natgillin/translations-raw huggingface dataset:
Resolor is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Zdravilo Resolor se ne priporoča v nosečnosti ali pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
- Use a reliable method of contraception while you're taking Resolor, to prevent pregnancy. 
- Med jemanjem zdravila Resolor uporabljajte zanesljiv način kontracepcije za preprečitev nosečnosti.
Older people (>65 years): Start with 1 mg once daily (see section 5.2); if needed the dose can be increased to 2 mg once daily. 
Starejši bolniki (>65 let): začne se z 1 mg enkrat na dan (glejte poglavje 5.2); po potrebi se lahko odmerek zviša na 2 mg enkrat na dan.
Other medicines and Resolor Tell your doctor if you are taking, or have recently taken, or might take any other medicines. 
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Compared with a constipation treatment working through osmotic action, prokinetic stimulation with prucalopride increased colonic motility as measured by the number of HAPCs during the first 12 hours after intake of the investigational product. 
V primerjavi z zdravljenjem zaprtosti, ki deluje z osmotskim učinkom, je prokinetična stimulacija s prukalopridom povečala gibljivost debelega črevesa, izmerjeno s številom HAPC v prvih 12 urah po zaužitju preizkušanega zdravila.
An overdose may result in symptoms resulting from an exaggeration of prucalopride's known pharmacodynamic effects and include headache, nausea and diarrhoea. 
Pri prevelikem odmerjanju se lahko pojavijo simptomi, ki so posledica povečanja znanih farmakodinamskih učinkov prukaloprida ter vključujejo glavobol, navzeo in diarejo.
In vitro, only at concentrations exceeding its 5-HT4 receptor affinity by at least 150-fold, affinity for other receptors was detected. 
In vitro je bila samo v koncentracijah, ki njegovo afiniteto za receptor 5-HT4 presegajo vsaj 150-krat, ugotovljena afiniteta za druge receptorje.
It is extensively excreted unchanged in urine (approximately 60% of the dose) and in vitro metabolism is very slow. 
V velikem obsegu se izloča nespremenjen v urinu (približno 60 % odmerka) in in vitro presnova je zelo počasna.
The effect of Resolor on spontaneous bowel movements (SBM) also proved to be statistically superior to placebo for the portion of patients that had an increase of ≥1 SBM/week over the 12-week treatment period. 
Tudi učinki zdravila Resolor na spontano odvajanje blata (SBM - spontaneous bowel movements) so bili statistično boljši kot placebo za delež bolnikov s povečanjem ≥1 SBM/teden v 12-tedenskem obdobju zdravljenja.
Resolor belongs to a group of gut motility enhancing medicines (gastrointestinal prokinetics). 
Zdravilo Resolor sodi v skupino zdravil za spodbujanje motilitete (gastrointestinalni prokinetiki).
In an integrated analysis of 17 double-blind placebo-controlled studies, Resolor was given orally to approximately 3,300 patients with chronic constipation. 
V celostni analizi 17 dvojno slepih, s placebom nadzorovanih študij je v študijah zdravilo Resolor peroralno prejemalo približno 3.300 bolnikov s kroničnim zaprtjem.
The following adverse reactions were reported in controlled clinical studies at the recommended dose of 2 mg with frequencies corresponding to very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 
V nadzorovanih kliničnih študijah pri priporočenem odmerku 2 mg so poročali o naslednjih neželenih učinkih po pogostnosti, ki je definirana kot 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 (ni mogoče oceniti iz razpoložljivih podatkov).
Prucalopride o.d. displays time-independent kinetics during prolonged treatment. 
Prukaloprid enkrat na dan kaže časovno neodvisno kinetiko med dolgotrajnim zdravljenjem.
Prucalopride had no clinically relevant effects on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine or oral contraceptives. 
Prukaloprid ni imel klinično pomembnih učinkov na farmakokinetiko varfarina, digoksina, alkohola, paroksetina ali peroralnih kontraceptivov.
These pharmacodynamic effects of prucalopride have been confirmed in human subjects with chronic constipation using manometry in an open-label, randomised, crossover, reader-blinded study investigating the effect of prucalopride 2 mg and an osmotic laxative on colon motility as determined by the number of colonic high-amplitude propagating contractions (HAPCs, also known as giant migrating contractions). 
Ti farmakodinamični učinki prukaloprida so bili pri ljudeh s kronično zaprtostjo potrjeni z manometrom v odprti, randomizirani, navzkrižni, za ocenjevalce slepi študiji, v kateri so preučevali učinek prukaloprida v odmerku 2 mg in osmotskega odvajala na gibljivost debelega črevesa, opredeljeno s številom kontrakcij debelega črevesa visoke amplitude (HAPC - high-amplitude propagating contractions, ki se imenujejo tudi velike seleče se kontrakcije).
A large fraction of the active substance is excreted unchanged (60-65% of the administered dose in urine and about 5% in faeces). 
Velika frakcija zdravilne učinkovine se izloči nespremenjena (60-65 % uporabljenega odmerka v urinu in okoli 5 % v blatu).
The difference between treatment groups in the average weekly frequency of ≥3 SCBMs per week was not statistically significant over Weeks 1-12 which is inconsistent with the 5 other multicentre, randomised, double-blind, 12-week placebo controlled studies demonstrating efficacy at this timepoint in adult patients. 
Razlika med zdravljenima skupinama v povprečni tedenski frekvenci treh ali več spontanih popolnih odvajanj blata od 1. do 12. tedna ni bila statistično značilna, kar ni skladno s 5 drugimi multicentričnimi, randomiziranimi, dvojno slepimi, 12-tedenskimi, s placebom nadzorovanimi študijami, ki so na tej časovni točki dokazale učinkovitost pri odraslih bolnikih.
Caution should be exercised when prescribing Resolor to patients with severe hepatic impairment (Child-Pugh class C) due to limited data in patients with severe hepatic impairment (see section 4.2). 
Pri predpisovanju zdravila Resolor bolnikom s hudo okvaro jeter (Child-Pugh stopnja C) je potrebna previdnost, saj so za bolnike s hudo okvaro jeter podatki omejeni (glejte poglavje 4.2).
Resolor is used for the treatment of chronic constipation in adults in whom laxatives do not work well enough. 
Zdravilo Resolor se uporablja za zdravljenje kroničnega zaprtja pri odraslih, pri katerih odvajala ne delujejo dovolj dobro.
After the first day of treatment, the most common adverse reactions were reported in similar frequencies (incidence no more than 1% different between prucalopride and placebo) during Resolor therapy as during placebo, with the exception of nausea and diarrhoea that still occurred more frequently during Resolor therapy, but less pronounced (differences in incidence between Resolor and placebo of 1.3% and 3.4%, respectively). 
Po prvem dnevu zdravljenja je bila pogostnost neželenih učinkov podobna (ne več kot 1 % razlike v pojavnosti med prukalopridom in placebom) med zdravljenjem z zdravilom Resolor in placebom, z izjemo navzee in diareje, ki sta se še vedno pogosteje pojavljali med zdravljenjem z zdravilom Resolor, vendar je bila razlika manj izrazita (razlika v pojavnosti med zdravilom Resolor in placebom 1,3 % oziroma 3,4 %).
A subcutaneous neonatal/juvenile toxicity study performed in rats 7-55 days of age resulted in a NOAEL of 10 mg/kg/day. 
V študiji toksičnosti subkutanih odmerkov, opravljeni pri novoskotenih/mladih podganah, starih od 7 do 55 dni, je bila vrednost NOAEL 10 mg/kg/dan.
These are equivalent to the colonic mass movements in humans, and provide the main propulsive force to defecation. 
Ti ustrezajo gibanju črevesne mase pri človeku in zagotavljajo glavno pogonsko silo za odvajanje blata.
The safety profile of Resolor was consistent with that seen in female patients. 
Varnostni profil zdravila Resolor je bil skladen s tistim pri ženskah.
Lactose monohydrate Microcrystalline cellulose Colloidal silicon dioxide Magnesium stearate 
Jedro tablete laktoza monohidrat mikrokristalna celuloza koloidni silicijev dioksid magnezijev stearat
Frequencies are calculated based on the integrated analysis of 17 double-blind placebo-controlled clinical studies. 
Pogostnost je izračunana na podlagi celostne analize 17 dvojno slepih, s placebom nadzorovanih kliničnih študij.
The efficacy of prucalopride has been established in double-blind, placebo-controlled studies for up to 3 months. 
Učinkovitost prukaloprida je bila ugotovljena v dvojno slepih, s placebom nadzorovanih študijah v obdobju do 3 mesecev.
In rats, prucalopride in vivo, at doses above 5 mg/kg (at and above 30-70 times the clinical exposure), induced hyperprolactinaemia caused by an antagonistic action at the D2 receptor. 
Pri podganah je prukaloprid in vivo v odmerkih nad 5 mg/kg (pri in nad 30-70-kratni klinični izpostavljenosti) povzročil hiperprolaktinemijo, povzročeno zaradi antagonističnega delovanja na receptor D2.
In dogs, prucalopride alters colonic motility patterns via serotonin 5-HT4 receptor stimulation: it stimulates proximal colonic motility, enhances gastroduodenal motility and accelerates delayed gastric emptying. 
Pri psih prukaloprid spremeni vzorce motilitete črevesa s stimulacijo serotoninskega receptorja 5-HT4: stimulira proksimalno motiliteto črevesa, poveča gastroduodenalno motiliteto in pospeši zakasnelo želodčno praznjenje.
Palpitations were reported in 0.7% of the placebo patients, 0.9% of the 1 mg prucalopride patients, 0.9% of the 2 mg prucalopride patients and 1.9% of the 4 mg prucalopride patients. 
O palpitacijah so poročali pri 0,7 % bolnikov, ki so prejemali placebo, 0,9 % bolnikov, ki so prejemali 1 mg prukaloprida, 0,9 % bolnikov, ki so dobivali 2 mg prukaloprida, in 1,9 % bolnikov, ki so prejemali 4 mg prukaloprida.
Metabolism is not the major route of elimination of prucalopride. 
Presnova ni glavni način izločanja prukaloprida.
Concomitant intake of food does not influence the oral bioavailability of prucalopride. 
Sočasno jemanje hrane ne vpliva na peroralno biološko uporabnost prukaloprida.
The majority of adverse events were mild to moderate in intensity. 
Večina neželenih učinkov je bila blaga do zmerna.
- If you do become pregnant during treatment with Resolor, tell your doctor. 
- Če med zdravljenjem z zdravilom Resolor zanosite, obvestite svojega zdravnika.
In subjects with severe renal impairment (ClCR ≤24 ml/min), plasma concentrations were 2.3 times the levels in healthy subjects (see section 4.2 and 4.4). 
Pri osebah s hudo ledvično okvaro (ClCR ≤ -24 ml/min) so bile plazemske koncentracije 2,3-krat višje kot pri zdravih osebah (glejte poglavji 4.2 in 4.4).
Store in the original blister package in order to protect from moisture. 
Shranjujte v originalnem pretisnem omotu za zagotovitev zaščite pred vlago.
The efficacy of Resolor was established in three multicentre, randomised, double-blind, 12-week placebo-controlled studies in subjects with chronic constipation (n=1,279 on Resolor, 1,124 females, 155 males). 
Učinkovitost zdravila Resolor je bila dokazana v treh multicentričnih randomiziranih, dvojno slepih dvanajsttedenskih s placebom nadzorovanih študijah pri osebah s kroničnim zaprtjem (n = 1.279 na zdravilu Resolor, 1.124 žensk, 155 moških).
Table 1: Adverse Drug Reactions (ADRs) Associated with Resolor 
Preglednica 1: Neželeni učinki, povezani z zdravilom Resolor
There is limited information on the safety and efficacy of Resolor for use in patients with severe and clinically unstable concomitant disease (e.g. cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders). 
Podatki o varnosti in učinkovitosti zdravila Resolor za uporabo pri bolnikih s hudimi in klinično nestabilnimi spremljevalnimi boleznimi (tj. srčno-žilnimi boleznimi ali pljučnimi boleznimi, nevrološkimi ali psihiatričnimi motnjami, rakom ali aidsom in drugimi boleznimi endokrinega sistema) so omejeni.
Patients with hepatic impairment: Patients with severe hepatic impairment (Child-Pugh class C) start with 1 mg once daily which may be increased to 2 mg if required to improve efficacy and if the 1 mg dose is well tolerated (see sections 4.4 and 5.2). 
Bolniki z jetrno okvaro: bolniki s hudo jetrno okvaro (Child-Pugh stopnja C) začnejo z odmerkom 1 mg enkrat na dan, nato pa se lahko odmerek poveča na 2 mg, če je to potrebno zaradi učinkovitosti in če bolnik odmerek 1 mg dobro prenaša (glejte poglavji 4.4 in 5.2).
Resolor is provided in aluminium/aluminium perforated unit dose blister (calendar marked) containing 7 tablets. 
Zdravilo Resolor je na voljo v aluminijastem/aluminijastem perforiranem pretisnem omotu za enkratni odmerek (s koledarskimi označbami), ki vsebuje 7 tablet.
Lactose monohydrate (see section 2), microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171), macrogol. 
Pomožne snovi so: laktoza monohidrat (glejte poglavje 2), mikrokristalna celuloza, koloidni silicijev dioksid, magnezijev stearat, hipromeloza, triacetin, titanov dioksid (E171), makrogol.
Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief. 
Zdravilo Resolor je indicirano za simptomatsko zdravljenje kroničnega zaprtja pri odraslih, ki z odvajali ne dosežejo ustreznega olajšanja.
The most frequently reported adverse reactions associated with Resolor 2 mg therapy are headache (17.8%) and gastrointestinal symptoms (abdominal pain (13.7%), nausea (13.7%) and diarrhoea (12.0%)). 
Najpogosteje poročani neželeni učinki, povezani z zdravljenjem z zdravilom Resolor v odmerku 2 mg, so glavobol (17,8 %) in prebavni simptomi (bolečine v trebuhu (13,7 %), navzea (13,7 %) ali diareja (12,0 %)).
Children weighing >50 kg received 2 mg/day Resolor tablets or matching placebo. 
Otroci s telesno maso > 50 kg so dobivali odmerek 2 mg/dan v obliki tablet zdravila Resolor ali ustrezni placebo.
Specific treatment is not available for Resolor overdose. 
Pri prevelikem odmerjanju zdravila Resolor specifičnega zdravljenja ni.
If you forget to take Resolor Do not take a double dose to make up for a forgotten tablet. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
The quantitatively most important metabolite in excreta, R107504, accounted for 3.2% and 3.1% of the dose in urine and faeces, respectively. 
R107504, ki je najpogostejši presnovek v izločkih, je predstavljal 3,2 % v urinu in 3,1 % v blatu.
The efficacy and safety of Resolor in paediatric patients (aged 6 months to 18 years) with functional constipation, were evaluated in an 8-week double-blind, placebo-controlled trial (N=213), followed by a 16 week open-label comparator-controlled (Polyethylene glycol 4000) study of up to 24 weeks (N=197). 
Učinkovitost in varnost zdravila Resolor pri pediatričnih bolnikih (starih od 6 mesecev do 18 let) s funkcionalno zaprtostjo so ocenili v 8-tedenskem dvojno slepem, s placebom nadzorovanem preskušanju (n = 213), ki mu je sledila 16-tedenska odprta študija, nadzorovana s primerjalnim zdravilom (polietilenglikol 4000), s trajanjem do 24 tednov (n = 197).
Aluminium/aluminium perforated unit dose blisters (calendar marked) containing 7 tablets. 
Aluminijast/aluminijast perforiran pretisni omot za enkratni odmerek (s koledarskimi označbami), ki vsebuje 7 tablet.
Excipients with known effect: Each film-coated tablet contains 156.75 mg lactose (as monohydrate). 
Pomožne snovi z znanim učinkom: ena filmsko obložena tableta vsebuje 156,75 mg laktoze (v obliki monohidrata).
Compared to subjects with normal renal function, plasma concentrations of prucalopride after a single 2 mg dose were on average 25% and 51% higher in subjects with mild (ClCR 50-79 ml/min) and moderate (ClCR 25-49 ml/min) renal impairment, respectively. 
V primerjavi z osebami z normalno ledvično funkcijo so bile plazemske koncentracije prukolaprida po enkratnem 2 mg odmerku pri osebah z blago (ClCR 50-79 ml/min) in zmerno (ClCR 25-49 ml/min) ledvično okvaro v povprečju 25 % oziroma 51 % višje.
Prucalopride did not inhibit specific CYP450 activities in in vitro studies in human liver microsomes at therapeutically relevant concentrations. 
Prukaloprid v in vitro študijah mikrosomov človeških jeter pri terapevtsko pomembnih koncentracijah ni zaviral specifičnih dejavnosti CYP450.
Resolor is not recommended for use during pregnancy. 
Uporaba zdravila Resolor med nosečnostjo se ne priporoča.
The results of the study showed no difference in efficacy between Resolor and placebo with response rates of 17% and 17.8% respectively (P=0.9002). 
Rezultati študije niso pokazali razlike v učinkovitosti med zdravilom Resolor in placebom - odziv je bil pri zdravilu Resolor 17 % in pri placebu 17,8 % (p = 0,9002).
The incidence of subjects with at least 1 treatment-emergent adverse event (TEAE) was similar between the Resolor treatment group (69.8%) and the placebo treatment group (60.7%). 
Incidenca preskušancev, pri katerih se je med zdravljenjem pojavil vsaj en neželeni učinek, je bila podobna v skupini z zdravilom Resolor (69,8 %) in v skupini, ki je prejemala placebo (60,7 %).
A dose of 1 mg is recommended in subjects with severe renal impairment (see section 4.2). 
Pri osebah s hudo ledvično okvaro se priporoča odmerek 1 mg (glejte poglavje 4.2).
- Renal impairment requiring dialysis. 
- Ledvične okvare, za katere je potrebna dializa.
The starting dose administered was 0.04 mg/kg/day titrated between 0.02 and 0.06 mg/kg/day (to a maximum of 2 mg daily) for children weighing ≤50 kg given as an oral solution of Resolor or matching placebo. 
Začetni odmerek pri otrocih s telesno maso ≤ 50 kg je bil 0,04 mg/kg/dan s postopnim povečanjem od 0,02 do 0,06 mg/kg/dan (do največ 2 mg dnevno), apliciran v obliki peroralne raztopine zdravila Resolor ali ustreznega placeba.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in na kartonski ovojnini poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
How to take Resolor 
Kako jemati zdravilo Resolor
On once daily treatment with 2 mg prucalopride, steady-state plasma concentrations fluctuate between trough and peak values of 2.5 and 7 ng/ml, respectively. 
Pri enkratnem dnevnem zdravljenju z 2 mg prukaloprida plazemske koncentracije v stanju dinamičnega ravnovesja nihajo med najnižjimi in najvišjimi vrednostmi 2,5 oziroma 7 ng/ml.
In addition, the efficacy, safety and tolerability of Resolor in male patients with chronic constipation were evaluated in a 12-week, multi-centre, randomised, double-blind, placebo-controlled study (N=370). 
Poleg tega so učinkovitost, varnost in prenašanje zdravila Resolor pri moških bolnikih s kronično zaprtostjo ovrednotili v 12-tedenski multicentrični, randomizirani, dvojno slepi, s placebom nadzorovani študiji (N = 370).
Vomiting, dyspepsia, flatulence, gastrointestinal sounds abnormal 
Pogosti bruhanje, dispepsija, flatulenca, nenormalni zvoki v prebavilih
The following uncommon side effects have also been seen (may affect up to 1 in 100 people): tremors, pounding heart, rectal bleeding, increase in frequency of passing urine (pollakiuria), fever and feeling unwell. 
Opaženi so bili tudi naslednji občasni neželeni učinki (prizadenejo lahko največ 1 od 100 bolnikov): tresenje, razbijanje srca, rektalne krvavitve, pogostejše mokrenje (polakiurija), zvišana telesna temperatura in slabo počutje.
Effects of prucalopride on pharmacokinetics of other medicinal products A 30% increase in plasma concentrations of erythromycin was found during prucalopride co-administration. 
Učinki prukaloprida na farmakokinetiko drugih zdravil Pri sočasnem dajanju prukaloprida so opazili 30-odstotno povečanje koncentracij eritromicina v plazmi.
The following side effects have been reported very commonly (may affect more than 1 in 10 people): headache, feeling sick, diarrhoea and abdominal pain. 
Zelo pogosto so poročali o naslednjih neželenih učinkih (prizadenejo lahko več kot 1 od 10 bolnikov): glavobol, občutek slabosti, driska in bolečine v trebuhu.
The active substance is prucalopride. 
Zdravilna učinkovina je prukaloprid.
A significant benefit on a number of Quality of Life measures, such as degree of satisfaction with treatment and with bowel habits, physical and psychosocial discomfort and worries and concerns, was also observed at both the 4 and 12 week assessment time points. 
V časovnih ocenjevalnih točkah v 4. in v 12. tednu so opažali tudi značilno korist za številna merila kakovosti življenja, denimo za stopnjo zadovoljstva z zdravljenjem in z režimom odvajanja blata, za telesno in psihosocialno neugodje in skrbi ter težave.
Response to the treatment was defined as having an average of ≥3 spontaneous bowel movements (SBMs) per week and an average number of faecal incontinence episodes of ≤1 per 2 weeks. 
Odziv na zdravljenje je bil opredeljen kot povprečno tri ali več spontanih odvajanj blata tedensko in povprečno največ ena epizoda fekalne inkontinence na dva tedna.
Incidence Category 
Kategorija pogostosti
A clinically meaningful improvement of ≥1 SCBM per week, the most important secondary efficacy endpoint, was achieved in 51.0% (week 4) and 44.2% (week 12) treated with 2 mg Resolor versus 21.7% (week 4) and 22.6% (week 12) of placebo patients. 
Klinično pomembno izboljšanje za ≥ 1 SCBM na teden, najpomembnejši sekundarni opazovani dogodek učinkovitosti, je bil dosežen pri 51,0 % (4. teden) in 44,2 % (12. teden) pri zdravljenju z 2 mg zdravila Resolor v primerjavi z 21,7 % (4. teden) in 22,6 % (12. teden) pri bolnikih, zdravljenih s placebom.
The 2 mg tablet also contains iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132). 
2 mg tableta vsebuje tudi rdeči železov oksid (E172), rumeni železov oksid (E172), indigotin (E132).
The proportion of female patients in whom laxatives fail to provide adequate relief treated with the recommended dose of 2 mg Resolor (n=458) that reached an average of ≥3 SCBM per week was 31.0% (week 4) and 24.7% (week 12), versus 8.6% (week 4) and 9.2% (week 12) on placebo. 
Razmerje bolnic, pri katerih laksativ ni privedel do ustreznega olajšanja, zdravljenih s priporočenim odmerkom 2 mg zdravila Resolor (n = 458), ki so dosegle ≥ 3 SCBM na teden, je bil 31,0 % (4. teden) in 24,7 % (12 teden) v primerjavi z 8,6 % (4. teden) in 9,2 % (12. teden) v primerjavi s placebom.
Patients with renal impairment: The dose for patients with severe renal impairment (GFR <30 ml/min/1.73 m2) is 1 mg once daily (see sections 4.3 and 5.2). 
Bolniki z ledvično okvaro: odmerek za bolnike s hudo ledvično okvaro (GFR < 30 ml/min/1,73 m2) je
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Resolor was generally well tolerated. 
Bolniki so v glavnem dobro prenašali zdravilo Resolor.
If pounding heart occurs, please tell your doctor. 
Če se pojavi razbijanje srca, o tem obvestite zdravnika.
The proportion of patients with an average weekly frequency of ≥3 Spontaneous Complete Bowel Movements (SCBMs) per week (i.e., responders) over the 24-week double-blind treatment phase was not statistically different (p=0.367) between the Resolor (25.1%) and placebo (20.7%) treatment groups. 
V deležu bolnikov s povprečno tedensko frekvenco treh ali več spontanih popolnih odvajanj blata (SCBM - Spontaneous Complete Bowel Movement) (tj. odzivnih bolnikov) v 24-tedenski dvojno slepi fazi zdravljenja ni bilo statistično značilnih razlik (p = 0,367) med skupinama z zdravilom Resolor (25,1 %) in placebom (20,7 %).