natgillin/translations-raw huggingface dataset:
Only events for which there is at least reasonable suspicion of a causal relationship to Rapamune treatment are listed.
Navedeni so le dogodki, za katere obstaja vsaj utemeljen sum o vzročni povezanosti s terapijo z zdravilom Rapamune.
Most patients were on immunosuppressive regimens which included Rapamune in combination with other immunosuppressive agents.
Večina bolnikov je bilo zdravljenih po imunosupresivnih shemah, ki so vključevale zdravilo Rapamune v kombinaciji z drugimi imunosupresivnimi zdravili.
8 System Organ Class
8
Very common ( 1/ 10)
Zelo pogosti (≥1/ 10)
Common ( 1/ 100 to < 1/ 10)
Pogosti (≥1/ 100 do < 1/ 10) CMV in herpes zoster)
Uncommon ( 1/ 1000 to < 1/ 100)
Občasni (≥1/ 1. 000 do < 1/ 100)
Rare ( 1/ 10000 to < 1/ 1000)
Redki (≥1/ 10. 000 do < 1/ 1. 000)
Infections and infestations
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
Skin Cancer
rak na koži
Lymphoma / post transplant lymphoproliferative disorder
limfom/ potransplan tacijska limfoproliferativna motnja pancitopenija
Thrombocytopenia Anaemia
trombocitopenija
Pancytopenia
trombotična
Immune system disorders
limfatičnega sistema Bolezni imunskega sistema Presnovne in prehranske motnje
Hypersensitivity reactions, including anaphylactic/ anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis (see section 4.4)
anemija hipokaliemija hipofosfatemija hiperholesterolemija hiperglikemija hipertrigliceridemija glavobol
Metabolism and Hypokalaemia nutrition disorders
trombocitopenična purpura/ hemolitično - uremični sindrom levkopenija nevtropenija
Hypophosphataemia Hypercholesterolaemia Hyperglycaemia Hypertriglyceridaemia
preobčutljivostne reakcije, vključno z anafilaktičnimi/ a nafilaktoidnimi reakcijami, angioedemom, eksfoliativnim dermatitisom in preobčutljivostni m vaskulitisom (glejte poglavje 4. 4).
9 System Organ Class Nervous system disorders
Bolezni živčevja Srčne bolezni
Very common ( 1/ 10) Headache
tahikardija
Common ( 1/ 100 to < 1/ 10)
perikardialni izliv (vključno s hemodinamsko pomembnimi izlivi pri otrocih in odraslih)
Uncommon ( 1/ 1000 to < 1/ 100)
Žilne bolezni
Rare ( 1/ 10000 to < 1/ 1000)
limfokela
Cardiac disorders
globoka venska
Tachycardia
pljučna embolija
Pericardial effusion (including haemodynamically significant effusions in children and adults)
limfedem
Vascular disorders Respiratory, thoracic, and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalneg a prostora
Lymphocele Hypertension
zvišan krvni tlak
Deep vein thrombosis Pneumonitis Pleural effusion Epistaxis
tromboza pnevmonitis plevralni izliv epistaksa
Pulmonary embolism Pulmonary haemorrhage
pljučna krvavitev
Lymphoedema Alveolar proteinosis
alveolarna proteinoza
Abdominal pain Diarrhoea Constipation Nausea
bolečine v trebuhu driska zaprtje navzea
Stomatitis
stomatitis nenormalni izvidi delovanja jeter
Hepatobiliary disorders
Organski sistem Bolezni kože in podkožja
Liver function tests abnormal
Zelo pogosti (≥1/ 10) akne
Skin and subcutaneous tissue disorders
Pogosti (≥1/ 100 do < 1/ 10) izpuščaj
Acne
Občasni (≥1/ 1. 000 do < 1/ 100)
Rash
Redki (≥1/ 10. 000 do < 1/ 1. 000)
Osteonecrosis
osteonekroza
Nephrotic syndrome (see section 4.4)
nefrotični sindrom (glejte poglavje 4. 4)
General disorders and administration site conditions
Splošne težave
Oedema peripheral Pyrexia Pain
periferni edemi
Impaired healing Oedema
slabše celjenje
Investigations
in spremembe na mestu aplikacije Preiskave
Blood lactate dehydrogenase increased Blood creatinine increased
pireksija bolečina zvišanje laktat - dehidrogenaze v krvi zvišanje kreatinina v krvi
Aspartate aminotransferase increased Alanine aminotransferase increased
edemi zvišanje aspartat - aminotransferaze zvišanje alanin - aminotransferaze
Immunosuppression increases the susceptibility to the development of lymphoma and other malignancies, particularly of the skin (see section 4.4).
Imunosupresija povečuje dovzetnost za limfome in druge malignome, zlasti malignome na koži (glejte poglavje 4. 4).
Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Rapamune.
Pri bolnikih, zdravljenih z imunosupresivi, med drugim tudi z zdravilom Rapamune, so poročali o primerih nefropatije, povezane z virusom BK, in o primerih progresivne multifokalne levkoencefalopatije (PML), povezane z virusom JC.
10 Hepatotoxicity has been reported, the risk may increase as the trough sirolimus level increases.
Opisani so hepatotoksični učinki; tveganje se lahko poveča z zvišanjem najnižje koncentracije sirolimusa.
There have been rare reports of fatal hepatic necrosis with elevated trough sirolimus levels.
Ob zvišani najnižji koncentraciji sirolimusa so bili opisani redki primeri usodne nekroze jeter.
Cases of interstitial lung disease (including pneumonitis and infrequently bronchiolitis obliterans organising pneumonia (BOOP) and pulmonary fibrosis), some fatal, with no identified infectious etiology have occurred in patients receiving immunosuppressive regimens including Rapamune.
Pri bolnikih, ki so se zdravili po imunosupresivni shemi, vključno z zdravilom Rapamune, so se pojavili primeri intersticijske bolezni pljuč (vključno s pnevmonitisom, redko z bronhiolitis obliterans organizirano pljučnico (BOOP – “ bronchiolitis obliterans organising pneumonia ”) in pljučno fibrozo)
In some cases, the interstitial lung disease has resolved upon discontinuation or dose reduction of Rapamune.
intersticijska bolezen pljuč po prekinitvi zdravljenja z zdravilom Rapamune ali zmanjšanju njegovega odmerka izzvenela.
Impaired healing following transplant surgery has been reported, including fascial dehiscence, incisional hernia, and anastomotic disruption (e. g. wound, vascular, airway, ureteral, biliary).
Poročali so o slabšem celjenju po presaditveni operaciji, vključno z dehiscenco fascije, postoperativno hernijo in uničenjem anastomoze (npr. rane, žilne, dihalne, ureterne, biliarne).
The concomitant use of sirolimus with a calcineurin inhibitor may increase the risk of calcineurin inhibitor-induced HUS/ TTP/ TMA.
Sočasna uporaba sirolimusa z zaviralcem kalcinevrina lahko poveča tveganje za hemolitično- uremični sindrom/ trombotično trombocitopenično purpuro/ trombotično mikroangiopatijo (HUS/ TTP/ TMA), izzvanimi z zaviralcem kalcinevrina.
In an ongoing study evaluating the safety and efficacy of conversion from calcineurin inhibitors to sirolimus (target levels of 12 - 20 ng/ mL) in maintenance renal transplant patients, enrollment was stopped in the subset of patients (n=90) with a baseline glomerular filtration rate of less than 40 mL/ min (see section 5.1).
10 V potekajoči študiji varnosti in učinkovitosti prehoda zdravljenja z zaviralcev kalcinevrina na sirolimus (s ciljno koncentracijo 12– 20 ng/ ml) pri bolnikih na vzdrževalnem zdravljenju po presaditvi ledvice so ustavili vključevanje podskupine bolnikov (n = 90) z izhodiščno glomerulno filtracijo manj kot 40 ml/ min (glejte poglavje 5. 1).
There was a higher rate of serious adverse events including pneumonia, acute rejection, graft loss and death in this sirolimus treatment arm (n=60, median time post-transplant 36 months).
Delež resnih neželenih učinkov, vključno s pljučnico, akutno zavrnitvijo, izgubo presadka in smrtjo je bil namreč v tej podskupini zdravljeni s sirolimusom večji (n=60, srednji čas po presaditvi 36 mesecev).
Paediatric population Controlled clinical trials with posology comparable to that currently indicated for the use of Rapamune in adults — that is, use in combination with ciclosporin and corticosteroids for 2 to 3 months post-transplantation followed by withdrawal of ciclosporin thereafter— have not been conducted in children or adolescents ( 18 years of age).
Pediatrična populacija Pri otrocih ali mladostnikih (< 18 let) niso bili napravljeni kontrolirani klinični preskusi z odmerki, primerljivimi s tistimi, ki se trenutno uporabljajo v zdravljenju z zdravilom Rapamune pri odraslih – to je uporaba sočasno s ciklosporinom in kortikosteroidi 2 do 3 mesece po presaditvi in nato ukinitev ciklosporina.
Safety was assessed in a controlled clinical trial enrolling renal transplant patients  18 years of age considered of high-immunologic risk, defined as a history of one or more acute allograft rejection episodes and/ or the presence of chronic allograft nephropathy on a renal biopsy (see section 5.1).
Varnost so ocenjevali v kontroliranem kliničnem preskusu, v katerega so bili vključeni bolniki, mlajši od 18 let, po presaditvi ledvic, z velikim imunološkim tveganjem, kar pomeni z anamnezo ene ali več akutnih epizod zavrnitve alografta in/ ali prisotnost kronične nefropatije alografta ob ledvični biopsiji (glejte poglavje 5. 1).
The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, serum lipid abnormalities (including but not limited to increased serum triglycerides and cholesterol), and urinary tract infections.
Uporaba zdravila Rapamune sočasno z zaviralci kalcinevrina in kortikosteroidi je bila povezana z zvečanim tveganjem poslabšanja ledvične funkcije, nenormalnimi izvidi serumskih lipidov (vključno z zvišanimi trigliceridi in holesterolom) in okužbami sečil.
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).
Preučevan režim zdravljenja (kontinuirana uporaba zdravila Rapamune sočasno z zaviralcem kalcinevrina) ni indiciran za odrasle ali pediatrične bolnike (glejte poglavje 4. 1).
In another study enrolling renal transplant patients  20 years of age 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).
V drugi študiji, v katero so bili vključeni bolniki po ledvični presaditvi, stari ≤ 20 let, in ki je bila namenjena za oceno varnosti postopnega zmanjševanja odmerka kortikosteroidov (z začetkom šest mesecev po presaditvi) iz imunosuporesivnega 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).
Among 89 patients known to be EBV seronegative prior to transplantation, 13 (15.6%) were reported to have developed PTLD.
Med 89 bolniki, ki so bili pred presaditvijo dokazano seronegativni za EBV, se je PTLD razvila pri 13 (15, 6%) bolnikih.
All patients who developed PTLD were aged  18 years.
Vsi bolniki, pri katerih se je razvila PTLD, so bili stari manj kot 18 let.
There is insufficient experience to recommend the use of Rapamune in children and adolescents (see section 4.2).
Zaradi nezadostnih izkušenj pri tej starostni skupini uporabe zdravila Rapamune ni mogoče priporočiti pri otrocih in mladostnikih (glejte poglavje 4. 2).
11 4.9 Overdose
4. 9 Preveliko odmerjanje
In general, the adverse effects of overdose are consistent with those listed in section 4.8.
Na splošno so neželeni učinki pri prevelikem odmerjanju enaki tistim, ki so navedeni v poglavju 4. 8.
ATC code:
Pripravki za selektivno zaviranje imunske odzivnosti, oznaka ATC:
L04A A10.
L04A A10
Sirolimus inhibits T cell activation induced by most stimuli, by blocking calcium dependent and calcium independent intracellular signal transduction.
Sirolimus zavira aktivacijo limfocitov T na večino dražljajev, in sicer tako da zavre od kalcija odvisni in od kalcija neodvisni intracelularni prenos signalov.
Experimental evidence suggests that sirolimus binds to the specific cytosolic protein FKPB-12 and that the FKPB 12-sirolimus complex inhibits the activation of the mammalian Target Of Rapamycin (mTOR), a critical kinase for cell cycle progression.
Testi kažejo na to, da se sirolimus veže na specifično beljakovino FKPB- 12 v citosolu in da kompleks sirolimus- FKPB- 12 zavira aktivacijo mTOR (mammalian Target of Rapamycin), kinaze,
In animals, sirolimus has a direct effect on T and B cell activation suppressing immune mediated reactions such as allograft rejection.
Pri živalih deluje sirolimus neposredno na aktivacijo limfocitov T in B in tako zavira imunske reakcije, na primer zavrnitev presajenega organa.
Clinical Trials Patients at low to moderate immunological risk were studied in the phase 3 ciclosporin elimination-Rapamune maintenance trial, which included patients receiving a renal allograft from a cadaveric or living donor.
Klinični preskusi V študijo vzdrževalnega zdravljenja z zdravilom Rapamune in ukinitve zdravljenja s ciklosporinom III. faze so bili vključeni bolniki z nizkim do zmernim imunskim tveganjem s presajeno kadavrsko ledvico ali ledvico živega darovalca.
Ciclosporin was not withdrawn in patients experiencing Banff Grade 3 acute rejection episodes, who were dialysis-dependent, who had a serum creatinine > 400  mol/ l, or who had inadequate renal function to support ciclosporin withdrawal.
Ciklosporina niso ukinili pri bolnikih, ki so imeli akutno zavrnitveno reakcijo stopnje 3 po Banffu, ki so bili odvisni od dialize, ki so imeli serumski kreatinin višji od 400 μmol/ l, ali ki so imeli nezadostno delovanje ledvic, da bi lahko prenesli ukinitev ciklosporina.
Patients at high immunological risk of graft loss were not studied in sufficient number in the ciclosporin elimination- Rapamune maintenance trials and are not recommended for this treatment regimen.
Bolnikov z visokim imunskim tveganjem za zavrnitev presadka je bilo v študiji s takšno shemo zdravljenja (ukinitev ciklosporina in vzdrževalno zdravljenje z zdravilom Rapamune) premalo, da bi jo lahko priporočali tudi pri njih.
At 12, 24 and 36 months, graft and patient survival were similar for both groups.
Po 12, 24 in 36 mesecih sta bila preživetje presadkov in preživetje bolnikov v obeh skupinah podobna.
4.2%, respectively).
V skupini po ukinitvi ciklosporina je bila zavrnitev, dokazana s prvo biopsijo, signifikantno pogostejša kot v skupini z vzdrževalnim zdravljenjem s ciklosporinom v času od randomizacije do 12 mesecev po randomizaciji (9, 8% proti 4, 2%).
The mean calculated glomerular filtration rate (GFR) at 12, 24, 36, 48 and 60 months was significantly higher for patients receiving Rapamune following ciclosporin elimination than for those in the Rapamune with ciclosporin therapy group.
Povprečna izračunana hitrost glomerulne filtracije (GFR) pri 12, 24, 36, 48 in 60 mesecih je bila signifikantno večja pri bolnikih, ki so prejemali zdravilo Rapamune po ukinitvi ciklosporina, kot pri tistih, ki so se zdravili z zdravilom Rapamune in s ciklosporinom.
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
Po 60 mesecih je bila incidenca ne- kožnih malignih bolezni signifikantno večja v kohorti, ki je nadaljevala s ciklosporinskim zdravljenjem, kot v kohorti, ki so ji ciklosporin ukinili (8, 4% proti 3. 8%).
The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients (6-120 months after transplantation) was assessed in a randomised, multicentre, controlled trial, stratified by calculated GFR at baseline (20-40 mL/ min vs > 40 mL/ min).
Varnost in učinkovitost prehoda z zaviralcev kalcinevrina na zdravilo Rapamune pri bolnikih na vzdrževalnem zdravljenju po presaditvi ledvice (6- 120 mesecev po presaditvi) so ocenjevali v randomizirani, multicentrični kontrolirani študiji, stratificirani glede na izračunano GFR v izhodišču (20- 40 ml/ min v primerjavi z > 40 ml/ min).
Concomitant immunosuppressive agents included mycophenolate mofetil, azathioprine, and corticosteroids.
Sočasno so bolniki prejemali tudi imunosupresivna zdravila, kot so mofetilijev mikofenolat, azatioprin in kortikosteroide.
Enrollment in the patient stratum with baseline calculated GFR < 40 mL/ min was discontinued due to an imbalance in safety events (see section 4.8).
Vključevanje v skupino bolnikov z izračunano izhodiščno GFR < 40 ml/ min so zaradi varnostnih razlogov prekinili (glejte poglavje 4. 8).
In the patient stratum with baseline calculated GFR > 40 mL/ min, renal function was not improved overall.
V skupini bolnikov z izhodiščno izračunano GFR > 40 ml/ min se ledvična funkcija v celoti gledano ni zvečala.
In the stratum with baseline calculated GFR > 40 mL/ min, the mean and median urinary protein to creatinine ratios were significantly higher in the Rapamune conversion group as compared to those of the calcineurin inhibitors continuation group at 24 months (see section 4.4).
V skupini z izhodiščno izračunano GFR > 40 ml/ min sta bila po 24 mesecih kvocienta povprečnih in medianih vrednosti beljakovin v urinu v primerjavi z vrednostmi kreatinina signifikantno večja v skupini po prehodu na zdravilo Rapamune kot v skupini, ki je nadaljevala z zaviralci kalcinevrina (glejte poglavje 4. 4).
New onset nephrosis (nephrotic syndrome) was also reported (see section 4.8).
Poročali so tudi o novo nastali nefrozi (nefrotičnem sindromu) (glejte poglavje 4. 8).
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%).
Po 2 letih je bila pogostnost ne- melanomskih kožnih malignih bolezni signifikantno manjša v skupini, ki je prešla na zdravilo Rapamune, kot v skupini, ki je nadaljevala z zaviralci kalcinevrina (1, 8% oziroma 6, 9%).
In a subset of the study patients with a baseline GFR > 40 mL/ min and normal urinary protein excretion, calculated GFR was higher at 1 and 2 years in patients converted to Rapamune than for the corresponding subset of calcineurin inhibitor continuation patients.
12 in normalno izločanje beljakovin z urinom, je bila izračunana GFR večja po 1 letu in 2 letih pri bolnikih, ki so prešli na zdravilo Rapamune, kot v odgovarjajoči podskupini bolnikov, ki so nadaljevali z zaviralci kalcinevrina.
In two multi-centre clinical studies, de novo renal transplant patients treated with Rapamune, 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).
V dveh multicentričnih kliničnih študijah so bolniki z de novo ledvičnim presadkom, zdravljeni z zdravilom Rapamune, mofetilijevim mikofenolatom (MMF), kortikosteroidi in antagonistom receptorjev IL- 2, imeli signifikantno večjo pogostnost akutne zavrnitve in številčno pogostejši smrtni izid kot bolniki, zdravljeni z zaviralci kalcinevrina, MMF, kortikosteroidi in antagonistom receptorjev IL- 2 (glejte poglavje 4. 4).
Renal function was not better in the treatment arms with de novo Rapamune without a calcineurin inhibitor.
Ledvična funkcija v krakih z zdravljenjem z zdravilom Rapamune de novo brez zaviralca kalcinevrina ni bila nič boljša.
Rapamune was assessed in a 36-month controlled clinical trial enrolling renal transplant patients  18 years of age considered at high-immunologic risk, defined as having a history of one or more acute allograft rejection episodes and/ or the presence of chronic allograft nephropathy on a renal biopsy.
Zdravilo Rapamune so ocenjevali v 36- mesečnem kontroliranem kliničnem preskusu, v katerega so bili vključeni bolniki, mlajši od 18 let, po presaditvi ledvic, z velikim imunološkim tveganjem, kar pomeni z anamnezo ene ali več akutnih epizod zavrnitve alografta in/ ali prisotnost kronične nefropatije alografta ob ledvični biopsiji.
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.
Preiskovanci so prejeli bodisi zdravilo Rapamune (tarčne koncentracije sirolimusa 5 do 15 ng/ ml) sočasno z zaviralcem kalcinevrina in kortikosteroidi bodisi imunosupresijo na osnovi zaviralca kalcinevrina brez zdravila Rapamune.
The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, serum lipid abnormalities (including but not limited to increased serum triglycerides and total cholesterol), and urinary tract infections (see section 4.8).
Uporaba zdravila Rapamune sočasno z zaviralci kalcinevrina in kortikosteroidi je bila povezana z zvečanim tveganjem poslabšanja ledvične funkcije, nenormalnimi izvidi serumskih lipidov (vključno z zvišanimi trigliceridi in holesterolom) in okužbami sečil (glejte poglavje 4. 8).
An unacceptably high frequency of PTLD was seen in a paediatric clinical transplant study when full dose Rapamune was administered to children and adolescents in addition to full dose calcineurin inhibitors with basiliximab and corticosteroids (see section 4.8).
V pediatrični klinični študiji po presaditvi so opažali nesprejemljivo visok delež PTLD, ko so zdravilo Rapamune v polnem odmerku dajali otrokom in mladostnikom poleg zaviralcev kalcinevrina, basiliksimaba in kortikosterodiov v polnih odmerkih (glejte poglavje 4. 8).
Following administration of the oral solution, sirolimus is rapidly absorbed, with a time to peak concentration of 1 hour in healthy subjects receiving single doses and 2 hours in patients with stable renal allografts receiving multiple doses.
Po uporabi peroralne raztopine se sirolimus hitro absorbira in doseže največjo koncentracijo v krvi pri zdravih prostovoljcih po enkratnem odmerku v 1 uri, pri bolnikih s stabilnim presadkom ledvice po večkratnih odmerkih pa po 2 urah.
Upon repeated
Sistemska biološka uporabnost sirolimusa pri sočasni uporabi s ciklosporinom (Sandimune) je približno 14%.
13 administration, the average blood concentration of sirolimus is increased approximately 3-fold.
Po ponavljajočih se odmerkih se povprečna krvna koncentracija sirolimusa poveča za približno 3- krat.
The terminal half-life in stable renal transplant patients after multiple oral doses was 62 16h.
Biološka razpolovna doba v končni fazi eliminacije pri stabilnih bolnikih po presaditvi ledvice po večkratnih peroralnih odmerkih znaša 62 ± 16 ur.
The blood to plasma ratio (B/ P) of 36 indicates that sirolimus is extensively partitioned into formed blood elements.
Razmerje koncentracij sirolimusa v krvi in plazmi (B/ P- blood to plasma ratio) je 36, kar pove, da sirolimus v veliki meri prehaja v krvne celice.
Pharmacokinetic parameters for sirolimus obtained from 19 renal transplant patients receiving microemulsion ciclosporin (4 hours prior to Rapamune) and corticosteroids, following daily doses of 2 mg Rapamune solution in a phase III clinical trial, were; Cmax, ss 12.2 6.2 ng/ ml, tmax, ss 3.01  2.40h, AUC, ss 158  70 ng h/ ml, CL/ F/ W 182 72 ml/ h/ kg (parameters calculated from LC-MS/ MS assay results).
Cmax ss je znašala 12, 2 ± 6, 2 ng/ ml, tmax ss 3, 01 ± 2, 40 ure, AUCτ ss 158 ± 70 ng. h/ ml, CL/ F/ W 182 ± 72 ml/ h/ kg (merjeno z LC- MS/ MS).
There was no significant difference in any of these parameters over time up to 6 months after transplantation.
Parametri, ki so jih spremljali do 6 mesecev po presaditvi, se niso bistveno spreminjali s časom.