FrancophonIA/ELRC3.0 huggingface dataset:
English: telithromycin, erythromycin and rifampicin
Croatian: telitromicin, eritromicin i rifampicin
English: In the pre and post-natal developmental study, slight developmental delay was seen in offspring at the mid- and high-doses.
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja, ustanovljeno je neznatno razvojno zaostajanje potomstva pri srednjim i visokim dozama.
English: Interaction with NUEDEXTA may result in an increased effect on QT interval (see sections 4.4 and 4.5).
Croatian: Posljedica interakcije s NUEDEXTOM može biti povećani učinak na QT interval (vidjeti dijelove 4.4 i 4.5).
English: However, cases of dextromethorphan abuse have been reported, predominately in adolescents.
Croatian: Međutim, slučajevi zlouporabe dekstrometorfana prijavljeni su uglavnom u adolescenata.
English: This may lead to lower, potentially subtherapeutic plasma concentrations of dextromethorphan and decreased efficacy of NUEDEXTA.
Croatian: To može dovesti do nižih, potencijalno subterapijskih plazmatskih koncentracija dekstrometorfana i smanjene djelotvornosti lijeka NUEDEXTA.
English: • medicines used to treat bacterial infections, including tuberculosis, containing clarithromycin,
Croatian: • lijekovi protiv bakterijskih infekcija, uključujući tuberkulozu, koji sadrže klaritromicin,
English: • if you have a heart problem called “complete heart block” or “long QT syndrome” or have had a problem with your heart called “torsades de pointes”.
Croatian: • ako imate srčanu tegobu pod nazivom „potpuni srčani blok“ ili „sindrom dugog QT intervala“ ili ste imali tegobu sa srcem pod nazivom „torsades de pointes“.
English: NUEDEXTA may be taken without regard to meals as food does not affect the exposure of dextromethorphan and quinidine significantly.
Croatian: NUEDEXTA se može uzimati bez obzira na obroke, jer hrana ne utječe značajno na izloženost dekstrometorfanu i kinidinu.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije nego uzmete ovaj lijek.
English: Depending on the severity of your problems, your doctor may carefully consider whether this medicine is suitable for you and monitor you more closely for potential side effects.
Croatian: Ovisno o težini Vaših tegoba, liječnik može pažljivo razmotriti je li ovaj lijek za Vas prikladan i pomnije Vas motriti zbog mogućih nuspojava.
English: Drugs that delay elimination of quinidine (cimetidine, carbonic anhydrase inhibitors, thiazide diuretics) should be withdrawn unless absolutely required.
Croatian: Lijekove koji odgađaju eliminaciju kinidina (cimetidin, inhibitori ugljične anhidraze, tijazidni diuretici) treba ukinuti, osim kad su neosporno potrebni.
English: A list of all other side effects is provided below:
Croatian: Popis drugih nuspojava nalazi se ispod:
English: • From the eighth day of treatment onwards: two capsules per day, one in the morning and one in the evening, 12 hours apart.
Croatian: • od osmog dana liječenja nadalje: dvije kapsule na dan, jedna ujutro i jedna uvečer, s razmakom od 12 sati.
English: Patients should be monitored for worsening clinical condition in myasthenia gravis and other conditions that may be adversely affected by anticholinergic effects.
Croatian: Bolesnike treba nadzirati zbog mogućeg pogoršanja kliničkog stanja u miasteniji gravis i drugim stanjima na koja mogu loše utjecati antikolinergički učinci.
English: Dextromethorphan may increase the risk of serotonin syndrome, and this risk is increased by overdose, particularly if taken with other serotonergic agents, SSRIs or tricyclic antidepressants.
Croatian: Dekstrometorfan može povećati rizik od serotoninskog sindroma, a taj se rizik povećava predoziranjem, posebice ako je lijek uzet s drugim serotonergičnim agensima, SSRI ili tricikličkim antidepresivima.
English: A population pharmacokinetic analysis revealed similar pharmacokinetics in patients <65 years and those ≥65 years of age (see section 5.2).
Croatian: Analiza populacijske farmakokinetike pokazala je sličnu farmakokinetiku u bolesnika u dobi <65 godina i onih ≥65 godina (vidjeti dio 5.2).
English: Due to the possibility of dextromethorphan abuse, physicians should evaluate patients for a history of drug abuse, and observe such patients closely for signs of misuse or abuse (e.g. development of tolerance, increases in dose, drug-seeking behaviour).
Croatian: Zbog moguće zlouporabe dekstrometorfana, liječnici trebaju procijeniti bolesnika s obzirom na zlouporabu droga u anamnezi te pažljivo pratiti takve bolesnike zbog znakova pogrešne upotrebe ili zlouporabe (npr. razvoj tolerancije, povećanje doze, ovisničko ponašanje).
English: If NUEDEXTA and paroxetine are prescribed concomitantly, the initial dose of paroxetine should be reduced.
Croatian: Ako je propisana istovremena primjena lijeka NUEDEXTA i paroksetina, potrebno je smanjiti početnu dozu paroksetina.
English: • heart problems, such as slow, fast or irregular heart beat, or altered results during an electrocardiogram (ECG - QT prolongation)
Croatian: • srčane tegobe kao što su spori, brzi ili nepravilni srčani otkucaji ili promijenjeni rezultati dobiveni snimanjem elektrokardiograma (EKG - produljenje QT intervala)
English: Caution should be used when this medicinal product is taken in combination with alcohol or other centrally acting medicinal products that might increase the risk of adverse reactions such as somnolence and dizziness.
Croatian: Potreban je oprez kada se ovaj lijek uzima u kombinciji s alkoholom ili drugim lijekovima s centralnim djelovanjem, koji bi mogli povećati rizik od nuspojava, kao što su somnolencija i omaglica.
English: What NUEDEXTA contains
Croatian: Što NUEDEXTA sadrži
English: Evaluation and treatment of overdose is based on experience with the individual components, dextromethorphan and quinidine.
Croatian: Procjena i liječenje predoziranja temelji se na iskustvu s pojedinačnim komponentama, dekstrometorfanom i kinidinom.
English: When taking two capsules within 24 hours, the recommended dose interval is 12 hours.
Croatian: Kada se uzimaju dvije kapsule unutar 24 sata, preporučeni dozni interval iznosi 12 sati.
English: • if you take a medicine called thioridazine, which is used for mental illness but can also affect the heart.
Croatian: • ako uzimate lijek pod nazivom tioridazin, koji se koristi pri duševnoj bolesti, ali može također utjecati na srce.
English: Please tell your doctor if you are taking any of the following medicines, as your doctor will closely monitor you for side effects.
Croatian: Molimo obavijestite liječnika ako uzimate neki od ovih lijekova jer će Vas liječnik pažljivo pratiti zbog nuspojava.
English: • you have had at any time a serious condition called “serotonin syndrome”, which can be caused by certain medicines e.g. antidepressants.
Croatian: • ako ste ikada prije imali ozbiljnu bolest koja se naziva „serotoninski sindrom“, a mogu je izazvati određeni lijekovi, npr. antidepresivi.
English: Nuedexta is suitable only for the treatment of PBA, not for other causes of emotional lability.
Croatian: NUEDEXTA je prikladna samo za liječenje pseudobulbarnog afekta, ali ne i drugih uzroka emocionalne nestabilnosti.
English: Hypokalemia and hypomagnesemia should be corrected prior to initiation of therapy, and serum potassium and serum magnesium levels should be monitored during treatment if clinically indicated.
Croatian: Hipokalijemiju i hipomagnezijemiju treba ispraviti prije započinjanja terapije, a koncentracije kalija i magnezija u serumu treba nadzirati za vrijeme liječenja, ako je klinički indicirano.
English: The European Medicines Agency has waived the obligation to submit the results of studies with NUEDEXTA in all subsets of the paediatric population in PBA (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka NUEDEXTA u svim podskupinama pedijatrijske populacije u pseudobulbarnom afektu (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • Educational material for Healthcare Professionals (HCPs)
Croatian: • edukacijski materijal za zdravstvene djelatnike
English: The pharmacokinetics of dextromethorphan/quinidine have not been investigated systematically in elderly subjects (aged >65 years) although such subjects were included in the clinical programme (14% ≥65 years, 2% ≥75 years).
Croatian: Farmakokinetike dekstrometorfana / kinidina nisu sustavno ispitivane u starijih ispitanika (u dobi >65 godina) iako su takvi ispitanici bili uključeni u klinički program (14% ≥65 godina, 2% ≥75 godina).
English: There was no significant difference in the plasma concentrations of dextromethorphan and dextrorphan before and after the administration of memantine, and there was no effect on the plasma concentrations of memantine before and after the administration of dextromethorphan/quinidine.
Croatian: Nije bilo značajne razlike u koncentracijama dekstrometorfana i dekstrorfana u plazmi prije i poslije primjene memantina i nije bilo učinka na koncentraciju memantina u plazmi prije i poslije primjene dekstrometorfana / kinidina.
English: As this medicinal product may cause foetal harm, it is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Budući da ovaj lijek može prouzročiti oštećenje fetusa, ne preporučuje se tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Quinidine inhibited CYP2D6 with a half maximal inhibitory concentration (IC50) of less than 0.05 µM.
Croatian: Kinidin je inhibirao CYP2D6 uz pola maksimalne inhibitorne koncentracije (IC50) od manje od 0,05 µM.
English: Most cases remit when quinidine is withdrawn.
Croatian: U većini se slučajeva povuče kada se prekine terapija kinidinom.
English: What NUEDEXTA looks like and contents of the pack
Croatian: Kako NUEDEXTA izgleda i sadržaj pakiranja
English: • heart attack (myocardial infarction), heart palpitations
Croatian: • srčani napadaj (infarkt miokarda), srčane palpitacije
English: Medicinal products that are dependent on CYP2D6 metabolism, especially those with a relatively narrow therapeutic index, should generally be avoided during treatment with NUEDEXTA, and patients must be instructed accordingly.
Croatian: Lijekove koji ovise o metabolizmu CYP2D6, osobito one s relaitvno uskim terapijskim indeksom, treba općenito izbjegavati za vrijeme terapije NUEDEXTOM, a bolesnicima treba dati upute u skladu s tim.
English: • Serotonin syndrome
Croatian: • serotoninski sindrom
English: Methods as to acidify the urine and dialysis are of no demonstrated benefit.
Croatian: Metode zakiseljavanja mokraće i dijaliza nisu pokazale korist.
English: Quinidine is an inhibitor of P-glycoprotein.
Croatian: Kinidin je inhibitor P-glikoproteina.
English: Administration of activated charcoal in conventional dose of 1 g/kg, administered every 2 to 6 hours as a slurry with 8 mL/kg of tap water may enhance the systemic elimination of quinidine; this measures should be avoided if an ileus is present.
Croatian: Primjena aktivnog ugljena u konvencionalnoj dozi od 1 g/kg svakih 2 do 6 sati u polutekućem obliku, uz 8 ml/kg vode iz slavine, može povećati sistemsku eliminaciju kinidina; ovu mjeru treba izbjegavati ako postoji ileus.
English: Do not take NUEDEXTA if you have taken these antidepressants during the last two weeks and allow at least 14 days after stopping NUEDEXTA before starting an MAOI.
Croatian: Ne uzimajte lijek NUEDEXTA ako ste uzimali te antidepresive u protekla dva tjedna i pustite da prođe najmanje 14 dana otkako ste prekinuli terapiju lijekom NUEDEXTA prije nego što počnete uzimati inhibitore monoaminoksidaze.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Dextromethorphan hydrobromide is the pharmacologically active ingredient that acts on the central nervous system (CNS).
Croatian: Dekstrometorfan hidrobromid je farmakološki aktivni sastojak koji djeluje na središnji živčani sustav (SŽS).
English: The recommended dose titration schedule is outlined below:
Croatian: Titracija preporučene doze provodi se prema sljedećem rasporedu:
English: There are no or limited amount of data from the use of NUEDEXTA in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni lijeka NUEDEXTA u trudnica ograničeni.
English: • if you have a history of a liver disease (hepatitis) caused by quinidine
Croatian: • ako ste u prošlosti imali bolest jetre (hepatitis) uzrokovanu kinidinom.
English: A review of the patient's current medicines is an essential part of the evaluation of patients for whom treatment with NUEDEXTA is proposed.
Croatian: Provjera lijekova koje bolesnik trenutačno uzima važan je dio procjene bolesnika kojima se predlaže terapija NUEDEXTOM.
English: Dextromethorphan may increase the risk of serotonin syndrome (see Warnings and precautions and Possible side effects).
Croatian: Dekstrometorfan može povećati rizik od serotoninskog sindroma (vidjeti Upozorenja i mjere opreza te Moguće nuspojave).
English: As NUEDEXTA may cause harm to your unborn baby, its use is not recommended when you are pregnant or if you are a women of childbearing potential not using contraception.
Croatian: Budući da NUEDEXTA može naškoditi Vašem nerođenom djetetu, upotreba tog lijeka ne preporučuje kada ste trudni ili ako ste žena reproduktivnog potencijala koja ne rabi kontracepciju.
English: The exact mechanism by which dextromethorphan exerts therapeutic effects in patients with pseudobulbar affect is unknown.
Croatian: Točni mehanizam kojim dekstrometorfan ostvaruje terapijski učinak u bolesnika s pseudobulbarnim afektom nije poznat.
English: • very rare (<1/10,000)
Croatian: • vrlo rijetko (<1/10 000)
English: Serious adverse reactions have been reported for NUEDEXTA; these are muscle spasticity, respiratory depression and decreased oxygen saturation in the blood.
Croatian: Za lijek NUEDEXTA prijavljene su ozbiljne nuspojave; to su mišićna spastičnost, depresija disanja i smanjena zasićenost krvi kisikom.
English: Ten patients discontinued study treatment due to ADRs, one of these patients due to a serious ADR (worsening muscle spasticity).
Croatian: Deset bolesnika prekinulo je liječenje u sklopu ispitivanja zbog nuspojava na lijek, jedan od tih bolesnika zbog ozbiljne nuspojave na lijek (pogoršanje mišićne spastičnosti).
English: Use in older persons No special dose adjustment of NUEDEXTA is required in older patients.
Croatian: U starijih bolesnika nije potrebna posebna prilagodba doze lijeka NUEDEXTA.
English: • Quinidine increases the amount of dextromethorphan in your body, by blocking the breakdown of dextromethorphan by the liver.
Croatian: • Kinidin povećava količinu dekstrometorfana u Vašem tijelu time što blokira razgradnju dekstrometorfana u jetri.
English: Approximately 74% were Caucasian, 4% were Black, 1% were Asian and 19% were of Hispanic origin.
Croatian: Otprilike njih 74% bili su bijelci, 4% crnci, 1% ispitanika bili su azijati a 19% latinoameričkog podrijetla.
English: 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.
Croatian: 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.
English: • Dextromethorphan acts on the brain.
Croatian: • Dekstrometorfan djeluje na mozak.
English: Blister of a PVC based clear film with aluminium foil seal.
Croatian: Blister s prozirnim filmom na PVC podlozi, zatvoren aluminijskom folijom.
English: Drug abuse and dependence
Croatian: Zloporaba lijeka i ovisnost
English: • excessively slow or shallow breathing (respiratory depression) and/or turning blue.
Croatian: • prekomjerno sporo ili plitko disanje (depresija disanja) i/ili pojava plave boje kože.
English: • thioridazine, a medicine used in the treatment of schizophrenia and psychosis, that may affect the heart,
Croatian: • tioridazin, lijek koji se koristi u liječenju shizofrenije i psihoze, a može utjecati na srce,
English: The patient alert card should be provided to all patients with instructions to carry it on them at all times.
Croatian: Karticu s upozorenjima za bolesnika trebali bi dobiti svi bolesnici uz naputak da je uvijek nose sa sobom.
English: • you have a condition called myasthenia gravis (an autoimmune neuromuscular disease that causes muscle weakness and fatigability).
Croatian: • ako imate bolest koja se naziva mijastenija gravis (autoimuna neuromišićna bolest koja uzrokuje mišićnu slabost i brzo umaranje).
English: 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.
Croatian: 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.
English: • bone fractures (skeletal injury)
Croatian: • prijelomi kostiju (ozljede kostiju)
English: 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.
Croatian: 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.
English: 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:
Croatian: 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:
English: Dextromethorphan is a low-affinity uncompetitive NMDA antagonist and sigma-1 receptor agonist that has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence.
Croatian: 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.
English: • Cardiac effects (QT prolongation) including pre-existing cardiovascular conditions and clinically significant electrolyte imbalances
Croatian: • učinke na aktivnost srca (produljenje QT intervala) uključujući prethodne kardiovaskularne bolesti i klinički značajne neravnoteže elektrolita
English: Mild to moderate hepatic impairment had little effect on quinidine pharmacokinetics.
Croatian: Blago do umjereno oštećenje funkcije jetre imalo je mali učinak na farmakokinetiku kinidina.
English: Do not use this medicine after the expiry date which is stated on the bottle, blister and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici, blisteru i kutiji iza Rok valjanosti ili EXP.
English: Dextromethorphan is a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist.
Croatian: Dekstrometorfan je agonist receptora sigma-1 i nekompeticijski antagonist receptora NMDA.
English: • medicines used to treat schizophrenia and other psychotic disorders, such as haloperidol,
Croatian: • lijekovi za liječenje shizofrenije i drugih psihotičnih poremećaja, kao što su haloperidol,
English: Likewise, this medicinal product should not be restarted in sensitised patients, because more rapid and more severe thrombocytopenia than the original episode can occur.
Croatian: 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.
English: What you need to know before you take NUEDEXTA
Croatian: Što morate znati prije nego počnete uzimati lijek NUEDEXTA
English: There are currently limited data on the magnitude of the effect of CYP3A4 inhibitors on the pharmacokinetic parameters of quinidine and its metabolites, including the potential for accumulation at steady state.
Croatian: 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.
English: The adverse reactions considered at least possibly related to treatment with NUEDEXTA in the placebo-controlled and the open-label extension phase of the above mentioned clinical study are listed below by body system organ class and frequency.
Croatian: 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.
English: The treatment of cardiac effects (haemodynamically unstable polymorphic ventricular tachycardia (including torsades de pointes)) is either immediate cardioversion or immediate overdrive pacing.
Croatian: Liječenje srčanih učinaka (hemodinamički nestabilna polimorfna ventrikularna tahikardija (uključujući torsades de pointes)) uključuje ili trenutnu kardioverziju ili trenutnu normalizaciju ritma povećanjem frekvencije (overdrive pacing).
English: Treatment of dextromethorphan overdose should be directed at symptomatic and supportive measures.
Croatian: Liječenje predoziranja dekstrometorfanom treba biti usmjereno na simptomatske i potporne mjere.
English: 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.
Croatian: 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.
English: Day 10
Croatian: 10. dan
English: 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.
Croatian: 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.
English: The maximum mean (95% upper confidence bound) difference from placebo after baseline correction was 10.2 (12.6) ms.
Croatian: Maksimalna prosječna razlika (95% gornje granice pouzdanosti) u odnosu na placebo nakon korekcije početnih vrijednosti bila je 10,3 (12,6) ms.
English: Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.
Croatian: 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.
English: In vitro CYP P450 interaction studies
Croatian: Ispitivanja interakcije CYP P450 in vitro
English: There is no relevant use of NUEDEXTA in the paediatric population for the symptomatic treatment of pseudobulbar affect.
Croatian: Nema relevantne primjene lijeka NUEDEXTA u pedijatrijske populacije za simptomatsko liječenje pseudobulbarnog afekta.