FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time.
Croatian: Liječnici moraju potaknuti bolesnice da im prijave bilo kakve uznemirujuće misli ili osjećaje te simptome depresije u bilo koje vrijeme.
English: What YENTREVE looks like and contents of the pack
Croatian: Kako YENTREVE izgleda i sadržaj pakiranja
English: Differences were observed at each visit after 4 weeks (duloxetine 54% and placebo 22%), 8 weeks (52% and 29%), and 12 weeks (52% and 33%) of medication.
Croatian: Razlike su primijećene pri svakom posjetu nakon 4 tjedna (duloksetin 54% i placebo 22%), 8 tjedana (52% i 29%) i 12 tjedana (52% i 33%) liječenja.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Croatian: S obzirom da poboljšanje ne mora nastupiti tijekom prvih nekoliko tjedana liječenja ili dulje, bolesnice se mora pomno pratiti sve dok ne nastupi poboljšanje.
English: The recommended dose of YENTREVE is 40 mg twice a day (in the morning and late afternoon/evening).
Croatian: Preporučena doza lijeka YENTREVE je 40 mg dvaput na dan (ujutro i kasno poslijepodne/navečer).
English: This may be due to the noradrenergic effect of duloxetine.
Croatian: To može biti zbog noradrenergičkog učinka duloksetina.
English: The requirements for submission of periodic safety update reports for this medicinal product are in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
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 je približno 0,14% majčine doze (vidjeti dio 5.2).
English: YENTREVE increases the levels of serotonin and noradrenaline in the nervous system.
Croatian: YENTREVE povećava razine serotonina i noradrenalina u živčanom sustavu.
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 bolesnica s poznatom hipertenzijom i/ili drugom srčanom bolešću preporučuje praćenje krvnog tlaka, osobito tijekom prvog mjeseca liječenja.
English: The use of more than one of these products concomitantly should be avoided.
Croatian: Mora se izbjegavati istodobna primjena više od jednog od takvih lijekova.
English: YENTREVE should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: YENTREVE se u trudnoći smije primjenjivati samo ako moguća korist opravdava mogući rizik za plod.
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 terapije zatrudne ili namjeravaju zatrudnjeti.
English: Your doctor should decide whether you can take YENTREVE with other medicines.
Croatian: Vaš liječnik mora donijeti odluku o tome smijete li uzimati YENTREVE s drugim lijekovima.
English: Age: 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: Dob: 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 promjena nije dovoljna da bi se opravdala prilagodba doze.
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 ili prestati uzimati bilo koji lijek, uključujući i one koje ste nabavili bez recepta i biljne pripravke, prije nego što to provjerite sa svojim liječnikom.
English: If you take more YENTREVE than you should
Croatian: Ako uzmete više lijeka YENTREVE nego što ste trebali
English: • serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips
Croatian: • ozbiljna alergijska reakcija koja uzrokuje teškoće pri disanju ili omaglicu s otečenim jezikom ili usnicama
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 Vaše dijete ima bilo koji od ovih simptoma kada se rodi, ili ste zabrinuti zbog djetetova zdravlja, obratite se liječniku ili primalji koji Vas mogu savjetovati.
English: Use in children and adolescents under 18 years of age YENTREVE 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 YENTREVE se ne smije primjenjivati u liječenju djece i adolescenata mlađih od 18 godina.
English: • If you take YENTREVE near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders.
Croatian: • Ako uzimate YENTREVE pred kraj trudnoće, postoji povećan rizik od prekomjernog vaginalnog krvarenja ubrzo nakon poroda, osobito ako u povijesti bolesti imate poremećaje krvarenja.
English: • tinnitus (hearing sound in the ear when there is no external sound), ear pain
Croatian: • zvonjava u ušima (doživljaj zvuka u ušima kada nema vanjskog zvuka), bol u uhu
English: • Yentreve 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: • YENTREVE može uzrokovati učinke kojih možda i niste svjesni, poput povišenja jetrenih enzima ili povišenih razina kalija, kreatin fosfokinaze, šećera ili kolesterola u krvi
English: If while on YENTREVE therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition.
Croatian: Ako se tijekom terapije lijekom YENTREVE u bolesnice razviju agitacija ili simptomi depresije, treba zatražiti savjet liječnika specijalista jer je depresija ozbiljno medicinsko stanje.
English: A similar mechanism in women is believed to result in stronger urethral closure during urine storage with physical stress that could explain the efficacy of duloxetine in the treatment of women with SUI.
Croatian: Vjeruje se da sličan mehanizam u žena rezultira snažnijim zatvaranjem uretre tijekom pohrane mokraće, uz fizički stres, što bi moglo objasniti djelotvornost duloksetina u liječenju žena sa SUI-om.
English: • large pupils (the dark centre of the eye), problems with eyesight, eyes feel dry
Croatian: • velike zjenice (tamno središte oka), poteškoće s vidom, suhe oči
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 (EMA): http://www.ema.europa.eu
English: Limited data suggest that the plasma levels of duloxetine are higher in these patients.
Croatian: Ograničeni podaci upućuju na to da su razine duloksetina u plazmi više u tih bolesnica.
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 do < 1/10), manje često (≥ 1/1000 do < 1/100),
English: Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness.
Croatian: Postupno povećavanje doze može smanjiti, premda ne i eliminirati rizik od mučnine i omaglice.
English: Duloxetine had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity.
Croatian: Duloksetin ne utječe na plodnost u muškaraca, a učinci u žena bili su primjetni samo pri dozama koje su izazvale toksičnost za majku.
English: YENTREVE is available in 2 strengths: 20 and 40 mg.
Croatian: YENTREVE je dostupan u 2 jačine: 20 mg i 40 mg.
English: 1 Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.
Croatian: 1 Slučajevi konvulzija i slučajevi tinitusa također su prijavljeni i nakon prekida liječenja.
English: If you stop taking YENTREVE
Croatian: Ako prestanete uzimati YENTREVE
English: These usually begin at birth or within a few days of your baby being born.
Croatian: Oni obično počinju pri porodu ili unutar nekoliko dana od rođenja djeteta.
English: The safety and efficacy of duloxetine for the treatment of stress urinary incontinence has not been studied.
Croatian: Sigurnost i djelotvornost duloksetina za liječenje stresne urinarne inkontinencije nisu ispitane.
English: • Make sure your midwife and/or doctor knows you are on YENTREVE.
Croatian: • Budite sigurni da primalja i/ili liječnik znaju da uzimate YENTREVE.
English: In an additional study limited to patients with severe SUI, all responses with duloxetine were achieved within 2 weeks.
Croatian: U dodatnom ispitivanju ograničenom na bolesnice s teškom SUI svi odgovori na duloksetin postignuti su unutar 2 tjedna.
English: Hepatitis/increased liver enzymes
Croatian: Hepatitis/povišeni jetreni enzimi
English: • Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking YENTREVE.
Croatian: • Obavijestite svog liječnika ako zatrudnite ili pokušavate zatrudnjeti dok uzimate YENTREVE.
English: YENTREVE should not be used for children and adolescents under 18 years.
Croatian: YENTREVE se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Croatian: Osim toga, nedostaju podaci o dugoročnoj sigurnosti kod djece i adolescenata u pogledu rasta, sazrijevanja te kognitivnog i bihevioralnog razvoja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Yentreve in all subsets of the paediatric population in the treatment of stress urinary incontinence.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka YENTREVE u svim podskupinama pedijatrijske populacije za liječenje stresne urinarne inkontinencije.
English: Do not stop taking YENTREVE, or change your dose, without talking to your doctor.
Croatian: Nemojte prekinuti uzimati YENTREVE niti mijenjati dozu lijeka bez prethodnog razgovora sa svojim liječnikom.
English: This is most likely to occur within the first few weeks of treatment.
Croatian: To se najčešće pojavljuje unutar prvih nekoliko tjedana liječenja.
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.
Croatian: Nisu bile opažene klinički značajne razlike u izmjerenim vrijednostima QT, PR, QRS ili QTcB između bolesnica liječenih duloksetinom i bolesnica koje su uzimale placebo.
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 koji se javljaju pri prekidu liječenja viđenih kod primjene SSRI-a i SNRI-ja može ovisiti o nekoliko faktora, uključujući trajanje i dozu terapije i brzinu smanjivanja doze.
English: The relevance of this mouse data to humans is unknown.
Croatian: Nije poznat značaj tih podataka za ljude.
English: Taking a MAOI together with many prescription medicines, including YENTREVE, can cause serious or even life-threatening side effects.
Croatian: Uzimanje MAOI zajedno s mnogim lijekovima na recept, uključujući YENTREVE, može uzrokovati ozbiljne, čak i po život opasne nuspojave.
English: In these women, YENTREVE may provide no benefit beyond that afforded by more conservative behavioural interventions.
Croatian: YENTREVE možda neće ostvariti korist značajniju od one koja se postiže nešto konzervativnijim bihevioralnim intervencijama.
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: Bolesnice se mora upozoriti da u slučaju osjećaja sedacije ili omaglice izbjegavaju moguće opasne poslove, poput upravljanja vozilima i rukovanja strojevima.
English: YENTREVE may cause a sensation of restlessness or an inability to sit or stand still.
Croatian: YENTREVE može uzrokovati osjećaj nemira ili nemogućnost mirnog sjedenja ili stajanja.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Croatian: Bolesnice s rijetkim nasljednim poremećajima nepodnošenja fruktoze, malapsorpcijom glukoze-galaktoze ili insuficijencijom saharaze-izomaltaze ne smiju uzimati ovaj lijek.
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 s ciproheptadinom i/ili kontrolom temperature).
English: • dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes
Croatian: • omaglica, ošamućenost ili nesvjestica pri ustajanju, hladni prsti na rukama i/ili nogama
English: Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood from clotting.
Croatian: Oralni antikoagulansi i antitrombocitni lijekovi: lijekovi koji razrjeđuju krv ili sprječavaju zgrušavanje krvi.
English: Please 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: If this happens to your baby you should contact your midwife and/or doctor immediately.
Croatian: Ako se to dogodi Vašem djetetu, odmah se javite primalji i/ili liječniku.
English: However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e.g. nausea).
Croatian: Međutim, većina najčešćih nuspojava bila je blaga do umjerena, a povukla se unutar 30 dana od pojave (npr. mučnina).
English: Based upon in vitro studies, the circulating metabolites of duloxetine are considered pharmacologically inactive.
Croatian: Na temelju in vitro ispitivanja, cirkulirajući metaboliti duloksetina smatraju se farmakološki neaktivnima.
English: • feeling the heart pumping in the chest, fast and/or irregular heart beat
Croatian: • osjećaj lupanja srca u prsima, ubrzani i/ili nepravilni otkucaji srca
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: • feeling of dizziness or “spinning” (vertigo)
Croatian: • osjećaj omaglice ili ”vrtnje” (vrtoglavica)
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 (SSRI) mogu povećati rizik od nastanka ozbiljnog stanja za dijete, zvanog trajna plućna hipertenzija novorođenčeta (PPHN), zbog koje dijete ubrzano diše i koža mu izgleda modra.
English: Biotransformation: Duloxetine is extensively metabolised and the metabolites are excreted principally in urine.
Croatian: Biotransformacija: duloksetin se opsežno metabolizira, a metaboliti se izlučuju prvenstveno u mokraći.
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: Na temelju preklapanja raspona vrijednosti klirensa, razlike u farmakokinetici između spolova ne opravdavaju preporuku za primjenu niže doze u bolesnica.
English: Gender: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Croatian: Spol: uočene su razlike u farmakokinetici između muškaraca i žena (prividni klirens iz plazme u žena je približno 50% niži).
English: As a general recommendation, caution should be exercised when treating the elderly (see sections 4.2 and 4.4).
Croatian: Općenito se preporučuje oprez kada se liječe starije osobe (vidjeti dijelove 4.2 i 4.4).
English: You should use YENTREVE only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Croatian: Smijete uzimati YENTREVE tek nakon što razgovarate s liječnikom o mogućim koristima i mogućim rizicima za nerođeno dijete.
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 a greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
Croatian: Poznato je da bolesnice koje u anamnezi imaju događaje povezane sa samoubojstvom, ili one koje su pokazivale značajan stupanj suicidalnih misli prije početka liječenja, imaju veći rizik od suicidalnih misli ili suicidalnog ponašanja te se moraju pažljivo pratiti tijekom liječenja.
English: It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors.
Croatian: Slabo inhibira ponovnu pohranu dopamina, bez značajnog afiniteta za histaminske, dopaminske, kolinergičke i adrenergičke receptore.
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 i SNRI ovi događaji blagi do umjereni i samoograničavajući, no u nekih bolesnica mogu biti teški i/ili produljeni.
English: HbA1c was stable in both duloxetine-treated and placebo-treated patients.
Croatian: HbA1c bio je stabilan i u bolesnica liječenih duloksetinom i u bolesnica koje su uzimale placebo.
English: Thoughts of suicide and worsening of depression or anxiety disorder Although YENTREVE is not indicated for the treatment of depression, its active ingredient (duloxetine) is used as an antidepressant medicine.
Croatian: Samoubilačke misli i pogoršanje depresije ili poremećaja tjeskobe Iako YENTREVE nije namijenjen za liječenje depresije, njegov djelatni sastojak (duloksetin) primjenjuje se kao antidepresivni lijek.
English: Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity.
Croatian: Općenito su ti simptomi blagi do umjereni, međutim u nekih bolesnica mogu biti teški po intenzitetu.
English: Medicines like Yentreve (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Croatian: Lijekovi poput lijeka Yentreve (takozvani SSRI-ovi/SNRI-ovi) mogu uzrokovati simptome poremećaja seksualne funkcije (vidjeti dio 4).
English: Lactation did not influence duloxetine pharmacokinetics.
Croatian: Laktacija nije utjecala na farmakokinetiku duloksetina.
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 SRNI-ma, ne može se isključiti mogući rizik kod primjene duloksetina uzimajući u obzir povezani mehanizam djelovanja (inhibicija ponovne pohrane serotonina).
English: YENTREVE is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities.
Croatian: Vjeruje se da YENTREVE djeluje tako da osnažuje mišić koji zadržava mokraću pri smijanju, kihanju ili izvođenju fizičkih aktivnosti.
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: Ženke miševa koje su primale duloksetin tijekom 2 godine imale su povećanu incidenciju hepatocelularnih adenoma i karcinoma samo pri visokim dozama (144 mg/kg/dan), no to se smatralo sekundarnom posljedicom indukcije mikrosomalnih enzima jetre.
English: As the safety of duloxetine in infants is not known, the use of YENTREVE while breast-feeding is not recommended.
Croatian: Budući da sigurnost duloksetina u dojenčadi nije poznata, ne preporučuje se primjena lijeka YENTREVE u dojilja.
English: When stopping treatment with YENTREVE 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 YENTREVE prekida, doza se mora smanjivati postupno tijekom razdoblja od najmanje jednog do dva tjedna kako bi se smanjio rizik reakcija prekida liječenja (vidjeti dijelove 4.4 i 4.8).
English: Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 5400 mg were reported.
Croatian: Prijavljeni su slučajevi predoziranja samim duloksetinom ili u kombinaciji s drugim lijekovima, s dozama duloksetina od 5400 mg.
English: If you forget to take YENTREVE
Croatian: Ako ste zaboravili uzeti YENTREVE
English: Caution should also be exercised when duloxetine is used with medicinal products that may impair its metabolism (see section 4.5).
Croatian: Oprez je također nužan i kada se duloksetin primjenjuje s lijekovima koji mogu poremetiti njegov metabolizam (vidjeti dio 4.5).
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: kliničkim su ispitivanjima suicidalno ponašanje (pokušaji suicida i suicidalne misli) i neprijateljsko ponašanje (prvenstveno agresija, protivljenje i bijes) uočeni češće u djece i adolescenata liječenih antidepresivima u usporedbi s onima koji su dobivali placebo.
English: • weight loss, weight gain
Croatian: • gubljenje tjelesne težine, dobivanje tjelesne težine
English: • diabetic neuropathic pain, depression, anxiety and urinary incontinence Using more than one of these medicines at the same time should be avoided.
Croatian: • bol kod dijabetičke neuropatije, depresije, tjeskobe i inkontinencije mokraće Morate izbjegavati istodobno uzimanje više od jednog takvog lijeka.
English: The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%).
Croatian: Apsolutna bioraspoloživost duloksetina nakon peroralne primjene kreće se u rasponu od 32% do 80% (srednja vrijednost 50%).
English: YENTREVE is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women.
Croatian: YENTREVE je lijek koji se uzima kroz usta za liječenje stresne urinarne inkontinencije (SUI) u žena.