FrancophonIA/ELRC3.0 huggingface dataset:
English: Sirolimus is the major component in human whole blood and contributes to greater than 90% of the immunosuppressive activity.
Slovenian: V polni krvi pri človeku prevladuje sirolimus, ki prispeva več kot 90 % učinka zaviranja imunske odzivnosti.
English: Rapamune tablets administered to 12 renal transplant patients above 65 years of age gave similar results to adult patients (n=167) 18 to 65 years of age.
Slovenian: Tablete zdravila Rapamune, dane 12 bolnikom s presajeno ledvico, starejšim od 65 let, so dale podobne rezultate kot pri odraslih bolnikih (n = 167), starih 18 do 65 let.
English: Sirolimus levels should be monitored and appropriate dose reductions of both medicinal products should be considered.
Slovenian: Ravni sirolimusa je treba spremljati in po potrebi ustrezno zmanjšati odmerka obeh zdravil.
English: Administration of multiple doses of rifampicin decreased sirolimus whole blood concentrations following a single 10 mg dose of Rapamune oral solution.
Slovenian: Dajanje večkratnih odmerkov rifampicina je zmanjšalo koncentracije sirolimusa v polni krvi po enkratnem 10 mg odmerku peroralne raztopine zdravila Rapamune.
English: In addition, re-transplant recipients whose previous grafts survived for at least 6 months after transplantation were included.
Slovenian: Vključili so tudi bolnike po ponovni presaditvi, pri katerih se je prejšnja presajena ledvica ohranila vsaj 6 mesecev po presaditvi.
English: Rapamune should be given with corticosteroids.
Slovenian: Zdravilo Rapamune je treba uporabljati skupaj s kortikosteroidi.
English: The concomitant administration of Rapamune and angiotensin-converting enzyme (ACE) inhibitors has resulted in angioneurotic oedema-type reactions.
Slovenian: Sočasna uporaba zdravila Rapamune in zaviralcev angiotenzinske konvertaze (ACE - AngiotensinConverting Enzyme) je povzročila reakcije vrste angionevrotičnega edema.
English: In most patients, dose adjustments can be based on simple proportion: new Rapamune dose=current dose x (target concentration/current concentration).
Slovenian: Pri večini bolnikov lahko prilagoditve odmerka temeljijo na preprostem razmerju: novi odmerek zdravila Rapamune = dosedanji odmerek x (ciljna koncentracija/sedanja koncentracija).
English: Multiples of 0.5 mg tablets should not be used as a substitute for 1 mg and 2 mg tablets, as the different strengths are not directly interchangeable.
Slovenian: Več 0,5 mg tablet ne smete uporabljati kot nadomestilo za 1 mg ali 2 mg tablete, ker različne jakosti med seboj niso neposredno zamenljive.
English: Ciclosporin was not withdrawn in patients experiencing Banff Grade 3 acute rejection episodes, who were dialysis-dependent, who had a serum creatinine higher than 400 mol/L, or who had inadequate renal function to support ciclosporin withdrawal.
Slovenian: Ciklosporina niso ukinili pri bolnikih, ki so imeli akutno zavrnitveno reakcijo stopnje 3 po Banffu, pri tistih, ki so bili odvisni od dialize, tistih, ki so imeli serumski kreatinin višji od 400 mol/l, ali tistih, ki so imeli nezadostno delovanje ledvic, da bi lahko prenesli ukinitev ciklosporina.
English: If you forget to take Rapamune
Slovenian: Če ste pozabili vzeti zdravilo Rapamune
English: Rapamune, like other immunosuppressive medicines, may decrease your body's ability to fight infection, and may increase the risk of developing cancer of the lymphoid tissues and skin.
Slovenian: zdravilo Rapamune, tako kot tudi druga zdravila za zaviranje imunske odzivnosti, lahko zmanjša sposobnost vašega organizma za obrambo pred okužbami in lahko zveča tveganje za nastanek raka limfnega tkiva in kože.
English: Sirolimus is extensively metabolised by the CYP3A4 isozyme in the intestinal wall and liver.
Slovenian: Sirolimus se obširno presnavlja preko izoencima CYP3A4 v črevesni steni in jetrih.
English: Grapefruit juice should be avoided (see section 4.5).
Slovenian: Bolniki se morajo izogibati soku grenivke (glejte poglavje 4.5).
English: Controlled clinical studies with posology comparable to that currently indicated for the use of Rapamune in adults have not been conducted in children or adolescents below 18 years of age.
Slovenian: Nadzorovane klinične študije z odmerki, primerljivimi s tistimi, ki se trenutno uporabljajo pri zdravljenju z zdravilom Rapamune pri odraslih, pri otrocih ali mladostnikih, mlajših od 18 let, niso bile izvedene.
English: Subjects were to receive Rapamune (sirolimus target concentrations of 5 to 15 ng/mL) in combination with a calcineurin inhibitor and corticosteroids or to receive calcineurin-inhibitor-based immunosuppression without Rapamune.
Slovenian: Preskušanci so prejeli bodisi zdravilo Rapamune (ciljne koncentracije sirolimusa od 5 do 15 ng/ml) sočasno z zaviralcem kalcinevrina in kortikosteroidi bodisi imunosupresijo na osnovi zaviralca kalcinevrina brez zdravila Rapamune.
English: The rates of acute rejection, graft loss, and death were similar, but urinary protein excretion was increased in the Rapamune treatment arm of this subset.
Slovenian: Pogostnost akutne zavrnitve, izgube presadka in smrti je bila podobna, izločanje beljakovin v urin pa se je v podskupini, ki je prejemala zdravilo Rapamune, zvečalo.
English: Clinical studies of Rapamune did not include a sufficient number of patients above 65 years of age to determine whether they will respond differently than younger patients.
Slovenian: V klinične študije zdravila Rapamune ni bilo vključenih dovolj bolnikov, starejših od 65 let, da bi lahko ugotovili, ali se le-ti na zdravljenje odzivajo drugače kot mlajši bolniki.
English: The tablets are supplied in blister packs of 30 and 100 tablets.
Slovenian: Tablete so na voljo v pretisnem omotu s 30 ali 100 tabletami.
English: Adjustments to the targeted range should be made according to the assay being utilised to determine the sirolimus trough concentrations.
Slovenian: Ciljni razpon je treba prilagajati v skladu z metodo, uporabljeno za določanje najmanjših koncentracij sirolimusa.
English: Sirolimus is a substrate for both cytochrome P450 IIIA4 (CYP3A4) and P-glycoprotein.
Slovenian: Sirolimus je substrat tako za citokrom P450 IIIA4 (CYP3A4) kot za P-glikoprotein.
English: Based upon the analysis of data from 36 months and beyond, which showed a growing difference in graft survival and renal function, as well as significantly lower blood pressure in the ciclosporin elimination group, it was decided to discontinue subjects from the Rapamune with ciclosporin group.
Slovenian: Na podlagi analize podatkov po 36. mesecu, ki je pokazala naraščajočo razliko v preživetju presadka in ledvičnem delovanju, pa tudi pomembno nižji krvni tlak v skupini po ukinitvi ciklosporina, so se odločili za izključitev preskušancev iz skupine, ki je prejemala zdravilo Rapamune in ciklosporin.
English: Much of the general pharmacokinetic information was obtained using the Rapamune oral solution, which is summarised first.
Slovenian: Veliko splošnih farmakokinetičnih podatkov so pridobili v študijah s peroralno raztopino zdravila Rapamune, zato so ti povzeti najprej.
English: Clinical studies with Rapamune oral solution did not include a sufficient number of patients above 65 years of age to determine whether they will respond differently than younger patients (see section 5.2).
Slovenian: Klinične študije s peroralno raztopino zdravila Rapamune niso vključevale zadostnega števila bolnikov, starejših od 65 let, za določitev ali se ti na sirolimus odzivajo drugače kot mlajši bolniki (glejte poglavje 5.2).
English: The terminal half-life in stable renal transplant patients after multiple oral doses was 62  16 hours.
Slovenian: Končni razpolovni čas pri stabilnih bolnikih po presaditvi ledvice po večkratnih peroralnih odmerkih je znašal 62 ± 16 ur.
English: Because of the potential for adverse reactions in breast-fed infants from sirolimus, breast-feeding should be discontinued during treatment with Rapamune.
Slovenian: Zaradi možnosti pojava neželenih učinkov sirolimusa pri dojenih otrocih, je med zdravljenjem z zdravilom Rapamune priporočljivo prenehati z dojenjem.
English: Special populations Black population
Slovenian: Pripadniki črne rase
English: Inhibitors of P-gp may decrease the efflux of sirolimus from intestinal cells and increase sirolimus levels.
Slovenian: Zaviralci P-gp lahko zmanjšajo izločanje sirolimusa iz črevesnih celic in povečajo koncentracije sirolimusa.
English: Pale yellow to yellow solution.
Slovenian: peroralna raztopina bledo rumena do rumena raztopina
English: The continued co-administration of ciclosporin and Rapamune as maintenance therapy cannot be recommended.
Slovenian: Nadaljevanje sočasnega zdravljenja s ciklosporinom in zdravilom Rapamune kot vzdrževalno zdravljenje ni priporočljivo.
English: During Rapamune therapy with or without CsA, patients should be monitored for elevated lipids, and patients administered an HMG-CoA reductase inhibitor and/or fibrate should be monitored for the possible development of rhabdomyolysis and other adverse reactions, as described in the respective Summary of Product Characteristics of these agents.
Slovenian: Med zdravljenjem z zdravilom Rapamune s ciklosporinom A ali brez njega je treba bolnike spremljati zaradi možnosti zvišanih lipidov, bolnike, ki prejemajo zaviralec reduktaze HMG-CoA in/ali fibrat pa je treba spremljati glede možnega razvoja rabdomiolize in drugih neželenih učinkov, ki so opisani v ustreznih povzetkih glavnih značilnosti teh zdravil.
English: On average, the sirolimus dose will need to be 4-fold higher to account for both the absence of the pharmacokinetic interaction (2-fold increase) and the augmented immunosuppressive requirement in the absence of ciclosporin (2-fold increase).
Slovenian: Odmerek sirolimusa bo moral biti v povprečju štirikrat večji, da bo nadomestil tako odsotnost farmakokinetične interakcije (dvakratno zvečanje) kot tudi zvečane potrebe po imunosupresiji v odsotnosti ciklosporina (dvakratno zvečanje).
English: The use of Rapamune was associated with increased serum cholesterol and triglycerides that may require treatment.
Slovenian: Uporaba zdravila Rapamune je bila povezana z zvišanjem serumskega holesterola in trigliceridov, ki lahko zahteva zdravljenje.
English: In healthy subjects, the mean extent of bioavailability of sirolimus after single-dose administration of the tablet formulation is about 27% higher relative to the oral solution.
Slovenian: Pri zdravih prostovoljcih je srednji obseg biološke uporabnosti sirolimusa po enkratnem odmerku tablet približno za 27 % večji kot po uporabi peroralne raztopine.
English: The treatment regimen studied (continuous use of Rapamune in combination with calcineurin inhibitor) is not indicated for adult or paediatric patients (see section 4.1).
Slovenian: Preučevana shema zdravljenja (kontinuirana uporaba zdravila Rapamune sočasno z zaviralcem kalcinevrina) za odrasle ali pediatrične bolnike ni indicirana (glejte poglavje 4.1).
English: Based on information from an open-label randomised study, conversion from the calcineurin inhibitor tacrolimus to Rapamune in maintenance renal transplant patients was associated with an unfavourable safety profile without efficacy benefit and can therefore not be recommended (see section 5.1).
Slovenian: Na podlagi podatkov iz odprte randomizirane študije je bil pri bolnikih na vzdrževalnem zdravljenju po presaditvi ledvice prehod z zaviralca kalcinevrina takrolimusa na zdravilo Rapamune povezan z neugodnim varnostnim profilom brez izboljšanja učinkovitosti in zato ni priporočljiv (glejte poglavje 5.1).
English: The dosing syringe should be used to withdraw the prescribed amount of Rapamune from the bottle.
Slovenian: S pomočjo odmerne brizge iz steklenice odvzamemo predpisano količino zdravila Rapamune.
English: It is recommended that Rapamune be used first in combination with ciclosporin and corticosteroids.
Slovenian: Priporočljivo je, da se zdravilo Rapamune najprej uporablja skupaj s ciklosporinom in kortikosteroidi.
English: This dose could potentially be harmful for those suffering from alcoholism and should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Slovenian: Ta odmerek bi lahko škodoval alkoholikom in ga moramo upoštevati pri nosečnicah, doječih materah, otrocih in skupinah z velikim tveganjem, na primer bolnikih z boleznijo jeter ali epilepsijo.
English: In reproduction toxicity studies decreased fertility in male rats was observed.
Slovenian: Pri študijah škodljivega vpliva na sposobnost razmnoževanja so opazili zmanjšano plodnost pri podganjih samcih.
English: The younger children had a higher weight-normalised CL/F (214 mL/h/kg) compared with the adolescents (136 mL/h/kg).
Slovenian: Mlajši otroci so imeli večjo vrednost na telesno maso normaliziranega CL/F (214 ml/h/kg) v primerjavi z mladostniki (136 ml/h/kg).
English: The safety and efficacy of Rapamune as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore such use is not recommended.
Slovenian: Varnost in učinkovitost zdravila Rapamune za imunosupresivno zdravljenje pri bolnikih s presadki jeter ali ledvic nista bili dokazani, zato taka uporaba ni priporočljiva.
English: Rapamune contains up to 3.17 vol % ethanol (alcohol).
Slovenian: Zdravilo Rapamune vsebuje do 3,17 volumskih % etanola (alkohola).
English: In clinical studies, the concomitant administration of Rapamune and HMG-CoA reductase inhibitors and/or fibrates was well-tolerated.
Slovenian: V kliničnih študijah so bolniki sočasno uporabo zdravila Rapamune in zaviralcev reduktaze HMGCoA in/ali fibratov dobro prenašali.
English: Frequent Rapamune dose adjustments based on non-steady-state sirolimus concentrations can lead to overdosing or underdosing because sirolimus has a long half-life.
Slovenian: Pogosto prilagajanje odmerka zdravila Rapamune na podlagi koncentracij sirolimusa, ki niso v stanju dinamičnega ravnovesja, lahko privede do prevelikega ali premajhnega odmerjanja, saj ima sirolimus dolg razpolovni čas.
English: If further dose adjustment(s) are required during maintenance therapy (after discontinuation of ciclosporin), in most patients these adjustments can be based on simple proportion: new Rapamune dose=current dose x (target concentration/current concentration).
Slovenian: Če so med vzdrževalnim zdravljenjem (po ukinitvi ciklosporina) potrebne nadaljnje prilagoditve odmerka, lahko pri večini bolnikov te prilagoditve temeljijo na preprostem razmerju: novi odmerek zdravila Rapamune = dosedanji odmerek x (ciljna koncentracija/sedanja koncentracija).
English: Multiples of 0.5 mg tablets should not be used as a substitute for the 1 mg tablet or for other strengths (see section 5.2).
Slovenian: Več 0,5 mg tablet se ne sme uporabljati kot nadomestilo za 1 mg tablete ali tablete drugih jakosti (glejte poglavje 5.2).
English: If you stop taking Rapamune
Slovenian: Če ste prenehali jemati zdravilo Rapamune
English: Instructions for use and handling:
Slovenian: Navodila za pripravo in ravnanje z zdravilom:
English: If you have a body mass index (BMI) greater than 30 kg/m2, you may be at increased risk of abnormal wound healing.
Slovenian: če imate indeks telesne mase (ITM) večji od 30 kg/m2, je vaše tveganje za nenormalno celjenje ran morda zvečano.
English: The rates of premature study discontinuation, adverse events overall (and infections, specifically), and biopsy-proven acute liver graft rejection at 12 months were all significantly greater in the sirolimus conversion group compared to the CNI continuation group.
Slovenian: Pogostnosti prezgodnje prekinitve študije, vseh neželenih učinkov skupaj (še zlasti okužb) in z biopsijo dokazanih akutnih zavrnitev presajenih jeter po 12 mesecih so bile statistično pomembno večje v skupini s prehodom na sirolimus kot v skupini, ki je nadaljevala s CNI.
English: Therefore, antimicrobial prophylaxis for Pneumocystis carinii pneumonia should be administered for the first 12 months following transplantation.
Slovenian: Zato je treba prvih 12 mesecev po presaditvi uporabljati protimikrobno profilakso za preprečitev s Pneumocystis carinii povzročene pljučnice.
English: Ciclosporin inhibits the metabolism of sirolimus, and consequently sirolimus levels will decrease when ciclosporin is discontinued, unless the sirolimus dose is increased.
Slovenian: Ciklosporin zavira presnovo sirolimusa, zato se bo ob ukinitvi ciklosporina koncentracija sirolimusa zmanjšala, če odmerka sirolimusa ne zvečamo.
English: Sirolimus inhibits the activated mTOR pathway and thus the proliferation of LAM cells.
Slovenian: Sirolimus zavira aktivirano pot mTOR in s tem proliferacijo celic LAM.
English: An initial dose of 6 mg contains up to 150 mg of alcohol which is equivalent to 3.80 mL beer or 1.58 mL wine.
Slovenian: 6 mg začetni odmerek vsebuje do 150 mg alkohola, kar ustreza 3,80 ml piva ali 1,58 ml vina.
English: The systemic availability of sirolimus in combination with simultaneously administered ciclosporin (Sandimune) is approximately 14%.
Slovenian: Sistemska biološka uporabnost sirolimusa pri sočasni uporabi s ciklosporinom je približno 14 %.
English: It is unknown whether sirolimus is excreted in human milk.
Slovenian: Ni znano, ali se sirolimus izloča tudi v materino mleko.
English: The active substance is sirolimus.
Slovenian: Učinkovina je sirolimus.
English: Therefore, the sirolimus dose was approximately 4-fold higher to account for both the absence of the pharmacokinetic interaction with ciclosporin (2-fold increase) and the augmented immunosuppressive requirement in the absence of ciclosporin (2-fold increase).
Slovenian: Odmerki sirolimusa so bili torej približno štirikrat večji, da so nadomestili tako odsotnost farmakokinetične interakcije s ciklosporinom (dvakratno zvečanje) kot tudi zvečano potrebo po imunosupresiji v odsotnosti ciklosporina (dvakratno zvečanje).
English: In rats, sirolimus caused embryo/foetotoxicity that was manifested as mortality and reduced foetal weights (with associated delays in skeletal ossification) (see section 4.6).
Slovenian: Pri podganah je sirolimus povzročil embriotoksične in fetotoksične učinke, ki so se kazali s smrtjo ploda in zmanjšanjem mase ploda (s povezano zapoznelo osifikacijo kosti) (glejte poglavje 4.6).
English: By 60 months, the incidence of non-skin malignancies was significantly higher in the cohort who continued ciclosporin as compared with the cohort who had ciclosporin withdrawn (8.4% vs. 3.8%, respectively).
Slovenian: Do 60. meseca je bila incidenca ne-kožnih malignih bolezni v kohorti, ki je nadaljevala z zdravljenjem s ciklosporinom pomembno večja kot v kohorti, ki so ji ciklosporin ukinili (8,4 % proti 3,8 %).
English: At 2 years, the rate of non-melanoma skin malignancies was significantly lower in the Rapamune conversion group as compared to the calcineurin inhibitors continuation group (1.8% and 6.9%).
Slovenian: Po 2 letih je bila pogostnost ne-melanomskih kožnih malignih bolezni v skupini, ki je prešla na zdravilo Rapamune pomembno manjša kot v skupini, ki je zdravljenje nadaljevala z zaviralci kalcinevrina (1,8 % oziroma 6,9 %).
English: If necessary, the patient may store the bottles at room temperatures up to 25C for a short period of time (24 hours).
Slovenian: Po potrebi lahko bolnik hrani steklenico tudi pri sobni temperaturi do 25 °C, vendar samo za kratek čas (24 ur).
English: Rapamune is also used for the treatment of patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or declining lung function.
Slovenian: Zdravilo Rapamune se uporablja tudi za zdravljenje bolnikov s sporadičnolimfangioleiomiomatozo (S-LAM), ki imajo zmerno pljučno bolezen ali poslabšanje pljučne funkcije.
English: In two multi-centre clinical studies, de novo renal transplant patients treated with sirolimus, mycophenolate mofetil (MMF), corticosteroids, and an IL-2 receptor antagonist had significantly higher acute rejection rates and numerically higher death rates compared to patients treated with a calcineurin inhibitor, MMF, corticosteroids, and an IL-2 receptor antagonist (see section 4.4).
Slovenian: V dveh multicentričnih kliničnih študijah je bila pri bolnikih z de novo ledvičnim presadkom, zdravljenih s sirolimusom, mofetilijevim mikofenolatom (MMF), kortikosteroidi in antagonistom receptorjev IL-2, pogostnost akutne zavrnitve pomembno večja in smrtni izid številčno pogostejši kot pri bolnikih, zdravljenih z zaviralcem kalcinevrina, MMF, kortikosteroidi in antagonistom receptorjev IL-2 (glejte poglavje 4.4).
English: S-LAM patients experienced similar side effects to those of kidney transplant patients, with the addition of weight loss, which may affect up to 1 in 10 people.
Slovenian: Bolnikom s S-LAM so se pojavili podobni neželeni učinki kot bolnikom s presadki ledvic, dodatno pa še izguba telesne mase, ki se lahko pojavi pri največ 1 od 10 bolnikov.
English: Also contains: lactose monohydrate, sucrose.
Slovenian: Vsebuje tudi: laktozo monohidrat, saharozo.
English: In another study enrolling renal transplant patients 20 years of age and below that was intended to assess the safety of progressive corticosteroid withdrawal (beginning at six months post-transplantation) from an immunosuppressive regimen initiated at transplantation that included full-dose immunosuppression with both Rapamune and a calcineurin inhibitor in combination with basiliximab induction, of the 274 patients enrolled, 19 (6.9%) were reported to have developed post-transplant lymphoproliferative disorder (PTLD).
Slovenian: V drugi študiji, v katero so bili vključeni bolniki po ledvični presaditvi, stari največ 20 let, in ki je bila namenjena oceni varnosti postopnega zmanjševanja odmerka kortikosteroidov (z začetkom šest mesecev po presaditvi) iz imunosupresivnega režima zdravljenja, začetega ob presaditvi, ki je vključeval polno imunosupresijo z zdravilom Rapamune in z zaviralcem kalcinevrina sočasno z indukcijo basiliksimaba, so pri 19 (6,9 %) od 274 vključenih bolnikov poročali o razvoju potransplantacijske limfoproliferativne bolezni (PTLD Post-Transplant Lymphoproliferative Disorder).
English: Your doctor will give you 2 mg of Rapamune each day, until otherwise directed by your doctor.
Slovenian: Zdravnik vam bo predpisal 2 mg zdravila Rapamune na dan, dokler se ne odloči drugače.
English: At steady-state, 8 children aged 6-11 years received mean  SD doses of 1.75  0.71 mg/day (0.064  0.018 mg/kg, 1.65  0.43 mg/m2) while 14 adolescents aged 12-18 years received mean  SD doses of 2.79  1.25 mg/day (0.053  0.0150 mg/kg, 1.86  0.61 mg/m2).
Slovenian: V stanju dinamičnega ravnovesja je 8 otrok, starih 6-11 let, prejelo povprečne odmerke ± SD 1,75 ± 0,71 mg/dan (0,064 ± 0,018 mg/kg, 1,65 ± 0,43 mg/m2), medtem ko je 14 mladostnikov, starih 12-18 let, prejelo povprečne odmerke ± SD 2,79 ± 1,25 mg/dan (0,053 ± 0,015 mg/kg, 1,86 ± 0,61 mg/m2).
English: Rapamune should not be taken with grapefruit juice.
Slovenian: Zdravila Rapamune ne smete jemati skupaj s sokom grenivke.
English: Carcinogenicity studies conducted in mouse and rat showed increased incidences of lymphomas (male and female mouse), hepatocellular adenoma and carcinoma (male mouse) and granulocytic leukaemia (female mouse).
Slovenian: Študije kancerogenosti zdravila na miših in podganah so pokazale povečano incidenco limfomov (pri mišjih samcih in samicah), hepatocelularnega adenoma in karcinoma (pri mišjih samcih) in granulocitne levkemije (pri mišjih samicah).
English: If necessary, you may store the bottle at room temperature up to 25C for a short period of time, but no longer than 24 hours.
Slovenian: Po potrebi lahko steklenico krajši čas shranjujete tudi pri sobni temperaturi do 25 C, vendar ne več kot 24 ur.
English: The corresponding results for the oral solution in the same clinical study were Cmin,ss 5.40  2.50 ng/mL, Cmax,ss 14.4  5.3 ng/mL, tmax,ss 2.12  0.84 hours, AUC,ss 194  78 ng.h/mL, CL/F/W 173  50 mL/h/kg.
Slovenian: Ustrezne vrednosti za peroralno raztopino v isti klinični študiji so bile naslednje: Cmin,ss 5,40 ± 2,50 ng/ml; Cmax,ss 14,4± 5,3 ng/ml; tmax,ss 2,12 ± 0,84 ur; AUC,ss 194 ± 78 ng.h/ml; CL/F/W 173 ± 50 ml/h/kg.