natgillin/translations-raw huggingface dataset:
En enkelt dosis sirolimus påvirkede ikke cyclosporins (microemulsion) farmakokinetik hos sunde frivillige personer ved indgivelse samtidig eller med 4 timers mellemrum.
Single-dose sirolimus did not affect the pharmacokinetics of ciclosporin (microemulsion) in healthy volunteers when administered simultaneously or 4 hours apart.
Det anbefales, at Rapamune indgives 4 timer efter cyclosporin (microemulsion).
It is recommended that Rapamune be administered 4 hours after ciclosporin (microemulsion).
Rifampicin (CYP3A4 fremmer):
6 Rifampicin (CYP3A4 inducer):
Administration af flere doser rifampicin nedsatte koncentrationen af sirolimus i helblod efter en enkelt dosis på 10 mg oral opløsning af Rapamune.
Administration of multiple doses of rifampicin decreased sirolimus whole blood concentrations following a single 10 mg dose of Rapamune oral solution.
82% og 71%.
Rifampicin increased the clearance of sirolimus by approximately 5.5-fold and decreased AUC and Cmax by approximately 82% and 71%, respectively.
4. 4).
Co-administration of sirolimus and rifampicin is not recommended (see section 4.4).
Ketoconazol (CYP3A4 hæmmer):
Ketoconazole (CYP3A4 inhibitor):
4, 4 gange, 1, 4 gange og 10, 9 gange.
Multiple-dose ketoconazole administration significantly affected the rate and extent of absorption and sirolimus exposure as reflected by increases in sirolimus Cmax, tmax, and AUC of 4.4-fold, 1.4-fold, and 10.9-fold, respectively.
4. 4).
Co-administration of sirolimus and ketoconazole is not recommended (see section 4.4).
Voriconazol (CYP3A4 hæmmer):
Voriconazole (CYP3A4 inhibitor):
Samtidig administration af sirolimus (2 mg enkeltdosis) og flerdosis administration af oral voriconazol (400 mg hver 12. time en dag, derefter 100 mg hver 12. time i 8 dage) til raske personer er rapporteret at øge sirolimus Cmax og AUC med gennemsnitligt 7 gange henholdsvis 11 gange.
Co-administration of sirolimus (2 mg single dose) with multiple-dose administration of oral voriconazole (400 mg every 12 hours for 1 day, then 100 mg every 12 hours for 8 days) in healthy subjects has been reported to increase sirolimus Cmax and AUC by an average of 7-fold and 11-fold respectively.
4. 4).
Co-administration of sirolimus and voriconazole is not recommended (see section 4.4).
6 Diltiazem (CYP3A4 hæmmer):
Diltiazem (CYP3A4 inhibitor):
Samtidig oral indgivelse af 10 mg Rapamune oral opløsning og 120 mg diltiazem havde en signifikant virkning på biotilgængeligheden af sirolimus.
The simultaneous oral administration of 10 mg of Rapamune oral solution and 120 mg of diltiazem significantly affected the bioavailability of sirolimus.
1, 4 gange, 1, 3 gange og 1, 6 gange.
Sirolimus Cmax, tmax, and AUC were increased 1.4-fold, 1.3-fold, and 1.6-fold, respectively.
Sirolimus påvirkede ikke farmakokinetikken for hverken diltiazem eller dennes metabolitter desacetyldiltiazem og desmethyldiltiazem.
Sirolimus did not affect the pharmacokinetics of either diltiazem or its metabolites desacetyldiltiazem and desmethyldiltiazem.
Hvis der gives diltiazem, bør niveauet af sirolimus i blodet overvåges, og det kan være nødvendigt at justere dosis.
If diltiazem is administered, sirolimus blood levels should be monitored and a dose adjustment may be necessary.
Verapamil (CYP3A4 hæmmer):
Verapamil (CYP3A4 inhibitor):
Flerdosis administration af verapamil og sirolimus oral opløsning påvirkede signifikant hastigheden og omfanget af absorptionen af begge stoffer.
Multiple-dose administration of verapamil and sirolimus oral solution significantly affected the rate and extent of absorption of both drugs.
Helblod sirolimus Cmax, tmax og AUC øgedes henholdsvis 2, 3 gange, 1, 1 gang og 2, 2 gange.
Whole blood sirolimus Cmax, tmax, and AUC were increased 2.3-fold, 1.1-fold, and 2.2-fold, respectively.
Plasma S - (-) verapamil Cmax og AUC steg begge 1, 5 gange, og tmax faldt 24%.
Plasma S-(-) verapamil Cmax and AUC were both increased 1.5-fold, and tmax was decreased 24%.
Sirolimus niveauerne skal monitoreres og passende dosisreduktion af begge medikamenter bør overvejes.
Sirolimus levels should be monitored and appropriate dose reductions of both medications should be considered.
Erythromycin (CYP3A4 hæmmer):
Erythromycin (CYP3A4 inhibitor):
Flerdosis administration af erythromycin og sirolimus oral opløsning påvirkede signifikant hastigheden og omfanget af absorptionen af begge stoffer.
Multiple-dose administration of erythromycin and sirolimus oral solution significantly increased the rate and extent of absorption of both drugs.
Helblod sirolimus Cmax, tmax og AUC øgedes henholdsvis 4, 4 gange, 1, 4 gang og 4, 2 gange.
Whole blood sirolimus Cmax, tmax, and AUC were increased 4.4-fold, 1.4-fold, and 4.2-fold, respectively.
Cmax, tmax og AUC for plasma erythomycin basis steg henholdsvis 1, 6 gange, 1, 3 gange og 1, 7 gange.
The Cmax, tmax, and AUC of plasma erythromycin base were increased 1.6-fold, 1.3-fold, and 1.7-fold, respectively.
Orale antikonceptionsmidler:
Oral contraceptives:
Ingen klinisk signifikant, farmakokinetisk interaktion blev observeret mellem sirolimus og 0, 3 mg norgestrel/ 0, 03 mg etinyløstradiol.
No clinically significant pharmacokinetic interaction was observed between sirolimus and 0.3 mg norgestrel/ 0.03 mg ethinyl estradiol.
Skønt resultaterne af interaktionsundersøgelser med en enkelt dosering med et oralt antikonceptionsmiddel ikke tyder på farmakokinetisk interaktion, kan resultaterne ikke udelukke ændringer i farmakokinetikken, som kan påvirke effekten af orale antikonceptionsmidler ved langtidsbehandling med Rapamune.
Although the results of a single dose drug interaction study with an oral contraceptive suggest the lack of a pharmacokinetic interaction, the results cannot exclude the possibility of changes in the pharmacokinetics that might affect the efficacy of the oral contraceptive during long term treatment with Rapamune.
Andre mulige interaktioner Moderate og svage CYP3A4 hæmmere kan nedsætte metaboliseringen af sirolimus og øge sirolimusniveauet (f. eks. kalcium- blokkere: verapamil; antisvampemidler: clotrimazol, fluconazol; antibiotika: troleandomycin; andre stoffer: bromocriptin, cimetidin, danazol, protease- hæmmere).
Other possible interactions Moderate and weak inhibitors of CYP3A4 may decrease the metabolism of sirolimus and increase sirolimus blood levels (e. g. calcium channel blockers: nicardipine; antifungal agents: clotrimazole, fluconazole; antibiotics: troleandomycin; other substances: bromocriptine, cimetidine, danazol, protease inhibitors).
CYP3A4 fremmere kan øge metaboliseringen af sirolimus og nedsætte sirolimusniveauet i blodet (f. eks.
Inducers of CYP3A4 may increase the metabolism of sirolimus and decrease sirolimus blood levels (e. g.
St.
St.
John’ s urt (Hyperikum perforatum) antikrampemidler: carbamazepin, phenobarbital, phenytoin).
John's wort (Hypericum perforatum), anticonvulsants: carbamazepine, phenobarbital, phenytoin).
Skønt sirolimus hæmmer det humane levermikrosomale cytokrom P450, CYP2C9, CYP2C19, CYP2D6 og CYP3A4/ 5 in vitro, forventes det aktive indholdsstof ikke at hæmme aktiviteten af disse isozymer in vivo, eftersom de sirolimus koncentrationer, som er nødvendige for hæmningen er meget højere end koncentrationerne set hos patienter, der får terapeutiske doser af Rapamune.
Although sirolimus inhibits human liver microsomal cytochrome P450 CYP2C9, CYP2C19, CYP2D6, and CYP3A4/ 5 in vitro, the active substance is not expected to inhibit the activity of these isozymes in vivo since the sirolimus concentrations necessary to produce inhibition are much higher than those observed in
P- gp hæmmere kan nedsætte udstrømningen af sirolimus fra tarmcellerne og øge sirolimusniveauet.
Inhibitors of P-gp may decrease the efflux of sirolimus from intestinal cells and increase sirolimus levels.
Grapefrugtjuice påvirker CYP3A4 formidlet metabolisering og bør derfor undgås.
Grapefruit juice affects CYP3A4 mediated metabolism and should therefore be avoided.
Farmakokinetiske interaktioner kan muligvis ses ved gastrointestinale prokinetiske midler som f. eks. cisaprid og metoclopramid.
Pharmacokinetic interactions may be observed with gastrointestinal prokinetic agents such as cisapride and metoclopramide.
Ingen klinisk signifikant, farmakokinetisk interaktion blev observeret mellem sirolimus og nogen af følgende stoffer: acyclovir, atorvastatin, digoxin, glibenclamid, methylprednisolon, nifedipin, prednisolon og trimethoprim/ sulphamethoxazol.
No clinically significant pharmacokinetic interaction was observed between sirolimus and any of the following substances: acyclovir, atorvastatin, digoxin, glibenclamide, methylprednisolone, nifedipine, prednisolone, and trimethoprim/ sulphamethoxazole.
Data for anvendelse af sirolimus til gravide er utilstrækkelige.
There are no adequate data from the use of sirolimus in pregnant women.
Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og indtil 12 uger efter behandlingen.
Effective contraception must be used during Rapamune therapy and for 12 weeks after Rapamune has been stopped.
7 Efter indgivelse af radioaktivt mærket sirolimus udskilles radioaktivitet i mælk fra diegivende rotter.
Following administration of radiolabelled sirolimus, radioactivity is excreted in the milk of lactating rats.
Det vides ikke, om sirolimus udskilles i modermælken hos mennesker.
It is not known whether sirolimus is excreted in human milk.
På grund af muligheden for uønskede virkninger af sirolimus hos det ammede barn, bør amning ophøre under behandlingen.
Because of the potential for adverse reactions in nursing infants from sirolimus, nursing should be discontinued during therapy.
5. 3).
These effects have been reversible upon discontinuation of Rapamune in most cases (see section 5.3).
De hyppigst rapporterede bivirkninger (forekommer hos > 10% af patienterne) er trombocytopeni, anæmi, pyreksi, hypertension, hypokaliæmi, hypofosfatæmi, urinvejsinfektion, hyperkolesterolæmi, hyperglykæmi, hypertriglyceridæmi, abdominalsmerter, lymfocele, perifert ødem, artralgi, akne, diarré, smerte, forstoppelse, kvalme, hovedpine, øget kreatinin i blodet og øget laktatdehydrogenase (LDH).
The most commonly reported adverse drug reactions (occurring in  10% of patients) are thrombocytopenia, anaemia, pyrexia, hypertension, hypokalaemia, hypophosphataemia, urinary tract infection, hypercholesterolaemia, hyperglycaemia, hypertriglyceridaemia, abdominal pain, lymphocoele, peripheral oedema, arthralgia, acne, diarrhoea, pain, constipation, nausea, headache, increased blood creatinine, and increased blood lactate dehydrogenase (LDH).
Incidensen af bivirkninger kan øges, når det laveste niveau af sirolimus stiger.
The incidence of any adverse event(s) may increase as the trough sirolimus level increases.
I nedenstående tabel angives de bivirkninger, der er baseret på erfaringer fra kliniske forsøg og erfaringer fra perioden efter markedsføringen, efter organklasse og hyppighed.
Adverse reactions based on experience from clinical trials and postmarketing experience are presented in the following table by system organ class and frequency of occurrence.
Der er kun angivet bivirkninger, for hvilke der er rimelig grund til at antage, at der foreligger en årsagssammenhæng med behandling med Rapamune.
Only events for which there is at least reasonable suspicion of a causal relationship to Rapamune treatment are listed.
De fleste patienter var i immunosuppressiv behandling, herunder behandling med Rapamune i kombination med andre immunosuppressive lægemidler.
Most patients were on immunosuppressive regimens which included Rapamune in combination with other immunosuppressive agents.
Organklasse
8 System Organ Class
Meget almindelig (≥ 1/ 10)
Very common ( 1/ 10)
Almindelig (≥ 1/ 100 til < 1/ 10)
Common ( 1/ 100 to < 1/ 10)
Ikke almindelig (≥ 1/ 1. 000 til < 1/ 100)
Uncommon ( 1/ 1000 to < 1/ 100)
Sjælden (≥ 1/ 10. 000 til < 1/ 1. 000)
Rare ( 1/ 10000 to < 1/ 1000)
Sepsis Lungebetændelse Pyelonephritis Herpes simplex Svampe -, virale og bakterielle infektioner (som f. eks. mycobakterielle infektioner, herunder tuberkulose, Epstein- Barr virus, CMV og herpes zoster)
Sepsis Pneumonia Pyelonephritis Herpes simplex Fungal, viral, and bacterial infections (such as mycobacterial infections, including tuberculosis, Epstein-Barr virus, CMV, and Herpes zoster)
Hudkræft
Skin Cancer
Lymfom/ lymfo proliferative sygdomme efter transplantation
Lymphoma / post transplant lymphoproliferative disorder
Trombocytopeni
Thrombocytopenia Anaemia
Trombotisk
Thrombotic thrombocytopenic purpura/ haemolytic uraemic syndrome Leukopenia Neutropenia
8 lymfesystem
Immune system disorders
trombocytopenisk purpura/ hæmolyti sk uræmisk syndrom Leukopeni Neutropeni
Hypersensitivity reactions, including anaphylactic/ anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis (see section 4.4)
Immunsystemet
Metabolism and Hypokalaemia nutrition disorders
4. 4)
Hypophosphataemia Hypercholesterolaemia Hyperglycaemia Hypertriglyceridaemia
Metabolisme og ernæring
9 System Organ Class Nervous system disorders
Hypokaliæmi Hypofosfatæmi Hypercholesterolæmi Hyperglykæmi Hypertriglyceridæmi
Very common ( 1/ 10) Headache
Nervesystemet
Common ( 1/ 100 to < 1/ 10)
Hovedpine
Uncommon ( 1/ 1000 to < 1/ 100)
Hjerte
Rare ( 1/ 10000 to < 1/ 1000)
Perikardialt ekssudat (inkl. hæmodynamis k signifikant ekssudat hos børn og voksne)
Pericardial effusion (including haemodynamically significant effusions in children and adults)
Vaskulære sygdomme
Vascular disorders Respiratory, thoracic, and mediastinal disorders
Lymfocele Hypertension
Lymphocele Hypertension
Pneumoni Pleuraekssudat Epistaxis
Deep vein thrombosis Pneumonitis Pleural effusion Epistaxis
Lungeblødning
Pulmonary embolism Pulmonary haemorrhage
Alveolær proteinose
Lymphoedema Alveolar proteinosis
Abdominalsmerter Diarré Forstoppelse Kvalme
Abdominal pain Diarrhoea Constipation Nausea
Unormale leverfunktions - prøver
Liver function tests abnormal
Knoglenekrose
Osteonecrosis
symptomer og reaktioner på administrations - stedet
General disorders and administration site conditions
Pyreksi Smerte
Oedema peripheral Pyrexia Pain
Undersøgelser
Impaired healing Oedema
Øget
Investigations
laktatdehydrogenase aspartataminotran
Blood lactate dehydrogenase increased Blood creatinine increased
s- ferase Øget alaninaminotransf erase
Aspartate aminotransferase increased Alanine aminotransferase increased
4. 4).
Immunosuppression increases the susceptibility to the development of lymphoma and other malignancies, particularly of the skin (see section 4.4).
Hos patienter behandlet med immunsuppressiva, herunder Rapamune, er der rapporteret tilfælde af både BK- virus associeret nephropati og JC- virus associeret progressiv multifokal leukoencefalopati (PML).
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.
Risikoen kan øges, når det laveste sirolimusniveau stiger.
10 Hepatotoxicity has been reported, the risk may increase as the trough sirolimus level increases.
Sjældne tilfælde af fatal hepatisk nekrose er rapporteret, når det laveste sirolimusniveau stiger.
There have been rare reports of fatal hepatic necrosis with elevated trough sirolimus levels.
Tilfælde af interstitiel lungesygdom (herunder pneumonitis og sjældent bronchiolit og pulmonal fibrose), nogle dødelige, uden identificeret smitsom ætiologi er opstået hos patienter, som fik immunosupressive behandlinger, herunder Rapamune.
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.
Risikoen kan være forhøjet, når det laveste sirolimusniveau stiger.
The risk may be increased as the trough sirolimus level increases.
Der er rapporteret om nedsat heling efter transplantation, herunder omfattende sårruptur i ansigtet, ventralhernie og anastomotisk sprængning (f. eks. sår, kar, luftveje, urinveje, galdeveje).
Impaired healing following transplant surgery has been reported, including fascial dehiscence, incisional hernia, and anastomotic disruption (e. g. wound, vascular, airway, ureteral, biliary).
Samtidig brug af sirolimus og calcineurinhæmmer øger muligvis risikoen for calcineurinhæmmer - induceret HUS/ TTP/ TMA.
The concomitant use of sirolimus with a calcineurin inhibitor may increase the risk of calcineurin inhibitor-induced HUS/ TTP/ TMA.
Der er indberetninger om fokal, segmentær glomerulosklerose.
Focal segmental glomerulosclerosis has been reported.
5. 1).
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).
Der var en højere frekvens af alvorlige bivirkninger inkl. pneumoni, akut afstødelse, graft- tab og død i gruppen behandlet med sirolimus (n=60, mediantid efter transplantation 36 måneder).
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).
Der er ikke udført kontrollerede kliniske forsøg med børn og unge (< 18 år) med dosering svarende til den nuværende indicerede for brugen af Rapamune til voksne - d. v. s. brug i kombination med cyclosporin og kortikosteroider i 2 til 3 måneder efter transplantationen, hvorefter cyclosporin fjernes.
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).
Brugen af Rapamune i kombination med
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).
10 calcineurinhæmmere og kortikosteroider blev forbundet med en øget risiko for svækkelse af nyrefunktionen, abnorme niveauer af serumlipider (herunder, men ikke begrænset til, forhøjede niveauer af serumtriglycerider og serumkolesterol) samt urinvejsinfektioner.
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.
Det undersøgte behandlingsregimen (kontinuert brug af Rapamune i kombination med en calcineurinhæmmer) er ikke indiceret til voksne eller børn (se afsnit 4. 1).
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).
I et andet forsøg, der omfattede nyretransplanterede patienter i alderen ≤ 20 år, hvor hensigten var at vurdere sikkerheden ved en gradvis seponering af kortikosteroider (begyndende seks måneder efter transplantationen) fra et immunosuppressivt regimen, som blev initieret ved transplantationen og indeholdt fuld dosis immunosuppression med både Rapamune og en calcineurinhæmmer i kombination med basiliximab- induktion, blev det observeret, at 19 (6, 9%) af de 274 inkluderede patienter udviklede lymfoproliferativ sygdom (PTLD) efter transplantationen.
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).
Af de 89 patienter, der var konstateret EBV- seronegative inden transplantationen, udviklede 13 (15, 6%) PTLD.
Among 89 patients known to be EBV seronegative prior to transplantation, 13 (15.6%) were reported to have developed PTLD.
Alle patienter, som udviklede PTLD, var under18 år.
All patients who developed PTLD were aged  18 years.
Der er ikke tilstrækkelig erfaring til at anbefale brugen af Rapamune til børn og unge (se afsnit 4. 2).
There is insufficient experience to recommend the use of Rapamune in children and adolescents (see section 4.2).
4. 9 Overdosering
11 4.9 Overdose
4. 8.
In general, the adverse effects of overdose are consistent with those listed in section 4.8.
Der bør iværksættes generelle støtteforanstaltninger i alle tilfælde af overdosering.
General supportive measures should be initiated in all cases of overdose.
På grundlag af Rapamunes dårlige vandopløselighed og høje erotrocyt - og plasmaproteinbinding, forventes Rapamune ikke at være dialysabel i signifikant grad.
Based on the poor aqueous solubility and high erythrocyte and plasma protein binding of Rapamune, it is anticipated that Rapamune will not be dialysable to any significant extent.
Selektive immunhæmmende stoffer.
Pharmacotherapeutic group: selective immunosuppressant agents.
Sirolimus hæmmer T- celleaktivering fremkaldt af de fleste stimuli, idet calciumafhængige og calciumuafhængige intracellulære signaltransduktioner blokeres.
Sirolimus inhibits T cell activation induced by most stimuli, by blocking calcium dependent and calcium independent intracellular signal transduction.
Undersøgelser viste, at virkningen formidles af en mekanisme, der adskiller sig fra cyclosporins, tarcrolimus og andre immunhæmmende stoffers mekanisme.
Studies demonstrated that its effects are mediated by a mechanism that is different from that of ciclosporin, tacrolimus, and other immunosuppressive agents.
Undersøgelsesresultater tyder på, at sirolimus bindes til det specifikke cytosoliske protein FKPB- 12, og at FKPB 12- sirolimuskomplex hæmmer aktiveringen af det mammale mål for Rapamycin (mTOR), en kritisk kinase for cellecyklusprogression.
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.
Nettoresultatet er hæmning af lymfocytaktiveringen, hvilket medfører immunhæmning.
The net result is the inhibition of lymphocyte activation, which results in immunosuppression.
Hos dyr har sirolimus en direkte virkning på T - og B- celleraktiveringen, idet der sker hæmning af immunformidlede reaktioner som f. eks. allograf afstødelse.
In animals, sirolimus has a direct effect on T and B cell activation suppressing immune mediated reactions such as allograft rejection.
Patienter med lav til moderat immunologisk risiko blev undersøgt i cyclosporin elimination- Rapamune fase 3 vedligeholdelsesstudiet, som omfattede patienter, der fik en nyre transplanteret fra en afdød eller levende donor.
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.
Yderligere blev gen- transplanterede patienter, hvis tidligere donororgan havde overlevet mindst 6 måneder efter transplantation, inkluderet.
In addition, re-transplant recipients whose previous grafts survived for at least 6 months after transplantation were included.