dobiti svi bolesnici uz naputak da je uvijek nose sa sobom.
• you have a condition called myasthenia gravis (an autoimmune neuromuscular disease that causes muscle weakness and fatigability). 
• ako imate bolest koja se naziva mijastenija gravis (autoimuna neuromišićna bolest koja uzrokuje mišićnu slabost i brzo umaranje).
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. 
Ako bolesnici imaju simptome koji bi mogli ukazivati na pojavu srčanih aritmija, npr. sinkopa ili palpitacije, davanje lijeka NUEDEXTA treba prekinuti i pričekati daljnju procjenu bolesnika.
• bone fractures (skeletal injury) 
• prijelomi kostiju (ozljede kostiju)
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. 
U otvorenoj fazi ispitivanja od 12 tjedana (u kojoj su svi ispitanici primali NUEDEXTA 23 mg/9 mg) pokazalo se da se održao učinak opažen u razdoblju kontroliranom placebom.
The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where Nuedexta is marketed, at launch and after launch, all healthcare professionals who are expected to prescribe Nuedexta are provided with the following items: 
Nakon razmatranja i dogovora edukacijskog programa s nadležnim državnim tijelom u svakoj zemlji članici u kojoj će Nuedexta biti stavljena u promet, nositelj odobrenja će osigurati da prije i poslije stavljanja u promet, svi zdravstveni djelatnici za koje se očekuje da će propisivati lijek Nuedexta, dobiju sljedeće materijale:
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 nekompeticijski antagonist niskog afiniteta za receptore NMDA i agonist receptora sigma-1, koji nije sustavno ispitan u životinja ili ljudi u odnosu na mogućnost zlouporabe, podnošljivost ili tjelesnu ovisnost.
• Cardiac effects (QT prolongation) including pre-existing cardiovascular conditions and clinically significant electrolyte imbalances 
• učinke na aktivnost srca (produljenje QT intervala) uključujući prethodne kardiovaskularne bolesti i klinički značajne neravnoteže elektrolita
Mild to moderate hepatic impairment had little effect on quinidine pharmacokinetics. 
Blago do umjereno oštećenje funkcije jetre imalo je mali učinak na farmakokinetiku kinidina.
Do not use this medicine after the expiry date which is stated on the bottle, blister and carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici, blisteru i kutiji iza Rok valjanosti ili EXP.
Dextromethorphan is a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist. 
Dekstrometorfan je agonist receptora sigma-1 i nekompeticijski antagonist receptora NMDA.
• medicines used to treat schizophrenia and other psychotic disorders, such as haloperidol, 
• lijekovi za liječenje shizofrenije i drugih psihotičnih poremećaja, kao što su haloperidol,
Likewise, this medicinal product should not be restarted in sensitised patients, because more rapid and more severe thrombocytopenia than the original episode can occur. 
Slično tomu, liječenje ovim lijekom ne smije se ponovno početi u senzitiziranih bolesnika, jer se trombocitopenija može pojaviti brže i u težem obliku nego što je bila prvotna epizoda.
What you need to know before you take NUEDEXTA 
Što morate znati prije nego počnete uzimati lijek 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. 
Trenutačno su dostupni tek ograničeni podaci o stupnju učinka inhibitora CYP3A4 na farmakokinetičke parametre kinidina i njegovih metabolita, uključujući potencijal za akumulaciju u stanju dinamičke ravnoteže.
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. 
Nuspojave za koje se smatralo da su barem moguće povezane s terapijom NUEDEXTOM, u placebom kontroliranoj i otvorenoj fazi produžetka gore spomenutog kliničkog ispitivanja, navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti.
The treatment of cardiac effects (haemodynamically unstable polymorphic ventricular tachycardia (including torsades de pointes)) is either immediate cardioversion or immediate overdrive pacing. 
Liječenje srčanih učinaka (hemodinamički nestabilna polimorfna ventrikularna tahikardija (uključujući torsades de pointes)) uključuje ili trenutnu kardioverziju ili trenutnu normalizaciju ritma povećanjem frekvencije (overdrive pacing).
Treatment of dextromethorphan overdose should be directed at symptomatic and supportive measures. 
Liječenje predoziranja dekstrometorfanom treba biti usmjereno na simptomatske i potporne mjere.
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. 
Da bi se procijenili dugoročni podaci, 253 ispitanika koji su završili dvostruko slijepu fazu ispitivanja mogli su se uključiti u otvorenu fazu produžetka ispitivanja i primati lijek NUEDEXTA 23 mg/9 mg još sljedeća 84 dana.
Day 10 
10. dan
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% ispitanika imalo je dijagnoze koje nisu bile ALS i MS, uključujući moždani udar, traumatsku ozljedu mozga, Parkinsonovu bolest, Alzheimerovu bolest i drugu demenciju, primarnu lateralnu sklerozu, progresivnu bulbarnu paralizu i progresivnu supranuklearnu paralizu.
The maximum mean (95% upper confidence bound) difference from placebo after baseline correction was 10.2 (12.6) ms. 
Maksimalna prosječna razlika (95% gornje granice pouzdanosti) u odnosu na placebo nakon korekcije početnih vrijednosti bila je 10,3 (12,6) ms.
Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls. 
Potrebno je poduzeti mjere kako bi se smanjila opasnost od padova, osobito u bolesnika s motoričkim oštećenjem koje utječe na držanje/hod ili u onih s padovima u anamnezi.
In vitro CYP P450 interaction studies 
Ispitivanja interakcije CYP P450 in vitro
There is no relevant use of NUEDEXTA in the paediatric population for the symptomatic treatment of pseudobulbar affect. 
Nema relevantne primjene lijeka NUEDEXTA u pedijatrijske populacije za simptomatsko liječenje pseudobulbarnog afekta.
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. 
I dekstrometorfan i memantin antagonisti su N-metil-D-aspartatnih (NMDA) receptora, što bi teoretski moglo rezultirati aditivnim učinkom na NMDA receptore i potencijalno povećanom incidencijom nuspojava.
Other P-gp substrates for which a dose reduction may be considered include ticagrelor and dabigatran-etexilate. 
Ostali supstrati P-glikoproteina, za koje se može uzeti u obzir smanjenje doze, uključuju tikagrelor i dabigatraneteksilat.
Only for NUEDEXTA 15 mg/9 mg: Blister packs consist of a PVC based clear film with aluminium foil seal and contains 13 hard capsules. 
Samo za lijek NUEDEXTA 15 mg/9 mg: Pakiranje blistera sastoji se od prozirnog filma na PVC podlozi zatvorenog aluminijskom folijom, a sadrži 13 tvrdih kapsula.
• 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). 
• ako ste u prošlosti imali bolest koja se naziva sindrom nalik lupusu prouzročenu kinidinom (to može izazvati bolove u zglobovima, osip na koži, pretjeranu osjetljivost kože na sunce i sveukupni osjećaj bolesti).
Take care if you consume alcohol while you are taking NUEDEXTA as might increase the risk of side effects such as dizziness and sleepiness. 
Pazite ako konzumirate alkohol dok uzimate lijek NUEDEXTA, jer to može povećati rizik od nuspojava kao što su omaglica i pospanost.
Efficacy has only been studied in patients with underlying Amyotrophic Lateral Sclerosis or Multiple Sclerosis (see section 5.1). 
Djelotvornost je ispitana samo u bolesnika u kojih su temeljne bolesti bile amiotrofna lateralna skleroza ili multipla skleroza (vidjeti dio 5.1).
• 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. 
• ako uzimate ili ste uzimali tijekom protekla dva tjedna određene lijekove protiv depresije, koji se nazivaju inhibitori monoaminoksidaze, kao što su fenelzin i moklobemid.
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. 
Smatra se da dekstrometorfan svojim vezanjem na receptore NMDA, sigma-1, SERT i 5-HT1B/D ima modulacijski učinak na neurotransmisiju, uključujući glutamat, monoamine (uključujući serotonin), a također i na funkciju ionskih kanala.
Quinidine plasma concentrations are proportional to quinidine dose. 
Koncentracije kinidina u plazmi proporcionalne su dozi kinidina.
The maximum daily dose from week 4 onwards is NUEDEXTA 23 mg/9 mg, twice daily. 
Maksimalna dnevna doza od 4. tjedna nadalje je NUEDEXTA 23 mg/9 mg, dvaput na dan.
It should not be used if immunemediated thrombocytopenia from structurally related active substances including quinine and mefloquine is suspected, as cross-sensitivity can occur. 
Lijek se ne smije uzimati ako postoji sumnja na imunološki posredovanu trombocitopeniju, izazvanu strukturno povezanim djelatnim tvarima uključujući kinin i meflokin, jer bi moglo doći do ukrižene osjetljivosti.
Each bottle consists of high density polyethylene (HDPE) with a child resistant polypropylene cap and contains 60 hard capsules. 
Svaka bočica izrađena je od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu, a sadrži 60 tvrdih kapsula.
Lactose warning 
Upozorenje na laktozu
No other drug interactions with CYP2D6 substrates have been systematically investigated. 
Druge interakcije lijekova sa supstratima CYP2D6 nisu sistematski ispitivane.
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. 
Dok su terapijske doze kinidina za liječenje srčanih aritmija ili malarije uglavnom ≥10 puta više od doze kinidina u ovom lijeku, potencijalno fatalne srčane aritmije, uključujući torsades de pointes, mogu se razviti pri izloženosti kinidinu kakvo je moguće u slučaju predoziranja NUEDEXTOM.
The effect of the combination on the patient's QTc interval should be evaluated with pre- and post-dose ECGs. 
Učinak kombinacije na QTc interval u bolesnika je potrebno procijeniti EKG-om prije i poslije primjene doze.
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). 
Kinidin u lijeku NUEDEXTA inhibira CYP2D6 u bolesnika u kojih CYP2D6 inače nije genetski odsutan ili je slabo aktivan („slabi metabolizatori CYP2D6“ vidjeti „Farmakogenomika“ u dijelu 5.2).
• St John's wort, a herbal medicine used to treat depression 
• gospina trava, biljni lijek koji se koristi za liječenje depresije
However, as there was a trend toward increased incidence of adverse reactions in patients with moderate hepatic impairment, additional monitoring of adverse reactions is advised in these patients. 
Međutim, s obzirom da je postojao trend prema povećanoj incidenciji nuspojava u bolesnika s umjerenim oštećenjem funkcije jetre, u tih se bolesnika savjetuje dodatni nadzor zbog mogućih nuspojava.
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. 
Viša doza kinidina primijenjena u tim ispitivanjima rezultirala bi približno 1,6 puta većom izloženošću dekstrometorfanu nego uz lijek NUEDEXTA 23 mg/9 mg.
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). 
Bolesnici s potpunim atrioventrikularnim (AV) blokom bez ugrađenih električnih stimulatora srca (pejsmejkera) ili bolesnici u kojih postoji visoki rizik od potpunog atrioventrikularnog bloka (vidjeti dio 4.4).
In such UM patients, dextromethorphan is rapidly metabolised, leading to lower, potentially subtherapeutic concentrations. 
U takvih bolesnika određenih kao ultra brzi metabolizatori, dekstrometorfan se brzo metabolizira što dovodi do nižih, potencijalno subterapijskih koncentracija.
The supratherapeutic doses are adequate to represent quinidine exposure increases due to drug-drug interactions and organ dysfunctions. 
Supraterapijske doze odgovarajuće su pokazale povećanja izloženosti kinidinu zbog interakcija lijekova i disfunkcija organa.
LVH and LVD are more likely to be present in patients with chronic hypertension, known coronary artery disease or history of stroke. 
Prisutnost LVH i LVD vjerojatnija je u bolesnika s kroničnom hipertenzijom, potvrđenom bolešću koronarnih arterija ili moždanim udarom u anamnezi.
The pharmacokinetics of dextromethorphan/quinidine in paediatric patients has not been studied (see section 5.1). 
Pedijatrijska populacija Farmakokinetika dekstrometorfana / kinidina u pedijatrijskih bolesnika nije ispitana (vidjeti dio 5.1).
• 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)). 
• Drugi sastojci su umrežena karmelozanatrij, mikrokristalična celuloza, koloidni silicijev dioksid, laktoza hidrat, magnezijev stearat i želatina, titanijev dioksid (E171), crveni željezov oksid (E172), tinta za označavanje (šelak glazura, propilenglikol, titanijev dioksid (E171)).
Pack size: 60 capsules 
Veličina pakiranja: 60 kapsula
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. 
Edukacijski materijal za zdravstvene djelatnike trebao bi im pomoći u pribavljanju i procjeni važnih bolesnikovih podataka o prethodnim komorbiditetima i lijekovima koje istovremeno uzima prije nego što započne terapiju lijekom Nuedexta.
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. 
Ako se istovremeno liječenje snažnim ili umjerenim inhibitorima CYP3A4 smatra potrebnim, preporučuje se da se prije primjene lijeka NUEDEXTA, a nakon toga u odgovarajućim vremenskim točkama, provodi procjena QT intervala elektrokardiogramom (EKG).
This medicine may cause dizziness and your doctor might need to discuss appropriate precautions to reduce the risk of falls. 
• ako ste skloni padovima; ovaj lijek može izazvati omaglicu i liječnik će možda trebati s Vama porazgovarati o odgovarajućim mjerama opreza, kako bi se umanjila opasnost od padova.
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). 
Učestalost epizoda pseudobulbarnog afekta mjerena kao „broj epizoda“ u obje skupine liječene NUEDEXTOM značajno se smanjila tijekom trajanja ispitivanja, postupnim smanjenjem od 47% odnosno 49% u odnosu na placebo (p<0,0001 za obje usporedbe).
These are medicines used to treat malaria or heart rhythm problems, 
To su lijekovi za liječenje malarije ili tegoba sa srčanim ritmom,
Quinidine is a potent inhibitor of CYP2D6. 
Kinidin je snažan inhibitor CYP2D6.
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. 
Prvo ispitivanje trajalo je 4 tjedna i provedeno je u ispitanika s pseudobulbarnim afektom i ALS u podlozi, a drugo je trajalo 12 tjedana i provedeno je u ispitanika s MS u podlozi.
You should not drink grapefruit juice or eat grapefruits while you are taking NUEDEXTA as this can increase the likelihood of serious side effects. 
Dok uzimate lijek NUEDEXTA ne smijete piti sok od grejpa ili jesti grejp, jer to može povećati vjerojatnost pojave ozbiljnih popratnih učinaka.
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. 
U oba ispitivanja mjera primarnog ishoda, CNS-LS te mjera sekundarnog ishoda „broj epizoda smijeha i plača“, bile su statistički značajno smanjene primjenom kombinacije dekstrometorfan / kinidin.
Quinidine at higher doses than in NUEDEXTA can cause immune-mediated thrombocytopenia that can be severe or fatal. 
Kinidin u dozama višim od onih koje sadrži NUEDEXTA može prouzročiti imunološki posredovanu trombocitopeniju, koja može biti teška ili smrtonosna.
• medicines used to prevent nausea and vomiting during chemotherapy and after surgery, such as aprepitant 
• lijekovi za sprječavanje mučnine i povraćanja tijekom kemoterapije i nakon kirurškog zahvata,
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). 
S obzirom na farmakodinamičke i farmakokinetičke interakcije, ne preporučuje se istovremena primjena lijeka NUEDEXTA i tricikličkih antidepresiva, zbog povećanog rizika od serotoninskog sindroma (vidjeti dio 4.5).
Mean changes in QTcF were 6.8 ms for NUEDEXTA 23 mg/ 9 mg and 9.1 ms for the reference positive control (moxifloxacin). 
Srednje vrijednosti promjena u QTcF iznosile su 6,8 ms za skupinu NUEDEXTA 23 mg/ 9 mg i 9,1 ms za referentnu pozitivnu kontrolnu skupinu (moksifloksacin).
It is not known whether the active substances of NUEDEXTA are expressed into human milk. 
Nije poznato prelaze li djelatne tvari lijeka NUEDEXTA u majčino mlijeko.
• 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) 
• ako ste u prošlosti imali niski broj krvnih stanica prouzročenih kinidinom, kininom ili meflokinom (to može izazvati sklonost krvarenju ili stvaranju modrica češće nego što je normalno).
Digoxin and other P-glycoprotein substrates 
Digoksin i drugi supstrati P-glikoproteina
Titanium dioxide (E171) Red iron oxide (E172) 
Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, crveni (172)
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. 
Oni uključuju, ali nisu ograničeni samo na njih, atazanavir, klaritromicin, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromicin, amprenavir, aprepitant, diltiazem, eritromicin, flukonazol, fosamprenavir, sok od grejpa i verapamil.
Rare (may affect up to 1 in 1,000 people) 
Rijetke (mogu se javiti u do 1 od 1000 osoba)
NUEDEXTA is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults (see section 4.4). 
NUEDEXTA indicirana je za simptomatsko liječenje pseudobulbarnog afekta u odraslih (vidjeti dio 4.4).
Do not take NUEDEXTA 
Nemojte uzimati NUEDEXTU
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). 
Kada se smatra da je neophodna istovremena upotreba lijeka koji je supstrat CYP2D6, dozu supstrata CYP2D6 treba smanjiti kako je odgovarajuće prema farmakokinetici uključenog supstrata (vidjeti dio 4.5).