natgillin/translations-raw huggingface dataset:
Store in the original package in order to protect from light and moisture.
Čuvati u originalnom pakiranju radi zaštite od svjetlosti i vlage.
Uncommon Unknown
Manje često Nepoznato
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).
Potreban je oprez kod primjene naldemedina u bolesnika s bilo kojim stanjem koje bi moglo dovesti do slabljenja integriteta stijenke gastrointestinalnog trakta (npr. peptička ulkusna bolest, Ogilviejev sindrom, zloćudna bolest gastrointestinalnog trakta, Crohnova bolest).
Rare (may affect up to 1 in 1,000 people):
Rijetko (mogu se pojaviti u najviše 1 na 1000 osoba):
If you stop taking Rizmoic
Ako prestanete uzimati Rizmoic
If you are being treated with an opioid medicine for chronic non-cancer pain.
Ako se liječite opioidnim lijekom zbog kronične nekarcinomske boli.
The recommended dose of naldemedine is 200 micrograms (one tablet) daily.
Preporučena doza naldemedina je 200 mikrograma (jedna tableta) dnevno.
No dose adjustment is required in patients with mild or moderate hepatic impairment.
Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
In clinical studies, patients with OIC who were administered 0.4 mg/day (twice the recommended dose) over 4 weeks had an increased incidence of GI-related adverse drug reactions including diarrhoea and abdominal pain frequently within 1-2 days after initial dosing.
Bolesnici s konstipacijom uzrokovanom opioidima kojima je u kliničkim ispitivanjima primjenjivano 0,4 mg na dan (dvostruko viša doza od preporučene) tijekom 4 tjedna, imali su povećanu incidenciju nuspojava povezanih s probavnim sustavom uključujući proljev i bol u abdomenu, često unutar 1-2 dana od početka doziranja.
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.
Sveukupno gledano, iako se prihvaća da su dokazi koji se odnose samo na naldemedin ograničeni, smatra se da ih potkrepljuju i informacije drugih lijekova iz te skupine, čiji se mehanizam djelovanja ne razlikuje od naldemedinovog i koji imaju slične učinke na gastrointestinalni trakt.
Available data in rats have shown excretion of naldemedine in milk (see section 5.3).
Dostupni podaci za štakore pokazuju da se naldemedin izlučuje u mlijeko (vidjeti dio 5.3).
Naldemedine is primarily metabolized by CYP3A to nor-naldemedine, with a minor contribution from UGT1A3 to form naldemedine 3-G.
Naldemedin se primarno metabolizira putem CYP3A do nor-naldemedina, uz manji doprinos UGT1A3 u stvaranju naldemedina 3-G.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
There are no data from the use of naldemedine in pregnant women.
Nema podataka o primjeni naldemedina u trudnica.
Stop taking Rizmoic and contact your doctor if you develop opioid withdrawal symptoms.
Prestanite uzimati Rizmoic i obratite se liječniku ako razvijete simptome ustezanja od opioida.
Based on this, naldemedine is expected to exert its anti-constipating effects on opioids without reversing their CNS-mediated analgesic effects.
Na temelju toga se očekuje da će naldemedin pokazati svoje antikonstipacijske učinke na opioide bez poništavanja njihovih analgetičkih učinaka posredovanih SŽS-om.
The peak plasma concentration and area under the plasma concentration-time curve increased in an almost dose-proportional manner within the dose range of 0.1 to 100 mg. A slight accumulation
Vršna koncentracija u plazmi i površina ispod krivulje plazmatska koncentracija-vrijeme povećavale su se gotovo proporcionalno dozi unutar raspona doza od 0,1 do 100 mg.
Rizmoic can be used in patients using an opioid medicine for cancer pain or long term non-cancer pain after they have previously been treated with a laxative.
Rizmoic se može primjenjivati u bolesnika koji dobivaju opioidni lijek zbog bolova prouzročenih rakom ili dugotrajnog nekarcinomskog bola nakon što su se prethodno liječili laksativima.
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.
Rizmoic je okrugla, žuta, filmom obložena tableta, približnog promjera 6,5 mm, s utisnutim „222“ i logom tvrtke Shionogi na jednoj strani i „0.2“ na drugoj.
Naldemedine 3-G was a minor metabolite in plasma, with a relative exposure to naldemedine of less than 3%.
Naldemedin 3-G bio je manje zastupljen metabolit u plazmi, uz relativnu izloženost u odnosu na naldemedin manju od 3%.
Additionally, naldemedine is a substrate of the P-glycoprotein (P-gp) efflux transporter, which may also be involved in reducing naldemedine penetration into the CNS.
Osim toga, naldemedin je supstrat efluksnog prijenosnika P-glikoproteina (P-gp), koji također može sudjelovati u smanjenju prodiranja naldemedina u SŽS.
The pharmacokinetics of naldemedine in the paediatric population has not been studied (see section 4.2).
Farmakokinetika naldemedina u pedijatrijskoj populaciji nije ispitana (vidjeti dio 4.2).
Following oral administration of radiolabelled naldemedine, 57.3% and 34.8% of the dose was excreted in urine and faeces for the [oxadiazole-14C]-naldemedine and 20.4% and 64.3% of the dose was excreted as the [carbonyl-14C]naldemedine in urine and faeces, respectively.
Nakon peroralne primjene radioaktivno označenog naldemedina, 57,3% doze bilo je izlučeno u obliku [oksadiazol-14C]-naldemedina u mokraći, a 34,8% u stolici, dok je 20,4% i 64,3% doze bilo izlučeno u obliku [karbonil-14C]-naldemedina u mokraći odnosno stolici.
Novel histopathology findings were observed at all doses tested in female rats in ovaries (tertiary follicles/luteal cysts) in addition to irregular oestrous cycles, hyperplasia of mammary gland, and vaginal mucification already observed in adult animals (the lowest dose tested corresponded to an exposure margin of 6 or more, depending on the age of the pups).
Pri svim ispitivanim dozama u ženki štakora pronađeni su novi patohistološki nalazi na jajnicima (tercijarni folikuli/lutealne ciste) uz neuredan ciklus estrusa, hiperplaziju mliječnih žlijezda i vaginalnu mucifikaciju, koji su već prije opaženi u odraslih životinja (najniža ispitana doza odgovara margini izloženosti od 6 ili više, ovisno o dobi mladunčadi).
Interactions with CYP3A inhibitors
Interakcije s inhibitorima CYP3A
From baseline to the last 2 weeks of treatment**
Od početka ispitivanja do zadnja 2 tjedna liječenja**
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 u visokom postotku veže na proteine u serumu, uglavnom za albumin i u manjoj mjeri za α1-kiseli-glikoprotein i γ-globulin u ljudskom serumu, te srednja vrijednost omjera vezanja za proteine u ljudi iznosi 93,2%.
- if your bowel is blocked or perforated, or if there is a high risk of your bowel becoming blocked, as a blockage may cause a hole to develop in the bowel wall.
- ako Vam je debelo crijevo blokirano, došlo je do puknuća crijeva ili postoji veliki rizik da postane blokirano, jer to može prouzročiti stvaranje otvora u stijenci debelog crijeva.
Alteration of the analgesic dosing regimen prior to initiating Rizmoic is not required.
Nije potrebno mijenjati režim doziranja analgetika prije početka primjene lijeka Rizmoic.
Talk to your doctor if you are already breast-feeding.
Obratite se liječniku ako već dojite.
Tablet core: Mannitol, croscarmellose sodium (see section 2 under ‘Rizmoic contains sodium') and magnesium stearate.
- Drugi sastojci su: Jezgra tablete: manitol, umrežena karmelozanatrij (pogledajte dio 2 pod naslovom „Rizmoic sadrži natrij“) i magnezijev stearat.
From baseline to week 1**
Od početka ispitivanja do 1. tjedna**
Talk to your doctor or pharmacist immediately whilst taking Rizmoic: - if you develop severe, lasting or worsening stomach pain as this could be a symptom of developing a hole in your bowel wall and can be life-threatening.
Odmah se obratite svom liječniku ili ljekarniku dok uzimate Rizmoic: - ako razvijete jaku bol u trbuhu ili bol u trbuhu koja je ustrajna ili se pogoršava jer bi to mogao biti simptom nastanka otvora u stijenci crijeva, što može biti opasno po život.
In studies V9222 and V9236, the mean age of the subjects was 64.3 years; 51.8% were 65 years of age or older; 39.4% were women and 97.1% were Japanese.
U ispitivanjima V9222 i V9236, srednja vrijednost dobi ispitanika bila je 64,3 godina; 51,8% ispitanika bilo je u dobi od 65 godina ili starije; 39,4% bile su žene i 97,1% bili su Japanci.
Two of the nine cases were excluded by the MAH because they were not considered valid, and in the remaining five cases the MAH excluded a causal relationship in addition to the reporter.
Nositelj odobrenja smatrao je nevažećim dva od devet slučajeva te ih je isključio, a u preostalih pet slučajeva nositelj odobrenja, kao i izvjestitelj, isključili su uzročno-posljedičnu povezanost.
Plasma concentrations of naldemedine in subjects with ESRD requiring dialysis were similar when naldemedine was administered either pre- or post-haemodialysis, indicating that naldemedine was not removed from the blood by haemodialysis.
Koncentracije naldemedina u plazmi ispitanika s ESRD-om na hemodijalizi bile su slične bez obzira na to je li naldemedin primijenjen prije ili poslije hemodijalize, što znači da se naldemedin hemodijalizom nije uklonio iz krvi.
- 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.
Odmah se obratite liječniku i prestanite uzimati Rizmoic. - ako bolujete od simptoma sindroma ustezanja od opioida (pogledajte dio 4 „Moguće nuspojave“) koji se može razviti u roku od nekoliko minuta do nekoliko dana nakon uzimanja lijeka kao što je Rizmoic.
A patient who took a single dose of naldemedine 1 mg experienced severe drug withdrawal syndrome, including nausea and stomach cramping and was given esomeprazole and ondansetron for nausea and midazolam hydrochloride for stomach cramping.
Jedan bolesnik koji je uzeo jednu dozu od 1 mg naldemedina razvio je teški sindrom ustezanja od lijeka, uključujući mučninu i grčeve u trbuhu, te je dobio esomeprazol i ondanzetron za mučninu i midazolam hidroklorid za grčeve u trbuhu.
It is a medicine used in adults to treat constipation caused by pain medicines, called opioids (e.g morphine, oxycodone, fentanyl, tramadol, codeine, hydromorphone, methadone).
To je lijek koji se primjenjuje u odraslih za liječenje zatvora uzrokovanog analgeticima koji se nazivaju opioidi (npr. morfij, oksikodon, fentanil, tramadol, kodein, hidromorfon, metadon).
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).
U LIR-podskupini opažen je veći udio bolesnika s terapijskim odgovorom uz naldemedin (46,4%) nego uz placebo (30,2%), a razlika između skupina (16,2%) bila je statistički značajna (p<0,0001).
Pack sizes of 7, 10, 28, 30, 84 or 100 film-coated tablets.
Veličine pakiranja od 7, 10, 28, 30, 84 ili 100 filmom obložene tablete.
Gastrointestinal disorders
Gastrointestinalne nuspojave
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.
Ukupno 547 bolesnika u ispitivanju V9231, 551 bolesnik u ispitivanju V9232 i 1246 bolesnika u ispitivanju V9235 bilo je randomizirano u omjeru 1:1 u skupine koje su primale 200 mikrograma naldemedina ili placebo jedanput dnevno tijekom 12 tjedana u ispitivanjima V9231 i V9232 te tijekom 52 tjedna u ispitivanju V9235.
Rizmoic may be used with or without laxative(s).
Rizmoic se može primjenjivati s laksativom (laksativima) ili bez laksativa.
Uncommon Rare
Manje često Rijetko
Naldemedine is not removed from the body by haemodialysis.
Naldemedin se ne uklanja iz tijela hemodijalizom.
For Study V9235, the efficacy of naldemedine vs. placebo was assessed as secondary endpoints by the frequency of BMs as presented in Table 4.
U ispitivanju V9235, djelotvornost naldemedina naspram placeba bila je procijenjena kao sekundarna mjera ishoda po učestalosti pražnjenja crijeva, kako je prikazano u tablici 4.
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.
Bolesnici koji su u vrijeme dolaska na probir bili na terapiji laksativima, trebali su ih nastaviti uzimati u stabilnoj dozi do kraja razdoblja liječenja.
The agreed update is aligned with the wording reflected in the product informations for methylnaltrexone and naloxegol.
Dogovoren ažuriran tekst usklađen je s onim u informacijama o lijeku za metilnatrekson i naloksegol.
Rizmoic must be discontinued if treatment with the opioid pain medicinal product is discontinued.
Primjenu lijeka Rizmoic mora se prekinuti ako se prekida liječenje opioidnim analgetikom.
Rizmoic contains sodium
Rizmoic sadrži natrij
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.
U ispitivanjima V9231 i V9232, bolesnici nisu smjeli uzimati laksative ili su morali biti voljni prekinuti uporabu laksativa u vrijeme probira te uzimati samo ponuđene laksative za hitno olakšanje tegoba tijekom razdoblja probira i razdoblja liječenja.
Cases of possible opioid withdrawal syndrome have been reported in the naldemedine clinical programme (see section 4.8).
U kliničkom programu ispitivanja naldemedina zabilježeni su slučajevi mogućeg sindroma ustezanja od opioida (vidjeti dio 4.8).
For Study V9235, long term efficacy data defined as the change in frequency of BMs at week 52 from baseline, assessed as a secondary endpoint, showed that subjects in the naldemedine group had improvements in the frequency of BMs compared with subjects in the placebo group in both LIR (3.10 vs 1.90, p=0.0210) and non-LIR (4.26 vs 3.39, p=0.1349) subgroups.
U ispitivanju V9235, podaci o dugotrajnoj djelotvornosti definiranoj kao promjena učestalosti pražnjenja crijeva u 52. tjednu u odnosu na početnu, koja se procjenjivala kao sekundarna mjera ishoda, pokazali su da su ispitanici u skupini koja je primala naldemedin imali poboljšanje učestalosti pražnjenja crijeva u odnosu na ispitanike u skupini koja je primala placebo i u LIR-podskupini (3,10 naspram 1,90, p=0,0210) i u ne-LIR-podskupini (4,26 naspram 3,39, p=0,1349).
There is no risk of interaction with concomitant use of mild CYP3A inhibitors.
Nema rizika od interakcije s istodobno primijenjenim slabim inhibitorima CYP3A.
Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.
Rizmoic je indiciran za liječenje konstipacije uzrokovane opioidima u odraslih bolesnika koji su prethodno primali laksative.
Patients should be monitored for the development of severe, persistent or worsening abdominal pain.
Bolesnike je potrebno pratiti zbog mogućeg razvoja jakog, perzistirajućeg ili pogoršavajućeg bola u abdomenu.
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 su, između ostalih, uključivali hiperhidrozu, zimicu, pojačano suzenje, navale vrućine/crvenila, pireksiju, kihanje, osjećaj hladnoće, bol u abdomenu, proljev, mučninu, povraćanje, artralgiju, mialgiju i tahikardiju (vidjeti dio 4.4).
Naldemedine is primarily metabolised by CYP3A with some contribution from UGT1A3 and is a substrate of P-glycoprotein (P-gp) (see section 5.2).
Naldemedin se primarno metabolizira putem CYP3A, a djelomično i putem UGT1A3, te je supstrat P-glikoproteina (P-gp) (vidjeti dio 5.2).
Naldemedine was found to have no clinically relevant adverse effects on fertility or reproductive performance in male and female rats (see section 5.3).
Ustanovljeno je da naldemedin nema klinički značajnih štetnih učinaka na plodnost ili reproduktivnu sposobnost mužjaka i ženki štakora (vidjeti dio 5.3).
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.
Naldemedin nije ispitan u programu kliničkog ispitivanja u bolesnika koji su u nedavnoj anamnezi unutar 3 mjeseca od probira imali infarkt miokarda, moždani udar ili tranzitornu ishemijsku ataku.
• watery eyes or runny nose
• suzne oči ili curenje nosa
Possible opioid withdrawal, defined as at least three adverse reactions potentially related to opioid withdrawal that occurred on the same day and that were not exclusively related to the gastrointestinal system, occurred in 0.8% (9/1,163) of patients with chronic non-cancer pain and OIC taking naldemedine compared to 0.2% (2/1,165) of patients taking placebo regardless of maintenance opioid treatment, and 0.6% (1/155) of patients with cancer and OIC taking naldemedine 200 micrograms compared to 0% (0/152) of patients taking placebo.
Moguće ustezanje od opioida, definirano kao najmanje tri nuspojave za koje postoji mogućnost da su povezane s ustezanjem od opioida a pojavile su se istog dana i nisu bile povezane isključivo s probavnim sustavom, nastalo je u 0,8% (9/1163) bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima koji su uzimali naldemedin u odnosu na 0,2% (2/1165) bolesnika koji su uzimali placebo bez obzira na terapiju održavanja opioidima te u 0,6% (1/155) bolesnika s karcinomom i konstipacijom uzrokovanom opioidima koji su uzimali naldemedin u dozi od 200 mikrograma u odnosu na 0% (0/152) bolesnika koji su uzimali placebo.
• diverticulitis (an illness where your gut is inflamed);
• divertikulitis (bolest kod koje je prisutna upala crijeva)
Concomitant use of P-gp inhibitors such as cyclosporine may increase plasma concentrations of naldemedine.
Istodobna primjena inhibitora P-gp-a poput ciklosporina može povećati koncentracije naldemedina u plazmi.
Round, approximately 6.5 mm diameter, yellow tablet debossed with '222' and Shionogi logo on one side and '0.2' on the other side.
Okrugla, žuta tableta, približnog promjera 6,5 mm, s utisnutim „222“ i logom tvrtke Shionogi na jednoj strani te „0.2“ na drugoj.
Naldemedine has no or negligible influence on the ability to drive and use machines.
Naldemedin ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
In Studies V9231, V9232 and V9235, the mean age of the subjects in these three studies was 53.2 years; 14.8% were 65 years of age or older; 62.0% were women; 80.2% were white.
U ispitivanjima V9231, V9232 i V9235, srednja vrijednost dobi ispitanika u sva tri ispitivanja iznosila je 53,2 godine; 14,8% bolesnika bilo je u dobi od 65 godina ili starije; 62,0% bile su žene; 80,2% bili su bijelci.
Use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
Ne preporučuje se primjena u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
The most commonly reported adverse reactions in patients with chronic non-cancer pain and OIC were abdominal pain (7.8%), diarrhoea (5.9%), nausea (3.6%), and vomiting (1.1%).
Najčešće zabilježene nuspojave u bolesnika s kroničnom nekarcinomskom boli i konstipacijom uzrokovanom opioidima bile su bol u abdomenu (7,8%), proljev (5,9%), mučnina (3,6%) i povraćanje (1,1%).
A SBM was defined as a bowel movement (BM) without rescue laxative taken within the past 24 hours.
Spontano pražnjenje crijeva definirano je kao pražnjenje crijeva bez pomoći laksativa za hitno olakšanje tegoba (engl. rescue laxative) uzetog unutar prethodna 24 sata.
Patients should be advised to discontinue naldemedine and to contact their physician if opioid withdrawal occurs.
Bolesnicima treba savjetovati da prestanu uzimati naldemedin i obrate se svom liječniku ako nastupi ustezanje od opioida.
All study participants took previous laxatives at some time for the treatment of OIC prior to entering the trials V9231 or V9232.
Svi su bolesnici u ispitivanju u nekom trenutku uzimali laksative za liječenje konstipacije uzrokovane opioidima prije uključenja u ispitivanja V9231 ili V9232.
[Carbonyl-14C]-naldemedine-derived radioactivity was excreted into milk in lactating rats.
Radioaktivnost porijekla iz [karbonil-14C]-naldemedina izlučivala se u mlijeko ženki štakora tijekom laktacije.
Clinical outcomes for studies V9231 and V9232
Tablica 3. Klinički ishodi u ispitivanjima V9231 i V9232
It is unknown whether naldemedine/metabolites are excreted in human milk.
Nije poznato izlučuju li se naldemedin/metaboliti u majčino mlijeko.
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.
Broj bolesnika u LIR i ne-LIR podskupinama u ispitivanjima V9231 i V9232 zajedno iznosio je 629 (naldemedin: 317 i placebo: 312) odnosno 451 (naldemedin: 223 i placebo: 228).
Yellow iron oxide (E172)
Film-ovojnica hipromeloza talk žuti željezov oksid (E172)
Tel.: +48 (12) 653 15 71 e-mail: biuro@molteni.com.pl
Molteni Farmaceutici Polska Sp. z o.o. Tel.: +48 (12) 653 15 71 e-mail: biuro@molteni.com.pl
The use of naldemedine is not recommended in these patients (see section 4.2).
Ne preporučuje se primjena naldemedina u ovih bolesnika (vidjeti dio 4.2).
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.
Smanjenje indeksa održanja mladunčadi na životu (engl. viability index) 4. dana nakon rođenja bilo je zabilježeno pri dozama od 30 i 1000 mg/kg na dan, a u mladunčadi su zabilježene niska tjelesna težina i kasnije odvajanje uški od glave pri dozi od 1000 mg/kg na dan.
In the non-LIR subgroup, consistent with the results in the LIR subgroup, a greater proportion of responders was observed with naldemedine (54.3%) compared with placebo (38.9%) and the difference between groups (15.6%) was statistically significant (p=0.0009).
U ne-LIR-podskupini, sukladno rezultatima u LIR-podskupini, veći udio ispitanika s terapijskim odgovorom bio je opažen uz naldemedin (54,3%) nego uz placebo (38,9%), a razlika je između skupina (15,6%) bila statistički značajna (p=0,0009).
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.