FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: V študijah in vitro v klinično pomembnih koncentracijah naldemedin ni inhibiral pomembnejših encimov CYP (vključno z izocimi CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19,
English: Shionogi Srl Tel: +39 06 94 805 118 contattaci@shionogi.eu
Slovenian: Shionogi Srl Tel: +39 06 94 805 118
English: Naldemedine also undergoes cleavage in the gastrointestinal tract to form benzamidine and naldemedine carboxylic acid.
Slovenian: Naldemedin se v prebavilih tudi cepi v benzamidin in naldemedin karboksilno kislino.
English: The use of naldemedine is not recommended in these patients (see section 4.2).
Slovenian: Uporaba naldemedina pri teh bolnikih ni priporočljiva (glejte poglavje 4.2).
English: 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).
Slovenian: 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.
English: 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.
Slovenian: (naldemedin: 317 in placebo: 312) in v podskupini non-LIR 451 (naldemedin: 223 in placebo: 228) v združenih študijah V9231 in V9232.
English: Common (may affect up to 1 in 10 people):
Slovenian: Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov):
English: There was a statistically significant difference for naldemedine treatment group versus placebo for the primary endpoint in Studies V9231 and V9232 (see Table 3).
Slovenian: 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).
English: • nausea (feeling sick) or vomiting
Slovenian: • navzea (občutek slabosti) in bruhanje,
English: Rizmoic 200 micrograms film-coated tablets
Slovenian: IME ZDRAVILA Rizmoic 200 mikrogramov filmsko obložene tablete
English: If you stop taking Rizmoic
Slovenian: Če ste prenehali jemati zdravilo Rizmoic
English: How to take Rizmoic
Slovenian: Kako jemati zdravilo Rizmoic
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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.
English: The majority of these gastrointestinal adverse reactions were mild to moderate severity and resolved with treatment.
Slovenian: Večina teh gastrointestinalnih neželenih učinkov je bila blago do zmerno izražena in je z zdravljenjem izzvenela.
English: Naldemedine 200 micrograms or placebo was administered for 2 weeks to cancer patients with OIC.
Slovenian: Bolnikom z rakom in OIC so 2 tedna dajali naldemedin 200 mikrogramov ali placebo.
English: 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).
Slovenian: Sočasne uporabe naldemedina z zmernimi induktorji CYP3A (npr. efavirenz) niso proučili in ga je treba uporabljati previdno (glejte poglavje 4.5).
English: You will be monitored for opioid withdrawal symptoms (see section 2, under ‘Warnings and Precautions', and section 4).
Slovenian: Spremljali vas bodo glede simptomov odtegnitve opioidov (glejte poglavje 2, pod
English: If used with moderate CYP3A inhibitors, monitor for adverse reactions.
Slovenian: Če se naldemedin uporablja z zmernimi inhibitorji CYP3A, bolnika spremljajte glede neželenih učinkov.
English: 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.
Slovenian: 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.
English: Naldemedine is primarily metabolized by CYP3A to nor-naldemedine, with a minor contribution from UGT1A3 to form naldemedine 3-G.
Slovenian: Naldemedin se pretežno presnavlja s CYP3A v nor-naldemedin, prispevek UGT1A3, s katerim se presnavlja v naldemedin 3-G, je manj pomemben.
English: What you need to know before you take Rizmoic Do not take Rizmoic:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Rizmoic Kako jemati zdravilo Rizmoic
English: Two serious cases of diarrhoea were reported in patients with cancer and OIC.
Slovenian: Pri bolnikih z rakom in OIC so poročali o dveh resnih primerih driske.
English: Naldemedine is absorbed with a time to achieve peak plasma concentration of approximately 0.75 hours in the fasted state.
Slovenian: Naldemedin po absorpciji na tešče doseže najvišjo koncentracijo v plazmi po približno 0,75 ure.
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.
Slovenian: Pri bolnikih, zdravljenih z opioidnim analgetikom/analgetiki v dnevnih odmerkih, večjih od ekvivalenta 400 mg morfina, je izkušenj malo.
English: • nausea (feeling sick)
Slovenian: • navzea (občutek slabosti),
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, and is therefore essentially “sodium-free”.
Slovenian: Zdravilo Rizmoic vsebuje natrij To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni ‘brez natrija'.
English: Adverse reactions presented by System Organ Class and frequency in patients with cancer and opioid-induced constipation
Slovenian: Neželeni učinki, navedeni po organskih sistemih in pogostnosti, pri bolnikih z rakom in zaprtjem, povzročenim z opioidi
English: Naldemedine (N=97)
Slovenian: naldemedin (N=97)
English: Naldemedine should not be used during breast-feeding.
Slovenian: Naldemedin se med dojenjem ne sme uporabljati.
English: 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.
Slovenian: V programu kliničnega preskušanja naldemedina niso raziskovali pri bolnikih z nedavno anamnezo miokardnega infarkta, možganske kapi ali prehodnega ishemičnega napada (transient ischaemic attack
English: Clinical studies in patients with cancer and OIC
Slovenian: Klinične študije pri bolnikih s kronično nerakasto bolečino in OIC
English: • There is no need to alter the dose of your opioid medicine before starting Rizmoic.
Slovenian: • Preden začnete jemati zdravilo Rizmoic, ni treba spreminjati odmerka opioidnega zdravila.
English: Naldemedine (N=58)
Slovenian: naldemedin (N=58)
English: 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.
Slovenian: 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.
English: Change in frequency of SBMs without straining per week (LS Mean)
Slovenian: Sprememba pogostnosti SBM brez napenjanja na teden (povprečje LS)
English: No dose adjustment is required in patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter prilagajanje odmerka ni potrebno.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Naldemedina zaradi možnosti gastrointestinalne perforacije ni dovoljeno uporabljati pri bolnikih z znano ali domnevno gastrointestinalno obstrukcijo, niti pri bolnikih z zvečanim tveganjem recidivne obstrukcije.
English: Pack sizes of 7, 10, 28, 30, 84 or 100 tablets.
Slovenian: Velikosti pakiranja po 7, 28 ali 84 tablet.
English: 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.
Slovenian: 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.
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.
Slovenian: - bolečine v trebuhu; - bolečino v danki med iztrebljanjem trdega blata; - po iztrebljanju blata imate občutek, da črevo še vedno ni prazno.
English: 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.
Slovenian: Izločanje Navidezni končni razpolovni čas eliminacije naldemedina je približno 11 ur, navidezni celotni očistek
English: 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).
Slovenian: 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).
English: Rizmoic may be used with or without laxative(s).
Slovenian: Zdravilo Rizmoic se lahko uporablja z odvajalom/odvajali ali brez njih.
English: 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.
Slovenian: 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.
English: Name and address of the manufacturers responsible for batch release Manufacturing Packaging Farmaca (MPF) bv Appelhof 13
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij Manufacturing Packaging Farmaca (MPF) bv
English: Elderly patients
Slovenian: Posebne skupine bolnikov
English: If naldemedine is used with strong P-gp inhibitors, monitor for adverse reactions.
Slovenian: Če uporabljate naldemedin sočasno z močnimi inhibitorji P-gp, spremljajte bolnika glede neželenih učinkov.
English: There were 4 secondary endpoints in Studies V9231 and V9232 (see Table 3).
Slovenian: V študijah V9231 in V9232 so bili 4 sekundarni opazovani dogodki (glejte preglednico 3).
English: 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).
Slovenian: 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
English: 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).
Slovenian: 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,
English: 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.
Slovenian: 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.
English: Manufacturing Packaging Farmaca (MPF) B.V., Appelhof 13,
Slovenian: Manufacturing Packaging Farmaca (MPF) B.V.,
English: 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.
Slovenian: Primarni opazovani dogodek učinkovitosti za študijo V9235 je bila sprememba pogostnosti BM na teden od izhodišča do
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Gastrointestinalna perforacija
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).
Slovenian: Pri bolnikih s katero koli boleznijo, ki bi lahko okrnila integriteto stene gastrointestinalnega trakta (npr. ulkusna bolezen, Ogilviejev sindrom, maligni tumorji prebavil, Crohnova bolezen), je potrebna previdnost pri uporabi naldemedina.
English: Proportion of SBM Responders
Slovenian: Povprečna pogostnost BM v izhodišču
English: Adverse reactions presented by System Organ Class and frequency in patients with chronic non-cancer pain and opioid-induced constipation
Slovenian: Neželeni učinki, navedeni po organskih sistemih in pogostnosti, pri bolnikih s kronično nerakasto bolečino in zaprtjem, povzročenim z opioidi
English: The pharmacokinetics of naldemedine between subjects with mild or moderate hepatic impairment and healthy subjects with normal hepatic function were similar.
Slovenian: Farmakokinetika naldemedina pri preiskovancih z blago ali zmerno okvaro jeter in pri zdravih preiskovancih z normalnim delovanjem jeter je bila podobna.
English: • 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.
Slovenian: Resne alergijske reakcije vključujejo: otekanje dlani, stopal, gležnjev, obraza, ustnic ali žrela, ki lahko oteži požiranje ali dihanje, srbenje kože in koprivnica.
English: These were mild or moderate in severity and resolved.
Slovenian: Ti so bili blago do zmerno izraženi in so izzveneli.
English: Tablet core: Mannitol, croscarmellose sodium (see section 2 under ‘Rizmoic contains sodium') and magnesium stearate.
Slovenian: Sredica tablete: manitol, premreženi natrijev karmelozat (glejte poglavje 2 pod 'Zdravilo
English: - if you have cancer of the brain or central nervous system, multiple sclerosis, or Alzheimer's disease.
Slovenian: • bolezen, ki povzroča hudo vnetje prebavnega trakta, na primer Crohnovo bolezen; - če imate raka možganov ali centralnega živčevja, multiplo sklerozo ali Alzheimerjevo bolezen.
English: Round, approximately 6.5 mm diameter, yellow tablet debossed with '222' and Shionogi logo on one side and '0.2' on the other side.
Slovenian: Okrogla rumena tableta s premerom približno 6,5 mm z vtisnjenim napisom '222' in logotipom družbe
English: Each film-coated tablet contains 200 micrograms naldemedine (as tosylate).
Slovenian: Ena filmsko obložena tableta vsebuje 200 mikrogramov naldemedina (v obliki tosilata).
English: Opioid withdrawal syndrome aOne serious report of hypersensitivity reaction was observed in clinical studies with naldemedine.
Slovenian: Splošne težave in spremembe na mestu aplikacije sindrom odtegnitve opioidov aIz kliničnih študij z naldemedinom izvira eno resno poročilo o preobčutljivostni reakciji.
English: 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.
Slovenian: Dejavniki tveganja, o katerih so najpogosteje poročali, so bili indeks telesne mase (ITM) ≥ 30 kg/m2 in anamneza hipertenzije in/ali dislipidemije.
English: Immune system disorders
Slovenian: Bolezni imunskega sistema preobčutljivosta
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.
Slovenian: V9235 so randomizirali v razmerju 1:1 na prejemanje 200 mikrogramov naldemedina ali placeba enkrat na dan, za 12 tednov v študijah V9231 in V9232 ter za 52 tednov v študiji V9235.
English: No dose adjustment is required in patients with renal impairment (see section 5.2).
Slovenian: Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Rizmoic Vsebina pakiranja in dodatne informacije
English: Opioid withdrawal syndrome aMedDRA Preferred Terms: abdominal pain, abdominal pain upper, abdominal pain lower and abdominal discomfort
Slovenian: Splošne težave in spremembe na mestu aplikacije sindrom odtegnitve opioidov aPreferenčni izrazi MedDRA: bolečina v trebuhu, bolečina v zgornjem delu trebuha, bolečina v spodnjem delu trebuha in nelagodje v trebuhu.
English: Naldemedine (N=621)
Slovenian: Naldemedin (N=621)
English: Rizmoic has no influence on your ability to drive or to use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Rizmoic ne vpliva na sposobnost upravljanja vozil in strojev.
English: Naldemedine did not cause significant induction of CYP1A2, CYP2B6 or CYP3A4 isozymes.
Slovenian: Naldemedin ni povzročil pomembne indukcije izocimov CYP1A2,
English: NAME OF THE MEDICINAL PRODUCT
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: The mean baseline SBMs was 1.31, 1.17, and 1.60, for Studies V9231, V9232 and V9235 respectively.
Slovenian: Povprečni izhodiščni SBM v študijah V9231, V9232 oziroma V9235 so bili 1,31, 1,17 oziroma 1,60.
English: You should stop taking Rizmoic when you stop taking your opioid pain medicine.
Slovenian: Ko prenehate jemati opioidno zdravilo, prenehajte jemati tudi zdravilo Rizmoic.
English: Dose-dependent increases in gastrointestinal-related adverse reactions, including abdominal pain, diarrhoea, and nausea, were observed.
Slovenian: Opazili so od odmerka odvisno zvečanje s prebavili povezanih neželenih učinkov, ki so obsegali bolečino v trebuhu, drisko in navzeo.
English: - Each tablet contains 200 micrograms of naldemedine (as tosylate).
Slovenian: - Ena tableta vsebuje 200 mikrogramov naldemedina (v obliki tosilata).
English: Naldemedine (N=276)
Slovenian: Naldemedin (N=276)
English: 8448CN,
Slovenian: Heerenveen, 8448CN, Nizozemska
English: How to store Rizmoic
Slovenian: Shranjevanje zdravila Rizmoic
English: 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
Slovenian: *** p=0,0003 v študiji V9231 in p=0,0011 v študiji V9232
English: • watery eyes or runny nose
Slovenian: • solzenje ali izcedek iz nosu,
English: Each tablet contains 200 micrograms naldemedine (as tosylate).
Slovenian: Ena tableta vsebuje 200 mikrogramov naldemedina (v obliki tosilata).
English: The frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Slovenian: Neželeni učinki 200-mikrogramskih tablet naldemedina pri bolnikih s kronično nerakasto bolečino in OIC in pri bolnikih z rakom in OIC, o katerih so poročali v kliničnih študijah, so navedeni v preglednicah v skladu z razvrstitvijo po organskih sistemih MedDRA. Skupine pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000) in neznana pogostnost
English: • inability to sleep
Slovenian: • nespečnost.
English: Tel.: +48 (12) 653 15 71 e-mail: biuro@molteni.com.pl
Slovenian: Tel.: +48 (12) 653 15 71
English: • pupils dilating
Slovenian: • razširjene zenice,
English: 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.
Slovenian: oziroma 1 % pri bolnikih s kronično nerakasto bolečino in OIC in 4,5 % oziroma 0 % pri bolnikih z rakom in OIC.