FrancophonIA/ELRC3.0 huggingface dataset:
English: They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Croatian: Obično se javljaju unutar prvih nekoliko dana nakon prekida liječenja, ali je bilo i vrlo rijetkih prijava ovih simptoma u bolesnika koji su nehotično propustili dozu lijeka.
English: Duloxetine Lilly with food, drink and alcohol
Croatian: Duloksetin Lilly s hranom, pićem i alkoholom
English: DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Croatian: NEMOJTE prestati uzimati kapsule a da se prethodno niste posavjetovali sa svojim liječnikom, čak i ako se osjećate bolje.
English: • large pupils (the dark centre of the eye), problems with eyesight
Croatian: • proširene zjenice (tamno središte oka), poteškoće s vidom
English: The following are reasons why Duloxetine Lilly may not be suitable for you.
Croatian: U nastavku su navedeni razlozi zbog kojih Duloksetin Lilly možda nije prikladan za Vas.
English: If you take Duloxetine Lilly near the end of your pregnancy, your baby might have some symptoms when it is born.
Croatian: Ako uzimate Duloksetin Lilly pred kraj trudnoće, Vaša beba može imati određene simptome kada se rodi.
English: • generalised anxiety disorder (chronic feeling of anxiety or nervousness)
Croatian: • generaliziranog anksioznog poremećaja (kroničnog osjećaja tjeskobe ili nervoze)
English: 3 See section 4.4.
Croatian: 3 Vidjeti dio 4.4.
English: Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11 %).
Croatian: Hrana produljuje vrijeme do postizanja vršne koncentracije sa 6 na 10 sati te donekle smanjuje opseg apsorpcije (za oko 11%).
English: Duloxetine is approximately 96% bound to human plasma proteins.
Croatian: Distribucija Približno 96% duloksetina veže se za ljudske proteine plazme.
English: The effect in some patients was apparent in the first week of treatment.
Croatian: U nekih je bolesnika učinak bio vidljiv u prvom tjednu liječenja.
English: However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up-titrations.
Croatian: Međutim, nema kliničkih dokaza koji bi upućivali na to da bi bolesnici koji ne reagiraju na početnu preporučenu dozu mogli imati koristi od povećanja doze.
English: Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
Croatian: Ženama treba savjetovati da obavijeste svog liječnika ako tijekom liječenja zatrudne ili namjeravaju zatrudnjeti.
English: Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Croatian: Ovi su simptomi uglavnom samoograničavajući te se povuku unutar 2 tjedna, iako kod nekih osoba mogu dulje trajati (2-3 mjeseca ili dulje).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika traži se da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: If your baby has any of these symptoms when it is born, or you are concerned about your baby's health, contact your doctor or midwife who will be able to advise you.
Croatian: Ako Vaša beba ima bilo koji od ovih simptoma kada se rodi, ili ste zabrinuti zbog bebina zdravlja, obratite se liječniku ili primalji koji će Vas savjetovati.
English: Manufacturer: Lilly S.A., Avda.
Croatian: Proizvođač: Lilly S.A., Avda.
English: Therefore, in patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment.
Croatian: Stoga se u bolesnika s poznatom hipertenzijom i/ili drugom srčanom bolešću preporučuje praćenje krvnog tlaka, osobito tijekom prvog mjeseca liječenja.
English: You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself - are a young adult.
Croatian: Veća je vjerojatnost da će Vam se pojaviti takve misli: - ako ste prethodno razmišljali o samoubojstvu ili samoozljeđivanju - ako ste mlađa odrasla osoba.
English: Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
Croatian: Nemojte početi ni prestati uzimati bilo koji lijek, uključujući i one koje ste nabavili bez recepta i biljne lijekove, prije nego što to provjerite sa svojim liječnikom.
English: SN:
Croatian: SN: {broj}
English: You should also tell your doctor if you are taking any of the following:
Croatian: Morate reći liječniku i ako uzimate neki od sljedećih lijekova:
English: You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.
Croatian: Može Vam koristiti ako kažete članu obitelji ili bliskom prijatelju da ste depresivni ili imate anksiozni poremećaj i zamolite ih da pročitaju ovu uputu.
English: This may be due to the noradrenergic effect of duloxetine.
Croatian: To može biti posljedica noradrenergičkog učinka duloksetina.
English: 7 Not statistically significantly different from placebo.
Croatian: Ne razlikuje se statistički značajno od placeba.
English: In addition, these conditions may be co-morbid with major depressive disorder.
Croatian: Nadalje, ta stanja mogu biti prisutna istodobno s velikim depresivnim poremećajem.
English: Response to treatment should be evaluated after 2 months.
Croatian: Terapijski odgovor mora se ocijeniti nakon 2 mjeseca.
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Duloxetine Lilly, you should see your doctor.
Croatian: Navedeni lijekovi povećavaju rizik od nuspojava; ako uočite bilo koji neuobičajen simptom dok uzimate neki od ovih lijekova zajedno s lijekom Duloksetin Lilly, morate se javiti svom liječniku.
English: The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the maternal dose (see section 5.2).
Croatian: Procijenjena dnevna doza u dojenčadi izražena u mg/kg iznosi približno 0,14% majčine doze (vidjeti dio 5.2).
English: In people with diabetic neuropathic pain it can take some weeks before you feel better.
Croatian: Osobama koje pate od boli kod dijabetičke neuropatije može biti potrebno nekoliko tjedana prije nego što se počnu osjećati bolje.
English: Children and adolescents under 18 years of age with depression treated with this medicine had some weight loss when they first start taking this medicine.
Croatian: Djeca i adolescenti mlađi od 18 godina koji boluju od depresije i liječe se ovim lijekom na početku su liječenja izgubili na tjelesnoj težini.
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms (see section 5.1).
Croatian: Ako se liječnik, u slučaju kliničke potrebe, ipak odluči za liječenje ovim lijekom, bolesnika je potrebno pomno pratiti zbog moguće pojave suicidalnih simptoma (vidjeti dio 5.1).
English: If your doctor has prescribed Duloxetine Lilly for a patient under 18 and you want to discuss this, please go back to your doctor.
Croatian: Ako je liječnik propisao Duloksetin Lilly bolesniku mlađem od 18 godina i želite o tome razgovarati, vratite se svom liječniku.
English: In animal studies, duloxetine had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity.
Croatian: U ispitivanjima na životinjama, duloksetin nije imao učinak na plodnost u muškaraca, a učinci u žena bili su primjetni samo pri dozama koje su izazivale toksičnost za majku.
English: Convulsion1
Croatian: konvulzije1
English: Patients meeting diagnostic criteria for major depressive disorder were excluded from these trials.
Croatian: Bolesnici koji su zadovoljavali dijagnostičke kriterije za veliki depresivni poremećaj nisu bili uključeni u ova ispitivanja.
English: Polyvinylchloride (PVC), polyethylene (PE), and polychlorotrifluoroethylene (PCTFE) blister sealed with an aluminium foil.
Croatian: Polivinilklorid (PVC), polietilen (PE), i poliklorotrifluoroetilen (PCTFE) blister zatvoren aluminijskom folijom.
English: Do not drive or use any tools or machines until you know how Duloxetine Lilly affects you.
Croatian: Nemojte voziti niti rukovati alatima ni strojevima dok ne vidite kako će Duloksetin Lilly utjecati na Vas.
English: The dose may be adjusted up to 120 mg a day based on your response to Duloxetine Lilly.
Croatian: Doza se može povisiti do 120 mg na dan, ovisno o Vašem odgovoru na Duloksetin Lilly.
English: Major Depressive Disorder and Generalised Anxiety Disorder: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Croatian: Veliki depresivni poremećaj i generalizirani anksiozni poremećaj: Depresija je povezana s povećanim rizikom od suicidalnih misli, samoozljeđivanja i samoubojstva (događaji povezani sa samoubojstvom).
English: • problems getting an erection, changes in ejaculation
Croatian: • otežano postizanje erekcije, promjene u ejakulaciji
English: • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Croatian: • upala krvnih žila u koži (kutani vaskulitis)
English: The majority of cases have occurred either at birth or within a few days of birth.
Croatian: Većina slučajeva javila se pri porodu ili unutar nekoliko dana nakon rođenja.
English: Physicians should encourage patients to report any distressing thoughts or feelings at any time.
Croatian: Liječnici moraju potaknuti bolesnike da im se u slučaju pojave tjeskobnih misli ili osjećaja jave u bilo koje vrijeme.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Duloxetine Lilly.
Croatian: Morate obavijestiti liječnika ako se pojavi ili pogorša bilo koji od gore navedenih simptoma kad bolesnik mlađi od 18 godina uzima Duloksetin Lilly.
English: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Croatian: Uočene su razlike u farmakokinetici između mlađih i starijih bolesnica (≥ 65 godina) (u starijih je osoba AUC oko 25% veći, a poluvijek oko 25% dulji), premda veličina ovih razlika nije dovoljna da bi se opravdalo prilagođavanje doze.
English: • tinnitus (hearing sound in the ear when there is no external sound)
Croatian: • zujanje/zvonjava u ušima (doživljaj zvuka u ušima kada nema vanjskog zvuka)
English: Blood pressure and heart rate
Croatian: Krvni tlak i srčana frekvencija
English: Other psychiatric conditions for which Duloxetine Lilly is prescribed can also be associated with an increased risk of suicide-related events.
Croatian: Druga psihijatrijska stanja za koja se propisuje Duloksetin Lilly također mogu biti povezana s povećanim rizikom od događaja povezanih sa samoubojstvom.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: There are no adequate data on the use of duloxetine in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni duloksetina u trudnica.
English: Specific in vivo drug interaction studies have not been performed.
Croatian: Nisu provedena specifična ispitivanja interakcija lijekova in vivo.
English: − are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
Croatian: − ako uzimate fluvoksamin, koji se obično koristi za liječenje depresije, ciprofloksacin ili enoksacin, koji se koriste za liječenje nekih infekcija
English: − are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
Croatian: − ako ste alergični na duloksetin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Croatian: Bolesnike (i one koji o njima skrbe) se mora upozoriti da trebaju pripaziti na pojavu bilo kakvog kliničkog pogoršanja, suicidalnih misli ili ponašanja i neuobičajenih promjena u ponašanju te da u slučaju pojave tih simptoma odmah potraže liječnički savjet.
English: These effects are normally mild to moderate and often disappear after a few weeks.
Croatian: Te su nuspojave obično blage do umjerene i često prestaju nakon nekoliko tjedana.
English: If your doctor thinks that you no longer need Duloxetine Lilly he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Croatian: Ako liječnik smatra da Vam Duloksetin Lilly više ne treba, uputit će Vas da dozu postupno smanjujete tijekom najmanje 2 tjedna prije nego što potpuno prestanete uzimati lijek.
English: However,
Croatian: Nadalje,
English: A conclusion on the overall benefit/risk in this age group has not been established (see also sections 4.2 and 4.8).
Croatian: Nije donesen zaključak o ukupnom omjeru koristi i rizika u ovoj dobnoj skupini (vidjeti i dijelove 4.2 i 4.8).
English: There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain)
Croatian: Moguć je gubitak osjeta u zahvaćenom području ili osjeti poput dodira, topline, hladnoće ili pritiska mogu izazvati bol).
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking (see section 4.8).
Croatian: Nadalje, nedostaju podaci o dugoročnoj sigurnosti kod djece i adolescenata u pogledu rasta, sazrijevanja te kognitivnog i bihevioralnog razvoja (vidjeti dio 4.8).
English: In patients with insufficient response the dose should be increased to 60 mg, which is the usual maintenance dose in most patients.
Croatian: U bolesnika s nedostatnim odgovorom doza se mora povećati na 60 mg, što je uobičajena doza održavanja u većine bolesnika.
English: Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting, however, in some patients they may be severe and/or prolonged.
Croatian: U načelu su kod primjene SSRI-ja i SNRI-ja ovi događaji blagi do umjereni i samoograničavajući, no u nekih bolesnika mogu biti teški i/ili dugotrajni.
English: Check with your doctor if you are already taking other medicines containing duloxetine.
Croatian: Provjerite sa svojim liječnikom uzimate li već neki drugi lijek koji sadrži duloksetin.
English: Limited data suggest that the plasma levels of duloxetine are higher in these patients.
Croatian: Malobrojni podaci ukazuju na to da je razina duloksetina u plazmi viša u tih bolesnika.
English: Patients not demonstrating a pain reduction of 30% within 60 days of treatment were unlikely to reach this level during further treatment.
Croatian: U bolesnika u kojih se bol nije smanjila za 30% unutar 60 dana liječenja nije bilo vjerojatno da će se to ostvariti daljnjim liječenjem.
English: Only a small proportion of patients included in pivotal clinical trials had severe depression (baseline HAM-D>25).
Croatian: Samo je malen udio bolesnika uključenih u pivotalna klinička ispitivanja imao tešku depresiju (HAM-D na početku liječenja > 25).
English: Most of them occurred during the first months of treatment.
Croatian: Većina tih slučajeva se pojavila tijekom prvih nekoliko mjeseci liječenja.
English: Date of first authorisation: 08 December 2014 Date of latest renewal:
Croatian: Datum prvog odobrenja: 8. prosinca.2014.
English: • Duloxetine Lilly may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol
Croatian: • Duloksetin Lilly može uzrokovati nuspojave kojih možda i niste svjesni, poput povišenih vrijednosti jetrenih enzima ili povišene koncentracije kalija, kreatin fosfokinaze, šećera ili kolesterola u krvi
English: Hepatitis/increased liver enzymes
Croatian: Hepatitis/povišene vrijednosti jetrenih enzima
English: The risk of withdrawal symptoms seen with SSRI's and SNRI's may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Croatian: Rizik od pojave simptoma ustezanja uočenih kod primjene SSRI-ja i SNRI-ja može ovisiti o nekoliko čimbenika, uključujući trajanje liječenja, terapijsku dozu i brzinu smanjivanja doze.
English: Clinical response rates (50% or greater improvement in pain) were analysed according to whether or not the patient experienced somnolence during treatment.
Croatian: Stope kliničkog odgovora (smanjenje boli za 50% ili više) analizirane su ovisno o tome je li se u bolesnika tijekom liječenja javila somnolencija.
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking Duloxetine Lilly.
Croatian: • Obavijestite svog liječnika ako zatrudnite ili pokušavate zatrudnjeti dok uzimate Duloksetin
English: 2 Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.
Croatian: 2 Slučajevi ortostatske hipotenzije i sinkope prijavljeni su osobito na početku liječenja.
English: The pattern of liver damage was predominantly hepatocellular.
Croatian: Oštećenje jetre uglavnom je bilo hepatocelularno.
English: Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood from clotting.
Croatian: Oralni antikoagulansi i antitrombotici: Lijekovi koji razrjeđuju krv ili sprečavaju zgrušavanje krvi.
English: The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status and CYP2D6 metaboliser status.
Croatian: Farmakokinetika duloksetina pokazuje veliku interindividualnu varijabilnost (općenito 50-60%), dijelom zbog spola, dobi, pušenja i statusa metabolizma posredovanog pomoću CYP2D6.
English: 4 Cases of aggression and anger have been reported particularly early in treatment or after treatment discontinuation.
Croatian: 4 Slučajevi agresije i bijesa prijavljeni su osobito u ranoj fazi liječenja ili nakon prekida liječenja.
English: Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.
Croatian: Bolesnike se mora upozoriti da u slučaju osjećaja sediranosti ili omaglice izbjegavaju moguće rizične poslove, poput upravljanja vozilom i rukovanja strojevima.
English: The relevance of this mouse data to humans is unknown.
Croatian: Nije poznato koliko su ti podaci dobiveni u miševa značajni za ljude.
English: The safety and efficacy of duloxetine for the treatment of generalised anxiety disorder in paediatric patients aged 7-17 years have not been established.
Croatian: Sigurnost i djelotvornost duloksetina za liječenje generaliziranog anksioznog poremećaja u pedijatrijskih bolesnika u dobi od 7 do 17 godina nisu ustanovljene.
English: If this happens to your baby you should contact your midwife and/or doctor immediately.
Croatian: Ako se to dogodi Vašoj bebi, odmah se javite primalji i/ili liječniku.
English: • suicidal behaviour, mania (over activity, racing thoughts and decreased need for sleep), hallucinations, aggression and anger
Croatian: • samoubilačko ponašanje, manija (prekomjerna aktivnost, brze misli i smanjena potreba za spavanjem), halucinacije, agresivnost i bijes
English: Duloxetine should not be used in children and adolescents under the age of 18 years for the treatment of major depressive disorder because of safety and efficacy concerns (see sections 4.4, 4.8 and 5.1).
Croatian: Duloksetin se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina za liječenje velikog depresivnog poremećaja zbog razloga sigurnosti i djelotvornosti (vidjeti dijelove 4.4, 4.8 i 5.1).
English: Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Croatian: Procjena učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100),
English: Some patients who stop taking Duloxetine Lilly suddenly have had symptoms such as:
Croatian: U nekih bolesnika koji naglo prestanu uzimati Duloksetin Lilly jave se simptomi kao što su:
English: The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%).
Croatian: Apsolutna bioraspoloživost duloksetina nakon peroralne primjene iznosi od 32% do 80% (srednja vrijednost 50%).
English: Hyponatraemia may be due to a syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Croatian: Hiponatrijemija može biti uzrokovana sindromom neprikladnog izlučivanja antidiuretskog hormona (engl. syndrome of inappropriate antidiuretic hormone secretion, SIADH).
English: Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
Croatian: Duloksetin se opsežno metabolizira, a metaboliti se izlučuju prvenstveno u mokraću.
English: Oral contraceptives and other steroidal agents: Results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A.
Croatian: Oralni kontraceptivi i ostali steroidni lijekovi: Rezultati ispitivanja in vitro pokazuju da duloksetin ne inducira katalitičku aktivnost CYP3A.
English: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Croatian: Uočene su razlike u farmakokinetici između muškaraca i žena (prividni klirens iz plazme u žena je približno 50% manji).
English: Use in children and adolescents under 18 years of age Duloxetine Lilly should not be used in the treatment of children and adolescents under the age of 18 years.
Croatian: Primjena u djece i adolescenata mlađih od 18 godina Duloksetin Lilly se ne smije primjenjivati u liječenju djece i adolescenata mlađih od 18 godina.
English: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Croatian: Srčani poremećaji palpitacije tahikardija supraventrikularna aritmija, uglavnom fibrilacija atrija
English: Each capsule may contain up to 111 mg sucrose.
Croatian: Jedna kapsula može sadržavati do 111 mg saharoze.
English: HbA1c was stable in both duloxetine-treated and placebo-treated patients.
Croatian: HbA1c bio je stabilan i u bolesnika liječenih duloksetinom i u onih koji su uzimali placebo.
English: Treatment of major depressive disorder.
Croatian: Liječenje velikog depresivnog poremećaja.
English: Effect of duloxetine on other medicinal products
Croatian: Učinak duloksetina na druge lijekove
English: Duloxetine Lilly starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better.
Croatian: U većine osoba s depresijom ili tjeskobom Duloksetin Lilly počinje djelovati unutar dva tjedna nakon početka liječenja, ali može biti potrebno 2-4 tjedna prije nego što se počnete osjećati bolje.
English: The plasma concentration of duloxetine displays large inter-individual variability (see section 5.2).
Croatian: Koncentracija duloksetina u plazmi pokazuje veliku intraindividualnu varijabilnost (vidjeti dio 5.2).