natgillin/translations-raw huggingface dataset:
Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.
Zdravilo Rizmoic je indicirano za zdravljenje zaprtja, povzročenega z opioidi (opioid-induced constipation - OIC) pri odraslih bolnikih, ki so se predhodno zdravili z odvajalom.
Patients were allowed to receive rescue laxative(s) as needed regardless of being on a stable laxative regimen at baseline (apart from within 24 hours of the start of the Treatment Period).
Bolniki so smeli prejemati reševalno/-a odvajalo/-a po potrebi ne glede na to, ali so v izhodišču prejemali stabilno shemo z odvajali (razen prvih 24 ur po začetku obdobja zdravljenja).
There is a theoretical possibility that naldemedine provokes opioid withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist.
Obstaja teoretična možnost, da bi naldemedin lahko povzročil odtegnitev opioidov pri dojenem novorojencu, katerega mati jemlje agonist opioidnega receptorja.
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.
Med jemanjem zdravila Rizmoic se nemudoma posvetujte z zdravnikom ali farmacevtom: - če se razvije huda, dolgotrajna ali naraščajoča bolečina v trebuhu, ker bi to lahko bil simptom nastajanja luknje v črevesni steni, ki je lahko življenje ogrožujoča.
Clinical outcomes for studies V9231 and V9232
Klinični izidi v študijah V9231 in V9232
Concomitant use with strong CYP3A inhibitors should be avoided.
Sočasni uporabi z močnimi inhibitorji CYP3A se je treba izogibati.
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 zdravilo, ki se uporablja pri odraslih za zdravljenje zaprtja, ki ga povzročajo zdravila proti bolečinam, ki se imenujejo opioidi (npr. morfin, oksikodon, fentanil, tramadol, kodein, hidromorfon, metadon).
From baseline to the last 2 weeks of treatment**
od izhodišča do zadnjih 2 tednov zdravljenja**
Following oral administration of [14C]-labelled naldemedine, the primary metabolite in plasma was nor-naldemedine, with a relative exposure compared to naldemedine of approximately 9 to 13%.
Po peroralnem dajanju s [14C] označenega naldemedina je bil primarni presnovek v plazmi nor-naldemedin, z relativno izpostavljenostjo približno 9 do 13 % izpostavljenosti naldemedinu.
Talk to your doctor or pharmacist before taking Rizmoic: - if you suffer from a disease which may affect your bowel wall such as:
Pred začetkom jemanja zdravila Rizmoic se posvetujte z zdravnikom ali farmacevtom: - če imate kako bolezen, ki bi lahko prizadela črevesno steno, na primer:
Naldemedine is an antagonist of opioid binding at the mu-, delta-, and kappa-opioid receptors.
Naldemedin je antagonist vezave opioidov na mu-, delta- in kappa-opioidne receptorje.
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.
Zdravilo Rizmoic lahko uporabljamo pri bolnikih, ki uporabljajo opioidno zdravilo proti bolečinam zaradi raka ali dolgotrajnim bolečinam drugega izvora, potem ko so se predhodno zdravili z odvajalom
None of the identified cases are without significant confounding factors and the difficulties in definitively determining causality are acknowledged.
V vseh ugotovljenih primerih so prisotni drugi pomembni možni vzročni dejavniki, kar otežuje definitivno določitev vzročnosti.
Film coating: hypromellose , talc and yellow iron oxide (E172).
Filmska obloga: hipromeloza, smukec in rumeni železov oksid (E172).
Use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2).
Uporaba pri bolnikih s hudo okvaro jeter ni priporočljiva (glejte poglavji 4.4 in 5.2).
Not all pack sizes may be marketed in your country.
V vaši državi na trgu morda ni vseh navedenih pakiranj.
If you are not sure, talk to your doctor or pharmacist before taking Rizmoic.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Rizmoic.
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.
V kliničnih študijah so imeli bolniki z OIC, ki so 4 tedne prejemali 0,4 mg/dan (dvakraten priporočeni odmerek), zvečano pogostnost neželenih učinkov na zdravilo, povezanih s prebavili, vključno z drisko in bolečino v trebuhu, pogosto v 1-2 dneh po začetku odmerjanja.
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.
57,3 % oziroma 34,8 % odmerka izločilo v urinu oziroma blatu v obliki [oksadiazol-14C]-naldemedina, 20,4 % oziroma 64,3 % odmerka pa se je izločilo v urinu oziroma blatu v obliki [karbonil-14C]
All study participants took previous laxatives at some time for the treatment of OIC prior to entering the trials V9231 or V9232.
Vsi preiskovanci v študiji so v določenem trenutku v preteklosti jemali odvajala za zdravljenje OIC pred vstopom v preskušanje V9231 oziroma V9232.
Two of the nine cases have been classified as cases of interest by the MAH, one of which they consider ‘possibly related' and other ‘probably related'.
Dva od teh devetih primerov je imetnik dovoljenja za promet z zdravilom opredelil kot pomembna, za enega od njiju je vzročno povezavo ocenil kot možno', za drugega pa kot verjetno.
Aluminium/aluminium blister containing 7, 10 or 14 film-coated tablets.
Pretisni omot iz aluminija/aluminija, ki vsebuje 7,10 ali 14 filmsko obloženih tablet.
Interaction with strong and moderate CYP3A inducers Rifampicin, a strong CYP3A inducer, significantly decreased exposure to naldemedine by 83% .
Interakcije z močnimi in zmernimi induktorji CYP3A Rifampicin, močan induktor CYP3A, je značilno zmanjšal izpostavljenost naldemedinu za 83 %.
From baseline to the last 2 weeks of treatment***
od izhodišča do zadnjih 2 tednov zdravljenja***
Very common (may affect more than 1 in 10 people):
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov):
Pack sizes of 7, 10, 28, 30, 84 or 100 film-coated tablets.
Velikosti pakiranja po 7, 10, 28,30, 84 ali 100 filmsko obloženih tablet.
There is no specific antidote for naldemedine.
Za naldemedin ni specifičnega antidota.
Change in the frequency of BMs per week from baseline to each visit (LS Mean) ITT population in study V9235
Sprememba pogostnosti BM na teden od izhodišča do vsakega pregleda (povprečje najmanjših kvadratov (LS)) v populaciji ITT v študiji V9235
The absolute bioavailability of naldemedine has not been established.
Absolutne biološke uporabnosti naldemedina niso ugotovili.
The pharmacokinetics of naldemedine in the paediatric population has not been studied (see section 4.2).
Farmakokinetike naldemedina v pediatrični populaciji niso raziskovali (glejte poglavje 4.2).
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni ‘brez natrija'.
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.
Dva od teh devetih primerov je imetnik dovoljenja za promet z zdravilom opredelil kot neutemeljena, pri preostalih petih primerih pa sta takoimetnik dovoljenja za promet z zdravilom kot tudi poročevalec izključila vzročno povezavo.
Caution should be exercised with regards to opioid withdrawal.
Pri odtegovanju opioidov je potrebna previdnost.
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.
Možna odtegnitev opioidov, opredeljena kot vsaj trije neželeni učinki, potencialno povezani z odtegnitvijo opioidov, ki so se pojavili istega dne in niso bili izključno povezani s prebavili, se je pojavila pri 0,8 % (9/1.163) bolnikov s kronično nerakasto bolečino in OIC, ki so jemali naldemedin, v primerjavi z 0,2 % (2/1.165) bolnikov, ki so jemali placebo, ne glede na vzdrževalno opioidno zdravljenje, in pri 0,6 % (1/155) bolnikov z rakom in OIC, ki so jemali po 200 mikrogramov naldemedina, v primerjavi z 0 % (0/152) bolnikov, ki so jemali placebo.
Itraconazole, a strong CYP3A inhibitor, increased exposure to naldemedine 2.9 fold that may result in an increased risk of adverse reactions.
Itrakonazol, močan inhibitor CYP3A, je 2,9-krat zvečal izpostavljenost naldemedinu, kar lahko zveča tveganje neželenih učinkov.
Using these medicines with Rizmoic may affect the way naldemedine works or increase its side effects.
Uporaba teh zdravil skupaj z zdravilom Rizmoic lahko vpliva na način delovanja naldemedina ali zveča tveganje za pojav njegovih neželenih učinkov.
The patients who participated in Studies V9231, V9232 and V9235 were taking a wide range of opioids.
Bolniki, ki so sodelovali v študijah V9231, V9232 in V9235, so jemali veliko vrst opioidov.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
For Study V9235, the efficacy of naldemedine vs. placebo was assessed as secondary endpoints by the frequency of BMs as presented in Table 4.
V študiji V9235 so učinkovitost naldemedina glede na placebo ocenili s pogostnostjo BM kot sekundarnimi opazovanimi dogodki, kot kaže preglednica 4.
Interactions with CYP3A inhibitors
Interakcije z inhibitorji CYP3A
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).
Na novo so opažali histopatološke spremembe pri vseh odmerkih, preskušenih pri podganjih samicah, v jajčnikih (terciarni folikli/lutealne ciste), poleg nerednih estrusnih ciklov, hiperplazije mlečnih žlez in vaginalne mucifikacije, ki so jih že ugotovili pri odraslih živalih (najmanjši preskušeni odmerek je ustrezal presežku izpostavljenosti pri ljudeh za 6-krat ali več, odvisno od starosti mladičev).
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca,
Rare (may affect up to 1 in 1,000 people):
Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov):
There is no experience in patients treated for constipation induced by partial opioid mu-agonists (e.g. buprenorphine).
Pri bolnikih, zdravljenih zaradi zaprtja, povzročenega z delnimi opioidnimi mu-agonisti (npr. buprenorfinom), ni izkušenj.
If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking Rizmoic.
Če karkoli od zgoraj navedenega velja za vas ali če ste negotovi, se pred začetkom jemanja zdravila Rizmoic posvetujte z zdravnikom ali farmacevtom.
Other medicines and Rizmoic
Druga zdravila in zdravilo Rizmoic
- if you have severe liver disease such as alcoholic liver disease, viral liver infection or impaired liver function.
- če imate hudo bolezen jeter, na primer alkoholno bolezen jeter, virusno okužbo jeter ali zmanjšano delovanje jeter;
Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids without reversing the central nervous system (CNS)-mediated opioid effects.
Naldemedin deluje kot periferno delujoč antagonist mu-opioidnih receptorjev v tkivih, kot so prebavila, in s tem zmanjšuje učinke opioidov, ki povzročajo zaprtje, ne da bi odpravil učinke opioid, ki jih posreduje centralno živčevje (CŽ).
Patients having disruptions to the blood-brain barrier (e.g., primary brain malignancies, central nervous system (CNS) metastases or other inflammatory conditions, active multiple sclerosis and advanced Alzheimer's disease) may be at increased risk of opioid withdrawal or reduced analgesia.
Pri bolnikih s prekinitvijo krvno-možganske pregrade (npr. primarne maligne bolezni možganov, metastaze v centralnem živčevju (CŽ) ali druga vnetna stanja, aktivna multipla skleroza in napredovala Alzheimerjeva bolezen) je lahko tveganje za sindrom odtegnitve opioidov ali zmanjšane analgezije zvečano.
The primary endpoint for Studies V9231 and V9232 was the proportion of SBM responders, defined as: ≥3 SBMs per week and a change from baseline of ≥1 SBM per week for at least 9 out of the 12 study weeks and 3 out of the last 4 weeks.
Primarni opazovani dogodek v študijah V9231 in V9232 je bil delež bolnikov, ki so se odzvali na zdravljenje z ozirom na SBM, definirano kot: ≥ 3 SBM na teden in sprememba od izhodišča za ≥ 1 SBM na teden v najmanj 9 od 12 tednih študije in 3 od zadnjih 4 tednov.
If obstruction or perforation are suspected, naldemedine must be discontinued (see section 4.3).
Če posumimo na zaporo ali perforacijo, moramo naldemedin ukiniti (glejte poglavje 4.3).
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.
Plazemske koncentracije naldemedina pri preiskovancih z ESRD, pri kateri je bila potrebna hemodializa, so bile podobne, če so dajali naldemedin bodisi pred hemodializo bodisi po njej, kar kaže na to, da se naldemedin ne odstranjuje iz krvi s hemodializo.
8465RX,
8465RX, Nizozemska
No human data on the effect of naldemedine on fertility are available.
Podatki o vplivu naldemedina na plodnost pri ljudeh niso na voljo.
Speak to your doctor immediately and stop taking Rizmoic.
Takoj se posvetujte z zdravnikom in prenehajte jemati zdravilo Rizmoic;
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
Najvišja koncentracija v plazmi in površina pod krivuljo plazemska koncentracija-čas sta se v razponu odmerkov od 0,1 do 100 mg zvečali na skoraj sorazmerno odmerku.
The overall benefit-risk of naldemedine should be considered in these patients with close monitoring for symptoms of opioid withdrawal.
Pri teh bolnikih je treba upoštevati celotno razmerje koristi in tveganja naldemedina in jih skrbno spremljati glede simptomov odtegnitve opioidov.
In studies V9222 and V9236, OIC was confirmed through a 2-week run-in period and was defined as ≤5 SBMs during the 14 consecutive days prior to the randomisation and ≥1 of the following bowel symptoms in ≥25% of all BMs regardless of the use of rescue laxatives: presence of straining during bowel movement, feeling of incomplete evacuation, passage of hard stools or small pellets.
V študijah V9222 in V9236 so OIC potrdili v 2-tedenskem uvajalnim obdobjem, opredeljeno pa je bilo kot ≤ 5 SBM v 14 zaporednih dneh pred randomizacijo in ≥ 1 od naslednjih črevesnih simptomov pri ≥ 25 % vseh BM ne glede na uporabo rešilnih odvajal: prisotnost napenjanja med iztrebljanjem, občutek nepopolne izraznitve, odvajanje trdega blata ali majhnih kroglic.
From baseline to week 1**
od izhodišča do 1. tedna**
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.
V študijah V9222 in V9236 je bila povprečna starost preiskovancev 64,3 leta; 51,8 % jih je bilo starih 65 let ali več; 39,4 % jih je bilo žensk in 97,1 % jih je bilo Japoncev.
Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea or vomiting, muscle aches, lacrimation or rhinorrhea, pupillary dilation or piloerection or sweating, diarrhoea, yawning, fever or insomnia.
Sindrom odtegnitve opioidov je skupina treh ali več naslednjih znakov ali simptomov: disforično razpoloženje, navzea ali bruhanje, bolečine v mišicah, solzenje ali izcedek iz nosu (rinoreja), razširitev zenic ali piloerekcija ali znojenje, driska, zehanje, zvišana telesna temperatura ali nespečnost.
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.
Poleg tega je naldemedin substrat izločevalnega prenašalca P-glikoproteina (P-gp), ki je tudi lahko vpleten v zmanjšanje penetracije naldemedina v CŽ.
Patients with known or suspected gastrointestinal obstruction or perforation or patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation (see section 4.4).
Bolniki z znano ali domnevno gastrointestinalno obstrukcijo ali perforacijo ali bolniki z zvečanim tveganjem za ponovitev obstrukcije, zaradi možnosti gastrointestinalne perforacije (glejte poglavje 4.4).
The recommended dose of naldemedine is 200 micrograms (one tablet) daily.
Priporočeni odmerek naldemedina je 200 mikrogramov (ena tableta) na dan.
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.
Pri enem bolniku, ki je vzel enkraten odmerek naldemedina 1 mg, se je pojavil hud sindrom odtegnitve zdravila, vključno z navzeo in krči v želodcu; prejel je esomeprazol in ondansetron proti navzei ter midazolamijev klorid proti krčem v želodcu.
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).
V podskupini non-LIR so v skladu z rezultati v skupini LIR ugotovili večji delež bolnikov, ki so se odzvali na zdravilo, pri naldemedinu (54,3 %) v primerjavi s placebom (38,9 %), razlika med skupinama (15,6 %) je bila statistično značilna (p=0,0009).
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
No dose adjustment is required in patients older than 65 years of age (see section 5.2).
Starejši bolniki Pri bolnikih, starejših od 65 let, prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
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.
V študiji V9235 so dolgoročni podatki glede učinkovitosti, opredeljeni kot sprememba pogostnosti BM od izhodišča do 52. tedna, ocenjeni kot sekundarni opazovani dogodek, pokazali, da se je pri bolnikih v skupini z naldemedinom izboljšala pogostnost BM v primerjavi z bolniki v skupini s placebom tako v podskupini LIR (3,10 proti 1,90; p=0,0210) kot v podskupini non-LIR (4,26 proti
Naldemedine is not removed from the body by haemodialysis.
Naldemedin se ne odstranjuje iz telesa s hemodializo.
Cases of possible opioid withdrawal syndrome have been reported in the naldemedine clinical programme (see section 4.8).
V kliničnem programu z naldemedinom so poročali o primerih možnega sindroma odtegnitve opioidov (glejte poglavje 4.8).
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.
V študijah V9231, V9232 in V9235 je bila povprečna starost preiskovancev 53,2 let; 14,8 % jih je bilo starih 65 let ali več; 62,0 % je bilo žensk; 80,2 % je bilo belcev.
[Carbonyl-14C]-naldemedine-derived radioactivity was excreted into milk in lactating rats.
Radioaktivnost, ki je izvirala iz [karbonil-14C]-naldemedina, se je pri doječih podganah izločala v mleko.
In Study V9232, they were back pain (53.6%); pain (10.2%) and arthralgia (7.8%).
V študiji V9232 so to bile bolečina v hrbtu (53,6 %); bolečina (10,2 %) in artralgija (7,8 %).
Store in the original package in order to protect the tablets from light and moisture.
Shranjujte v originalni ovojnini za zagotovitev zaščite tablet pred svetlobo in vlago.
In Studies V9231 and V9232, patients who, based on concomitant medication records, were on laxative therapy prior to entering the study and who stopped its use within 30 days prior to Screening, and had self-reported OIC, were considered to be a LIR.
V študijah V9231 in V9232 so bolniki, ki so se na podlagi spremljajočih kartotek o zdravljenju zdravili z odvajali pred vključitvijo v študijo in ki so odvajala prenehali uporabljati v 30 dneh pred presejanjem in so poročali o OIC, veljali za LIR.
If you have taken more Rizmoic than you should, talk to your doctor or go to the hospital.
Če ste vzeli večji odmerek zdravila Rizmoic, kot bi smeli Če ste vzeli večji odmerek zdravila Rizmoic, kot bi smeli, se posvetujte z zdravnikom ali pojdite v bolnišnico.
Stop taking Rizmoic and contact your doctor if you develop opioid withdrawal symptoms.
Prenehajte jemati zdravilo Rizmoic in se posvetujte z zdravnikom, če se pri vas razvijejo simptomi odtegnitve opioidov;
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%).
Neželeni učinki, o katerih so najpogosteje poročali pri bolnikih s kronično nerakasto bolečino in OIC, so bili bolečina v trebuhu (7,8 %), driska (5,9 %), navzea (3,6 %) in bruhanje (1,1 %).
Based on this, naldemedine is expected to exert its anti-constipating effects on opioids without reversing their CNS-mediated analgesic effects.
Na podlagi tega pričakujemo, da bo naldemedin izrazil svoje učinke na opioide, ki delujejo proti zaprtju, ne da bi odpravil njihove analgetične učinke preko CŽ.
In the run-in and treatment periods for all three studies, bisacodyl was used as rescue laxative if patients had not had a BM for 72 hours and were allowed one-time use of an enema if after 24 hours of taking bisacodyl, they still had not had a BM.
V uvodnem obdobju in obdobju zdravljenja v vseh treh študijah so kot rešilno odvajalo uporabljali bisakodil, če bolniki niso imeli BM 72 ur.
Patients receiving a stable opioid morphine equivalent daily dose of ≥ 30 mg for at least 4 weeks before enrollment and self-reported OIC were eligible to participate.
Primerni za sodelovanje v študiji so bili bolniki, ki so prejemali stabilen odmerek opioida, enakovreden dnevnemu odmerku morfina ≥ 30 mg, vsaj 4 tedne pred vključitvijo, in so sami poročali o OIC.
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.