natgillin/translations-raw huggingface dataset:
The primary efficacy endpoint for Study V9235 was the change in the frequency of BMs per week from baseline to Weeks 12, 24, 36 and 52. 
Primarna mjera ishoda djelotvornosti u ispitivanju V9235 bila je promjena učestalosti pražnjenja crijeva tjedno od početka ispitivanja do 12., 24., 36. i 52. tjedna.
(≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data). 
vrlo rijetko (<1/10 000) i nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
Patients with cardiovascular disease risk factors were not excluded from the naldemedine clinical trial programme, with BMI ≥ 30 kg/m2, and a medical history of hypertension and/or dyslipidaemia being the most commonly reported risk factors. 
Bolesnici s čimbenicima rizika za kardiovaskularnu bolest nisu bili isključeni iz programa kliničkog ispitivanja naldemedina, s time da su najčešće zabilježeni čimbenici rizika bili indeks tjelesne mase (ITM) ≥30 kg/m2 te hipertenzija i/ili dislipidemija u anamnezi.
In Studies V9231 and V9232, OIC was confirmed through a 2-week run-in period and was defined as no more than 4 spontaneous bowel movements (SBMs) total over 14 consecutive days and <3 SBMs in a given week with at least 25% of the SBMs associated with one or more of the following conditions: (1) straining, (2) hard or lumpy stools; (3) having a sensation of incomplete evacuation; and (4) having a sensation of anorectal obstruction/blockage. 
U ispitivanjima V9231 i V9232, konstipacija uzrokovana opioidima bila je potvrđena tijekom dvotjednog uvodnog (engl. run-in) razdoblja, a definirana je kao ne više od ukupno 4 spontana pražnjenja crijeva u 14 uzastopnih dana i <3 spontana pražnjenja crijeva u danom tjednu uz najmanje 25% spontanih pražnjenja crijeva povezanih s jednim ili više sljedećih stanja: (1) naprezanje, (2) tvrde ili kugličaste stolice; (3) osjećaj nepotpunog pražnjenja crijeva; i (4) osjećaj anorektalne opstrukcije/blokade.
Naldemedine is absorbed with a time to achieve peak plasma concentration of approximately 0.75 hours in the fasted state. 
Naldemedin se apsorbira tijekom vremena i postiže vršnu vrijednost koncentracije u plazmi nakon približno 0,75 sati u stanju natašte.
If you forget to take Rizmoic 
Ako ste zaboravili uzeti Rizmoic
Concomitant use with strong CYP3A inducers is not recommended (see section 4.5). 
Ne preporučuje se istodobna primjena s jakim induktorima CYP3A (vidjeti dio 4.5).
Caution should be exercised with regards to opioid withdrawal. 
Kod ustezanja od opioida potreban je oprez.
From baseline to the last 2 weeks of treatment*** 
2 tjedna liječenja***
Concomitant use of naldemedine with moderate CYP3A inducers (e.g. efavirenz) has not been established and should be used with caution (see section 4.5). 
Istodobna primjena naldemedina s umjerenim induktorima CYP3A (npr. efavirenzom) nije ustanovljena i treba je provoditi s oprezom (vidjeti dio 4.5).
Opioid withdrawal syndrome 
Sindrom ustezanja od opioida
Cases of gastrointestinal perforation have been reported in the post-marketing setting, including fatal cases, when naldemedine was used in patients who were at an increased risk of gastrointestinal (GI) perforation, (e.g. diverticular disease and underlying malignancies of the gastrointestinal tract or peritoneal metastases). 
U razdoblju nakon stavljanja lijeka u promet zabilježeni su slučajevi gastrointestinalne perforacije, uključujući i slučajeve sa smrtnim ishodom, kada se naldemedin primjenjivao u bolesnika u kojih je postojao povećan rizik od gastrointestinalne perforacije (npr. divertikuloza i osnovne zloćudne bolesti gastrointestinalnog trakta ili metastaze na peritoneumu).
A responder was defined as a patient with ≥3 frequency of SBMs per week and an increase from baseline ≥1 SBM per week during the 2-week Treatment Period 
Bolesnik s terapijskim odgovorom definiran je kao bolesnik s učestalošću spontanog pražnjenja crijeva ≥3 tjedno i povećanjem u odnosu na početak za ≥1 spontano pražnjenje crijeva tjedno tijekom dvotjednog razdoblja liječenja.
Cases of gastrointestinal perforation have been reported in post-marketing setting, including fatal cases, when naldemedine was used in patients who were at an increased risk of gastrointestinal perforation. 
Slučajevi gastrointestinalne perforacije, uključujući smrtne slučajeve, prijavljeni su i u razdoblju nakon stavljanja lijeka u promet kada se naldemedin primjenjivao u bolesnika u kojih je postojao povećan rizik od gastrointestinalne perforacije.
The primary endpoint for Studies V9231 and V9232 was the proportion of SBM responders, defined as: ≥3 SBMs per week and a change from baseline of ≥1 SBM per week for at least 9 out of the 12 study weeks and 3 out of the last 4 weeks. 
Primarna mjera ishoda u ispitivanjima V9231 i V9232 bila je udio ispitanika s terapijskim odgovorom u vidu spontanog pražnjenja crijeva definiranog kao: ≥3 spontana pražnjenja crijeva tjedno i promjena u odnosu na početak za ≥1 spontanog pražnjenja crijeva tjedno tijekom najmanje 9 od 12 tjedana ispitivanja i tijekom 3 od zadnja 4 tjedna.
Patients with known or suspected gastrointestinal obstruction or perforation or patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation (see section 4.4). 
Bolesnici u kojih se zna ili sumnja na to da imaju gastrointestinalnu opstrukciju ili perforaciju ili bolesnici s povećanim rizikom od rekurentne opstrukcije, zbog mogućnosti nastanka gastrointestinalne perforacije (vidjeti dio 4.4).
The adverse reactions with naldemedine 200 microgram tablets in patients with chronic non-cancer pain and OIC and in patients with cancer and OIC reported in clinical studies are presented in the tables according to the MedDRA system organ classification. 
Nuspojave tableta naldemedina od 200 mikrograma u bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima i u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima zabilježene u kliničkim ispitivanjima, prikazane su u tablicama prema MedDRA-inoj klasifikaciji organskih sustava.
The primary endpoint for Study V9236 and the secondary endpoint, without multiplicity adjustment, for Study V9222 were the proportion of SBM responders during the 2-week Treatment Period. 
Primarna mjera ishoda u ispitivanju V9236 i sekundarna mjera ishoda u ispitivanju V9222, bez podešavanja na višestruko testiranje, bila je udio bolesnika s odgovorom u vidu spontanog pražnjenja crijeva tijekom dvotjednog razdoblja liječenja.
Naldemedine has not been studied in patients with severe hepatic impairment. 
Naldemedin nije ispitan u bolesnika s teškim oštećenjem funkcije jetre.
How to take Rizmoic 
Kako uzimati Rizmoic
In the pre- and postnatal development study in rats, one dam died at parturition at 1000 mg/kg/day, and poor nursing, suppression of body weight gain and decrease in food consumption were noted at 30 and 1000 mg/kg/day. 
U ispitivanjima prenatalnog i postnatalnog razvoja u štakora, jedna je skotna ženka uginula tijekom koćenja pri dozi od 1000 mg/kg na dan, dok su slabo dojenje, izostanak dobivanja na tjelesnoj težini i smanjenje uzimanja hrane zabilježeni pri dozama od 30 i 1000 mg/kg na dan.
Concomitant use of naldemedine with moderate inducers (e.g. efavirenz) has not been established, and patients should be monitored (see section 4.4). 
Istodobna primjena naldemedina s umjerenim induktorima (npr. efavirenzom) nije ustanovljena te je bolesnike potrebno pratiti (vidjeti dio 4.4).
Manufacturing Packaging Farmaca (MPF) bv Neptunus 12 
Manufacturing Packaging Farmaca (MPF) putem Neptunus 12
In Study V9235, OIC was confirmed through a 2-week run-in period and was defined as no more than 4 SBMs total over 14 consecutive days and <3 SBMs in a given week. 
U ispitivanju V9235, konstipacija uzrokovana opioidima bila je potvrđena tijekom dvotjednog uvodnog razdoblja, a definirana je kao ne više od ukupno 4 spontana pražnjenja crijeva u 14 uzastopnih dana i <3 spontana pražnjenja crijeva u danom tjednu.
In Studies V9231 and V9232, patients who, based on concomitant medication records, were on laxative therapy prior to entering the study and who stopped its use within 30 days prior to Screening, and had self-reported OIC, were considered to be a LIR. 
U ispitivanjima V9231 i V9232, LIR-bolesnicima smatrali su se bolesnici koji su, na temelju zabilježenih istodobno uzimanih lijekova, bili na terapiji laksativima prije ulaska u ispitivanje i koji su prestali s uzimanjem laksativa unutar 30 dana prije probira te su prijavili da imaju konstipaciju uzrokovanu opioidima.
In Study V9232, they were back pain (53.6%); pain (10.2%) and arthralgia (7.8%). 
U ispitivanju V9232, najčešće su bile bol u leđima (53,6%); bol (10,2%) i artralgija (7,8%).
There was no adverse effect on pre- and postnatal development at 1 mg/kg/day (12 times the exposure [AUC0-24hr] in humans at an oral dose of 200 micrograms). 
Nije bilo štetnog učinka na prenatalni i postnatalni razvoj pri dozi od 1 mg/kg na dan (12 puta veća izloženost [AUC0-24hr] nego u ljudi kod primjene peroralne doze od 200 mikrograma).
Concomitant use of moderate CYP3A inhibitors such as fluconazole, may increase the plasma concentration of naldemedine. 
Istodobna primjena umjerenih inhibitora CYP3A poput flukonazola može povećati koncentracije naldemedina u plazmi.
If used with moderate CYP3A inhibitors, monitor for adverse reactions. 
Ako se primjenjuje s umjerenim inhibitorima CYP3A, pratite bolesnika zbog mogućih nuspojava.
Common (may affect up to 1 in 10 people): 
Često (mogu se pojaviti u najviše 1 na 10 osoba):
The discontinuation rate due to gastrointestinal treatment emergent adverse events with naldemedine 200 micrograms compared to placebo was 3.2% and 1% respectively in patients with chronic non-cancer pain and OIC and 4.5% and 0% respectively for patients with cancer and OIC. 
Stopa prekida terapije zbog gastrointestinalnih štetnih događaja nastalih tijekom liječenja naldemedinom u dozi od 200 mikrograma iznosila je 3,2% u usporedbi s 1% uz placebo u bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima te 4,5% odnosno 0% u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima.
Abdominal pain, diarrhoea, nausea and vomiting were the most commonly reported adverse reactions in clinical studies with patients with chronic non-cancer pain and OIC and with patients with cancer and OIC. 
Bol u abdomenu, proljev, mučnina i povraćanje bile su najčešće zabilježene nuspojave u kliničkim ispitivanjima u bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima te u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima.
Clinical studies in patients with chronic non-cancer pain and OIC The safety and efficacy of naldemedine was evaluated in two identical, 12-week randomised, doubleblind placebo-controlled trials (Studies V9231 and V9232) in which naldemedine was used without laxatives and in a third long-term 52-week randomised, double-blind placebo-controlled trial (Study V9235) in which naldemedine was used with or without stable laxatives in patients with chronic noncancer pain and OIC. 
Sigurnost i djelotvornost naldemedina procijenjene su u bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima u dva identična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja u trajanju od 12 tjedana (ispitivanja V9231 i V9232) u kojima se naldemedin primjenjivao bez laksativa, te u trećem dugotrajnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 52 tjedna (ispitivanje V9235) u kojem se naldemedin primjenjivao s laksativima u stabilnoj dozi ili bez njih.
The most commonly reported adverse reactions in patients with cancer and OIC were diarrhoea (24.5%) and abdominal pain (3.9%). 
Najčešće zabilježene nuspojave u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima bile su proljev (24,5%) i bol u abdomenu (3,9%).
In studies V9222 and V9236, OIC was confirmed through a 2-week run-in period and was defined as ≤5 SBMs during the 14 consecutive days prior to the randomisation and ≥1 of the following bowel symptoms in ≥25% of all BMs regardless of the use of rescue laxatives: presence of straining during bowel movement, feeling of incomplete evacuation, passage of hard stools or small pellets. 
U ispitivanjima V9222 i V9236, konstipacija uzrokovana opioidima bila je potvrđena tijekom dvotjednog uvodnog razdoblja i definirana kao ≤5 spontanih pražnjenja crijeva tijekom 14 uzastopnih dana prije randomizacije i ≥1 od sljedećih crijevnih simptoma u ≥25% svih pražnjenja crijeva bez obzira na primjenu laksativa za hitno olakšanje tegoba: prisutnost naprezanja tijekom pražnjenja crijeva, osjećaj nepotpuno ispražnjenih crijeva, tvrda stolica ili stolica u obliku kuglica.
The effect of hepatic impairment on the pharmacokinetics of a single 200 microgram dose of naldemedine was studied in subjects with hepatic impairment classified as mild (Child-Pugh class A) or moderate (Child-Pugh class B) and compared with healthy subjects with normal hepatic function. 
Učinak oštećenja funkcije jetre na farmakokinetiku jedne doze naldemedina od 200 mikrograma ispitan je u ispitanika s oštećenjem funkcije jetre kategoriziranim kao blago (Child-Pugh stadij A) ili umjereno oštećenje (Child-Pugh stadij B) i uspoređen sa zdravim ispitanicima s normalnom funkcijom jetre.
Concomitant use of strong CYP3A inhibitors such as grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin should be avoided. 
Potrebno je izbjegavati istodobnu primjenu jakih inhibitora CYP3A poput soka od grejpa, itrakonazola, ketokonazola, ritonavira, indinavira, sakvinavira, telitromicina i klaritromicina.
Rizmoic 200 micrograms film-coated tablets 
Rizmoic 200 mikrograma filmom obložene tablete
Dose-dependent increases in gastrointestinal-related adverse reactions, including abdominal pain, diarrhoea, and nausea, were observed. 
Opaženo je povećanje nuspojava povezanih s probavnim sustavom ovisno o dozi, uključujući bol u abdomenu, proljev i mučninu.
No adverse effects were observed in male or female fertility and reproductive performance at up to 1000 mg/kg/day (in excess of 16,000 times the exposure [AUC0-24hr] in humans at an oral dose of 200 micrograms). 
Nisu bili opaženi štetni učinci na plodnost mužjaka i ženki te njihovu reproduktivnu sposobnost pri dozama do 1000 mg/kg na dan (više od 16 000 puta veća izloženost [AUC0-24hr] od one u ljudi kod primjene peroralne doze od 200 mikrograma).
Concomitant use of naldemedine with strong CYP3A inducers (e.g. St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin) leads to a decrease in naldemedine exposure and may reduce the efficacy of naldemedine. 
Istodobna primjena naldemedina s jakim induktorima CYP3A (npr. gospinom travom (Hypericum perforatum), rifampicinom, karbamazepinom, fenobarbitalom i fenitoinom) dovodi do smanjene izloženosti naldemedinu i može smanjiti djelotvornost naldemedina.
Patients receiving a stable opioid morphine equivalent daily dose of ≥ 30 mg for at least 4 weeks before enrollment and self-reported OIC were eligible to participate. 
Pogodnima za sudjelovanje smatrali su se bolesnici koji su prije uključenja primali stabilnu dnevnu dozu od ≥30 mg opioida ekvivalentnog morfiju tijekom najmanje 4 tjedna i izjavili su da imaju konstipaciju uzrokovanu opioidima.
The overall benefit-risk of naldemedine should be considered in these patients with close monitoring for symptoms of opioid withdrawal. 
U ovih se bolesnika mora razmotriti cjelokupni omjer koristi i rizika naldemedina uz pažljivo praćenje simptoma ustezanja od opioida.
Opioid withdrawal syndrome aOne serious report of hypersensitivity reaction was observed in clinical studies with naldemedine. 
Opći poremećaji i reakcije na mjestu primjene sindrom ustezanja od opioida aJedan slučaj ozbiljne preosjetljivosti povezane s liječenjem zabilježen je u kliničkim ispitivanjima naldemedina.
Concomitant use with strong CYP3A inhibitors and inducers Concomitant use of naldemedine with strong CYP3A inhibitors (e.g. grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin) leads to an increase in naldemedine exposure and may increase the risk of adverse reactions. 
Istodobna primjena s jakim inhibitorima i induktorima CYP3A Istodobna primjena naldemedina s jakim inhibitorima CYP3A (npr. sokom od grejpa, itrakonazolom, ketokonazolom, ritonavirom, indinavirom, sakvinavirom, telitromicinom i klaritromicinom) dovodi do povećane izloženosti naldemedinu i može povećati rizik od nuspojava.
How to store Rizmoic 
Kako čuvati Rizmoic
Very Common Common 
Vrlo često
In Study V9235, the three most common types of pain were back pain (58.0%); osteoarthritis (9.5%) and neck pain (8.1%). 
U ispitivanju V9235, tri najčešće vrste bola bile su bol u leđima (58,0%); osteoartritis (9,5%) i bol u vratu (8,1%).
CI=Confidence Interval *Statistically significant: p-values based on the Cochran-Mantel-Haenszel test. ** p<0.0001 *** p=0.0003 for study V9231 and p=0.0011 for study V9232 
** p<0,0001 ***p=0,0003 za ispitivanje V9231 i p=0,0011 za ispitivanje V9232.
In the rat fertility and early embryonic development study, prolongation of the dioestrous phase was observed at 10 mg/kg/day and above, but was not observed at 1 mg/kg/day (12 times the exposure [AUC0-24hr] in humans at an oral dose of 200 micrograms). 
U ispitivanju utjecaja na plodnost i rani embrionalni razvoj u štakora bilo je opaženo produljenje faze diestrusa pri dozi od 10 mg/kg na dan i višoj, ali to nije bilo opaženo pri dozi od 1 mg/kg na dan (12 puta veća izloženost [AUC0-24hr] od one u ljudi kod primjene peroralne doze od 200 mikrograma).
The safety and efficacy of naldemedine was also evaluated in 2 randomised, double-blind and placebocontrolled studies (V9222 and V9236) in patients with cancer and OIC. 
Klinička ispitivanja u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima Sigurnost i djelotvornost naldemedina također je bila procijenjena u 2 randomizirana, dvostruko slijepa i placebom kontrolirana ispitivanja (V9222 i V9236) u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima.
Talk to your doctor or pharmacist if you are taking any of the following medicines: - Rifampicin, clarithromycin or telithromycin (antibiotic medicines) - Itraconazole or ketoconazole (medicines to treat fungal infections) - Ritonavir, indinavir or saquinavir (medicines for HIV infection) - Phenytoin, carbamazepine, phenobarbital (medicines to treat epilepsy) - St John's wort (Hypericum perforatum), a herbal medicine used for depression 
- itrakonazol ili ketokonazol (lijekovi za liječenje gljivičnih infekcija) - ritonavir, indinavir ili sakvinavir (lijekovi za liječenje HIV-infekcije) - fenitoin, karbamazepin, fenobarbital (lijekovi za liječenje epilepsije) - gospina trava (Hypericum perforatum), biljni lijek koji se primjenjuje kod depresije.
In Study V9231, the three most common types of pain were back pain (62.0%); neck pain (8.3%) and osteoarthritis (5.3%). 
U ispitivanju V9231, tri najčešće vrste bola bile su bol u leđima (62,0%); bol u vratu (8,3%) i osteoartritis (5,3%).
Stopping Rizmoic while continuing to take your opioid medicine may cause the constipation to return. 
Ako prestanete uzimati Rizmoic dok i dalje uzimate opioidni analgetik, možete ponovno dobiti zatvor.
If naldemedine is used with strong P-gp inhibitors, monitor for adverse reactions. 
Ako se naldemedin primjenuje s jakim inhibitorima P-gp-a, pratite bolesnika zbog mogućih nuspojava.
The efficacy and safety of naldemedine has been established in patients with chronic non-cancer pain and OIC and in patients with cancer and OIC. 
Djelotvornost i sigurnost naldemedina ustanovljene su u bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima te u bolesnika s karcinomom i konstipacijom uzrokovanom opioidima.
• fever 
• vrućicu
Concomitant use with strong CYP3A inhibitors should be avoided. 
Istodobnu primjenu s jakim inhibitorima CYP3A treba izbjegavati.
The majority of these gastrointestinal adverse reactions were of mild to moderate severity and resolved without discontinuation of naldemedine treatment. 
Ove gastrointestinalne nuspojave bile su većinom blage do umjereno teške i povukle su se bez prekida primjene naldemedina.
You should stop taking Rizmoic when you stop taking your opioid pain medicine. 
Ako prestanete uzimati opioidni analgetik Trebate prestati uzimati Rizmoic kad prestanete uzimati opioidni analgetik.
Concomitant use of strong CYP3A inducers such as St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital and phenytoin is not recommended. 
Ne preporučuje se istodobna primjena jakih induktora CYP3A poput gospine trave (Hypericum perforatum), rifampicina, karbamazepina, fenobarbitala i fenitoina.
• nausea (feeling sick) or vomiting 
• mučninu ili povraćanje
• If you experience a serious allergic reaction, stop taking Rizmoic and see a doctor or go to a hospital straight away.. Serious allergic reactions include: swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash. 
Ozbiljna alergijska reakcija uključuje: oticanje šaka, stopala, gležnjeva, lica, usana ili grla, što može otežati gutanje ili disanje, svrbež kože i koprivnjača.
All study participants took laxatives previously for the treatment of OIC. 
Svi bolesnici u ispitivanju prethodno su uzimali laksative za liječenje konstipacije uzrokovane opioidima.
The pharmacokinetics of naldemedine after administration of a single 200 microgram dose of naldemedine was studied in subjects with mild, moderate or severe renal impairment, or with endstage renal disease (ESRD) requiring haemodialysis, and compared with healthy subjects with normal renal function. 
Farmakokinetika naldemedina nakon primjene jedne doze od 200 mikrograma naldemedina ispitana je u ispitanika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega ili završnim stadijem bolesti bubrega (engl. end-stage renal disease, ESRD) koja zahtijeva hemodijalizu te uspoređena s onom u zdravih ispitanika s normalnom funkcijom bubrega.
Croscarmellose sodium Magnesium stearate 
Jezgra tablete manitol karmelozanatrij, umrežena magnezijev stearat
If use with strong CYP3A inhibitors is unavoidable, monitor for adverse reactions (see section 4.4). 
Ako se primjena s jakim inhibitorima CYP3A ne može izbjeći, pratite bolesnika zbog mogućih nuspojava (vidjeti dio 4.4).
• a stomach ulcer; 
• vrijed želuca
Naldemedine also undergoes cleavage in the gastrointestinal tract to form benzamidine and naldemedine carboxylic acid. 
Naldemedin se i cijepa u gastrointestinalnom traktu, čime nastaju benzenkarboksamid i naldemedinkarboksamid.
• Periodic safety update reports 
Periodička izvješća o neškodljivosti
No dose adjustment is required in patients with renal impairment (see section 5.2). 
Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
Opioid withdrawal syndrome aMedDRA Preferred Terms: abdominal pain, abdominal pain upper, abdominal pain lower and abdominal discomfort 
Opći poremećaji i reakcije na mjestu primjene sindrom ustezanja od opioida aMedDRA preporučeni pojmovi: bol u abdomenu, bol u gornjem dijelu abdomena, bol u donjem dijelu abdomena i nelagoda u abdomenu
Placental transfer of [carbonyl-14C]-naldemedine-derived radioactivity was observed in pregnant rats. 
U skotnih ženki štakora opažen je placentalni prijenos radioaktivnosti s porijeklom iz [karbonil-14C]naldemedina.
A single dose of naldemedine up to 100 mg and multiple doses of up to 30 mg/day for 10 days were administered to healthy volunteers in clinical studies. 
Zdravim dobrovoljcima u kliničkim ispitivanjima davana je jedna doza naldemedina do 100 mg i višestruke doze do 30 mg na dan tijekom 10 dana.