natgillin/translations-raw huggingface dataset:
In cases of known or suspected overdose of naloxegol, symptomatic treatment as well as monitoring of vital functions should be performed.
V primeru znanega prevelikega odmerjanja naloksegola ali suma nanj je treba uporabiti simptomatsko zdravljenje in kontrolirati vitalne funkcije.
• other medicines for constipation (any laxatives)
• druga zdravila proti zaprtju (katero koli odvajalo),
No dose adjustment is recommended based on age (see section 5.2).
Odmerka ni treba prilagoditi glede na starost (glejte poglavje 5.2).
In these patients renal impairment may adversely affect other clearance pathways (hepatic/gut drug metabolism, etc.) resulting in higher exposure.
Pri teh bolnikih okvara ledvic morda neugodno vpliva na druge poti očistka (presnova v jetrih/črevesu itn.) in tako poveča izpostavljenost.
Carcinogenicity studies of naloxegol were conducted in rats and mice.
Študije kancerogenosti naloksegola so izvedli na podganah in miših.
It is recommended that Moventig is taken in the morning, for patient convenience to avoid bowel movements in the middle of the night.
Način uporabe peroralna uporaba Priporočljivo je, da bolniki zdravilo Moventig vzamejo zjutraj, da se izognejo odvajanju blata sredi noči.
Interaction with P-gp inhibitors
Medsebojno delovanje z zaviralci P-gp
The blood brain barrier integrity is important for minimizing naloxegol uptake into the CNS.
Integriteta krvno-možganske pregrade je pomembna za omejitev prehajanja naloksegola v CNS.
Note: Selection of ADRs and their frequencies based on the 25 mg dose a Reflects MedDRA Preferred Terms of: “abdominal pain”, “abdominal pain upper”, “abdominal pain lower” and “gastrointestinal pain”.
Opomba: Izbrani neželeni učinki zdravila in njihove pogostnosti na podlagi odmerka 25 mg. a Zajema prednostne izraze MedDRA: »bolečine v trebuhu«, »bolečine v zgornjem delu trebuha«, »bolečine v spodnjem delu trebuha« in »gastrointestinalne bolečine«.
The effect of naloxegol on fertility in humans has not been studied.
Vpliv naloksegola na plodnost pri človeku ni raziskan.
Following oral administration of radiolabelled naloxegol, 68% and 16% of total administered dose were recovered in the faeces and urine, respectively.
Po peroralni uporabi radioaktivno označenega naloksegola se je v blatu pojavilo 68 % celotnega uporabljenega odmerka, v urinu pa 16 %.
The effect of race on the pharmacokinetics of naloxegol is small (approximately 20% decrease in the AUC of naloxegol when other groups are compared to Caucasian) and, therefore, no dose adjustment is necessary.
Rasa malo vpliva na farmakokinetiko naloksegola (približno 20 % nižja AUC naloksegola ob primerjavi drugih rasnih skupin z belci), zato odmerka ni treba prilagoditi.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
It is a medicine used in adults to treat constipation specifically caused by pain medicines, called opioids, (e.g. morphine, oxycodone, fentanyl, tramadol, codeine) taken on a regular basis.
Uporabljamo ga za zdravljenje zaprtja, ki je izrecno posledica rednega jemanja protibolečinskih zdravil, imenovanih opioidi (npr. morfin, oksikodon, fentanil, tramadol, kodein).
How to take Moventig
Kako jemati zdravilo Moventig
Conditions in patients with cancer pain
Bolniki z bolečinami zaradi raka
Kodiac 8 was a Phase III, 52-week, multi-center, open-label, randomized, parallel group, safety and tolerability study of naloxegol versus usual care in the treatment of OIC in patients with non-cancer-related pain.
Kodiac 8 je bila 52-tedenska, multicentrična, odprta, randomizirana študija III. faze z vzporednimi skupinami za preučitev varnosti in prenašanja naloksegola v primerjavi z običajnim zdravljenjem OIC pri bolnikih, ki so imeli OIC in bolečine, nepovezane z rakom.
When naloxegol therapy is initiated, it is recommended that all currently used maintenance laxative therapy should be halted, until clinical effect of naloxegol is determined.
Ob uvedbi zdravljenja z naloksegolom je priporočljivo popolnoma prekiniti vse trenutno vzdrževalno zdravljenje z odvajali, dokler ni ugotovljen klinični učinek naloksegola.
• if you have kidney problems
• če imate težave z ledvicami;
• if you develop severe, persistent or worsening stomach pain.
• če se vam pojavijo hude, dolgotrajne bolečine v trebuhu ali se vam takšne bolečine poslabšajo.
This medicine contains less than 1 mmol sodium (23 mg) per 12.5 mg / 25 mg tablet, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 12,5 mg / 25 mg tableto, kar v bistvu pomeni ‘brez natrija'.
The majority of gastrointestinal adverse reactions were graded as mild to moderate, occurred early in treatment and resolved with continued treatment.
Večina neželenih učinkov na prebavilih je bila razvrščenih med blage do zmerne, pojavili so se zgodaj med zdravljenjem in so med nadaljevanjem zdravljenja izginili.
• nasopharyngitis (runny or stuffy nose)
• nazofaringitis (izcedek iz nosu ali zamašen nos)
Naloxegol should be prescribed with caution in such patients taking into account their individual benefit-risk balance with observation for potential CNS effects, such as symptoms of opioid withdrawal and/or interference with opioid-mediated analgesia.
Takšnim bolnikom je treba naloksegol predpisovati previdno, upoštevaje njihovo individualno razmerje med koristjo in tveganjem, in jih je treba spremljati glede morebitnih učinkov na CNS, npr. glede simptomov odtegnitve opioidov in/ali oviranja analgezije z opioidi.
Therefore, naloxegol has not been studied in OIC patients with moderate or severe hepatic impairment.
Zato naloksegol ni raziskan pri bolnikih z OIC in zmerno ali hudo okvaro jeter.
What Moventig looks like and contents of the pack
Izgled zdravila Moventig in vsebina pakiranja
Moventig is not expected to affect you being able to drive a car or use any tools or machines.
Ni pričakovati, da bi zdravilo Moventig vplivalo na vašo sposobnost za upravljanje vozil ali strojev.
Tell your doctor, you may need to stop taking Moventig.
O tem obvestite zdravnika; morda boste morali nehati jemati zdravilo Moventig.
There is limited clinical experience with the use of naloxegol in OIC patients with cancer-related pain.
Kliničnih izkušenj z uporabo naloksegola pri bolnikih z OIC in bolečinami zaradi raka je malo.
Moventig contains sodium
Moventig vsebuje natrija
• ritonavir, indinavir or saquinavir - to treat HIV
• ritonavir, indinavir ali sakvinavir - za zdravljenje HIV.
Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
Zdravilo Moventig je indicirano za zdravljenje zaprtja, povzročenega z opioidi (OIC - opioid-induced constipation), pri odraslih bolnikih z nezadostnim odzivom na odvajala.
The responder rates in this population were placebo 30.0%, 12.5 mg 44.3% and 25 mg 44.4%.
Deleži odziva so bili v tej populaciji 30,0 % s placebom, 44,3 % z 12,5 mg in 44,4 % s 25 mg.
Concomitant use with strong CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, itraconazole or telithromycin; protease inhibitors such as ritonavir, indinavir or saquinavir; grapefruit juice when consumed in large quantities), see section 4.5.
Močni zaviralci CYP3A4 Sočasna uporaba močnih zaviralcev CYP3A4 (npr. klaritromicina, ketokonazola, itrakonazola ali telitromicina; zaviralcev proteaz, npr. ritonavirja, indinavirja ali sakvinavirja; grenivkinega soka v velikih količinah), glejte poglavje 4.5.
Caution with regards to the use of naloxegol should be exercised in patients with any condition which might result in impaired integrity of the gastrointestinal tract wall (e.g. severe peptic ulcer disease, Crohn's Disease, active or recurrent diverticulitis, infiltrative gastrointestinal tract malignancies or peritoneal metastases).
Naloksegol je treba uporabljati previdno pri bolnikih z boleznijo, ki bi lahko okrnila integriteto stene prebavil (npr. s hudo peptično ulkusno boleznijo, Crohnovo boleznijo, aktivnim ali ponavljajočim se divertikulitisom, infiltrativnimi malignimi boleznimi prebavil ali peritonealnimi metastazami).
• if your bowels are, or may be, blocked (obstructed) or you have been warned that your bowels are at risk of becoming blocked.
• če imate ali bi lahko imeli zaporo (obstrukcijo) črevesa ali če so vas opozorili, da se vam lahko pojavi zapora črevesa;
Plasma protein binding of naloxegol in humans was low and the fraction unbound ranged from 80% to
Vezava naloksegola na beljakovine v plazmi je pri človeku majhna in nevezani delež sega od 80 do 100 %.
• If you miss a dose of Moventig, take it as soon as you remember.
Če ste pozabili vzeti zdravilo Moventig • Če izpustite odmerek zdravila Moventig, ga vzemite, čim se spomnite.
It is important to flush the nasogastric tube through with water after administration of the mixture.
Pomembno je, da nazogastrično sondo po dajanju mešanice sperete z vodo.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo.
A double-blind, randomized, 2-part, crossover, single centre study was conducted to evaluate the effect of quinidine on the pharmacokinetics of naloxegol and the effect of the co-administration of naloxegol and quinidine on morphine-induced miosis in healthy volunteers.
Izvedli so dvojno slepo, randomizirano, 2-delno navzkrižno študijo v enem centru za oceno vpliva kinidina na farmakokinetiko naloksegola ter vpliva sočasne uporabe naloksegola in kinidina na morfinsko povzročeno miozo pri zdravih prostovoljcih.
Due to poorer permeability and increased efflux of naloxegol across the blood-brain barrier, related to P-gp substrate properties, the CNS penetration of naloxegol is minimal.
Zaradi slabše permeabilnosti in večjega iztoka naloksegola preko krvno-možganske pregrade, kar je povezano z lastnostmi substrata P-gp, naloksegol le minimalno prodre v osrednje živčevje.
You may need to stop taking Moventig
Morda boste morali nehati jemati zdravilo Moventig,
• To make sure there is no medicine left, rinse the empty glass with another half a glass of water (120 ml), and drink it
• Da boste zagotovo zaužili celoten odmerek zdravila, prazni kozarec splaknite z dodatnega pol kozarca vode (120 ml) in to vodo popijte.
Cancer-related pain
Z rakom povezane bolečine
Naloxegol as a crushed tablet mixed in water, given orally or administered through a nasogastric tube into the stomach, is bioequivalent to the whole tablet, with a median tmax of 0.75 and 1.50 hours (range 0.23 to 5.02 hours) for the crushed tablet given orally and the crushed tablet given via NG tube, respectively.
Naloksegol v obliki zdrobljene tablete, zmešane z vodo, uporabljen peroralno ali po nazogastrični sondi v želodec, je biološko enakovreden celi tableti: mediani tmax za peroralno uporabljeno zdrobljeno tableto je 0,75 ure in za zdrobljeno tableto, uporabljeno po nazogastrični sondi, 1,50 ure (razpon: od
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja hiperhidroza
In a pooled analysis of Kodiac 4 and Kodiac 5 (90, 88 and 99 patients in the placebo, 12.5 mg and 25 mg groups respectively), higher response rates in this population was observed for the 25 mg dose group compared with placebo (p=0.040).
V kumulativni analizi Kodiac 4 in Kodiac 5 (90 bolnikov v skupini s placebom, 88 z 12,5 mg in 99 s 25 mg) so v tej populaciji ugotovili večji delež odziva z odmerkom 25 mg kot s placebom (p = 0,040).
Results from a QWBA (Quantitative Whole Body Autoradiography) study in the rat and the lack of antagonism of CNS opiate effects in humans at naloxegol doses less than 250 mg, indicate minimal distribution of naloxegol into the CNS.
(Quantitative Whole Body Autoradiography) pri podganah in odsotnost antagoniziranja opiatnih učinkov v osrednjem živčevju pri človeku ob odmerkih naloksegola manj kot 250 mg kažejo na minimalno porazdelitev naloksegola v osrednje živčevje.
Paediatric population The use of naloxegol in the paediatric population has not been studied.
Pediatrična populacija Uporaba naloksegola pri pediatrični populaciji ni raziskana.
Tabulated list of adverse reactions Adverse reactions are classified according to frequency and System Organ Class.
Neželeni učinki so razvrščeni po pogostnosti in organskem sistemu.
In vitro studies demonstrate that naloxegol is a full neutral antagonist at the mu-opioid receptor.
Študije in vitro kažejo, da je naloksegol polni nevtralni antagonist na mi-opioidnih receptorjih.
Safety and tolerability over an extended 12-week period Kodiac 7 was a 12-week safety extension that allowed for patients from Kodiac 4 to continue the same blinded treatment from Kodiac 4 for an additional 12 weeks (placebo, naloxegol 12.5 mg or 25 mg daily).
Študija Kodiac 7 je bila 12-tedensko varnostno podaljšanje, ki je bolnikom v Kodiac 4 omogočilo nadaljevanje istega slepljenega zdravljenja, kot so ga prejemali v Kodiac 4, še dodatnih 12 tednov (placebo, naloksegol 12,5 mg ali 25 mg enkrat na dan).
• passing wind
• vetrovi
Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea, vomiting, muscle aches, lacrimation, rhinorrhoea, pupillary dilation,
Sindrom odtegnitve opioidov je skupek treh ali več izmed naslednjih znakov ali simptomov: disforično razpoloženje, navzea ali bruhanje, mišične bolečine, solzenje ali rinoreja, razširjenost zenice ali piloerekcija ali znojenje, driska, zehanje, zvišana telesna temperatura ali nespečnost.
Concurrent methadone use
Sočasna uporaba metadona
There is a theoretical possibility that naloxegol could provoke opioid withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist.
Obstaja teoretična možnost, da bi naloksegol povzročil odtegnitev opioidov pri dojenem novorojenčku, čigar mati jemlje agonist opioidnih receptorjev.
Posology The recommended dose of Moventig is 25 mg once daily.
Priporočeni odmerek zdravila Moventig je 25 mg enkrat na dan.
In Kodiac 5 the corresponding times to first post dose SBM were 38.2, 12.8, and 18.1 hours, respectively.
V Kodiac 5 so bili ustrezni časi do prvega spontanega iztrebljanja po odmerku 38,2, 12,8 in 18,1 ure.
Other possible side effects: Very common (may affect more than 1 in 10 people):
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Therefore, concomitant use with strong CYP3A4 inhibitors is contraindicated (see section 4.3).
Zato je sočasna uporaba močnih zaviralcev CYP3A4 kontraindicirana (glejte poglavje 4.3).
Patients taking methadone as primary therapy for their pain condition were observed in clinical trials to have a higher frequency of gastrointestinal adverse reactions (such as abdominal pain and diarrhoea) than patients not receiving methadone.
V kliničnih preskušanjih so opažali, da imajo bolniki, ki za primarno zdravljenje bolečinskega stanja jemljejo metadon, pogosteje neželene učinke na prebavilih (npr. bolečine v trebuhu in drisko) kot bolniki, ki ne dobivajo metadona.
Tablet core mannitol (E421) cellulose microcrystalline (E460) croscarmellose sodium (E468) magnesium stearate (E470b) propyl gallate (E310)
Jedro tablete manitol (E421) mikrokristalna celuloza (E460) premreženi natrijev karmelozat (E468) magnezijev stearat (E470b) propilgalat (E310)
There is a theoretical potential for provoking opioid withdrawal in the foetus with use of an opioid receptor antagonist in the mother, who is being treated with a concurrent opioid.
Obstaja teoretična možnost za sprožitev odtegnitve opioidov pri plodu, če je antagonist opioidnih receptorjev uporabljen pri materi, ki je sočasno prejemala tudi opioid.
Very Common Common Uncommon Rare
Neznana pogostnost
Naloxegol must not be used in patients with known or suspected gastrointestinal obstruction or in patients at increased risk of recurrent obstruction, or in patients with underlying cancer who are at heightened risk of GI perforation (see section 4.3).
Naloksegola ne smete dajati bolnikom z znano ali domnevno obstrukcijo prebavil, niti bolnikom s povečanim tveganjem za ponovno obstrukcijo, niti bolnikom z rakom, pri katerih je tveganje za perforacijo prebavil zvečano (glejte poglavje 4.3).
Patients who had a QTcF >500 msec at screening, had a recent history of myocardial infarction within 6 months before randomization, had symptomatic congestive heart failure, or had any other overt CV disease were excluded from the clinical studies.
V klinične študije niso bili vključeni bolniki, ki so imeli ob presejanju QTcF > 500 msec, ali so imeli v anamnezi miokardni infarkt v 6 mesecih pred randomizacijo, so imeli kongestivno srčno popuščanje ali kakšno drugo manifestno kardiovaskularno bolezen.
If side effects impacting tolerability occur, naloxegol should be discontinued.
Če se pojavijo neželeni učinki, ki vplivajo na prenašanje, je treba z uporabo naloksegola prenehati.
In the pooled data from clinical trials the most commonly reported adverse reactions with naloxegol (≥ 5%) are: abdominal pain, diarrhoea, nausea, headache and flatulence.
V zbranih podatkih kliničnih preskušanj so bili najpogosteje poročani neželeni učinki naloksegola (≥ 5 %) bolečine v trebuhu, driska, navzea, glavobol in flatulenca.
The use of naloxegol is not recommended in such patients.
Uporaba naloksegola pri takšnih bolnikih ni priporočljiva.
Stop taking the medicine and tell your doctor straight away if you develop opioid withdrawal symptoms (if you have a combination of three or more of these symptoms: feeling depressed, nausea, vomiting, muscle aches, increased tearing, runny nose, dilation of the pupils, goosebumps, excess sweating, diarrhoea, yawning, fever or insomnia) which would usually occur within the first few days after starting naloxegol.
Prenehajte jemati zdravilo in nemudoma povejte zdravniku, če se pri vas razvijejo simptomi odtegnitve opioidov (če imate kombinacijo treh ali več od naslednjih simptomov: občutek potrtosti, slabost v želodcu, bruhanje, bolečine v mišicah, močnejše solzenje, izcedek iz nosu, razširjene zenice,
No data are available on the concomitant use of naloxegol with grapefruit juice.
O sočasni uporabi naloksegola z grenivkinim sokom ni podatkov.
Co-administration of the P-gp inhibitor quinidine resulted in a 1.4 fold increase in the AUC (90% CI: 1.3-1.5) and a 2.4 fold increase in the Cmax (90% CI: 2.2-2.8) of naloxegol.
Sočasna uporaba zaviralca P-gp, kinidina, je povzročila 1,4-kratno (90 % IZ: 1,3-1,5) zvišanje AUC naloksegola in 2,4-kratno (90 % IZ: 2,2-2,8)
If you take more Moventig than you should, talk to a doctor or go to hospital.
Če ste vzeli večji odmerek zdravila Moventig, kot bi smeli Če ste vzeli večji odmerek zdravila Moventig, kot bi smeli, se posvetujte z zdravnikom ali pojdite v bolnišnico.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and fertility.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in plodnosti ne kažejo posebnega tveganja za človeka.
• if you have stomach ulcers, Crohn's Disease (an illness where your gut is inflamed), diverticulitis (another illness where your gut is inflamed), cancer in your gut or ‘peritoneum' (the lining of your stomach area), or any conditon that might damage the wall of your bowel
• če imate razjede na želodcu, Crohnovo bolezen (bolezen, ki povzroči vnetje črevesa), divertikulitis (druga bolezen, pri kateri se pojavi vnetje črevesa), raka na črevesu ali potrebušnici (to je mrena, ki prekriva trebušne organe) ali kakršno koli bolezen ali motnjo, ki lahko poškoduje steno črevesa, • če imate trenutno nenavadno hude, dolgotrajne bolečine v trebuhu ali se vam takšne bolečine poslabšajo,
There was no relevant impact on abdominal symptoms in either study (p=0.256 and p=0.916, Kodiac 4 and 5, respectively).
Niti v eni niti v drugi študiji ni bilo pomembnega vpliva na trebušne simptome (Kodiac 4 p = 0,256 in Kodiac 5 p = 0,916).
There was a higher incidence of discontinuations in patients taking the 25 mg dose compared to placebo due to diarrhoea (0.7% for placebo versus 3.1% for naloxegol 25 mg) and abdominal pain (0.2% versus 2.9%, respectively).
Incidenca prekinitev zdravljenja je bila pri bolnikih, ki so dobivali odmerek 25 mg, večja kot med prejemniki placeba, in sicer tako zaradi driske (0,7 % za placebo in 3,1 % za 25 mg naloksegola) kot zaradi bolečin v trebuhu (0,2 % za placebo in 2,9 % za 25 mg naloksegola).
Thus renal excretion is a minor clearance pathway for naloxegol.
Izločanje skozi ledvice je tako manj pomembna pot očistka naloksegola.
Therefore, Moventig is not recommended in patients who are taking strong CYP3A4 inducers (see section 4.4).
Zato zdravilo Moventig ni priporočljivo za bolnike, ki jemljejo močne induktorje CYP3A4 (glejte poglavje 4.4).
Pregnancy There are limited data from the use of naloxegol in pregnant women.
Podatkov o uporabi naloksegola pri nosečnicah je malo.
Clinical studies of naloxegol did not include sufficient numbers of patients aged 75 years or over to determine whether they respond differently than younger patients, however, based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in this age group.
Klinične študije naloksegola niso vključile dovolj bolnikov v starosti 75 let in več, da bi bilo mogoče ugotoviti, ali se starejše osebe odzivajo drugače kot mlajše.
Long-term exposure to naloxegol 25 mg, up to 52 weeks, was generally safe and well tolerated in the treatment of OIC patients with non-cancer-related pain.
Med dolgotrajno izpostavljenostjo 25 mg naloksegola do 52 tednov je bilo zdravilo pri bolnikih z OIC in bolečinami, nepovezanimi z rakom, na splošno varno in so ga dobro prenašali.
In this study, naloxegol at doses of 12.5 mg and 25 mg was generally safe and well tolerated as compared with placebo in the treatment of OIC patients with non-cancer-related pain.
V tej študiji je bil naloksegol v odmerkih 12,5 mg in 25 mg v primerjavi s placebom pri bolnikih z OIC in bolečinami, nepovezanimi z rakom, na splošno varen in so ga dobro prenašali.
For definition of inadequate response to laxative(s), see section 5.1.
Za opredelitev nezadostnega odziva na odvajala glejte poglavje 5.1.
Patients with mean Numeric Rating Scale (NRS) pain scores equal to or higher than 7 were not studied due to the risk of confounding the efficacy result as a result of uncontrolled pain.
Preučili niso bolnikov s povprečno oceno bolečin na NRS (Numeric Rating Scale) ≥ 7, in sicer zaradi tveganja, da bi nenadzorovane bolečine moteče vplivale na rezultat učinkovitosti.
• nausea (feeling sick to the stomach)
• slabost v želodcu (siljenje na bruhanje)
Doses of naloxegol up to 1,000 mg were administered in healthy volunteers in clinical studies.
V kliničnih študijah so zdravi prostovoljci dobili odmerke naloksegola do 1.000 mg.
To qualify as LIR, in the two weeks prior to first study visit patients had to have reported concurrent OIC symptoms of at least moderate severity while taking at least one laxative class for a minimum of four days during the pre study period.
Opredelitev nezadostnega odziva na odvajala (LIR - laxative inadequate responder) Med bolnike z nezadostnim odzivom na odvajala so se uvrstili tisti, ki so imeli v dveh tednih pred prvim obiskom v študiji sočasne in vsaj zmerno hude simptome OIC ter so uporabljali vsaj eno skupino odvajal najmanj štiri dni med obdobjem pred študijo.