FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients for whom recent use of opioids is suspected.
Croatian: Bolesnici kod kojih se sumnja na nedavnu uporabu opioida.
English: Each film-coated tablet contains 60.68 mg lactose.
Croatian: Svaka filmom obložena tableta sadrži 60,68 mg laktoze.
English: This effect was considered to be an indirect effect related to toxicity to the dams.
Croatian: Smatra se da je to neizravni učinak povezan s toksičnošću gravidnih ženki.
English: If you are going to have a surgical procedure, talk to your doctor at least 1 week before the procedure.
Croatian: Ako ćete se podvrgnuti kirurškom zahvatu, obratite se svom liječniku barem 1 tjedan prije zahvata.
English: DK-2500 Valby Denmark
Croatian: DK-2500 Valby Danska
English: Overall, the studies included 1,941 patients, 1,144 of whom were treated with Selincro 18 mg as-needed.
Croatian: Sveukupno, ispitivanja su uključila 1941 bolesnika, od kojih je 1144 bilo liječeno s 18 mg Selincra prema potrebi.
English: Your use of Selincro may affect your doctor's choice of emergency treatment.
Croatian: Primjena Selincra može utjecati na liječnikov izbor hitnog liječenja.
English: Very common (may affect more than 1 in 10 people) - feeling sick - dizziness - inability to sleep - headache
Croatian: Vrlo često (može zahvatiti više od 1 od 10 osoba) - mučnina - omaglica - nemogućnost spavanja - glavobolja
English: The increased suicidal risk in alcohol and substances abusers, with or without accompanying depression, is not reduced by the intake of nalmefene.
Croatian: Povećani rizik od suicida kod osoba koje zlorabe alkohol i opojna sredstva, sa ili bez popratne depresije, ne smanjuje se uzimanjem nalmefena.
English: Therefore, the patients who maintained a high or very high DRL at randomisation were defined post hoc as the target population.
Croatian: Stoga su bolesnici koji su zadržali visok ili vrlo visok RPP u trenutku randomizacije post hoc definirani kao ciljana populacija.
English: If you require emergency medical attention, tell your doctor that you are taking Selincro.
Croatian: Ako Vam je potrebna hitna medicinska pomoć, obavijestite svog liječnika da uzimate Selincro.
English: Selincro is to be taken as-needed: On each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking.
Croatian: Selincro treba uzimati prema potrebi: svakoga dana kada bolesnik prepozna rizik od pijenja alkohola, treba uzeti jednu tabletu, po mogućnosti 1-2 sata prije očekivanoga vremena pijenja.
English: Responder analyses of the pooled data from the two studies are provided in Table 2.
Croatian: Analiza odgovora na liječenje iz udruženih podataka iz dvaju ispitivanja prikazana je u Tablici 2.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 49 film-coated tablets 98 film-coated tablets
Croatian: 7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 42 filmom obloženih tableta 49 filmom obloženih tableta 98 filmom obloženih tableta
English: Other medicines and Selincro
Croatian: Drugi lijekovi i Selincro
English: However, body size seems to affect the clearance of nalmefene to a minor degree (clearance increases with increasing body size), but this is considered unlikely to be of clinical relevance.
Croatian: Međutim, čini se da veličina tijela utječe na klirens nalmefena u manjem stupnju (klirens se povećava s porastom veličine tijela), ali se smatra da nije vjerojatno da je to od kliničke važnosti.
English: In Studies 1 (n=579), and 2 (n=655), 18%, and 33%, of the total population, respectively, considerably reduced their alcohol consumption in the period between screening and randomisation.
Croatian: U ispitivanjima 1 (n=579) i 2 (n=655), 18%, odnosno, 33% od ukupne populacije je značajno smanjilo konzumaciju alkohola u razdoblju između probira i randomizacije.
English: Selincro can help you reduce the amount of alcohol you drink, and keep the reduced level of alcohol consumption.
Croatian: Selincro Vam može pomoći da smanjite količinu alkohola koju pijete te održite smanjenu razinu konzumacije alkohola.
English: Disturbance in attention Paraesthesia Hypoaesthesia
Croatian: Poremećaj pažnje Parestezije Hipoestezija
English: If you continue treatment with Selincro, or start again after a break in treatment, you will probably not have side effects.
Croatian: Ako nastavite liječenje Selincrom, ili počinjete opet nakon prekida u liječenju, vjerojatno nećete imati nuspojave.
English: The average protein-bound fraction of nalmefene in plasma is approximately 30%.
Croatian: Prosječni dio nalmefena koji se veže na proteine plazme je približno 30%.
English: TAC R70 0-4 HDD
Croatian: UKA R70 0-4 DTPP
English: If you believe you have taken too many Selincro tablets, contact your doctor or pharmacist.
Croatian: Ako mislite da ste uzeli previše Selincro tableta, obratite se svom liječniku ili ljekarniku.
English: In an emergency situation when opioids must be administered to a patient taking Selincro, the amount of opioid required to obtain the desired effect may be greater than usual.
Croatian: U hitnoj situaciji kada se moraju dati opioidi bolesnicima koji uzimaju Selincro, količina opioida potrebna za dobivanje željenih učinaka može biti veća od uobičajene.
English: Selincro works by affecting processes in the brain that are responsible for your urge to continue drinking.
Croatian: Selincro djeluje tako što utječe na procese u mozgu koji Vas navode da nastavite piti.
English: Selincro was prescribed as-needed, which resulted in patients taking Selincro, on average, approximately half of the days.
Croatian: Selincro se propisivao prema potrebi, što je rezultiralo time da su bolesnici prosječno uzimali Selincro približno polovinu dana.
English: No clinically relevant changes were seen in tmax for any of the groups.
Croatian: Nisu opažene klinički relevantne promjene u tmax za bilo koju od skupina.
English: The absolute oral bioavailability of nalmefene is 41%.
Croatian: Apsolutna oralna bioraspoloživost nalmefena je 41%.
English: Psychiatric effects were reported in clinical studies (see section 4.8).
Croatian: U kliničkim ispitivanjima prijavljeni su psihijatrijski učinci (vidjeti dio 4.8).
English: An HDD was defined as a day with a consumption ≥60 g of pure alcohol for men and ≥40 g for women.
Croatian: DTPP je definiran kao dan s konzumacijom ≥60 g čistog alkohola za muškarce i ≥40 g za žene.
English: What Selincro is and what it is used for
Croatian: Što je Selincro i za što se koristi
English: However, the effect of nalmefene and alcohol in combination did not exceed the sum of the effects of each substance when taken alone.
Croatian: Međutim, učinak nalmefena i alkohola u kombinaciji nije premašivao zbroj učinaka svake tvari uzete zasebno.
English: What Selincro is and what it is used for What you need to know before you take Selincro How to take Selincro
Croatian: Što je Selincro i za što se koristi Što morate znati prije nego počnete uzimati Selincro Kako uzimati Selincro
English: If you take medicines containing opioids, the effects of these medicines will be reduced, or the medicines may not work at all if you take them together with Selincro.
Croatian: Ako uzimate lijekove koji sadrže opioide, učinci ovih lijekova bit će smanjeni ili lijekovi možda neće uopće djelovati ako ih uzmete zajedno sa Selincrom.
English: The majority of the patients had low (55% had a score of 0-13) or intermediate (36% had a score of 14-21) alcohol dependence according to the Alcohol Dependence Scale.
Croatian: Većina ovih bolesnika imala je nisku (55% imalo je rezultat od 0-13) ili srednju (36% imalo je rezultat od 14-21) ovisnost o alkoholu prema skali ovisnosti o alkoholu.
English: A high level of alcohol consumption is defined as drinking more than 60 g of pure alcohol per day for men and more than 40 g of pure alcohol per day for women.
Croatian: Visoka razina konzumacije alkohola definira se kao pijenje više od 60 g čistog alkohola dnevno za muškarce i više od 40 g čistog alkohola dnevno za žene.
English: If you and your doctor have decided that your immediate goal is abstinence (not drinking any alcohol), you should not take Selincro because Selincro is indicated for reduction of alcohol consumption.
Croatian: Ako ste Vi i Vaš liječnik odlučili da Vam je neposredni cilj apstinencija (da ne pijete alkohol uopće), ne biste trebali uzimati Selincro jer je Selincro indiciran za smanjenje konzumacije alkohola.
English: The following side effects have been reported with Selincro:
Croatian: Sljedeće su nuspojave prijavljene sa Selincrom:
English: Patients with a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, and delirium tremens).
Croatian: Bolesnici s nedavnom anamnezom akutnog sindroma ustezanja od alkohola (uključujući halucinacije, napadaje i delirijum tremens).
English: - In vivo studies have demonstrated that nalmefene reduces alcohol consumption, possibly by modulating cortico-mesolimbic functions.
Croatian: - In vivo ispitivanja pokazala su da nalmefen smanjuje konzumaciju alkohola, moguće moduliranjem kortiko-mezolimbičkih funkcija.
English: Selincro is extensively metabolised by the liver and excreted predominantly in the urine.
Croatian: Selincro se opsežno metabolizira putem jetre i izlučuje pretežno u urinu.
English: There seems to be a small impairment in cognitive and psychomotor performance after administration of nalmefene.
Croatian: Čini se da postoji malo oštećenje kognitivnog i psihomotornog djelovanja nakon primjene nalmefena.
English: There are no or limited data (fewer than 300 pregnancy outcomes) from the use of nalmefene in pregnant women.
Croatian: Nema podataka ili su podatci o primjeni nalmefena u trudnica ograničeni (manje od 300 ishoda trudnoća).
English: Consequently, Selincro may have minor to moderate influence on the ability to drive and use machines and patients should exercise caution particular when starting treatment with Selincro.
Croatian: Stoga, Selincro može imati manji do umjeren utjecaj na sposobnost upravljanja vozilima i rada sa strojevima, a bolesnici trebaju biti oprezni posebno kad počinju liječenje lijekom Selincro.
English: Studies in animals do not indicate direct harmful effects with respect to fertility, pregnancy, embryonic/foetal development, parturition, or postnatal development.
Croatian: Ispitivanja na životinjama nisu upućivala na izravne štetne učinke na plodnost, trudnoću, embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj.
English: Selincro has not been investigated in patients with unstable psychiatric disease.
Croatian: Selincro nije ispitivan u bolesnika s nestabilnom psihijatrijskom bolešću.
English: Patients with acute symptoms of opioid withdrawal.
Croatian: Bolesnici s akutnim simptomima ustezanja od opioida.
English: Selincro is available in packs of 7, 14, 28, 42, 49 or 98 tablets in blister cards.
Croatian: Selincro je dostupan u pakiranjima koja sadrže 7, 14, 28, 42, 49 ili 98 tableta u blisterima.
English: The majority (80%) of the patients included had a high or very high DRL (alcohol consumption >60 g/day for men and >40 g/day for women according to the WHO DRLs of alcohol consumption) at screening, of these 65% maintained a high or very high DRL between screening and randomisation.
Croatian: Većina (80%) uključenih bolesnika imala je visoki ili vrlo visoki RPP (konzumacija alkohola >60 g/dan za muškarce i >40 g/dan za žene prema definiciji Svjetske zdravstvene organizacije (WHO) za RPP konzumiranja alkohola) pri probiru, 65% od njih zadržalo je visoki ili vrlo visoki RPP između probira i randomizacije.
English: After you stop treatment with Selincro, you may be less sensitive to the effects of medicines containing opioids for a few days.
Croatian: Ako prekinete liječenje Selincrom, možda ćete nekoliko dana biti manje osjetljivi na učinke lijekova koji sadrže opioide.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Selincro in all subsets of the paediatric population for the treatment of alcohol dependence (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Selincro u svim podskupinama pedijatrijske populacije za liječenje ovisnosti od alkohola (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency 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: Data from the nonclinical studies, the clinical studies, and the literature do not suggest any form of dependence or abuse potential with Selincro.
Croatian: Podaci iz nekliničkih ispitivanja, kliničkih ispitivanja i literature ne upućuju na bilo kakav oblik ovisnosti ili zlouporabe Selincra.
English: - Swallow the tablet whole, do not crush or divide the tablet because Selincro may cause skin sensitisation when in direct contact with the skin.
Croatian: - Progutajte tabletu cijelu, nemojte lomiti ili dijeliti tabletu jer Selincro može uzrokovati osjetljivost kože kad je u direktnom kontaktu s kožom.
English: Limited data are available for Selincro in the 1-month run-out period.
Croatian: Dostupni su ograničeni podaci za Selincro u jednomjesečnom završnom razdoblju.
English: Selincro should be temporarily discontinued for 1 week prior to the anticipated use of opioids, for example, if opioid analgesics might be used during elective surgery.
Croatian: Liječenje Selincrom treba privremeno prekinuti tijekom 1 tjedna prije očekivane primjene opioida, na primjer, ako bi se opioidni analgetici mogli primjenjivati tijekom zakazanog kirurškog zahvata.
English: Your doctor has prescribed Selincro because you were not able to reduce your alcohol consumption on your own.
Croatian: Liječnik Vam je propisao Selincro jer sami niste mogli smanjiti svoju konzumaciju alkohola.
English: The metabolites are not considered to contribute with significant pharmacological effect on the opioid receptors in humans, except for nalmefene 3-O-sulphate, which has a potency comparable to that of nalmefene.
Croatian: Smatra se da metaboliti ne doprinose značajnim farmakološkim učincima na opioidne receptore u ljudi, osim nalmefen 3-O-sulfata, koji ima snagu usporedivu s nalmefenom.
English: Do not take Selincro:
Croatian: Nemojte uzimati Selincro:
English: However, nalmefene 3-O-sulphate is present in concentrations less than 10% of that of nalmefene and thus considered highly unlikely to be a major contributor to the pharmacological effect of nalmefene.
Croatian: Međutim, nalmefen 3-O-sulfat je prisutan u koncentracijama manjim od 10% od nalmefena te se stoga smatra da nije vjerojatno da će značajnije doprinijeti farmakološkom učinku nalmefena.
English: These medicines include certain types of cough and cold medicines, certain medicines for diarrhoea and strong pain killers.
Croatian: Ovi lijekovi uključuju određene vrste lijekova protiv kašlja i prehlade, određene lijekove protiv proljeva i snažne lijekove protiv bolova.
English: Detailed information on this medicine is available on the European Medicines Agency 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: There is no clinically relevant pharmacokinetic drug-drug interaction between nalmefene and alcohol.
Croatian: Ne postoji klinički značajna farmakokinetička interakcija lijek-lijek između nalmefena i alkohola.
English: Both studies were randomised, double-blind, parallel-group and placebo-controlled, and after 6 months of treatment, patients who received Selincro were re-randomised to receive either placebo or Selincro in a 1-month run-out period.
Croatian: Oba ispitivanja bila su randomizirana, dvostruko slijepa, paralelnih skupina i placebom kontrolirana, i nakon 6 mjeseci liječenja bolesnici koji su primali Selincro bili su ponovno randomizirani da prime ili placebo ili Selincro u jednomjesečnom završnom razdoblju.
English: No clinically relevant changes were seen in tmax or elimination half-life for any of the groups.
Croatian: Nisu opažene klinički relevantne promjene u tmax ili poluvijeku eliminacije za bilo koju od skupina.
English: - Do not use this medicine after the expiry date (EXP) that is printed on the blister and carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti (EXP/Rok valjanosti) navedenog na blisteru i kutiji.
English: Caution should be exercised when prescribing Selincro to patients with elevated ALAT or ASAT (>3 times ULN) as these patients were excluded from the clinical development programme.
Croatian: Potreban je oprez kada se Selincro propisuje bolesnicima s povišenim ALT ili AST (>3 puta GGN) jer su ti bolesnici bili isključeni iz programa kliničkog razvoja.
English: 52% of these patients had a high or very high DRL at baseline; of these, 52% (representing 27% of the total population) continued to have a high or very high DRL at randomisation.
Croatian: 52% bolesnika imalo je visoki ili vrlo visoki RPP pri početnim vrijednostima; od njih, 52% (koji predstavljaju 27% ukupne populacije) je nastavilo imati visoki ili vrlo visoki RPP u trenutku randomizacije.
English: This is unlikely to present a problem with occasional use, but if long-term concurrent treatment with a potent UGT2B7 inhibitor is initiated, a potential for an increase in nalmefene exposure cannot be excluded (see section 4.4).
Croatian: To vjerojatno neće predstavljati problem kod povremene primjene, no, ako se započne dugotrajno istodobno liječenje snažnim inhibitorom UGT2B7, ne može se isključiti mogućnost povećane izloženosti nalmefenu (vidjeti dio 4.4).
English: Simultaneous intake of alcohol and Selincro does not prevent the intoxicating effects of alcohol.
Croatian: Istodobna konzumacija alkohola i Selincra ne sprječava intoksicirajuće učinke alkohola.
English: Caution should be exercised if Selincro is prescribed to patients with current psychiatric comorbidity such as major depressive disorder.
Croatian: Potreban je oprez pri propisivanju Selincra bolesnicima s trenutnim psihijatrijskim komorbiditetom, kao što je veliki depresivni poremećaj.
English: Metabolism by glucuronide conjugation is the primary mechanism of clearance for nalmefene, with renal excretion being the main route of elimination of nalmefene and its metabolites.
Croatian: Metabolizam putem konjugacije glukuronida je primarni mehanizam klirensa nalmefena, pri čemu je renalno izlučivanje glavni put eliminacije nalmefena i njegovih metabolita.
English: Selincro is a white, oval, biconvex, film-coated tablet of 6.0 x 8.75 mm.
Croatian: Selincro je bijela, ovalna, bikonveksna, filmom obložena tableta veličine 6,0 x 8,75 mm.
English: From distribution, metabolism, and excretion data, it appears that nalmefene has a high hepatic extraction ratio.
Croatian: Na temelju podataka o distribuciji, metabolizmu i izlučivanju, čini se da nalmefen ima visoki omjer jetrene ekstrakcije.
English: - This medicine does not require any special storage conditions.
Croatian: - Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: A significant reduction in the number of HDDs and TAC occurred in some patients in the period between the initial visit (screening) and randomisation due to non-pharmacological effects.
Croatian: Značajno smanjenje broja DTPP-a i UKA-a javilo se u nekih bolesnika u razdoblju između početnog posjeta (probir) i randomizacije zbog nefarmakoloških učinaka.
English: Patients with a history of delirium tremens, hallucinations, seizures, significant psychiatric comorbidity, or significant abnormalities of liver function as well as those with significant physical withdrawal symptoms at screening or randomisation were excluded.
Croatian: Bolesnici s delirijumom tremens, halucinacijama, napadajima, značajnim psihijatrijskim komorbiditetom ili značajnim abnormalnostima funkcije jetre u anamnezi, kao i oni sa značajnim fizičkim simptomima ustezanja u vrijeme probira ili randomizacije bili su isključeni.
English: In this post-hoc target population, more patients receiving nalmefene discontinued (45%) as compared to those receiving placebo (31%).
Croatian: U ovoj post-hoc ciljanoj populaciji je odustalo više bolesnika koji su primali nalmefen (45%) u usporedbi s onima koji su primali placebo (31%).
English: You may need to stop taking Selincro temporarily.
Croatian: Možda ćete trebati privremeno prestati uzimati Selincro.
English: At baseline, the patients had, on average, 23 HDDs per month (11% of patients had fewer than 14 HDDs per month) and consumed 106 g/day.
Croatian: Pri početnim vrijednostima bolesnici su imali prosječno 23 DTPP-a mjesečno (11% bolesnika imalo je manje od 14 DTPP-a mjesečno) i konzumiralo je 106 g/dan.
English: Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.
Croatian: Selincro se treba propisati samo u kombinaciji s neprekidnom psihosocijalnom potporom, usmjerenom na pridržavanje liječenja i smanjenje konzumacije alkohola.
English: Limited clinical data are available on the use of Selincro in patients ≥65 years of age with alcohol dependence.
Croatian: Dostupni su ograničeni klinički podaci o primjeni Selincra u bolesnika s ovisnošću o alkoholu koji su stariji od 65 godina.
English: Administration of high-fat food increases the total exposure (AUC) by 30% and the peak concentration (Cmax) by 50%; the time to peak concentration (tmax) is delayed by 30 min (tmax is 1.5 hours).
Croatian: Uzimanje hrane s visokim udjelom masti povećava ukupnu izloženost (AUC) za 30%, a vršne koncentracije (Cmax) za 50%; vrijeme do vršnih koncentracija (tmax) odgođeno je za 30 min (tmax je 1,5 sati).
English: If patients develop psychiatric symptoms that are not associated with treatment initiation with Selincro, and/or that are not transient, the prescriber should consider alternative causes of the symptoms and assess the need for continuing treatment with Selincro.
Croatian: Ako bolesnici razviju psihijatrijske simptome koji nisu povezani s početkom liječenja Selincrom, i/ili koji nisu prolazni, liječnik koji propisuje lijek bi trebao razmotriti druge moguće uzroke simptoma te procijeniti potrebu za nastavkom liječenja Selincrom.
English: 54% of the total dose is excreted in the urine as nalmefene 3-O-glucuronide, while nalmefene and its other metabolites are present in the urine in amounts of less than 3% each.
Croatian: U urinu se izlučuje 54% ukupne doze u obliku nalmefen 3-O-glukuronida, dok su nalmefen i njegovi drugi metaboliti prisutni u urinu u količanama manjim od 3% svaki.
English: If you have started drinking alcohol without taking Selincro, take one tablet as soon as possible.
Croatian: Ako ste počeli piti alkohol, a niste uzeli Selincro, uzmite jednu tabletu što prije moguće.
English: Caution is advised if Selincro is co-administered with a potent UGT2B7 inhibitor (see section 4.5).
Croatian: Savjetuje se oprez kada se Selincro primjenjuje istodobno sa snažnim inhibitorom UGT2B7 (vidjeti dio 4.5).
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Selincro should be initiated only in patients who continue to have a high DRL two weeks after initial assessment.
Croatian: Liječenje Selincrom treba započeti samo u bolesnika koji i dalje imaju visoki RPP dva tjedna nakon početne procjene.