natgillin/translations-raw huggingface dataset:
In the prevention of osteoporosis, women receiving Evista had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%. 
Pri preprečevanju osteoporoze se je pri ženskah, ki so prejemale zdravilo Evista, v dveh letih gostota kosti v kolkih ali hrbtenici povečala za 1,6 %, pri tistih, ki so prejemale placebo, pa se je zmanjšala za
What is Evista used for? 
Za kaj se zdravilo Evista uporablja?
The Committee decided that Evista's benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women. 
Odbor je sklenil, da so koristi zdravila Evista pri zdravljenju in preprečevanju osteoporoze pri ženskah po menopavzi večje od z njim povezanih tveganj.
How is Evista used? 
Kako se zdravilo Evista uporablja?
The full EPAR for Evista is available here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Evista je na voljo tukaj.
How has Evista been studied? 
Kako je bilo zdravilo Evista raziskano?
What is Evista? 
Kaj je zdravilo Evista?
There was no effect of Evista on hip fractures. 
Na zlome kolkov zdravilo Evista ni imelo učinka.
How does Evista work? 
Kako zdravilo Evista deluje?
Both of these cases were fatal. 
Oba ta primera sta bila smrtna.
Date of first authorisation: 18 February 2019 
Datum prve odobritve: 18. februar 2019
The apparent volume of distribution is approximately 155 litres. 
Navidezni volumen porazdelitve je približno 155 litrov.
It may be taken at any time of the day but it is recommended to be taken at the same time every day. 
Lahko se jemlje ob katerem koli času dneva, vendar ga je priporočljivo jemati vsak dan ob istem času.
Do not take this medicine if any of the above applies to you. 
Ne jemljite tega zdravila, če karkoli od zgoraj navedenega velja za vas.
- if you have had a heart attack within the last 3 months or if you have other severe problems with your heart which cause daily symptoms 
- če ste v zadnjih 3 mesecih doživeli srčni infarkt ali če imate druge hude težave s srcem, ki povzročajo vsakodnevne simptome;
- The other ingredients are: 
- Druge sestavine zdravila so:
Treatment Difference [95% Cl] 
razlika zaradi zdravljenja [95 % IZ]
This medicine is not for children or adolescents under the age of 18 years because the effects of the medicine in children and adolescents are not known. 
To zdravilo ni namenjeno za otroke ali mladostnike, mlajše od 18 let, ker učinki zdravila pri otrocih in mladostnikih niso znani.
Hexal AG 
DE Hexal AG
Prior to enrollment, patients had been using their current opioid for an average of 5 years. 
Pred vključitvijo v študijo so bolniki uporabljali svoj trenutni opioid povprečno 5 let.
However, once you start taking the medicine, take it at around the same time each day. 
Ko pa zdravilo začnete jemati, ga jemljite vsak dan ob približno istem času.
Film-coated tablet (tablet). 
Filmsko obložena tableta (tableta).
There is no clinically significant food effect. 
Hrana nima klinično pomembnega učinka.
• You can take Rizmoic at any time of the day, with food or between meals. 
• Zdravilo Rizmoic lahko jemljete ob katerem koli času dneva, bodisi s hrano ali med obroki.
Approximately 20% of the naldemedine dose is excreted unchanged in urine. 
Približno 20 % odmerka naldemedina se je izločilo nespremenjenega v urinu.
However if it is less than 12 hours until your next dose, skip the missed dose, and wait until it is time to take your next tablet. 
Če pa je do vašega naslednjega odmerka manj kot 12 ur, preskočite izpuščeni odmerek in počakajte do takrat, ko bo čas za naslednjo tableto.
Age, gender, body weight and race 
Starost, spol, telesna masa in rasa
The safety and efficacy of naldemedine in children and adolescents aged below 18 years have not yet been established. 
Varnosti in učinkovitosti naldemedina pri otrocih in mladostnikih, mlajših od 18 let, še niso dokazali.
Not Known (frequency cannot be estimated from the available data) 
Neznana (ni mogoče oceniti iz razpoložljivih podatkov):
The effects of the medicine in pregnant women are not known. 
Učinki zdravila pri nosečnicah niso znani.
Patients with OIC 
Bolniki z OIC
Your doctor will advise you about whether you can use Rizmoic if you are pregnant. 
Zdravnik vam bo svetoval, ali lahko jemljete zdravilo Rizmoic, če ste noseči.
Pharmacokinetics in subpopulations 
Farmakokinetika v podskupinah
The studies included a 2-week Screening Period, 2-week Treatment Period and 4-week Follow-up Period. 
Študije so vključevale 2-tedensko obdobje presejanja, 2-tedensko obdobje zdravljenja in 4-tedensko obdobje kontroliranja po zdravljenju.
A SBM was defined as a bowel movement (BM) without rescue laxative taken within the past 24 hours. 
SBM je bilo opredeljeno kot iztrebljanje (bowel movement - BM) brez uporabe rešilnega odvajala v zadnjih 24 urah.
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Učinki drugih zdravil na naldemedin
The absolute bioavailability of naldemedine is estimated to be in the range of 20% to 56%. 
Ocenjujejo, da je absolutna biološka uporabnost naldemedina v mejah od 20 % do 56 %.
Opioid withdrawal syndrome typically develops within minutes to several days following administration of an opioid antagonist. 
Sindrom odtegnitve opioidov se značilno razvije nekaj minut do več dni po uporabi opioidnega antagonista.
It is therefore considered that the presented cases are sufficient to support an update to the product information to both section 4.4 and 4.8. 
Mnenje je, da ob upoštevanju teh informacij predstavljeni primeri zadostno podpirajo posodobitev informacij o zdravilu v poglavjih 4.4 in 4.8.
• hairs of the skin standing on end 
• dlačice na koži se postavijo pokonci,
Gastrointestinal perforation is added a new adverse reaction with a frequency “Not known”. 
Gastrointestinalna perforacija je dodana kot nov neželeni učinek s pogostnostjo “neznana”.
Rizmoic should be taken once daily, with or without food (see section 5.2). 
Zdravilo Rizmoic je treba jemati enkrat na dan, s hrano ali brez nje (glejte poglavje 5.2).
A QTc study performed with naldemedine in healthy volunteers did not indicate any prolongation of the QT interval. 
Študija intervala QTc, opravljena z naldemedinom pri zdravih prostovoljcih, ni pokazala podaljšanja intervala QT.
If you miss a tablet of Rizmoic, take it as soon as you remember. 
Če ste pozabili vzeti tableto zdravila Rizmoic, jo vzemite takoj, ko se spomnite.
Treatment difference 
razlika zaradi zdravljenja
Whilst the more limited information provided in these five cases is acknowledged the assessor considers that the potential role of Naldemedine cannot be excluded in all of these. 
Kljub potrditvi, da so razpoložljivi podatki v teh petih primerih pomanjkljivi, po mnenju ocenjevalca, v nobenem od teh primerov ni mogoče izključiti možne vloge naldemedina.
• Gastrointestinal perforation (a hole developing in the bowel wall) 
• gastrointestinalna perforacija (v črevesni steni nastane luknja).
The overall benefit risk for each patient should be taken into account. 
Pri vsakem bolniku je treba upoštevati celotno razmerje koristi in tveganja.
- if you are taking certain medicines such as itraconazole to treat fungal infections, or an antibiotic called rifampicin to treat tuberculosis and other infections. 
- če jemljete nekatera zdravila, na primer itrakonazol, za zdravljenje glivičnih okužb, ali antibiotik, ki se imenuje rifampicin, za zdravljenje tuberkuloze in drugih okužb.
• sweating 
• znojenje,
(95% CI: 10.8%, 27.0%, p<0.0001*) 
(95 % IZ: 10,8 %, 27,0 %, p < 0,0001*)
The symptoms resolved. 
Simptomi so izzveneli.
• diverticulitis (an illness where your gut is inflamed); 
• divertikulitis (bolezen, pri kateri je črevo vneto);
The efficacy and safety were also assessed in the laxative inadequate responders (LIR) and non-LIR subgroups. 
Učinkovitost in varnost so ocenili tudi v podskupinah preiskovancev, ki so se nezadostno odzvali na odvajalo (laxative inadequate responders - LIR) in preiskovancev, ki niso prejemali odvajala (non-LIR).
Kingsfordweg 151 1043GR Amsterdam The Netherlands 
Kingsfordweg 151 1043GR Amsterdam
These patients should be clinically monitored when taking Rizmoic. 
Te bolnike je treba med jemanjem zdravila Rizmoic klinično spremljati.
Patients responding, n (%) p value* *Statistically significant: p-values based on the Chi-square test. 
bolniki, ki so se odzvali na zdravljenje, n (%) vrednost p* *Statistično značilno: vrednosti p na podlagi testa hi kvadrat.
- if you have severe diarrhoea or stomach ache, tell your doctor, so that the doctor can monitor you and treat you with rehydration and appropriate medicines if needed. 
- če imate hudo drisko ali bolečine v trebuhu, povejte zdravniku, da vas bo zdravnik lahko spremljal in po potrebi zdravil z rehidracijo in ustreznimi zdravili.
The package leaflet is updated accordingly. 
Navodilo za uporabo je ustrezno posodobljeno.
Patients should be advised to report severe, persistent or worsening symptoms to their physician. 
Bolnikom je treba svetovati, naj o hudih, trdovratnih ali naraščajočih simptomih poročajo svojemu zdravniku.
If you have these conditions and develop opioid withdrawal symptoms (see section 4) or if the opioid medicine no longer controls your pain, contact your doctor immediately. 
Če imate katero od teh bolezni in se pri vas razvijejo simptomi odtegnitve opioidov (glejte poglavje 4) ali vam opioidno zdravilo ne obvladuje več bolečine, se takoj posvetujte z zdravnikom;
In juvenile toxicity studies in rats, at the same dose levels, exposure in juvenile animals (PND 10) was increased compared to adult animals (2.3 to 7.4-fold). 
V študijah juvenilne toksičnosti pri podganah pri enakih ravneh odmerkov je bila izpostavljenost pri juvenilnih živalih (PND 10) v primerjavi z odraslimi živalmi zvečana (za 2,3 do 7,4-krat).
- 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. 
- če imate simptome sindroma odtegnitve opioidov (glejte poglavje 4 Možni neželeni učinki), ki se lahko razvijejo v času od nekaj minut do več dni po jemanju zdravila, kakršno je zdravilo Rizmoic.
Interaction with strong P-gp inhibitors 
Interakcije z močnimi inhibitorji P-gp
7 film-coated tablets 10 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 100 film-coated tablets 
7 filmsko obloženih tablet 10 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 84 filmsko obloženih tablet 100 filmsko obloženih tablet
• The recommended dose is one 200 microgram tablet once daily. 
• Priporočeni odmerek je ena 200-mikrogramska tableta enkrat na dan.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Therefore, treatment with naldemedine is not expected to alter the pharmacokinetics of co-administered medicines that are substrates of these enzymes and transporters. 
Zato ne pričakujemo, da bo zdravljenje z naldemedinom spremenilo farmakokinetiko sočasno uporabljanih zdravil, ki so substrati teh encimov in prenašalcev.
• feeling depressed 
• občutek potrtosti,
(95% CI: 4.8%, 21.3%, p=0.0020*) 
(95 % IZ: 4,8 %, 21,3 %, p=0,0020*)
In Study V9235, patients on a stable laxative regimen at screening (52.4%) were allowed to continue using that same regimen without change throughout the study duration. 
V študiji V9235 je bilo bolnikom na stabilni shemi odvajal ob presejanju (52,4 %) dovoljeno še naprej uporabljati isto shemo brez sprememb ves čas trajanja študije.
Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists, ATC code: A06AH05. 
Farmakoterapevtska skupina: zdravila proti zaprtju, periferno delujoči antagonisti opioidnih receptorjev, oznaka ATC: A06AH05.
contact@shionogi.eu 
contattaci@shionogi.eu
Due to the limited therapeutic experience in patients 75 years old and older, naldemedine therapy should be initiated with caution in this age group. 
Zaradi omejenih terapevtskih izkušenj pri bolnikih, starih 75 let ali več, je treba pri tej starostni skupini zdravljenje z naldemedinom uvajati previdno.
Stop taking Rizmoic and contact your doctor if you get a combination of 3 or more of the following symptoms of opioid withdrawal on the same day: 
Prenehajte jemati zdravilo Rizmoic in se obrnite na zdravnika, če dobite istega dne kombinacijo 3 ali več od naslednjih simptomov odtegnitve opioidov:
Naldemedine should not be used during pregnancy unless the clinical condition of the woman requires treatment with naldemedine. 
Naldemedina v nosečnosti ne smemo uporabljati, razen če klinično stanje nosečnice zahteva zdravljenje z naldemedinom.
NL-8448 CN Heerenveen 8448 CN Heerenveen 
NL-8448 CN Heerenveen 8448 CN Heerenveen Nizozemska
See 'Other medicines and Rizmoic'. 
Glejte 'Druga zdravila in zdravilo Rizmoic'.
Alteration of the analgesic dosing regimen prior to initiating Rizmoic is not required. 
Spreminjanje sheme odmerjanja analgetika pred uvajanjem zdravila Rizmoic ni potrebno.
If you are being treated with an opioid medicine for cancer. 
Če se zdravite z opioidnim zdravilom zaradi raka.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
4.3 Kontraindikacije Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
In vitro data also showed that naldemedine is not a direct inhibitor of OATP1B1, OATP1B3, OAT1 and OAT3 transporters. 
Podatki in vitro so pokazali tudi, da naldemedin ni direkten inhibitor prenašalcev OATP1B1, OATP1B3, OAT1 in OAT3.
In the event of an overdose, patients should be closely monitored for potential signs and symptoms of opioid withdrawal syndrome (see section 4.4) and provided with appropriate supportive care. 
V primeru prevelikega odmerka je treba bolnike skrbno spremljati glede možnih znakov in simptomov sindroma odtegnitve opioidov (glejte poglavje 4.4) in jim nuditi ustrezno podporno nego.
Subjects were required to be treated with opioids for ≥14 days prior to Screening and had to be receiving a stable dose. 
Preiskovanci so morali biti zdravljeni z opioidi ≥ 14 dni pred presejanjem in so morali prejemati stabilen odmerek.
Based on these data, naldemedine can be taken with or without food (see section 4.2). 
Na podlagi teh podatkov se naldemedin lahko jemlje s hrano ali brez nje (glejte poglavje 4.2).
Do not breast-feed during treatment with Rizmoic as it is not known if naldemedine passes into breast milk. 
Med zdravljenjem z zdravilom Rizmoic ne dojite, ker ni znano, ali naldemedin prehaja v materino mleko.
Rizmoic must be discontinued if treatment with the opioid pain medicinal product is discontinued. 
Zdravilo Rizmoic je treba ukiniti, če se prekine zdravljenje z opioidnim protibolečinskim zdravilom.
• an enlarged colon due to a condition known as Ogilvie's syndrome; 
• zvečano debelo črevo zaradi bolezni, ki se imenuje Ogilviejev sindrom;
At therapeutic doses, most opioids (e.g morphine, meperidine, methadone) are excreted into breast milk in minimal amounts. 
V terapevtskih odmerkih se večina opioidov (npr. morfin, meperidin, metadon) v minimalnih količinah izloča v mleko.
The European Medicines Agency has deferred the obligation to submit the results of studies with Rizmoic in one or more subsets of the paediatric population in the treatment of opioid-induced constipation (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Rizmoic za eno ali več podskupin pediatrične populacije za zdravljenje z opioidi povzročenega zaprtja (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
For patients receiving laxative therapy at the Screening visit, it had to be continued at a stable dose until the end of the Treatment Period. 
Bolniki, ki so ob presejalnem pregledu prejemali zdravljenje z odvajali, so morali nadaljevati s stabilnim odmerkom do konca obdobja zdravljenja.
Available data in rats have shown excretion of naldemedine in milk (see section 5.3). 
Podatki, ki so na voljo pri podganah, so pokazali izločanje naldemedina v mleko (glejte poglavje 5.3).
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. 
Ugotovili so tudi tri dni zgodnejše vaginalno odprtje, ki kaže na zgodnji nastop spolne zrelosti, a le pri velikih izpostavljenostih, za katere so smatrali, da dovolj presegajo največjo človeško izpostavljenost pri peroralnem odmerku 200 mikrogramov.
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). 
V primeru hude driske ali bolečin v trebuhu je treba bolnika spremljati in zdraviti dehidracijo z uporabo rehidracije in ustreznega zdravljenja po potrebi (glejte poglavje 4.8).
The agreed update is aligned with the wording reflected in the product informations for methylnaltrexone and naloxegol. 
Dogovorjena posodobitev je usklajena z besedilom v informacijah o zdravilu za metilnaltrekson in naloksegol.
The medicine is available in aluminium blisters, containing 7,10 or 14 tablets. 
Zdravilo je na voljo v aluminijastih pretisnih omotih, ki vsebujejo po 7 ali 14 tablet.
EU/1/18/1291/001 7 film-coated tablets EU/1/18/1291/002 28 film-coated tablets EU/1/18/1291/003 84 film-coated tablets EU/1/18/1291/004 10 film-coated tablets EU/1/18/1291/005 30 film-coated tablets EU/1/18/1291/006 100 film-coated tablets 
EU/1/18/1291/001 7 filmsko obloženih tablet EU/1/18/1291/002 28 filmsko obloženih tablet EU/1/18/1291/003 84 filmsko obloženih tablet EU/1/18/1291/004 10 filmsko obloženih tablet EU/1/18/1291/005 30 filmsko obloženih tablet EU/1/18/1291/006 100 filmsko obloženih tablet
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%. 
Naldemedin se v veliki meri veže na plazemske beljakovine, pretežno na človeški serumski albumin in v manjši meri na α1-kisli-glikoprotein in γ-globulin, s povprečnim razmerjem vezave beljakovin pri ljudeh 93,2 %.
Opioid pain medicinal products 
Opioidna protibolečinska zdravila
There are no data from the use of naldemedine in pregnant women. 
Ni podatkov o uporabi naldemedina pri nosečnicah.
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. 
Na podlagi znanstvenih zaključkov za naldemedin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) naldemedin, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Naldemedine has no or negligible influence on the ability to drive and use machines. 
Naldemedin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• cancer of the bowel or peritoneum. 
• raka črevesa ali peritoneja (potrebušnice).
Patients should be monitored for the development of severe, persistent or worsening abdominal pain. 
Bolnike je treba spremljati glede razvoja hude, trdovratne ali naraščajoče bolečine v trebuhu.
The effect on oestrous cycle is not considered clinically relevant at the proposed therapeutic dose. 
Menijo, da vpliv na estrusni cikel pri predlaganem terapevtskem odmerku ni klinično pomemben.
• a stomach ulcer; 
• želodčno razjedo (ulkus);
Patients with evidence of significant structural abnormalities of the gastrointestinal tract were not enrolled in these studies. 
Bolnikov z znaki pomembnih strukturnih nepravilnosti prebavil v te študije niso vključili.
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. 
Poleg njih so bolniki, ki v 30 dneh pred presejanjem niso bili na odvajalih ali so prejeli samo rešilno odvajalo ob presejanju ali po njem, veljali za non-LIR.
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 
Bolnik, ki se je odzval na zdravljenje, je bil opredeljen kot bolnik s pogostnostjo ≥ 3 SBM na teden in zvečanjem od izhodišča ≥ 1 SBM na teden med 2-tedenskim obdobjem zdravljenja.
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. 
Populacijska farmakokinetična analiza podatkov iz kliničnih študij z naldemedinom ni pokazala klinično pomembnega vpliva starosti, spola, telesne mase ali rase na farmakokinetiko naldemedina.
If you stop taking your opioid medicine 
Če ste prenehali jemati opioidno zdravilo
Patients should be advised to discontinue naldemedine and to contact their physician if opioid withdrawal occurs. 
Bolnikom je treba svetovati, naj prekinejo jemanje naldemedina in se obrnejo na svojega zdravnika, če pride do sindroma odtegnitve opioidov.
The use of naldemedine during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier. 
Uporaba naldemedina v nosečnosti lahko povzroči odtegnitev opioidov pri plodu zaradi nezrele fetalne krvno-možganske pregrade.
The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naldemedine was not evaluated. 
Učinka hude okvare jeter (razred C po Child-Pughu) na farmakokinetiko naldemedina niso ovrednotili.
Shionogi B.V. Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ: 
Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ: contact@shionogi.eu
Proportion of SBM responders in patients with cancer and OIC during the 2-week treatment period (Studies V9222 and V9236) 
Delež bolnikov z rakom in OIC, ki so se odzvali na zdravljenje z ozirom na SBM med 2-tedenskim obdobjem zdravljenja (študiji V9222 in V9236)
Nevertheless, given the times to onset and the mechanism of action of Naldemedine which leads to an increase in the propulsive contractions of the intestinal muscle it is considered that Naldemedine could plausibly have contributed to perforation events in these patients who were already at increased risk due to the presence of additional risk factors including underlying disease and concomitant treatments. 
Kljub temu, glede na časovno obdobje od pričetka zdravljenja z namedelinom do pojava gastrointestinalne perforacije in mehanizem delovanja naldemedina, ki povzroči zvečanje propulzivnih kontrakcij črevesne mišice, obstaja možnost, da bi naldemedin lahko pomembno prispeval k perforaciji pri teh bolnikih, pri katerih je bilo tveganje zaradi prisotnosti dodatnih dejavnikov tveganja, vključno z osnovno boleznijo in sočasnim zdravljenjem, že izhodiščno zvečano.
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. 
Naldemedin je izpeljanka naltreksona, ki so mu dodali stransko verigo, ki zveča molekulsko maso in površino polarnega predela, s čimer se zmanjša njegova sposobnost prečkanja krvno-možganske pregrade (blood-brain barrier - BBB); pričakujemo, da bo penetracija naldemedina v CŽ pri priporočenem odmerku zanemarljiva.
Due to the limited therapeutic experience, patients with severe renal impairment should be clinically monitored when initiating therapy with naldemedine. 
Zaradi omejenih terapevtskih izkušenj je treba bolnike s hudo okvaro ledvic ob uvajanju zdravljenja z naldemedinom klinično spremljati.