FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking into account the PRAC Assessment Report on the PSUR(s) for naldemedine, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za naldemedin, znanstveni zaključci CHMP-a su sljedeći:
English: Rizmoic has no influence on your ability to drive or to use machines.
Croatian: Rizmoic ne utječe na sposobnost upravljanja vozilima ili rada pomoću strojeva.
English: There is limited experience in patients treated with opioid pain medicinal product(s) at daily doses of more than the equivalent of 400 mg of morphine.
Croatian: Iskustvo je ograničeno u bolesnika liječenih opioidnim analgetikom (analgeticima) u dnevnim dozama višim od onih koje odgovaraju 400 mg morfija.
English: Three-day earlier vaginal opening indicative of an early onset of sexual maturity was also observed, but only at high exposures considered sufficiently in excess of the maximum human exposure at an oral dose of 200 micrograms.
Croatian: Opaženo je i tri dana ranije otvaranje vagine, što ukazuje na rani nastup spolne zrelosti, ali samo pri izloženosti visokim dozama koje se smatraju dovoljno većima od maksimalne izloženosti u ljudi kod primjene peroralne doze od 200 mikrograma.
English: Using these medicines with Rizmoic may affect the way naldemedine works or increase its side effects.
Croatian: Primjena ovih lijekova s lijekom Rizmoic može utjecati na način na koji naldemedin djeluje i pojačati njegove nuspojave.
English: If obstruction or perforation are suspected, naldemedine must be discontinued (see section 4.3).
Croatian: U slučaju sumnje na opstrukciju ili perforaciju, primjenu naldemedina mora se prekinuti (vidjeti dio 4.3).
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Croatian: Prilog IV. Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: Patients having disruptions to the blood-brain barrier (e.g., primary brain malignancies, central nervous system (CNS) metastases or other inflammatory conditions, active multiple sclerosis and advanced Alzheimer's disease) may be at increased risk of opioid withdrawal or reduced analgesia.
Croatian: Bolesnici s narušenom krvno-moždanom barijerom (npr. primarne zloćudne bolesti mozga, metastaze u središnjem živčanom sustavu (SŽS) ili druga upalna stanja, aktivna multipla skleroza ili uznapredovala Alzheimerova bolest) mogu imati povećan rizik od ustezanja od opioida i smanjene analgezije.
English: No human data on the effect of naldemedine on fertility are available.
Croatian: Nema dostupnih podataka o učinku naldemedina na plodnost u ljudi.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
English: Additionally, patients who were not on laxatives within 30 days prior to Screening and only received rescue laxative at or after Screening were considered non-LIR.
Croatian: Nadalje, bolesnici koji nisu primali laksative unutar 30 dana prije probira ili su primili samo laksativ za hitno olakšanje tegoba na probiru ili poslije njega smatrali su se ne-LIR-bolesnicima.
English: There is a theoretical possibility that naldemedine provokes opioid withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist.
Croatian: Postoji teoretska mogućnost da naldemedin izazove ustezanje od opioida u dojenog novorođenčeta čija majka uzima agonist opioidnih receptora.
English: Naldemedine did not cause significant induction of CYP1A2, CYP2B6 or CYP3A4 isozymes.
Croatian: Naldemedin nije uzrokovao značajnu indukciju izoenzima CYP1A2, CYP2B6 ili CYP3A4.
English: In cases of severe diarrhoea or abdominal pain, the patient should be monitored and treated for dehydration using rehydration and appropriate treatment as needed (see section 4.8).
Croatian: U slučajevima jakog proljeva ili bola u abdomenu, bolesnika treba pratiti i po potrebi dehidraciju bolesnika liječiti rehidracijom i odgovarajućom terapijom (vidjeti dio 4.8).
English: On the basis of the scientific conclusions for naldemedine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing naldemedine is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za naldemedin, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) naldemedin nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Due to the limited therapeutic experience, patients with severe renal impairment should be clinically monitored when initiating therapy with naldemedine.
Croatian: Zbog ograničenog terapijskog iskustva, bolesnike s teškim oštećenjem funkcije bubrega potrebno je klinički pratiti kad započinju terapiju naldemedinom.
English: • There is no need to alter the dose of your opioid medicine before starting Rizmoic.
Croatian: • Nije potrebno mijenjati dozu opioidnog analgetika prije početka uzimanja lijeka Rizmoic.
English: Naldemedine is an antagonist of opioid binding at the mu-, delta-, and kappa-opioid receptors.
Croatian: Naldemedin je antagonist opioida koji se vežu na mi-, delta- i kapa-opioidne receptore.
English: A population pharmacokinetic analysis from clinical studies with naldemedine did not identify a clinically meaningful effect of age, gender, body weight or race on the pharmacokinetics of naldemedine.
Croatian: Populacijskom farmakokinetičkom analizom u kliničkim ispitivanjima naldemedina nije utvrđen klinički značajan utjecaj dobi, spola, tjelesne težine ili etničke pripadnosti na farmakokinetiku naldemedina.
English: Naldemedine is a derivative of naltrexone to which a side chain has been added that increases the molecular weight and the polar surface area, thereby reducing its ability to cross the blood-brain barrier (BBB); the CNS penetration of naldemedine is expected to be negligible at the recommended dose.
Croatian: Naldemedin je derivat naltreksona kojemu je dodan postranični lanac koji povećava molekulsku težinu i polarnu površinu molekule i tako smanjuje njezinu sposobnost prolaska kroz krvno-moždanu barijeru; očekuje se zanemarivo prodiranje naldemedina u SŽS pri preporučenoj dozi.
English: In in vitro studies at clinically relevant concentrations, naldemedine did not inhibit the major CYP enzymes (including CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A, or CYP4A11 isozymes) and is not an inhibitor of OCT1, OCT2, BCRP, P-gp, MATE1, MATE2-K or BSEP transporters.
Croatian: U ispitivanjima in vitro, naldemedin u klinički značajnim koncentracijama nije inhibirao glavne enzime CYP-a (uključujući izoenzime CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A ili CYP4A11) i nije inhibirao prijenosnike OCT1, OCT2, BCRP, P-gp, MATE1, MATE2-K ili BSEP.
English: Gastrointestinal perforation
Croatian: Gastrointestinalna perforacija
English: The overall benefit risk for each patient should be taken into account.
Croatian: Za svakog pojedinog bolesnika potrebno je uzeti u obzir ukupan omjer koristi i rizika.
English: The patients who participated in Studies V9231, V9232 and V9235 were taking a wide range of opioids.
Croatian: Bolesnici koji su sudjelovali u ispitivanjima V9231, V9232 i V9235 uzimali su razne vrste opioida.
English: Your opioid pain medicine may cause the following symptoms: - reduction in how often you pass stools - hard stools - stomach ache - pain in the rectum when pushing hard stools out - a feeling that the bowel is still not empty after passing stools.
Croatian: Opioidni analgetik može Vam izazvati sljedeće simptome: - smanjenje broja stolica - tvrdu stolicu - bol u trbuhu - bol u završnom dijelu debelog crijeva tijekom istiskivanja tvrde stolice - osjećaj da nakon pražnjenja crijeva u crijevu i dalje ima stolice.
English: In the run-in and treatment periods for all three studies, bisacodyl was used as rescue laxative if patients had not had a BM for 72 hours and were allowed one-time use of an enema if after 24 hours of taking bisacodyl, they still had not had a BM.
Croatian: U uvodnom razdoblju i razdoblju liječenja u sva tri ispitivanja, kao laksativ za hitno olakšanje tegoba primjenjivao se bisakodil ako bolesnici nisu imali stolicu 72 sata i smjeli su jedanput dobiti klistir ako 24 sata nakon uzimanja bisakodila i dalje nisu imali stolicu.
English: • Gastrointestinal perforation (a hole developing in the bowel wall)
Croatian: • gastrointestinalna perforacija (stvaranje otvora u stijenci crijeva)
English: Interaction with strong and moderate CYP3A inducers Rifampicin, a strong CYP3A inducer, significantly decreased exposure to naldemedine by 83% .
Croatian: Interakcija s jakim i umjerenim induktorima CYP3A Rifampicin, jaki induktor CYP3A, značajno je smanjio izloženost naldemedinu i to za 83%.
English: Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea or vomiting, muscle aches, lacrimation or rhinorrhea, pupillary dilation or piloerection or sweating, diarrhoea, yawning, fever or insomnia.
Croatian: Sindrom ustezanja od opioida obuhvaća skupinu od tri ili više sljedećih znakova ili simptoma: disforično raspoloženje, mučnina ili povraćanje, bolovi u mišićima, suzenje ili rinoreja, dilatacija zjenica ili piloerekcija ili znojenje, proljev, zijevanje, vrućica ili nesanica.
English: Following oral administration of [14C]-labelled naldemedine, the primary metabolite in plasma was nor-naldemedine, with a relative exposure compared to naldemedine of approximately 9 to 13%.
Croatian: Nakon peroralne primjene nalmedina označenog pomoću [14C], primarni metabolit u plazmi bio je nor-naldemedin, uz relativnu izloženost u usporedbi s naldemedinom od približno 9 do 13%.
English: Store in the original package in order to protect the tablets from light and moisture.
Croatian: Čuvati u originalnom pakiranju radi zaštite tableta od svjetlosti i vlage.
English: Itraconazole, a strong CYP3A inhibitor, increased exposure to naldemedine 2.9 fold that may result in an increased risk of adverse reactions.
Croatian: Itrakonazol, jaki inhibitor CYP3A, povećava izloženost naldemedinu 2,9 puta, što može dovesti do povećanog rizika od nuspojava.
English: Store in the original package in order to protect from light and moisture.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti i vlage.
English: Uncommon Unknown
Croatian: Manje često Nepoznato
English: Caution with regards to the use of naldemedine should be exercised in patients with any conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g. peptic ulcer disease, Ogilvie's syndrome, malignancy of the GI tract, Crohn's disease).
Croatian: Potreban je oprez kod primjene naldemedina u bolesnika s bilo kojim stanjem koje bi moglo dovesti do slabljenja integriteta stijenke gastrointestinalnog trakta (npr. peptička ulkusna bolest, Ogilviejev sindrom, zloćudna bolest gastrointestinalnog trakta, Crohnova bolest).
English: Rare (may affect up to 1 in 1,000 people):
Croatian: Rijetko (mogu se pojaviti u najviše 1 na 1000 osoba):
English: If you stop taking Rizmoic
Croatian: Ako prestanete uzimati Rizmoic
English: If you are being treated with an opioid medicine for chronic non-cancer pain.
Croatian: Ako se liječite opioidnim lijekom zbog kronične nekarcinomske boli.
English: The recommended dose of naldemedine is 200 micrograms (one tablet) daily.
Croatian: Preporučena doza naldemedina je 200 mikrograma (jedna tableta) dnevno.
English: No dose adjustment is required in patients with mild or moderate hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
English: In clinical studies, patients with OIC who were administered 0.4 mg/day (twice the recommended dose) over 4 weeks had an increased incidence of GI-related adverse drug reactions including diarrhoea and abdominal pain frequently within 1-2 days after initial dosing.
Croatian: Bolesnici s konstipacijom uzrokovanom opioidima kojima je u kliničkim ispitivanjima primjenjivano 0,4 mg na dan (dvostruko viša doza od preporučene) tijekom 4 tjedna, imali su povećanu incidenciju nuspojava povezanih s probavnim sustavom uključujući proljev i bol u abdomenu, često unutar 1-2 dana od početka doziranja.
English: Overall, whilst the limitations in the evidence base solely for Naldemedine are acknowledged it is considered that supporting information is also provided by other agents in the class which are mechanistically indistinguishable from Naldemedine and which have similar effects on the GI tract.
Croatian: Sveukupno gledano, iako se prihvaća da su dokazi koji se odnose samo na naldemedin ograničeni, smatra se da ih potkrepljuju i informacije drugih lijekova iz te skupine, čiji se mehanizam djelovanja ne razlikuje od naldemedinovog i koji imaju slične učinke na gastrointestinalni trakt.
English: Available data in rats have shown excretion of naldemedine in milk (see section 5.3).
Croatian: Dostupni podaci za štakore pokazuju da se naldemedin izlučuje u mlijeko (vidjeti dio 5.3).
English: Naldemedine is primarily metabolized by CYP3A to nor-naldemedine, with a minor contribution from UGT1A3 to form naldemedine 3-G.
Croatian: Naldemedin se primarno metabolizira putem CYP3A do nor-naldemedina, uz manji doprinos UGT1A3 u stvaranju naldemedina 3-G.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: There are no data from the use of naldemedine in pregnant women.
Croatian: Nema podataka o primjeni naldemedina u trudnica.
English: Stop taking Rizmoic and contact your doctor if you develop opioid withdrawal symptoms.
Croatian: Prestanite uzimati Rizmoic i obratite se liječniku ako razvijete simptome ustezanja od opioida.
English: Based on this, naldemedine is expected to exert its anti-constipating effects on opioids without reversing their CNS-mediated analgesic effects.
Croatian: Na temelju toga se očekuje da će naldemedin pokazati svoje antikonstipacijske učinke na opioide bez poništavanja njihovih analgetičkih učinaka posredovanih SŽS-om.
English: The peak plasma concentration and area under the plasma concentration-time curve increased in an almost dose-proportional manner within the dose range of 0.1 to 100 mg. A slight accumulation
Croatian: Vršna koncentracija u plazmi i površina ispod krivulje plazmatska koncentracija-vrijeme povećavale su se gotovo proporcionalno dozi unutar raspona doza od 0,1 do 100 mg.
English: Rizmoic can be used in patients using an opioid medicine for cancer pain or long term non-cancer pain after they have previously been treated with a laxative.
Croatian: Rizmoic se može primjenjivati u bolesnika koji dobivaju opioidni lijek zbog bolova prouzročenih rakom ili dugotrajnog nekarcinomskog bola nakon što su se prethodno liječili laksativima.
English: Rizmoic is a round, approximately 6.5 mm diameter, yellow film-coated tablet debossed with '222' and the Shionogi logo on one side and '0.2' on the other side.
Croatian: Rizmoic je okrugla, žuta, filmom obložena tableta, približnog promjera 6,5 mm, s utisnutim „222“ i logom tvrtke Shionogi na jednoj strani i „0.2“ na drugoj.
English: Naldemedine 3-G was a minor metabolite in plasma, with a relative exposure to naldemedine of less than 3%.
Croatian: Naldemedin 3-G bio je manje zastupljen metabolit u plazmi, uz relativnu izloženost u odnosu na naldemedin manju od 3%.
English: Additionally, naldemedine is a substrate of the P-glycoprotein (P-gp) efflux transporter, which may also be involved in reducing naldemedine penetration into the CNS.
Croatian: Osim toga, naldemedin je supstrat efluksnog prijenosnika P-glikoproteina (P-gp), koji također može sudjelovati u smanjenju prodiranja naldemedina u SŽS.
English: The pharmacokinetics of naldemedine in the paediatric population has not been studied (see section 4.2).
Croatian: Farmakokinetika naldemedina u pedijatrijskoj populaciji nije ispitana (vidjeti dio 4.2).
English: Following oral administration of radiolabelled naldemedine, 57.3% and 34.8% of the dose was excreted in urine and faeces for the [oxadiazole-14C]-naldemedine and 20.4% and 64.3% of the dose was excreted as the [carbonyl-14C]naldemedine in urine and faeces, respectively.
Croatian: Nakon peroralne primjene radioaktivno označenog naldemedina, 57,3% doze bilo je izlučeno u obliku [oksadiazol-14C]-naldemedina u mokraći, a 34,8% u stolici, dok je 20,4% i 64,3% doze bilo izlučeno u obliku [karbonil-14C]-naldemedina u mokraći odnosno stolici.
English: Novel histopathology findings were observed at all doses tested in female rats in ovaries (tertiary follicles/luteal cysts) in addition to irregular oestrous cycles, hyperplasia of mammary gland, and vaginal mucification already observed in adult animals (the lowest dose tested corresponded to an exposure margin of 6 or more, depending on the age of the pups).
Croatian: Pri svim ispitivanim dozama u ženki štakora pronađeni su novi patohistološki nalazi na jajnicima (tercijarni folikuli/lutealne ciste) uz neuredan ciklus estrusa, hiperplaziju mliječnih žlijezda i vaginalnu mucifikaciju, koji su već prije opaženi u odraslih životinja (najniža ispitana doza odgovara margini izloženosti od 6 ili više, ovisno o dobi mladunčadi).
English: Interactions with CYP3A inhibitors
Croatian: Interakcije s inhibitorima CYP3A
English: From baseline to the last 2 weeks of treatment**
Croatian: Od početka ispitivanja do zadnja 2 tjedna liječenja**
English: Naldemedine is highly bound to serum proteins, predominantly to human serum albumin and to a lesser extent to α1-acid-glycoprotein and γ-globulin, with a mean protein binding ratio in humans of 93.2%.
Croatian: Naldemedin se u visokom postotku veže na proteine u serumu, uglavnom za albumin i u manjoj mjeri za α1-kiseli-glikoprotein i γ-globulin u ljudskom serumu, te srednja vrijednost omjera vezanja za proteine u ljudi iznosi 93,2%.
English: - if your bowel is blocked or perforated, or if there is a high risk of your bowel becoming blocked, as a blockage may cause a hole to develop in the bowel wall.
Croatian: - ako Vam je debelo crijevo blokirano, došlo je do puknuća crijeva ili postoji veliki rizik da postane blokirano, jer to može prouzročiti stvaranje otvora u stijenci debelog crijeva.
English: Alteration of the analgesic dosing regimen prior to initiating Rizmoic is not required.
Croatian: Nije potrebno mijenjati režim doziranja analgetika prije početka primjene lijeka Rizmoic.
English: Talk to your doctor if you are already breast-feeding.
Croatian: Obratite se liječniku ako već dojite.
English: Tablet core: Mannitol, croscarmellose sodium (see section 2 under ‘Rizmoic contains sodium') and magnesium stearate.
Croatian: - Drugi sastojci su: Jezgra tablete: manitol, umrežena karmelozanatrij (pogledajte dio 2 pod naslovom „Rizmoic sadrži natrij“) i magnezijev stearat.
English: From baseline to week 1**
Croatian: Od početka ispitivanja do 1. tjedna**
English: Talk to your doctor or pharmacist immediately whilst taking Rizmoic: - if you develop severe, lasting or worsening stomach pain as this could be a symptom of developing a hole in your bowel wall and can be life-threatening.
Croatian: Odmah se obratite svom liječniku ili ljekarniku dok uzimate Rizmoic: - ako razvijete jaku bol u trbuhu ili bol u trbuhu koja je ustrajna ili se pogoršava jer bi to mogao biti simptom nastanka otvora u stijenci crijeva, što može biti opasno po život.
English: In studies V9222 and V9236, the mean age of the subjects was 64.3 years; 51.8% were 65 years of age or older; 39.4% were women and 97.1% were Japanese.
Croatian: U ispitivanjima V9222 i V9236, srednja vrijednost dobi ispitanika bila je 64,3 godina; 51,8% ispitanika bilo je u dobi od 65 godina ili starije; 39,4% bile su žene i 97,1% bili su Japanci.
English: Two of the nine cases were excluded by the MAH because they were not considered valid, and in the remaining five cases the MAH excluded a causal relationship in addition to the reporter.
Croatian: Nositelj odobrenja smatrao je nevažećim dva od devet slučajeva te ih je isključio, a u preostalih pet slučajeva nositelj odobrenja, kao i izvjestitelj, isključili su uzročno-posljedičnu povezanost.
English: Plasma concentrations of naldemedine in subjects with ESRD requiring dialysis were similar when naldemedine was administered either pre- or post-haemodialysis, indicating that naldemedine was not removed from the blood by haemodialysis.
Croatian: Koncentracije naldemedina u plazmi ispitanika s ESRD-om na hemodijalizi bile su slične bez obzira na to je li naldemedin primijenjen prije ili poslije hemodijalize, što znači da se naldemedin hemodijalizom nije uklonio iz krvi.
English: - if you suffer from symptoms of opioid withdrawal syndrome (see section 4 Possible side effects) which can develop within minutes to several days after taking a medicine such as Rizmoic.
Croatian: Odmah se obratite liječniku i prestanite uzimati Rizmoic. - ako bolujete od simptoma sindroma ustezanja od opioida (pogledajte dio 4 „Moguće nuspojave“) koji se može razviti u roku od nekoliko minuta do nekoliko dana nakon uzimanja lijeka kao što je Rizmoic.
English: A patient who took a single dose of naldemedine 1 mg experienced severe drug withdrawal syndrome, including nausea and stomach cramping and was given esomeprazole and ondansetron for nausea and midazolam hydrochloride for stomach cramping.
Croatian: Jedan bolesnik koji je uzeo jednu dozu od 1 mg naldemedina razvio je teški sindrom ustezanja od lijeka, uključujući mučninu i grčeve u trbuhu, te je dobio esomeprazol i ondanzetron za mučninu i midazolam hidroklorid za grčeve u trbuhu.
English: It is a medicine used in adults to treat constipation caused by pain medicines, called opioids (e.g morphine, oxycodone, fentanyl, tramadol, codeine, hydromorphone, methadone).
Croatian: To je lijek koji se primjenjuje u odraslih za liječenje zatvora uzrokovanog analgeticima koji se nazivaju opioidi (npr. morfij, oksikodon, fentanil, tramadol, kodein, hidromorfon, metadon).
English: In the LIR subgroup, a greater proportion of responders was observed with naldemedine (46.4%) compared with placebo (30.2%) and the difference between groups (16.2%) was statistically significant (p<0.0001).
Croatian: U LIR-podskupini opažen je veći udio bolesnika s terapijskim odgovorom uz naldemedin (46,4%) nego uz placebo (30,2%), a razlika između skupina (16,2%) bila je statistički značajna (p<0,0001).
English: Pack sizes of 7, 10, 28, 30, 84 or 100 film-coated tablets.
Croatian: Veličine pakiranja od 7, 10, 28, 30, 84 ili 100 filmom obložene tablete.
English: Gastrointestinal disorders
Croatian: Gastrointestinalne nuspojave
English: A total of 547 patients in Study V9231, 551 patients in Study V9232 and 1246 patients in Study V9235 were randomised in a 1:1 ratio to receive 200 micrograms of naldemedine or placebo once daily for 12 weeks for Studies V9231 and V9232, for 52 weeks for Study V9235.
Croatian: Ukupno 547 bolesnika u ispitivanju V9231, 551 bolesnik u ispitivanju V9232 i 1246 bolesnika u ispitivanju V9235 bilo je randomizirano u omjeru 1:1 u skupine koje su primale 200 mikrograma naldemedina ili placebo jedanput dnevno tijekom 12 tjedana u ispitivanjima V9231 i V9232 te tijekom 52 tjedna u ispitivanju V9235.
English: Rizmoic may be used with or without laxative(s).
Croatian: Rizmoic se može primjenjivati s laksativom (laksativima) ili bez laksativa.
English: Uncommon Rare
Croatian: Manje često Rijetko
English: Naldemedine is not removed from the body by haemodialysis.
Croatian: Naldemedin se ne uklanja iz tijela hemodijalizom.
English: For Study V9235, the efficacy of naldemedine vs. placebo was assessed as secondary endpoints by the frequency of BMs as presented in Table 4.
Croatian: U ispitivanju V9235, djelotvornost naldemedina naspram placeba bila je procijenjena kao sekundarna mjera ishoda po učestalosti pražnjenja crijeva, kako je prikazano u tablici 4.