natgillin/translations-raw huggingface dataset:
In Studies V9231 and V9232, patients had to either not be using laxatives or be willing to discontinue laxative use at the time of Screening and be willing to use only the provided rescue laxatives during the Screening and Treatment Periods. 
V študijah V9231 in V9232 so bili bolniki, ki bodisi niso uporabljali odvajal ali pa so bili pripravljeni jemanje odvajal v času presejanja prekiniti in v času presejanja in zdravljenja uporabljati samo rešilna odvajala, ki so jih imeli na voljo.
Concomitant use of naldemedine with moderate inducers (e.g. efavirenz) has not been established, and patients should be monitored (see section 4.4). 
Sočasne uporabe naldemedina z zmernimi induktorji (npr. efavirenz) niso proučili in je bolnike treba spremljati (glejte poglavje 4.4).
Store in the original package in order to protect from light and moisture. 
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
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. 
Klinična učinkovitost in varnost Učinkovitost in varnost naldemedina so dokazali pri bolnikih s kronično nerakasto bolečino in OIC in pri bolnikih z rakom in OIC.
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. 
Primarni opazovani dogodek v študiji V9236 in sekundarni opazovani dogodek, brez prilagoditve za večkratnost, v študiji V9222 je bil delež bolnikov, ki so se odzvali na zdravljenje z ozirom na SBM
Package leaflet: Information for the patient Rizmoic 200 micrograms film-coated tablets naldemedine This medicine is subject to additional monitoring. 
Navodilo za uporabo Rizmoic 200 mikrogramov filmsko obložene tablete naldemedin Za to zdravilo se izvaja dodatno spremljanje varnosti.
Patients with cardiovascular conditions 
Bolniki z boleznimi srca in ožilja
Gastrointestinal adverse reactions 
Gastrointestinalni neželeni učinki
Concomitant use of strong CYP3A inhibitors such as grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin should be avoided. 
Sočasni uporabi močnih inhibitorjev CYP3A, npr. soka grenivke, itrakonazola, ketokonazola, ritonavirja, indinavirja, sakvinavirja, telitromicina in klaritromicina, se je treba izogibati.
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. 
O primerih gastrointestinalne perforacije so poročali v okviru trženja zdravila, vključno s smrtnimi primeri, kadar so naldemedin uporabljali pri bolnikih, pri katerih je bilo tveganje gastrointestinalne perforacije zvečano.
The mean baseline opioid morphine equivalent daily dosage was 132.42 mg, 120.93 mg, and 122.06 mg per day for Studies V9231, V9232 and V9235 respectively. 
Povprečni izhodiščni dnevni odmerek opioida je bil enakovreden odmerku morfina 132,42 mg v študiji V9231, 120,93 mg v študiji V9232 in 122,06 mg na dan v študiji V9235.
Concomitant use with strong CYP3A inducers is not recommended (see section 4.5). 
Sočasna uporaba z močnimi induktorji CYP3A ni priporočljiva (glejte poglavje 4.5).
Naldemedine was found to have no clinically relevant adverse effects on fertility or reproductive performance in male and female rats (see section 5.3). 
Ugotovili so, da naldemedin nima klinično pomembnih neželenih učinkov na plodnost ali reproduktivno uspešnost pri samcih in samicah podgan (glejte poglavje 5.3).
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). 
(46,4 %) v primerjavi s placebom (30,2 %), razlika med skupinama (16,2 %) je bila statistično značilna (p < 0,0001).
If use with strong CYP3A inhibitors is unavoidable, monitor for adverse reactions (see section 4.4). 
Če je uporaba z močnimi inhibitorji CYP3A neizogibna, bolnika spremljajte glede neželenih učinkov (glejte poglavje 4.4).
Naldemedine 3-G was a minor metabolite in plasma, with a relative exposure to naldemedine of less than 3%. 
Naldemedin 3-G je bil manj pomemben presnovek v plazmi, z relativno izpostavljenostjo manj kot
Stopping Rizmoic while continuing to take your opioid medicine may cause the constipation to return. 
Če prenehate jemati zdravilo Rizmoic, opioidno zdravilo pa jemljete še naprej, se lahko zaprtje ponovi.
Do not use this medicine after the expiry date which is stated on the carton and blisters after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnih omotih poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
The majority of these gastrointestinal adverse reactions were of mild to moderate severity and resolved without discontinuation of naldemedine treatment. 
Večina teh gastrointestinalnih neželenih učinkov je bila blago do zmerno izražena in je izzvenela brez prekinitve zdravljenja z naldemedinom.
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. 
Izgled zdravila Rizmoic in vsebina pakiranja Zdravilo Rizmoic je okrogla rumena filmsko obložena tableta s premerom približno 6,5 mm z vtisnjenim napisom '222' in logotipom družbe Shionogi na eni strani in '0.2' na drugi strani.
Concomitant use of P-gp inhibitors such as cyclosporine may increase plasma concentrations of naldemedine. 
Sočasna uporaba inhibitorjev P-gp, na primer ciklosporina, lahko zveča plazemske koncentracije naldemedina.
In Study V9231, the three most common types of pain were back pain (62.0%); neck pain (8.3%) and osteoarthritis (5.3%). 
V študiji V9231 so bile tri najpogostejše vrste bolečine bolečina v hrbtu (62,0 %); bolečina v vratu (8,3 %) in osteoartritis (5,3 %).
If you forget to take Rizmoic 
Če ste pozabili vzeti zdravilo Rizmoic
It is unknown whether naldemedine/metabolites are excreted in human milk. 
Ni znano, ali se naldemedin ali njegovi presnovki izločajo v mleko pri ljudeh.
Shionogi SLU Tel: +34 911 239 258 contacta@shionogi.eu 
Shionogi SLU Tel: +34 911 239 258
You should not drink large amounts of grapefruit juice whilst taking Rizmoic. 
Zdravilo Rizmoic skupaj s pijačo Ne pijte velikih količin soka grenivke tačas ko jemljete zdravilo Rizmoic.
All study participants took laxatives previously for the treatment of OIC. 
Vsi udeleženci študije so predhodno jemali odvajala za zdravljenje
• You can take Rizmoic with or without laxatives. 
• Zdravilo Rizmoic lahko jemljete z odvajali ali brez njih.
The peak plasma concentration was reduced by 35% and time to achieve peak plasma concentration was delayed from 0.75 hours in the fasted state to 2.5 hours in the fed state, whereas no significant difference was observed in the area under the plasma concentration-time curve by food intake. 
Najvišja koncentracija v plazmi se je znižala za 35 %, čas za dosego najvišje koncentracije v plazmi pa se je podaljšal z 0,75 ure na tešče na 2,5 ure po obroku,
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. 
Klinične študije pri bolnikih z rakom in OIC Varnost in učinkovitost naldemedina so ovrednotili tudi v 2 randomiziranih, dvojno slepih in s placebom kontroliranih študijah (V9222 in V9236) pri bolnikih z rakom in OIC.
Opioid withdrawal syndrome 
Sindrom odtegnitve opioidov
Concomitant use of moderate CYP3A inhibitors such as fluconazole, may increase the plasma concentration of naldemedine. 
Sočasna uporaba zmernih inhibitorjev CYP3A, na primer flukonazola, lahko zveča plazemsko koncentracijo naldemedina.
The most commonly reported adverse reactions in patients with cancer and OIC were diarrhoea (24.5%) and abdominal pain (3.9%). 
Neželena učinka, o katerih so najpogosteje poročali pri bolnikih z rakom in OIC, sta bila driska (24,5 %) in bolečina v trebuhu (3,9 %).
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. 
Zaradi omejene baze dokazov samo za naldemedin so koristne tudi informacije o drugih zdravilih v tej skupini, ki imajo podoben mehanizemdelovanja kot naldemedin in imajo podobne učinke na GI trakt.
What Rizmoic is and what it is used for 
Kaj vsebuje navodilo Kaj je zdravilo Rizmoic in za kaj ga uporabljamo
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. 
Sočasna uporaba naldemedina z močnimi induktorji CYP3A (npr. šentjanževka (Hypericum perforatum), rifampicin, karbamazepin, fenobarbital in fenitoin) zmanjša izpostavljenost naldemedinu in lahko zmanjša učinkovitost naldemedina.
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. 
V študijah in vitro v klinično pomembnih koncentracijah naldemedin ni inhibiral pomembnejših encimov CYP (vključno z izocimi CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19,
Shionogi Srl Tel: +39 06 94 805 118 contattaci@shionogi.eu 
Shionogi Srl Tel: +39 06 94 805 118
Naldemedine also undergoes cleavage in the gastrointestinal tract to form benzamidine and naldemedine carboxylic acid. 
Naldemedin se v prebavilih tudi cepi v benzamidin in naldemedin karboksilno kislino.
The use of naldemedine is not recommended in these patients (see section 4.2). 
Uporaba naldemedina pri teh bolnikih ni priporočljiva (glejte poglavje 4.2).
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). 
Neželenih učinkov na prenatalni in postnatalni razvoj pri odmerku 1 mg/kg/dan (12-krat večja izpostavljenost [AUC0-24hr] kot pri ljudeh po peroralnem odmerku 200 mikrogramov) ni bilo.
The number of patients in the LIR and non-LIR subgroups were 629 (naldemedine: 317 and placebo: 312) and 451 (naldemedine: 223 and placebo: 228) for pooled Studies V9231 and V9232. 
(naldemedin: 317 in placebo: 312) in v podskupini non-LIR 451 (naldemedin: 223 in placebo: 228) v združenih študijah V9231 in V9232.
Common (may affect up to 1 in 10 people): 
Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov):
There was a statistically significant difference for naldemedine treatment group versus placebo for the primary endpoint in Studies V9231 and V9232 (see Table 3). 
Med skupino, zdravljeno z naldemedinom, in skupino, ki je prejemala placebo, je bila glede primarnega opazovanega dogodka v študijah V9231 in V9232 obstajala statistično značilna razlika (glejte preglednico 3).
• nausea (feeling sick) or vomiting 
• navzea (občutek slabosti) in bruhanje,
Rizmoic 200 micrograms film-coated tablets 
IME ZDRAVILA Rizmoic 200 mikrogramov filmsko obložene tablete
If you stop taking Rizmoic 
Če ste prenehali jemati zdravilo Rizmoic
How to take Rizmoic 
Kako jemati zdravilo Rizmoic
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. 
Varnost in učinkovitost naldemedina so ocenili v dveh enakih 12-tedenskih randomiziranih, dvojno slepih preskušanjih, kontroliranih s placebom (študiji V9231 in V9232), v katerih so uporabljali naldemedin brez odvajal, in v tretjem dolgoročnem 52-tedenskem randomiziranem, dvojno slepem preskušanju, kontroliranem s placebom (študija V9235), v katerem so uporabljali naldemedin s stabilnimi odvajali ali brez njih pri bolnikih s kronično nerakasto bolečino in OIC.
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. 
Opredeljeno je bilo kot vsega skupaj največ štiri spontana iztrebljanja blata (spontaneous bowel movements - SBM) v 14 zaporednih dneh in < 3 SBM v posameznem tednu, pri čemer je bilo najmanj 25 % SBM povezanih z enim ali več od naslednjih stanj: (1) napenjanje, (2) trdo ali kepasto blato; (3) občutek nepopolnega izpraznenja in (4) občutek anorektalne obstrukcije/blokade.
Decreases in the viability index on Day 4 after birth were noted at 30 and 1000 mg/kg/day and low body weights and delayed pinna unfolding were noted at 1000 mg/kg/day in pups. 
Pri mladičih so opazili zmanjšanje indeksa preživetja 4. dne po skotitvi pri odmerkih 30 in 1.000 mg/kg/dan ter manjšo telesno maso in zapoznelo razvijanje uhlja pri odmerku 1.000 mg/kg/dan.
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). 
Neželenih učinkov na plodnost in reproduktivno uspešnost samcev in samic pri odmerkih do 1000 mg/kg/dan (več kot 16.000-krat večja izpostavljenost [AUC0-24hr] kot pri ljudeh po peroralnem odmerku 200 mikrogramov) niso ugotovili.
The majority of these gastrointestinal adverse reactions were mild to moderate severity and resolved with treatment. 
Večina teh gastrointestinalnih neželenih učinkov je bila blago do zmerno izražena in je z zdravljenjem izzvenela.
Naldemedine 200 micrograms or placebo was administered for 2 weeks to cancer patients with OIC. 
Bolnikom z rakom in OIC so 2 tedna dajali naldemedin 200 mikrogramov ali placebo.
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). 
Sočasne uporabe naldemedina z zmernimi induktorji CYP3A (npr. efavirenz) niso proučili in ga je treba uporabljati previdno (glejte poglavje 4.5).
You will be monitored for opioid withdrawal symptoms (see section 2, under ‘Warnings and Precautions', and section 4). 
Spremljali vas bodo glede simptomov odtegnitve opioidov (glejte poglavje 2, pod
If used with moderate CYP3A inhibitors, monitor for adverse reactions. 
Če se naldemedin uporablja z zmernimi inhibitorji CYP3A, bolnika spremljajte glede neželenih učinkov.
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. 
Okvara jeter Vpliv okvare jeter na farmakokinetiko enkratnega 200-mikrogramskega odmerka naldemedina so proučevali pri preiskovancih z blago (razred A po Child-Pughu) in zmerno (razred B po Child-Pughu) okvaro jeter in ju primerjali z zdravimi preiskovanci z normalnim delovanjem jeter.
Naldemedine is primarily metabolized by CYP3A to nor-naldemedine, with a minor contribution from UGT1A3 to form naldemedine 3-G. 
Naldemedin se pretežno presnavlja s CYP3A v nor-naldemedin, prispevek UGT1A3, s katerim se presnavlja v naldemedin 3-G, je manj pomemben.
What you need to know before you take Rizmoic Do not take Rizmoic: 
Kaj morate vedeti, preden boste vzeli zdravilo Rizmoic Kako jemati zdravilo Rizmoic
Two serious cases of diarrhoea were reported in patients with cancer and OIC. 
Pri bolnikih z rakom in OIC so poročali o dveh resnih primerih driske.
Naldemedine is absorbed with a time to achieve peak plasma concentration of approximately 0.75 hours in the fasted state. 
Naldemedin po absorpciji na tešče doseže najvišjo koncentracijo v plazmi po približno 0,75 ure.
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. 
Pri bolnikih, zdravljenih z opioidnim analgetikom/analgetiki v dnevnih odmerkih, večjih od ekvivalenta 400 mg morfina, je izkušenj malo.
• nausea (feeling sick) 
• navzea (občutek slabosti),
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, and is therefore essentially “sodium-free”. 
Zdravilo Rizmoic vsebuje natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni ‘brez natrija'.
Adverse reactions presented by System Organ Class and frequency in patients with cancer and opioid-induced constipation 
Neželeni učinki, navedeni po organskih sistemih in pogostnosti, pri bolnikih z rakom in zaprtjem, povzročenim z opioidi
Naldemedine (N=97) 
naldemedin (N=97)
Naldemedine should not be used during breast-feeding. 
Naldemedin se med dojenjem ne sme uporabljati.
Naldemedine was not studied in the clinical trial programme in patients who had a recent history of myocardial infarction, stroke or transient ischaemic attack within 3 months of screening. 
V programu kliničnega preskušanja naldemedina niso raziskovali pri bolnikih z nedavno anamnezo miokardnega infarkta, možganske kapi ali prehodnega ishemičnega napada (transient ischaemic attack
Clinical studies in patients with cancer and OIC 
Klinične študije pri bolnikih s kronično nerakasto bolečino in OIC
• There is no need to alter the dose of your opioid medicine before starting Rizmoic. 
• Preden začnete jemati zdravilo Rizmoic, ni treba spreminjati odmerka opioidnega zdravila.
Naldemedine (N=58) 
naldemedin (N=58)
A single dose of naldemedine (0.01 mg to 3 mg) and multiple doses of 0.4 mg/day have been administered to patients with OIC in clinical studies. 
V kliničnih študijah so bolnikom z OIC dajali enkraten odmerek naldemedina (0,01 mg do 3 mg) in večkratne odmerke po 0,4 mg/dan.
Change in frequency of SBMs without straining per week (LS Mean) 
Sprememba pogostnosti SBM brez napenjanja na teden (povprečje LS)
No dose adjustment is required in patients with mild or moderate hepatic impairment. 
Pri bolnikih z blago ali zmerno okvaro jeter prilagajanje odmerka ni potrebno.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and embryo-fetal development. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Naldemedine must not be used in patients with known or suspected gastrointestinal obstruction or in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation. 
Naldemedina zaradi možnosti gastrointestinalne perforacije ni dovoljeno uporabljati pri bolnikih z znano ali domnevno gastrointestinalno obstrukcijo, niti pri bolnikih z zvečanim tveganjem recidivne obstrukcije.
Pack sizes of 7, 10, 28, 30, 84 or 100 tablets. 
Velikosti pakiranja po 7, 28 ali 84 tablet.
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. 
Zdravi prostovoljci V kliničnih študijah so zdravim prostovoljcem dajali enkratne odmerke naldemedina do 100 mg in večkratne odmerke po največ 30 mg/dan 10 dni.
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. 
- bolečine v trebuhu; - bolečino v danki med iztrebljanjem trdega blata; - po iztrebljanju blata imate občutek, da črevo še vedno ni prazno.
The apparent terminal elimination half-life of naldemedine is approximately 11 hours, and the apparent total clearance (CL/F) of naldemedine is 8.4 L/h. 
Izločanje Navidezni končni razpolovni čas eliminacije naldemedina je približno 11 ur, navidezni celotni očistek
Naldemedine must not be used in patients with known or suspected GI obstruction or in patients at increased risk of recurrent obstruction, due to the potential for GI perforation (see section 4.3). 
Uporaba naldemedina ni dovoljena pri bolnikih z znano ali domnevno GI zaporo in pri bolnikih z zvečanim tveganjem recidivne zapore zaradi možnosti GI perforacije (glejte poglavje 4.3).
Rizmoic may be used with or without laxative(s). 
Zdravilo Rizmoic se lahko uporablja z odvajalom/odvajali ali brez njih.
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. 
Proučevali so farmakokinetiko naldemedina po dajanju enkratnega 200-miligramskega odmerka naldemedina pri preiskovancih z blago, zmerno ali hudo okvaro ledvic ali z boleznijo ledvic v končnem stadiju (end-stage renal disease - ESRD), pri kateri je bila potrebna hemodializa, in jo primerjali z zdravimi preiskovanci z normalnim delovanjem ledvic.
Name and address of the manufacturers responsible for batch release Manufacturing Packaging Farmaca (MPF) bv Appelhof 13 
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij Manufacturing Packaging Farmaca (MPF) bv
Elderly patients 
Posebne skupine bolnikov
If naldemedine is used with strong P-gp inhibitors, monitor for adverse reactions. 
Če uporabljate naldemedin sočasno z močnimi inhibitorji P-gp, spremljajte bolnika glede neželenih učinkov.
There were 4 secondary endpoints in Studies V9231 and V9232 (see Table 3). 
V študijah V9231 in V9232 so bili 4 sekundarni opazovani dogodki (glejte preglednico 3).
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). 
V študiji plodnosti in zgodnjega razvoja zarodka pri podganah so ugotovili podaljšanje faze diestrusa pri 10 mg/kg/dan in večjih odmerkih, ne pa pri odmerku 1 mg/kg/dan (12-krat večja izpostavljenost
Symptoms included, but were not limited to hyperhidrosis, chills, lacrimation increased, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhoea, nausea, vomiting, arthralgia, myalgia, and tachycardia (see section 4.4). 
Simptomi so med drugim obsegali hiperhidrozo, mrzlico, zvečano solzenje, vročinske oblive/pordevanje, zvišano telesno temperaturo, kihanje, občutek mraza, bolečino v trebuhu, drisko, navzeo, bruhanje, bolečine v sklepih,
The pharmacokinetics of naldemedine between subjects with mild, moderate or severe renal impairment, or subjects with ESRD requiring hemodialysis and healthy subjects with normal renal function were similar. 
Farmakokinetika naldemedina pri preiskovancih z blago, zmerno ali hudo okvaro ledvic, preiskovancih z ESRD, pri kateri je bila potrebna hemodializa, in zdravih preiskovancih z normalnim delovanjem ledvic je bila podobna.
Manufacturing Packaging Farmaca (MPF) B.V., Appelhof 13, 
Manufacturing Packaging Farmaca (MPF) B.V.,
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. 
Primarni opazovani dogodek učinkovitosti za študijo V9235 je bila sprememba pogostnosti BM na teden od izhodišča do