FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients had previously responded to duloxetine during open-label duloxetine treatment (28 to 34 weeks) at a dose of 60 to 120 mg/day.
Croatian: Svi bolesnici su prethodno ostvarili odgovor na duloksetin tijekom otvorenog liječenja duloksetinom (28 do 34 tjedna) i to pri dnevnim dozama od 60 do 120 mg.
English: Your doctor may continue to give you Duloxetine Lilly when you are feeling better to prevent your depression or anxiety from returning
Croatian: Liječnik Vam može nastaviti propisivati Duloksetin Lilly i nakon što se počnete osjećati bolje, kako bi se spriječio povratak depresije ili tjeskobe.
English: The underlying mechanism and the clinical relevance are unknown.
Croatian: Mehanizam u podlozi te pojave kao ni njezin klinički značaj nisu poznati.
English: Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Croatian: Prekid uzimanja duloksetina (osobito kada se liječenje naglo prekida) često dovodi do pojave simptoma ustezanja.
English: Do not stop taking Duloxetine Lilly, or change your dose, without talking to your doctor.
Croatian: Nemojte prestati uzimati Duloksetin Lilly niti mijenjati dozu lijeka a da se prethodno niste posavjetovali sa svojim liječnikom.
English: No specific antidote is known for duloxetine but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered.
Croatian: Nije poznat specifični antidot za duloksetin, ali u slučaju pojave serotoninskog sindroma može se razmotriti specifično liječenje (primjerice ciproheptadinom i/ili regulacijom temperature).
English: Duloxetine Lilly may be taken with or without food.
Croatian: Duloksetin Lilly se može uzimati s hranom ili bez nje.
English: 1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.
Croatian: 1 Slučajevi konvulzija i tinitusa prijavljeni su i nakon prekida liječenja.
English: To help you remember to take Duloxetine Lilly, you may find it easier to take it at the same times every day.
Croatian: Možda ćete se lakše sjetiti da morate uzeti Duloksetin Lilly ako ga svakog dana budete uzimali u isto vrijeme.
English: Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
Croatian: Poznato je da bolesnici koji u anamnezi imaju događaje povezane sa samoubojstvom, ili oni koji su pokazivali značajan stupanj suicidalnih misli prije početka liječenja, imaju veći rizik od suicidalnih misli ili suicidalnog ponašanja te se moraju pažljivo nadzirati tijekom liječenja.
English: Excipient(s) with known effect:
Croatian: Pomoćne tvari s poznatim učinkom:
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with Duloxetine Lilly 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4 and 5.2).
Croatian: Međutim, kao i kod svih drugih lijekova, mora se s oprezom liječiti starije osobe, osobito kada se primjenjuje Duloksetin Lilly u dozi od 120 mg dnevno za liječenje velikog depresivnog poremećaja ili generaliziranog anksioznog poremećaja, za što su podaci ograničeni (vidjeti dijelove 4.4 i 5.2).
English: d. Paediatric population
Croatian: d. Pedijatrijska populacija
English: Abrupt discontinuation should be avoided.
Croatian: Prekid liječenja Nagli prekid liječenja mora se izbjegavati.
English: A flexible dose regimen was used in this study, to allow for slow dose escalation from 30 mg once daily to higher doses (maximum 120 mg once daily).
Croatian: U ovom se ispitivanju koristio fleksibilan režim doziranja kako bi se omogućilo polagano povećavanje doze s 30 mg jednom dnevno do viših doza (najviše 120 mg jednom dnevno).
English: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Croatian: Ako u bilo kojem trenutku pomislite na samoozljeđivanje ili samoubojstvo, odmah se javite svom liječniku ili idite u bolnicu.
English: Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Croatian: U kliničkim su ispitivanjima suicidalno ponašanje (pokušaji samoubojstva i suicidalne misli) i neprijateljsko ponašanje (prvenstveno agresija, protivljenje i bijes) uočeni češće u djece i adolescenata liječenih antidepresivima u odnosu na one koji su dobivali placebo.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom sukrazaizomaltaza ne bi smjeli uzimati ovaj lijek.
English: You should ask your doctor or pharmacist for advice.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet.
English: Tell your doctor if you do not start to feel better after this time.
Croatian: Obavijestite svoga liječnika ako se nakon toga razdoblja ne počnete osjećati bolje.
English: In patients with co-morbid major depressive disorder, the starting and maintenance dose is 60 mg once daily (please see also dosing recommendation above).
Croatian: U bolesnika s istodobno prisutnim velikim depresivnim poremećajem početna doza i doza održavanja je 60 mg jednom dnevno (molimo pogledajte i prethodno navedene preporuke za doziranje).
English: NN:
Croatian: NN: {broj}
English: − have liver disease
Croatian: − ako imate bolest jetre
English: Diabetic Peripheral Neuropathic Pain: As with other medicinal products with similar pharmacological action (antidepressants), isolated cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation.
Croatian: Bol kod dijabetičke periferne neuropatije: Kao i kod drugih lijekova sa sličnim farmakološkim djelovanjem (antidepresivi), prijavljeni su izolirani slučajevi suicidalnih misli i suicidalnog ponašanja tijekom liječenja duloksetinom ili ubrzo nakon prekida liječenja.
English: Contents of the pack and other information What Duloxetine Lilly contains
Croatian: Sadržaj pakiranja i druge informacije Što Duloksetin Lilly sadrži
English: Although no studies have investigated the association of PPHN to SNRI treatment, this potential risk cannot be ruled out with duloxetine taking into account the related mechanism of action (inhibition of the re-uptake of serotonin).
Croatian: Iako se ni u jednom ispitivanju nije ispitivala povezanost između PPHN-a i liječenja SNRI-ma, ne može se isključiti mogući rizik kod primjene duloksetina uzimajući u obzir mehanizam djelovanja (inhibicija ponovne pohrane serotonina).
English: Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic).
Croatian: Primjeri inhibitora MAO uključuju moklobemid (antidepresiv) i linezolid (antibiotik).
English: No dosage adjustment is recommended for elderly patients solely on the basis of age.
Croatian: Za starije osobe nije potrebno prilagođavati dozu isključivo na temelju dobi.
English: Other medicines and Duloxetine Lilly
Croatian: Drugi lijekovi i Duloksetin Lilly
English: Based upon the overlap in the range of clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.
Croatian: S obzirom na preklapanje raspona vrijednosti klirensa, razlike u farmakokinetici između spolova ne opravdavaju preporuku za primjenu niže doze u bolesnica.
English: The majority of cases of hyponatraemia were reported in the elderly, especially when coupled with a recent history of, or condition pre-disposing to, altered fluid balance.
Croatian: U većini slučajeva hiponatrijemija je prijavljena u starijih osoba, posebno kada je udružena s nedavnom anamnezom promjene ravnoteže tekućina ili s predisponirajućim stanjima za razvoj takvog poremećaja.
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.
Croatian: Nije bilo klinički značajnih razlika u izmjerenim vrijednostima QT, PR, QRS ni QTcB između bolesnika liječenih duloksetinom i onih koji su uzimali placebo.
English: • night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
Croatian: • noćno znojenje, koprivnjača, hladan znoj, osjetljivost na sunčevu svjetlost, povećana sklonost nastanku modrica
English: These usually begin at birth or within a few days of your baby being born.
Croatian: Oni se obično javljaju pri porodu ili unutar nekoliko dana od rođenja djeteta.
English: Duloxetine Lilly should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Duloksetin Lilly se u trudnoći smije uzimati samo ako moguća korist liječenja opravdava mogući rizik za plod.
English: In patients with insufficient response to 60 mg, escalation up to 90 mg or 120 mg may therefore be considered.
Croatian: U bolesnika s nedostatnim odgovorom na dozu od 60 mg može se stoga razmotriti povećanje doze do 90 mg ili 120 mg.
English: Pharmacotherapeutic group: psychoanaleptics, antidepressants, other antidepressants.
Croatian: Farmakoterapijska skupina: psihoanaleptici, antidepresivi, ostali antidepresivi.
English: Moderate liver disease (Child Pugh Class B) affected the pharmacokinetics of duloxetine.
Croatian: Umjereno teška bolest jetre (Child Pugh stadij B) utjecala je na farmakokinetiku duloksetina.
English: How to store Duloxetine Lilly Contents of the pack and other information
Croatian: Kako čuvati Duloksetin Lilly Sadržaj pakiranja i druge informacije
English: Despite this, your doctor may prescribe Duloxetine Lilly for patients under 18 because he/she decides that this is in their best interests.
Croatian: Ipak, Vaš liječnik može propisati Duloksetin Lilly bolesnicima mlađima od 18 godina ako procijeni da je to u njihovu najboljem interesu.
English: Caution is required in patients at increased risk for hyponatraemia, such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.
Croatian: Oprez je nužan u bolesnika s povećanim rizikom od hiponatrijemije, poput starijih osoba, bolesnika s cirozom, dehidriranih bolesnika ili bolesnika koji se liječe diureticima.
English: The co-administration of duloxetine (40 mg twice daily) increases steady state AUC of tolterodine (2 mg twice daily) by 71 %, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended.
Croatian: Istodobna primjena duloksetina (40 mg dvaput dnevno) povećava AUC tolterodina (2 mg dvaput dnevno) u stanju dinamičke ravnoteže za 71%, ali ne utječe na farmakokinetiku njegova aktivnog 5-hidroksil metabolita pa se prilagodba doze ne preporučuje.
English: If concomitant treatment with duloxetine and other serotonergic agents that may affect the serotonergic and/or dopaminergic neurotransmitter systems is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Croatian: Ako je istodobno liječenje duloksetinom i drugim serotoninergičkim lijekovima koji mogu utjecati na sustave serotoninergičke i/ili dopaminergičke neurotransmisije klinički neophodno, preporučuje se strogi nadzor bolesnika, osobito pri uvođenju lijeka i povećanju doze.
English: Cases of hypertensive crisis have been reported with duloxetine, especially in patients with pre-existing hypertension.
Croatian: Prijavljeni su slučajevi hipertenzivne krize kod primjene duloksetina, osobito u bolesnika s već postojećom hipertenzijom.
English: The pain inhibitory action of duloxetine is believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous system.
Croatian: Smatra se da je inhibitorno djelovanje duloksetina na bol rezultat potenciranja descendentnih puteva koji inhibiraju bol u središnjem živčanom sustavu.
English: Lactation did not influence duloxetine pharmacokinetics.
Croatian: Dojenje nije utjecalo na farmakokinetiku duloksetina.
English: • increased pressure in the eye (glaucoma)
Croatian: • povišen očni tlak (glaukom)
English: After consolidation of the antidepressive response, it is recommended to continue treatment for several months, in order to avoid relapse.
Croatian: Nakon što se postigne trajan antidepresivni odgovor, preporučuje se nastaviti liječenje još nekoliko mjeseci kako bi se izbjegao relaps.
English: It may make you feel sleepy or dizzy.
Croatian: Može izazvati pospanost ili omaglicu.
English: It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors.
Croatian: Slabo inhibira ponovnu pohranu dopamina i ne pokazuje značajan afinitet za histaminske, dopaminske, kolinergičke ni adrenergičke receptore.
English: When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish.
Croatian: Kada se uzimaju tijekom trudnoće, slični lijekovi (selektivni inhibitori ponovne pohrane serotonina) mogu povećati rizik od nastanka ozbiljnog stanja za bebu, zvanog trajna plućna hipertenzija novorođenčeta (PPHN), zbog koje dijete ubrzano diše i koža mu izgleda modra.
English: Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Croatian: Lijekovi koji izazivaju pospanost: Tu se ubrajaju lijekovi koje Vam je propisao liječnik, uključujući benzodiazepine, jake lijekove protiv bolova, antipsihotike, fenobarbital i antihistaminike.
English: The general toxicity profile of duloxetine in juvenile rats was similar to that in adult rats.
Croatian: Opći profil toksičnosti duloksetina u mladih štakora bio je sličan onome u odraslih štakora.
English: Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost pri razinama sustavne izloženosti (AUC) duloksetinu manjima od maksimalne kliničke izloženosti (vidjeti dio 5.3).
English: Elimination The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours).
Croatian: Poluvrijeme eliminacije duloksetina kreće se u rasponu od 8 do 17 sati (srednja vrijednost 12 sati).
English: During the 10-week acute treatment period, suicidal behaviours were reported (duloxetine 0/333 [0%], fluoxetine 2/225 [0.9%], placebo 1/220 [0.5%]).
Croatian: Tijekom 10-tjednog razdoblja akutnog liječenja prijavljena su suicidalna ponašanja (duloksetin 0/333 [0%], fluoksetin 2/225 [0,9%], placebo
English: Inducers of CYP1A2: Population pharmacokinetic analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.
Croatian: Induktori CYP1A2: Populacijske farmakokinetičke analize pokazale su da su u pušača koncentracije duloksetina u plazmi gotovo 50% niže nego u nepušača.
English: Major depressive disorder
Croatian: Veliki depresivni poremećaj
English: Two randomized, double-blind, parallel clinical trials were performed in 800 paediatric patients aged 7 to 17 years with major depressive disorder (see section 4.2).
Croatian: Provedena su dva randomizirana, dvostruko slijepa klinička ispitivanja s paralelnim skupinama, u kojima je sudjelovalo 800 pedijatrijskih bolesnika u dobi od 7 do 17 godina s velikim depresivnim poremećajem (vidjeti dio 4.2).
English: If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Croatian: Ako se nakon smanjenja doze ili prekida liječenja pojave nepodnošljivi simptomi, treba razmotriti nastavak liječenja prethodno propisanom dozom.
English: • falls (mostly in elderly people), fatigue
Croatian: • padovi (najčešće u starijih osoba), umor
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant
Croatian: Podaci iz kliničkih ispitivanja pokazali su povećan rizik od samoubilačkog ponašanja u odraslih koji su mlađi od 25 godina, a zbog psihijatrijskih stanja su liječeni antidepresivima.
English: The primary outcome measure was the weekly mean of 24-hour average pain, which was collected in a daily diary by patients on an 11-point Likert scale.
Croatian: Primarna mjera ishoda bila je tjedna srednja vrijednost 24-satnog prosjeka boli, koje su bolesnici svakodnevno bilježili u dnevnik prema Likertovoj ljestvici s 11 bodova.
English: • feeling the heart pumping in the chest,
Croatian: • osjećaj lupanja srca u prsnom košu
English: Hence, some patients that respond insufficiently to 60 mg may benefit from a higher dose.
Croatian: Stoga bi neki bolesnici s nedovoljnim odgovorom na dozu od 60 mg mogli imati koristi od povećanja doze.
English: Close supervision of patients and in particular those at high risk should accompany medicinal product therapy especially in early treatment and following dose changes.
Croatian: Mora se strogo nadzirati bolesnike, osobito one visokorizične, posebno na početku liječenja i nakon promjene doze.
English: Female mice receiving duloxetine for 2 years had an increased incidence of hepatocellular adenomas and carcinomas at the high dose only (144 mg/kg/day), but these were considered to be secondary to hepatic microsomal enzyme induction.
Croatian: ženki miševa koje su primale duloksetin tijekom 2 godine uočena je povećana incidencija hepatocelularnih adenoma i karcinoma, ali samo kod visokih doza (144 mg/kg/dan); no to se smatra posljedicom indukcije mikrosomalnih jetrenih enzima.
English: Monoamine oxidase inhibitors (MAOIs): You should not take Duloxetine Lilly if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Croatian: Inhibitore monoaminooksidaze (MAOI): Ne smijete uzimati Duloksetin Lilly ako uzimate ili ste nedavno (u posljednjih 14 dana) uzimali drugi antidepresiv koji se naziva inhibitorom monoaminooksidaze (MAOI).
English: Duloxetine Lilly increases the levels of serotonin and noradrenaline in the nervous system.
Croatian: Duloksetin Lilly povećava razinu serotonina i noradrenalina u živčanom sustavu.
English: Talk with your doctor about how long you should keep taking Duloxetine Lilly.
Croatian: Razgovarajte s liječnikom o tome koliko dugo trebate uzimati Duloksetin Lilly.
English: Make sure your midwife and/or doctor knows you are on Duloxetine Lilly.
Croatian: Budite sigurni da primalja i/ili liječnik znaju da uzimate Duloksetin Lilly.
English: Care should be taken if you drink alcohol while you are being treated with Duloxetine Lilly.
Croatian: Budite oprezni ako pijete alkohol dok se liječite lijekom Duloksetin Lilly.
English: However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or S-warfarin.
Croatian: Međutim, istodobna primjena duloksetina s varfarinom u stanju dinamičke ravnoteže u zdravih dobrovoljaca, u okviru kliničkog farmakološkog ispitivanja, nije rezultirala klinički značajnom promjenom INR-a u odnosu na početne vrijednosti, kao ni farmakokinetike
English: Your doctor should decide whether you can take Duloxetine Lilly with other medicines.
Croatian: Liječnik mora donijeti odluku o tome smijete li uzimati Duloksetin Lilly s drugim lijekovima.
English: Duloxetine Lilly may cause a sensation of restlessness or an inability to sit or stand still.
Croatian: Duloksetin Lilly može izazvati osjećaj nemira ili nemogućnost mirnog sjedenja ili stajanja.
English: Each capsule may contain up to 56 mg sucrose.
Croatian: Jedna kapsula može sadržavati do 56 mg saharoze.
English: For generalised anxiety disorder:
Croatian: Za generalizirani anksiozni poremećaj:
English: However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.
Croatian: Međutim, većina čestih nuspojava bila je blaga do umjerena, obično se javljala na početku liječenja te se većinom povukla čak i uz nastavak liječenja.
English: This is most likely to occur within the first few weeks of treatment.
Croatian: To se najčešće pojavljuje u prvih nekoliko tjedana liječenja.
English: In studies of up to 9 months an overall mean decrease of 1% in height percentile (decrease of 2% in children (7-11 years) and increase of 0.3% in adolescents (12-17 years)) was observed in duloxetinetreated paediatric patients (see section 4.4).
Croatian: U ispitivanjima u trajanju do 9 mjeseci, u pedijatrijskih bolesnika liječenih duloksetinom primijećena je ukupna srednja vrijednost smanjenja percentila visine za 1% (smanjenje za 2% u djece (7-11 godina) i porast od 0,3% u adolescenata (12-17 godina)) (vidjeti dio 4.4).
English: • trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience orgasm, unusual dreams
Croatian: • tegobe sa spavanjem, uznemirenost, smanjena seksualna želja, tjeskoba, poteškoće ili nemogućnost postizanja orgazma, neuobičajeni snovi
English: When stopping treatment with Duloxetine Lilly the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Croatian: Kada se liječenje lijekom Duloksetin Lilly prekida, doza se mora smanjivati postupno tijekom razdoblja od najmanje jednog do dva tjedna kako bi se smanjio rizik od pojave simptoma ustezanja (vidjeti dijelove 4.4 i 4.8).
English: Subsequently, over the four- to six-month extension period, patients on average trended toward recovery to their expected baseline weight percentile based on population data from age- and gender-matched peers.
Croatian: Nakon toga je, tijekom četiri do šest mjeseci produžetka ispitivanja, u tih bolesnika u prosjeku primijećena tendencija prema oporavku na početni percentil tjelesne težine koji se očekivao na temelju populacijskih podataka prikupljenih u vršnjaka istog spola.
English: Duloxetine is administered as a single enantiomer.
Croatian: Duloksetin se primjenjuje u obliku samo jednog enantiomera.
English: The amount of duloxetine in breast milk is approximately 7 µg/day while on 40 mg twice daily dosing.
Croatian: Količina duloksetina u majčinom mlijeku iznosi približno 7 µg/dan ako majke uzimaju dozu od 40 mg dva puta dnevno.
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Croatian: Također, morate znati da bolesnici mlađi od 18 godina koji se liječe ovom skupinom lijekova imaju povećan rizik od pojave nuspojava poput pokušaja samoubojstva, misli o samoubojstvu i neprijateljskog ponašanja (prvenstveno agresivnosti, protivljenja i bijesa).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/ risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,