FrancophonIA/ELRC3.0 huggingface dataset:
English: Resolor is unlikely to affect your ability to drive or use machines.
Slovenian: Ni verjetno, da bi zdravilo Resolor vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: Efficacy beyond three months has not been demonstrated in placebo-controlled studies (see Section 5.1).
Slovenian: Učinkovitost zdravljenja, daljšega od treh mesecev, ni bila dokazana v študijah, nadzorovanih s placebom (glejte poglavje 5.1).
English: In a study in healthy volunteers, treatment with prucalopride was well tolerated when given in an up-titrating scheme up to 20 mg once daily (10 times the recommended therapeutic dose).
Slovenian: V študiji z zdravimi prostovoljci je bila toleranca zdravljenja s prukalopridom dobra ob postopnem povečevanju odmerka do 20 mg enkrat na dan (10-kratni priporočeni terapevtski odmerek).
English: A human study has shown that prucalopride is excreted in breast milk.
Slovenian: Študija pri ljudeh je pokazala, da se prukaloprid izloča v materino mleko.
English: A population pharmacokinetic analysis showed that the apparent total clearance of prucalopride was correlated with creatinine clearance, but that age, body weight, sex or race had no influence.
Slovenian: Analiza populacijske farmakokinetike je pokazala, da je očitni skupni očistek prukaloprida soodvisen od očistka kreatinina, vendar pa starost, telesna masa, spol ali rasa niso imeli vpliva.
English: The pharmacokinetics of prucalopride is dose-proportional within and beyond the therapeutic range (tested up to 20 mg).
Slovenian: Farmakokinetika prukaloprida je sorazmerna z odmerkom v terapevtskem razponu in izven njega (preskušeno do 20 mg).
English: Taking a higher dose than recommended will not make the product work better.
Slovenian: Če jemljete večji odmerek zdravila, kot je priporočeno, zdravilo ne deluje boljše.
English: At therapeutic doses of Resolor, no effects on breast-fed newborns/infants are anticipated.
Slovenian: Pri terapevtskih odmerkih zdravila Resolor se ne pričakuje učinkov na dojene novorojence/dojenčke.
English: This confirmed the results of two placebo controlled QT studies.
Slovenian: To je potrdilo rezultate dveh s placebom nadzorovanih študij QT.
English: However, the totality of the data including the other double-blind placebo controlled 12 week studies support the efficacy of Resolor.
Slovenian: Vendar podatki v celoti, vključno s tistimi iz drugih dvojno slepih, s placebom nadzorovanih, 12-tedenskih študij, podpirajo učinkovitost zdravila Resolor.
English: The plasma clearance of prucalopride averages 317 ml/min.
Slovenian: Izločanje prukaloprida iz plazme znaša povprečno 317 ml/min.
English: Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
Slovenian: Če pride do prevelikega odmerjanja, je treba bolnika zdraviti simptomatsko in uvesti podporno zdravljenje, če je potrebno.
English: The safety profile of Resolor in this 24 week study was consistent with that seen in the previous 12 week studies.
Slovenian: Varnostni profil zdravila Resolor v tej 24-tedenski študiji je skladen s tistim v prejšnjih, 12-tedenskih študijah.
English: Prucalopride is a dihydrobenzofurancarboxamide with gastrointestinal prokinetic activities.
Slovenian: Prukaloprid je dihidrobenzofuran karboksamid z gastrointestinalnimi prokinetičnimi aktivnostmi.
English: Prucalopride is rapidly absorbed; after a single oral dose of 2 mg in healthy subjects, Cmax was attained in 2-3 hours.
Slovenian: Prukaloprid se hitro absorbira; po enkratnem peroralnem odmerku 2 mg zdravim prostovoljcem je bila vrednost Cmax dosežena v 2-3 urah.
English: In vitro, human liver metabolism is very slow and only minor amounts of metabolites are found.
Slovenian: In vitro je jetrna presnova človeka zelo počasna in so bile odkrite samo manjše količine presnovkov.
English: There is a limited amount of data from the use of prucalopride in pregnant women.
Slovenian: Podatki o uporabi prukaloprida pri nosečnicah so omejeni.
English: Effects of other medicinal products on pharmacokinetics of prucalopride Ketoconazole (200 mg twice daily), a potent inhibitor of CYP3A4 and of P-gp, increased the systemic exposure to prucalopride by approximately 40%.
Slovenian: Učinki drugih zdravil na farmakokinetiko prukaloprida Ketokonazol (200 mg dvakrat na dan), močan zaviralec CYP3A4 in P-gp, je povečal sistemsko izpostavljenost prukalopridu za približno 40 %.
English: Each pack contains 7 x 1, 14 x 1, 28 x 1 or 84 x 1 film-coated tablet.
Slovenian: Vsako pakiranje vsebuje 7 x 1, 14 x 1, 28 x 1 ali 84 x 1 filmsko obloženo tableto.
English: Not for use in children and adolescents younger than 18 years.
Slovenian: Zdravilo ni primerno za uporabo pri otrocih in mladostnikih, starih manj kot 18 let.
English: Therapeutic doses of probenecid, cimetidine, erythromycin and paroxetine did not affect the pharmacokinetics of prucalopride.
Slovenian: Terapevtski odmerki probenecida, cimetidina, eritromicina in paroksetina niso vplivali na farmakokinetiko prukaloprida.
English: What Resolor is and what it is used for What you need to know before you take Resolor How to take Resolor
Slovenian: Kaj je zdravilo Resolor in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Resolor Kako jemati zdravilo Resolor Možni neželeni učinki
English: Prucalopride is extensively distributed, and has a steady-state volume of distribution (Vdss) of 567 litres.
Slovenian: Prukaloprid se obsežno porazdeli in ima volumen porazdelitve v stanju dinamičnega ravnovesja (Vdss) 567 litrov.
English: Take special care with Resolor and tell your doctor if you: - suffer from severe kidney disease, - suffer from severe liver disease, - are currently under supervision by a doctor for a serious medical problem such as lung or heart disease, nervous system or mental health problems, cancer, AIDS or a hormonal disorder.
Slovenian: Bodite posebno pozorni pri jemanju zdravila Resolor in povejte zdravniku, če: - imate hudo ledvično bolezen, - imate hudo jetrno bolezen, - ste trenutno pod nadzorom zdravnika zaradi resnega zdravstvenega stanja, kot so pljučna ali srčna bolezen, težave z živčevjem ali duševnim zdravjem, rak, AIDS ali hormonske motnje.
English: The side effects mostly occur at the start of treatment and usually disappear within a few days with continued treatment.
Slovenian: Neželeni učinki se večinoma pojavijo ob začetku zdravljenja in običajno izzvenijo v nekaj dneh nadaljnjega zdravljenja.
English: The plasma protein binding of prucalopride is about 30%.
Slovenian: Na plazemske beljakovine se veže približno 30 % prukaloprida.
English: Women of childbearing potential have to use effective contraception during treatment with prucalopride
Slovenian: Ženske v rodni dobi Ženske v rodni dobi morajo med zdravljenjem s prukalopridom uporabljati učinkovito kontracepcijo.
English: In dogs, the effects observed in the gastrointestinal tract are sensitive to blockade with selective 5-HT4 receptor antagonists illustrating that the observed effects are exerted via selective action on 5-HT4 receptors.
Slovenian: Pri psih so učinki, opaženi v prebavnem traktu, občutljivi na blokado s selektivnim antagonistom receptorja 5-HT4, kar kaže, da se opaženi učinki izvajajo prek selektivnega delovanja na receptorje 5-HT4.
English: Resolor is only for adults and should not be taken by children and adolescents up to 18 years.
Slovenian: Zdravilo Resolor je namenjeno samo odraslim, zato ga ne smejo jemati otroci in mladostniki, mlajši od 18 let.
English: In double-blind clinical studies, the incidence of QT-related adverse events and ventricular arrhythmias was low and comparable to placebo.
Slovenian: V dvojno slepih študijah je bila pogostnost s QT povezanih neželenih učinkov in ventrikularnih aritmij nizka in primerljiva s placebom.
English: Prucalopride is a selective, high affinity serotonin (5-HT4) receptor agonist, which is likely to explain its prokinetic effects.
Slovenian: Prukaloprid je selektiven agonist z veliko afiniteto za serotoninski (5-HT4) receptor, kar verjetno razloži njegove prokinetične učinke.
English: In a small pharmacokinetic study, the Cmax and AUC of prucalopride were, on average, 10-20% higher in patients with moderate to severe hepatic impairment compared with healthy subjects (see sections 4.2 and 4.4).
Slovenian: V majhni farmakokinetični študiji sta bila Cmax in AUC prukaloprida povprečno 10-20 % višja pri bolnikih z zmerno do hudo jetrno okvaro v primerjavi z zdravimi osebami (glejte poglavji 4.2 in 4.4).
English: Warnings and precautions Talk to your doctor before taking Resolor.
Slovenian: Opozorila in previdnostni ukrepi Pred jemanjem zdravila Resolor se posvetujte s svojim zdravnikom.
English: After once daily dosing of 1 mg, peak plasma concentrations and AUC of prucalopride in older people were 26% to 28% higher than in young adults.
Slovenian: Po enkratnem dnevnem odmerku 1 mg so bile najvišje plazemske koncentracije in AUC prukaloprida pri starejših osebah 26 % do 28 % višje kot pri mladih odraslih.
English: 7 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 84 x 1 film-coated tablets
Slovenian: 7 x 1 filmsko obložena tableta 14 x 1 filmsko obložena tableta 28 x 1 filmsko obložena tableta 84 x 1 filmsko obložena tableta
English: In an oral dose study with radiolabelled prucalopride in man, small amounts of seven metabolites were recovered in urine and faeces.
Slovenian: V študiji peroralnega odmerka z radioaktivno označenim prukalopridom pri človeku so bile v urinu in blatu odkrite majhne količine sedmih presnovkov.
English: Caution should be exercised when prescribing Resolor to patients with these conditions especially when used in patients with a history of arrhythmias or ischaemic cardiovascular disease.
Slovenian: Pri predpisovanju zdravila Resolor bolnikom s temi stanji je potrebna previdnost, zlasti pri bolnikih z aritmijo ali ishemično boleznijo srca v anamnezi.
English: An extended series of safety pharmacology studies with special emphasis on cardiovascular parameters showed no relevant changes in haemodynamic and ECG derived parameters (QTc) with the exception of a modest increase in heart rate and blood pressure observed in anaesthetised pigs after intravenous administration, and an increase in blood pressure in conscious dogs after bolus intravenous administration, which was not observed either in anaesthetised dogs or after oral administration in dogs reaching similar plasma levels.
Slovenian: Razširjena serija študij farmakološke varnosti s posebnim poudarkom na srčno-žilnih parametrih ni pokazala pomembnih sprememb hemodinamike in iz EKG izpeljanih parametrov (QTc), z izjemo majhnega povišanja srčnega utripa in krvnega tlaka, opaženih pri anesteziranih prašičih po intravenski uporabi, in povišanja krvnega tlaka pri psih pri zavesti po intravenskem bolusu, ki ni bilo opaženo pri anesteziranih psih ali po peroralni uporabi pri psih, ki so dosegli podobne plazemske ravni.
English: In all three studies, treatment with Resolor also resulted in significant improvements in a validated and disease specific set of symptom measures (PAC-SYM), including abdominal (bloating, discomfort, pain and cramps), stool (incomplete bowel movements, false alarm, straining, too hard, too small) and rectal symptoms (painful bowel movements, burning, bleeding/tearing), determined at week 4 and week 12.
Slovenian: V vseh treh študijah je zdravljenje z zdravilom Resolor povzročilo tudi pomembno izboljšanje potrjenega in za bolezen specifičnega seta meril simptomov (PAC-SYM), vključno s trebušnimi (napihnjenost, nelagodje, bolečine in krči), simptomi, povezanimi z odvajanjem blata (nepopolno odvajanje, lažni alarm, napenjanje, pretrdo blato, premalo blata), in rektalnimi simptomi (boleče odvajanje, pekoč občutek, krvavitev/raztrganine), določenimi 4. in 12. teden.
English: Other metabolites identified and quantified in urine and faeces were R084536 (formed by N-dealkylation) accounting for 3% of the dose and products of hydroxylation (3% of the dose) and N-oxidation (2% of the dose).
Slovenian: Drugi presnovki, opredeljeni in izmerjeni v urinu in blatu, so bili R084536 (nastane z Ndealkilacijo), ki predstavlja 3 % odmerka, ter produkti hidroksilacije (3 % odmerka) in N-oksidacije (2 % odmerka).
English: This study did not show significant differences between Resolor and placebo at either dose, based on mean QT measurements and outlier analysis.
Slovenian: Študija ni pokazala pomembnih razlik med zdravilom Resolor in placebom v kateremkoli odmerku na podlagi povprečnih meritev QT in analize ubežnikov.
English: TQT study
Slovenian: Podrobna študija QT
English: When breast-feeding, prucalopride can pass into breast milk.
Slovenian: Pri dojenju prukaloprid lahko prehaja v materino mleko.
English: Resolor is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravilo Resolor se ne priporoča v nosečnosti ali pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: - Use a reliable method of contraception while you're taking Resolor, to prevent pregnancy.
Slovenian: - Med jemanjem zdravila Resolor uporabljajte zanesljiv način kontracepcije za preprečitev nosečnosti.
English: 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.
Slovenian: 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.
English: Other medicines and Resolor Tell your doctor if you are taking, or have recently taken, or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: 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.
Slovenian: 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.
English: An overdose may result in symptoms resulting from an exaggeration of prucalopride's known pharmacodynamic effects and include headache, nausea and diarrhoea.
Slovenian: Pri prevelikem odmerjanju se lahko pojavijo simptomi, ki so posledica povečanja znanih farmakodinamskih učinkov prukaloprida ter vključujejo glavobol, navzeo in diarejo.
English: In vitro, only at concentrations exceeding its 5-HT4 receptor affinity by at least 150-fold, affinity for other receptors was detected.
Slovenian: In vitro je bila samo v koncentracijah, ki njegovo afiniteto za receptor 5-HT4 presegajo vsaj 150-krat, ugotovljena afiniteta za druge receptorje.
English: It is extensively excreted unchanged in urine (approximately 60% of the dose) and in vitro metabolism is very slow.
Slovenian: V velikem obsegu se izloča nespremenjen v urinu (približno 60 % odmerka) in in vitro presnova je zelo počasna.
English: 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.
Slovenian: 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.
English: Resolor belongs to a group of gut motility enhancing medicines (gastrointestinal prokinetics).
Slovenian: Zdravilo Resolor sodi v skupino zdravil za spodbujanje motilitete (gastrointestinalni prokinetiki).
English: In an integrated analysis of 17 double-blind placebo-controlled studies, Resolor was given orally to approximately 3,300 patients with chronic constipation.
Slovenian: V celostni analizi 17 dvojno slepih, s placebom nadzorovanih študij je v študijah zdravilo Resolor peroralno prejemalo približno 3.300 bolnikov s kroničnim zaprtjem.
English: 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).
Slovenian: 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).
English: Prucalopride o.d. displays time-independent kinetics during prolonged treatment.
Slovenian: Prukaloprid enkrat na dan kaže časovno neodvisno kinetiko med dolgotrajnim zdravljenjem.
English: Prucalopride had no clinically relevant effects on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine or oral contraceptives.
Slovenian: Prukaloprid ni imel klinično pomembnih učinkov na farmakokinetiko varfarina, digoksina, alkohola, paroksetina ali peroralnih kontraceptivov.
English: 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).
Slovenian: 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).
English: A large fraction of the active substance is excreted unchanged (60-65% of the administered dose in urine and about 5% in faeces).
Slovenian: Velika frakcija zdravilne učinkovine se izloči nespremenjena (60-65 % uporabljenega odmerka v urinu in okoli 5 % v blatu).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Resolor is used for the treatment of chronic constipation in adults in whom laxatives do not work well enough.
Slovenian: Zdravilo Resolor se uporablja za zdravljenje kroničnega zaprtja pri odraslih, pri katerih odvajala ne delujejo dovolj dobro.
English: 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).
Slovenian: 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 %).
English: A subcutaneous neonatal/juvenile toxicity study performed in rats 7-55 days of age resulted in a NOAEL of 10 mg/kg/day.
Slovenian: V študiji toksičnosti subkutanih odmerkov, opravljeni pri novoskotenih/mladih podganah, starih od 7 do 55 dni, je bila vrednost NOAEL 10 mg/kg/dan.
English: These are equivalent to the colonic mass movements in humans, and provide the main propulsive force to defecation.
Slovenian: Ti ustrezajo gibanju črevesne mase pri človeku in zagotavljajo glavno pogonsko silo za odvajanje blata.
English: The safety profile of Resolor was consistent with that seen in female patients.
Slovenian: Varnostni profil zdravila Resolor je bil skladen s tistim pri ženskah.
English: Lactose monohydrate Microcrystalline cellulose Colloidal silicon dioxide Magnesium stearate
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza koloidni silicijev dioksid magnezijev stearat
English: Frequencies are calculated based on the integrated analysis of 17 double-blind placebo-controlled clinical studies.
Slovenian: Pogostnost je izračunana na podlagi celostne analize 17 dvojno slepih, s placebom nadzorovanih kliničnih študij.
English: The efficacy of prucalopride has been established in double-blind, placebo-controlled studies for up to 3 months.
Slovenian: Učinkovitost prukaloprida je bila ugotovljena v dvojno slepih, s placebom nadzorovanih študijah v obdobju do 3 mesecev.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Metabolism is not the major route of elimination of prucalopride.
Slovenian: Presnova ni glavni način izločanja prukaloprida.
English: Concomitant intake of food does not influence the oral bioavailability of prucalopride.
Slovenian: Sočasno jemanje hrane ne vpliva na peroralno biološko uporabnost prukaloprida.
English: The majority of adverse events were mild to moderate in intensity.
Slovenian: Večina neželenih učinkov je bila blaga do zmerna.
English: - If you do become pregnant during treatment with Resolor, tell your doctor.
Slovenian: - Če med zdravljenjem z zdravilom Resolor zanosite, obvestite svojega zdravnika.
English: 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).
Slovenian: 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).