FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people)
Croatian: Česte nuspojave (mogu se javiti u do 1 od 10 osoba)
English: The patient should take one NUEDEXTA 15 mg/9 mg capsule once daily, in the morning, for the initial 7 days.
Croatian: Bolesnik treba uzeti jednu kapsulu NUEDEXTA 15 mg/9 mg jedanput na dan, ujutro, prvih 7 dana.
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.
Croatian: Nakon jedne i ponovljenih kombiniranih doza lijeka NUEDEXTA 23 mg/9 mg, ispitanici su pokazali približno 20 puta veću izloženost dekstrometorfanu u usporedbi s ispitanicima koji su primili dekstrometorfan bez kinidina.
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.
Croatian: P-vrijednost za lijek NUEDEXTA 23 mg/9 mg naspram placebu bila je p=0,0002, a za lijek NUEDEXTA 15 mg/9 mg naspram placebu p=0,008.
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.
Croatian: Prosječne stope dnevnih epizoda pseudobulbarnog afekta na početku (izračunatih iz ukupnog broja epizoda zabilježenih u do 7 dana prije liječenja) bile su 4,7 u skupini NUEDEXTA 23 mg/9 mg, 6,8 u skupini NUEDEXTA 15 mg/9 mg i 4,5 u skupini koja je primala placebo.
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.
Croatian: Analiza populacijske farmakokinetike u odnosu na rasnu pripadnost provedena na 109 ispitanika (21 bijelac; 71 latinoamerikanac; 18 crnaca) nije pokazala vidljive razlike s obzirom na farmakokinetiku dekstrometorfana / kinidina.
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.
Croatian: Učinak lijeka NUEDEXTA 23 mg/9 mg (u 7 uzastopnih doza) na produljenje QTc intervala procijenjen je u randomiziranom dvostruko slijepom ispitivanju (osim za moksifloksacin), kontroliranom placebom i pozitivnom kontrolom (400 mg moksifloksacin) sveobuhvatnom ukriženom ispitivanju QT intervala provedenom natašte u 50 normalnih zdravih muškaraca i žena s genotipom ekstenzivnih metabolizatora CYP2D6.
English: Patients with moderate hepatic impairment showed an increased frequency of adverse reactions.
Croatian: Bolesnici s umjerenim oštećenjem funkcije jetre pokazali su povećanu učestalost nuspojava.
English: Concomitant use of NUEDEXTA and TCAs is not recommended (see section 4.4).
Croatian: Ne preporučuje se istovremena uporaba lijeka NUEDEXTA i tricikličkih antidepresiva (vidjeti dio 4.4).
English: Plasma concentrations of quinidine increased 20-30% when memantine was added.
Croatian: Dodatkom memantina, koncentracija kinidina u plazmi povećala se za 20-30%.
English: Patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes ventricular tachycardia (see section 4.4).
Croatian: Bolesnici s produljenim QT intervalom, sindromom prirođeno produljenog QT intervala ili anamnezom koja upućuje na ventrikularnu tahikardiju torsades de pointes (vidjeti dio 4.4).
English: • Bruxism, Confusional state, Depressed mood, Depression, Disorientation, Early morning awakening, Flat affect, Hallucination, Impulsive behaviour, Indifference, Insomnia, Restlessness, Sleep disorder
Croatian: Rijetko bruksizam, stanje konfuzije, depresivno raspoloženje, depresija, dezorijentiranost, rano buđenje, zaravnjen afekt, halucinacije, impulzivno ponašanje, ravnodušnost, nesanica, nemir, poremećaj spavanja
English: Treatment with NUEDEXTA may therefore result in elevated plasma levels and accumulation of co-administered medicinal products that undergo extensive CYP2D6 metabolism.
Croatian: Terapija NUEDEXTOM stoga može rezultirati povišenim plazmatskim razinama istovremeno primijenjenih lijekova koji se opsežno metaboliziraju putem CYP2D6.
English: The risk of thrombocytopenia in association with the lower dose of quinidine in NUEDEXTA is unknown.
Croatian: Rizik od trombocitopenije povezan s nižom dozom kinidina, kakvu sadrži NUEDEXTA, nije poznat.
English: • very common (≥1/10)
Croatian: • vrlo često (≥1/10)
English: • Drug misuse and abuse
Croatian: • pogrešnu primjenu i zloporabu lijeka
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.
Croatian: • ako nakon uzimanja ovog lijeka razvijete simptome alergijske reakcije, kao što su oticanje grla ili jezika, otežano disanje, omaglica, vrućica, osip ili koprivnjača.
English: Other adverse reactions include ataxia, nystagmus, dystonia, blurred vision, and changes in muscle reflexes.
Croatian: Druge nuspojave uključuju ataksiju, nistagmus, distoniju, zamućen vid i promjene u refleksima mišića.
English: Plasma digoxin concentrations should be closely monitored in patients taking NUEDEXTA concomitantly, and the digoxin dose reduced, as necessary.
Croatian: U bolesnika koji istovremeno uzimaju NUEDEXTU, koncentracije plazmatskog digoksina treba pomno nadzirati, a dozu digoksina smanjiti prema potrebi.
English: If the clinical response with NUEDEXTA 15 mg/9 mg is adequate, the dose taken in weeks 2-4 should be continued.
Croatian: Ako je s lijekom NUEDEXTA 15 mg/9 mg postignut odgovarajući klinički odgovor, treba nastaviti s dozom koju je bolesnik uzimao od 2. do 4. tjedna.
English: Patients with a history of quinidine-, quinine-, mefloquine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome (see section 4.4).
Croatian: Bolesnici s trombocitopenijom izazvanom kinidinom, kininom, meflokinom, bolesnici s hepatitisom, depresijom koštane srži ili sindromom poput lupusa u anamnezi (vidjeti dio 4.4).
English: Neither dextromethorphan alone nor dextromethorphan/quinidine has been evaluated in patients with severe hepatic impairment.
Croatian: Ni sam dekstrometorfan ni kombinacija dekstrometorfan / kinidin nisu bili procijenjeni u bolesnika s teškim oštećenjem funkcije jetre.
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.
Croatian: Učinci supraterapijskih doza dekstrometorfana / kinidina (23 mg / 26 mg i 46 mg / 53 mg, za 7 uzastopnih doza) na produljenje QTc intervala procijenjeni su u 36 zdravih dobrovoljaca u randomiziranom, placebom kontroliranom dvostruko slijepom ispitivanju s ukrižavanjem lijeka uz dodatnu otvorenu pozitivnu kontrolnu skupinu (400 mg moksifloksacina).
English: The concomitant use of thioridazine is contraindicated (see section 4.3).
Croatian: Kontraindicirana je istovremena uporaba tioridazina (vidjeti dio 4.3).
English: Uncommon side effects (may affect up to 1 in 100 people)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 od 100 osoba)
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.
Croatian: Kinidin u koncentracijama do 5 µM nije inhibirao (<30% inhibicije) CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1 ili CYP3A4 u ljudskim mikrosomima.
English: The most common adverse reactions were mild to moderate nausea, dizziness, and headache.
Croatian: Najčešće nuspojave bile su blaga do umjerena mučnina, omaglica i glavobolja.
English: Drug interactions with desipramine and paroxetine have been studied in controlled clinical trials with a higher dose combination of dextromethorphan/quinidine (dextromethorphan 23 mg/ quinidine 26 mg) than in this medicinal product; study results are described below.
Croatian: Interakcije lijekova s desipraminom i paroksetinom ispitivane su u kontroliranim kliničkim ispitivanjima s kombiniranom dozom dekstrometorfana / kinidina (dekstrometorfan 23 mg / kinidin 26 mg) višom nego što je u ovom lijeku; rezultati ispitivanja opisani su u narednim odlomcima.
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.
Croatian: Srednje vrijednosti početnih rezultata na ljestvici CNS-LS iznosile su 19,8 u skupini NUEDEXTA 23 mg/9 mg, 21,0 u skupini NUEDEXTA 15 m/9 mg i 19,9 u skupini koja je primala placebo.
English: NUEDEXTA is used for the treatment of pseudobulbar affect (PBA) in adults.
Croatian: NUEDEXTA se primjenjuje za liječenje pseudobulbarnog afekta u odraslih.
English: • distorted sense of taste (dysgeusia), sleepiness (hypersomnia), muscle spasticity, fainting
Croatian: • promijenjen osjet okusa (disgeuzija), pospanost (hipersomnija), mišićna ukočenost, nesvjestica
English: NUEDEXTA should be discontinued immediately if thrombocytopenia occurs, unless the thrombocytopenia is clearly not drug-related.
Croatian: Ako se pojavi trombocitopenija, terapiju NUEDEXTOM treba odmah prekinuti, osim kad je jasno da trombocitopenija nije povezana s lijekom.
English: Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used to increase the systemic bioavailability of dextromethorphan.
Croatian: Kinidin sulfat specifični je inhibitor oksidacijskog metabolizma ovisnog o CYP2D6, koji služi za povećanje sistemske bioraspoloživosti dekstrometorfana.
English: • musculoskeletal stiffness, muscle pain (myalgia), neck pain, pain in the limbs
Croatian: • mišićno-koštana ukočenost, bol u mišićima (mialgija), bol u vratu, bol u udovima
English: • gall stones, increased bilirubin levels in the blood, abnormal liver function test
Croatian: • žučni kamenci, povišene razine bilirubina u krvi, poremećeni nalazi jetrene funkcije
English: Thioridazine, a CYP2D6 substrates that also prolong the QT interval is contraindicated (see section 4.3).
Croatian: Kontraindiciran je tioridazin, supstrat CYP2D6 koji također produljuje QT interval (vidjeti dio 4.3).
English: The quinidine component of NUEDEXTA serves to selectively inhibit CYP2D6-dependent oxidative metabolism of dextromethorphan, thus increasing dextromethorphan plasma concentrations.
Croatian: Komponenta kinidina u NUEDEXTI služi za selektivnu inhibiciju oksidacijskog metabolizma dekstrometorfana ovisnog o CYP2D6, čime se povećavaju koncentracije dekstrometorfana u plazmi.
English: The most commonly reported adverse reactions are gastrointestinal disorders (such as diarrhoea, nausea), nervous system disorders (such as dizziness, headache, somnolence) and fatigue.
Croatian: Najčešće prijavljivane nuspojave bile su gastrointestinalni poremećaji (kao što su proljev, mučnina). poremećaji živčanog sustava (kao što su omaglica, glavobolja, somnolencija) i umor.
English: Concomitant use of flecainide, chlorpromazine or haloperidol, CYP2D6 substrates that also prolong QT interval, requires caution (see section 4.4).
Croatian: Oprez zahtijeva istovremena upotreba flekainida, klorpromazina ili haloperidola, supstrata CYP2D6 koji također produljuju QT interval (vidjeti dio 4.4).
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.
Croatian: Dekstrometorfan u koncentracijama do 5 µM nije inhibirao (<20% inhibicije) nijedan od ispitanih izoenzima: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ili CYP3A4 u mikrosomima ljudske jetre.
English: • Co-administration of a strong CYP3A4 inhibitor
Croatian: • istovremenu primjenu snažnog inhibitora CYP3A4
English: PBA is a consequence of neurological diseases affecting the brain, or brain, injury and is defined by episodes of involuntary, uncontrollable emotional expressions of laughing and/or crying that are incongruous or disproportionate to the patient's emotional state or mood.
Croatian: Pseudobulbarni afekt je posljedica neurološke bolesti koja utječe na mozak, ili ozljede mozga, a definira se na temelju pojave epizoda nevoljnih izražavanja emocija, koje se ne mogu kontrolirati; smijeha i/ili plača koji nisu u skladu ili su u nerazmjeru s bolesnikovim emocionalnim stanjem ili raspoloženjem.
English: OUTER CARTON - NUEDEXTA 15 mg/9 mg capsules: PACK OF 13 CAPSULES
Croatian: KUTIJA - NUEDEXTA 15 mg/9 mg kapsule: PAKIRANJE OD 13 KAPSULA
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.
Croatian: Na temelju ispitivanja inhibicije prijenosnika, tijekom liječenja NUEDEXTOM ne očekuju se interakcije lijekova u odnosu na inhibiciju dekstrometorfana povezanu s P-gp, OATP1B1, OATP1B3, OCT2, OAT1, OAT3 ili BSEP.
English: • Epistaxis, Pharyngolaryngeal pain, Respiratory depression, Rhinorrhoea, Yawning
Croatian: Rijetko epistaksa, faringolaringealna bol, depresija disanja, rinoreja, zijevanje
English: Therefore, dosage adjustment is not required in patients with mild and moderate hepatic impairment, although additional monitoring for adverse reactions should be considered in patients with moderate hepatic impairment.
Croatian: Stoga u bolesnika s blagim i umjerenim oštećenjem funkcije jetre nije potrebna prilagodba doze, ali u bolesnika s umjerenim oštećenjem funkcije jetre potrebno je voditi računa o dodatnom nadzoru zbog mogućih nuspojava.
English: Dose adjustment is therefore not required in mild or moderate renal impairment.
Croatian: Stoga prilagodba doze nije potrebna u bolesnika s blagim ili umjerenim oštećenjem bubrega.
English: Gastric lavage may be of use.
Croatian: Može biti korisna lavaža želuca.
English: Brick red gelatin capsule, size 1, with “DMQ / 20-10” printed in white ink on the capsule.
Croatian: Ciglasto-crvena želatinska kapsula, veličine 1, s oznakom „DMQ / 20-10“ otisnutom bijelom tintom na kapsuli.
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.
Croatian: U ispitivanju kombinirane doze dekstrometorfana 23 mg / kinidina 26 mg dvaput na dan u 12 ispitanika s blagim ili umjerenim oštećenjem funkcije jetre (kako je pokazala Child-Pugh metoda; po 6 ispitanika za svako oštećenje) u usporedbi s 9 zdravih ispitanika (usklađenih s ispitanicima s oštećenjem po spolu, dobi i rasponu tjelesne težine), ispitanici s umjerenim oštećenjem funkcije jetre pokazali su slične vrijednosti dekstrometorfana za AUC i Cmax te klirens u usporedbi sa zdravim ispitanicima.
English: Patients should be warned about the potential for CNS-related effects like somnolence, dizziness and syncope or impaired vision (see section 4.8), and advised not to drive or operate machinery if these symptoms occur.
Croatian: NUEDEXTA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima Bolesnike treba upozoriti na moguće učinke na središnji živčani sustav, kao što su somnolencija, omaglica i sinkopa ili oštećen vid (vidjeti dio 4.8) te im savjetovati da ne upravljaju vozilima i ne rukuju strojevima, ako se u njih pojave ti simptomi.
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.
Croatian: Drugi znakovi i simptomi predoziranja mogu uključivati povraćanje, proljev, tinitus, gubitak sluha za visoke frekvencije, vrtoglavicu, zamućen vid, diplopiju, fotofobiju, glavobolju, konfuziju i delirij.
English: Two additional phase III studies were conducted using a higher dose combination of dextromethorphan 23 mg/quinidine 26 mg.
Croatian: Provedena su dva dodatna ispitivanja faze III s višom kombiniranom dozom dekstrometorfana 23 mg / kinidina 26 mg.
English: Approximately 7-8% of individuals of Caucasian descent, 3-6% of Black African descent, 2-3% of Arab descent and 1-2% of Asian descent generally lack the capacity to metabolize CYP2D6 substrates and are classified as Poor
Croatian: Nedostatak sposobnosti za metabolizaciju supstrata CYP2D6 uglavnom ima približno 7-8% bijelaca, 3-6% crnaca, 2-3% osoba arapskog podrijetla i 1-2% azijata pa su klasificirani kao slabi metabolizatori.
English: • you have a history of drug abuse.
Croatian: • ako ste u prošlosti uzimali droge.
English: Cardiac effects
Croatian: Učinci na srce
English: In patients with severe hepatic impairment (Child-Pugh C) or severe renal impairment (Creatinine Clearance < 30 mL/min/1.73m
Croatian: U bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C) ili teškim oštećenjem funkcije bubrega (klirens kreatinina <30 ml/min/1,73m2), potencijalne rizike povezane s primjenom ovog lijeka treba procijeniti u odnosu na medicinsku potrebu (vidjeti dio 5.2).
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.
Croatian: Svi ispitanici imali su klinički relevantne simptome pseudobulbarnog afekta, izražene kao rezultat na ljestvici CNS-LS od 13 ili više.
English: • nose bleeds, throat pain, excessively slow or shallow breathing (respiratory depression), runny nose, yawning
Croatian: • krvarenje iz nosa, bol u grlu, prekomjerno sporo ili plitko disanje (depresija disanja), curenje nosa, zijevanje
English: Quinidine is metabolized by CYP3A4.
Croatian: Kinidin se metabolizira putem enzima CYP3A4.
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.
Croatian: Pseudobulbarni afekt je neurološko stanje koje obilježavaju nevoljne epizode smijeha i/ili plača koje ne možete kontrolirati, a one ne odgovaraju Vašem emocionalnom stanju ili raspoloženju.
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.
Croatian: U ispitivanju kombinirane doze dekstrometorfana 23 mg / kinidina 26 mg dvaput na dan u 12 ispitanika s blagim (CLCR 50-80 ml/min) ili umjerenim (CLCR 30-50 ml/min) oštećenjem funkcije bubrega (za svako oštećenje 6 ispitanika) u usporedbi s 9 zdravih ispitanika (usklađenih po spolu, dobi i rasponu tjelesne težine s ispitanicima s oštećenjem), ispitanici su pokazali malu razliku u farmakokinetici kinidina ili dekstrometorfana u usporedbi sa zdravim ispitanicima.
English: Patients with renal and hepatic impairment
Croatian: Bolesnici s oštećenjem funkcije bubrega i jetre
English: • rare (≥1/10,000 to <1/1,000)
Croatian: • rijetko (≥1/10 000 i <1/1000)
English: Quinidine is metabolised by CYP3A4.
Croatian: Kinidin se metabolizira enzimom CYP3A4.
English: How to take NUEDEXTA
Croatian: Kako uzimati lijek NUEDEXTA
English: • common (≥1/100 to <1/10)
Croatian: • često (≥1/100 i <1/10)
English: Uncommon Anxiety
Croatian: Manje često anksioznost
English: • medicines used to treat various heart conditions, such as diltiazem, verapamil, digoxin,
Croatian: • lijekovi za liječenje raznih srčanih stanja, kao što su diltiazem, verapamil, digoksin, flekainid i beta blokatori (kao što je metoprolol)
English: Anorexia
Croatian: Rijetko anoreksija
English: The potential for dextromethorphan and quinidine to inhibit or induce cytochrome P450 in vitro were evaluated in human microsomes.
Croatian: Potencijal dekstrometorfana i kinidina da inhibiraju ili induciraju citokrom
English: CYP2D6 genotype
Croatian: Genotip CYP2D6
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.
Croatian: Ciglasto-crvena želatinska kapsula, veličine 1, s oznakom „DMQ / 30-10“ otisnutom bijelom tintom na kapsuli i tri bijele pruge oko tijela kapsule.
English: NUEDEXTA 23 mg/9 mg hard capsules
Croatian: NUEDEXTA 23 mg/9 mg tvrde kapsule
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.
Croatian: Podobni bolesnici bili su oni s dijagnozom pseudobulbarnog afekta definiranom epizodama nevoljnih emocionalnih ekspresija smijeha i/ili plača koje nisu mogli kontrolirati, a koje su u raskoraku ili nerazmjeru s njihovim emocionalnim stanjem ili raspoloženjem.
English: NUEDEXTA 15 mg/9 mg hard capsules
Croatian: NUEDEXTA 15 mg/9 mg tvrde kapsule
English: Dextromethorphan / quinidine has not been studied in patients with severe renal impairment.
Croatian: Dekstrometorfan / kinidin nije ispitivan u bolesnika s teškim oštećenjem funkcije bubrega.
English: • abnormally frequent daytime urination
Croatian: • abnormalno učestalo mokrenje tijekom dana
English: Paroxetine (CYP2D6 inhibitor and substrate)
Croatian: Paroksetin (inhibitor i supstrat CYP2D6)
English: Desipramine (CYP2D6 substrate)
Croatian: Desipramin (supstrat CYP2D6)
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.
Croatian: ≥65 godina) koji su primali dekstrometorfan 23 mg / kinidin 26 mg, otkrila je sličnu farmakokinetiku u ispitanika <65 godina i onih ≥65 godina.
English: Concomitant medicinal products that both prolong the QT interval and are primarily metabolised by CYP2D6 (see below) are of particular potential concern.
Croatian: Osobitu potencijalnu važnost imaju lijekovi koji se istovremeno uzimaju, a produljuju QT interval, a ujedno se metaboliziraju putem CYP2D6 (vidjeti niže).
English: Regardless of which strength of NUEDEXTA has been prescribed to you: • continue the treatment with: two capsules per day (one capsule every 12 hours).
Croatian: Bez obzira koja Vam je jačina lijeka NUEDEXTA propisana: • nastavite s terapijom:
English: CYP2D6 substrates
Croatian: Supstrati CYP2D6
English: How to store NUEDEXTA
Croatian: Kako čuvati lijek NUEDEXTA
English: • abnormal faeces, indigestion, inflammation of the lining of the stomach (gastritis), numbness and abnormal sensation in the mouth, rectal pain, dry tongue
Croatian: • neuobičajena stolica, loša probava, upala sluznice želuca (gastritis), utrnulost i poremećen osjet u ustima, bol završnog dijela debelog crijeva, suh jezik
English: Concomitant use of CYP2D6 substrates/inhibitors
Croatian: Istovremena uporaba supstrata / inhibitora CYP2D6
English: Strong and moderate CYP3A4 inhibitors should be avoided during treatment with NUEDEXTA.
Croatian: Za vrijeme terapije NUEDEXTOM potrebno je izbjegavati snažne i umjerene inhibitore CYP3A4.
English: Symptoms of serotonin syndrome include agitation, high blood pressure, restlessness, muscle spasms and twitching, high body temperature, excessive sweating, shivering, and tremor.
Croatian: Simptomi serotoninskog sindroma uključuju tjelesnu i psihičku uznemirenost (agitacija), visoki krvni tlak, nemir, mišićne grčeve i trzaje, visoku tjelesnu temperaturu, prekomjerno znojenje, tresavicu i nevoljno drhtanje.