natgillin/translations-raw huggingface dataset:
Andre interaktioner som har klinisk skadelig effekt Samtidig brug af tacrolimus og lægemidler med kendt nefrotoksisk eller neurotoksisk effekt kan øge toksiciteten (f. eks. aminoglycosider, gyrase- hæmmere, vancomysin, cotrimoxazol, NSAID’ s, gangliclovir og aciclovir).
Other interactions which have led to clinically detrimental effects Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects (e. g., aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir or aciclovir).
Da tacrolimus kan give hyperkaliæmi eller forstærke en allerede eksisterende hyperkaliæmi, bør man undgå høj kaliumindtagelse eller kaliumbesparende diuretika (f. eks. amilorid, triameteren og spironolakton).
As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e. g., amiloride, triamterene, or spironolactone) should be avoided.
7 Immunsuppressorer kan påvirke respons på vaccinationer, der under behandling med tacrolimus kan vise sig mindre effektive.
Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective.
Proteinbinding Tacrolimus bindes kraftigt til plasmaproteiner.
Protein binding considerations 7 Tacrolimus is extensively bound to plasma proteins.
NSAID’ s, orale antikoagulantia og orale antidiabetika).
Possible interactions with other medicinal products known to have high affinity for plasma proteins should be considered (e. g., NSAIDs, oral anticoagulants, or oral antidiabetics).
Humane data viser, at tacrolimus er i stand til at passere placenta.
Human data show that tacrolimus crosses the placenta.
Begrænsede data fra organtransplantaterede recipienter, der sammenligner tacrolimus med andre immunsuppressive midler viser ingen tegn på øget risiko for bivirkninger på selve graviditen eller dens forløb ved behandling med tacrolimus.
Limited data from organ transplant recipients show no evidence of an increased risk of adverse events on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products.
Der er risiko for præmatur fødsel (< 37 uger) såvel som hyperkaliæmi hos den nyfødte (forekomst hos 8 ud af 111 nyfødte. i. e.
In case of in utero exposure, monitoring of the newborn for the potential adverse events of tacrolimus is recommended (in particular effects on the kidneys). There is a risk for premature delivery (< 37 week) as well as for hyperkalaemia in the newborn (incidence 8 of 111 neonates, i. e.
7, 2%), hvilket dog normaliseres spontant.
7.2%) which, however normalises spontaneously.
5. 3).
In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see section 5.3).
5. 3).
Tacrolimus affected fertility in male rats (see section 5.3).
Amning Humane data viser, at tacrolimus udskilles i modermælk.
Lactation Human data demonstrate that tacrolimus is excreted in breast milk.
Denne effekt kan forøges, hvis Advagraf er administreret sammen med alkohol.
This effect may be enhanced if Advagraf is administered in association with alcohol.
Det er vanskeligt at fastslå bivirkningsprofilen ved immunsuppressiv behandling som følge af den tilgrundliggende lidelse og samtidig indtagelse af anden medicin.
The adverse reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medications.
Mange af de nedennævnte bivirkninger er reversible og/ eller responderer på reduktion af dosis.
Many of the adverse reactions stated below are reversible and/ or respond to dose reduction.
Meget almindelig (≥1/ 10), almindelig (≥1/ 100 til < 1/ 10), ikke almindelig (≥1/ 1. 000 til < 1/ 100), sjælden (≥1/ 10. 000 til < 1/ 1. 000), meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Adverse reactions are listed below in descending order by frequency of occurrence: 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), not known (cannot be estimated from the available data).
Ikke almindelig:
Cardiac disorders common: uncommon:
iskæmiske tilstande, takykardi ventrikulære arytmier og hjertestop, hjertesvigt, kardiomyopati, ventrikulær hypertrofi, supraventrikulær arytmi, palpitationer, EKG- forandringer, forandringer i hjerterytme og puls
ischaemic coronary artery disorders, tachycardia ventricular arrhythmias and cardiac arrest, heart failures, cardiomyopathies, ventricular hypertrophy, supraventricular arrhythmias, palpitations, ECG investigations abnormal, heart rate and pulse investigations abnormal
Meget sjælden:
rare: very rare:
perikardial ekssudation unormalt ekkokardiogram
pericardial effusion echocardiogram abnormal
Almindelig:
Blood and lymphatic system disorders common:
anæmi, leukopeni, thrombocytopeni, leukocytose, unormale analyser af røde blodlegemer
anaemia, leukopenia, thrombocytopenia, leukocytosis, red blood cell analyses abnormal
Ikke almindelig:
uncommon:
koagulationsforstyrrelser, unormale koagulations - og blødningsanalyser, pancytopeni, neutropeni
coagulopathies, coagulation and bleeding analyses abnormal, pancytopenia, neutropenia
Sjælden:
rare:
thrombotisk thrombocytopenisk purpura, hypoprothrombinæmi
thrombotic thrombocytopenic purpura, hypoprothrombinaemia
Almindelig:
Nervous system disorders very common: common:
tremor, hovedpine krampeanfald, bevidsthedsforstyrrelser, ændringer i følesansen (f. eks. paræstesier og dysæstesier), perifer neuropati, svimmelhed, nedsat skriveevne, forstyrrelser i nervesystemet
tremor, headache seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders 8
koma, blødning i centralnervesystemet og hjerneblødning, paralyse og pareser, encephalopati, taleforstyrrelser, amnesi
coma, central nervous system haemorrhages and cerebrovascular accidents, paralysis and paresis, encephalopathy, speech and language abnormalities, amnesia
hypertoni myasteni
hypertonia myasthenia
Almindelig:
Eye disorders
Sjælden:
common: uncommon: rare:
sløret syn, fotofobi, øjenlidelser katarakt blindhed
vision blurred, photophobia, eye disorders cataract blindness
Sjælden:
Ear and labyrinth disorders common: uncommon: rare: very rare:
tinnitus hypoacusis døvhed nedsat hørelse
tinnitus hypoacusis deafness neurosensory hearing impaired
Luftveje, thorax og mediastinum Almindelig:
Respiratory, thoracic and mediastinal disorders common:
dyspnø, parenkym lungelidelse, pleural ekssudation, pharyngitis, hoste, tilstopning og inflammation i næsen
dyspnoea, parenchymal lung disorders, pleural effusion, pharyngitis, cough, nasal congestion and inflammations
Ikke almindelig:
uncommon: rare:
nedsat åndedrætsfunktion, lidelse i luftvejene, astma akut respiratory distress syndrom
respiratory failures, respiratory tract disorders, asthma acute respiratory distress syndrome
Almindelig:
Gastrointestinal disorders very common: common:
diarré, kvalme inflammatoriske og ulcerative lidelser i mave- tarmkanalen, blødning i mave - tarmkanalen, ulcerøs stomatitis, ascites, opkastning, smerter i abdomen, dyspepsi, obstipation, flatulens, oppustethed, tynd afføring, symptomer fra mave- tarmkanalen
diarrhoea, nausea gastrointestinal inflammatory conditions, gastrointestinal ulceration and perforation, gastrointestinal haemorrhages, stomatitis and ulceration, ascites, vomiting, gastrointestinal and abdominal pains, dyspeptic signs and symptoms, constipation, flatulence, bloating and distension, loose stools, gastrointestinal signs and symptoms
paralytisk ileus, peritonitis, akut og kronisk pankreatitis, øget blod amylase, gastroøsofagal refluks, nedsat tømning af mavesækken
ileus paralytic, peritonitis, acute and chronic pancreatitis, blood amylase increased, gastrooesophageal reflux disease, impaired gastric emptying
subileus, cyster i pancreas
subileus, pancreatic pseudocyst
Almindelig:
Renal and urinary disorders very common: common:
nyreinsufficiens nyresvigt, akut nyresvigt, oliguri, renal tubulær nekrose, toksisk neuropati, vandladningsproblemer, symptomer fra blære og urinveje
renal impairment renal failure, renal failure acute, oliguria, renal tubular necrosis, nephropathy toxic, urinary abnormalities, bladder and urethral symptoms
Ikke almindelig:
uncommon: very rare:
anuri, hæmolytisk uræmisk syndrom neuropati, hæmaturi
anuria, haemolytic uraemic syndrome nephropathy, cystitis haemorrhagic
Meget sjælden:
Skin and subcutaneous tissue disorders common: uncommon: rare: very rare:
pruritus, udslæt, alopecia, akne, svedudbrud dermatitis, fotosensibilisering toksisk epidermal nekrolyse (Lyell' s syndrom) Stevens- Johnson syndrom
pruritus, rash, alopecias, acne, sweating increased dermatitis, photosensitivity toxic epidermal necrolysis (Lyell’ s syndrome) Stevens Johnson syndrome
Ikke almindelig:
Musculoskeletal and connective tissue disorders common: uncommon:
artralgi, muskelkramper, smerter i lemmer, rygsmerter ledproblemer
arthralgia, muscle cramps, pain in limb, back pain joint disorders
9 Det endokrine system Sjælden:
Endocrine disorders rare: hirsutism
Almindelig:
Metabolism and nutrition disorders very common: common:
hyperglykæmi, diabetes mellitus, hyperkaliæmi hypomagnesæmi, hypofosfatæmi, hypokaliæmi, hypocalcæmi, hyponatriæmi, hypervolæmi, hyperurikæmi, nedsat appetit, anoreksi, metabolisk acidose, hyperlipidæmi, hypercholesterolæmi, hypertriglyceridæmi, andre elektrolytforstyrrelser
hyperglycaemic conditions, diabetes mellitus, hyperkalaemia hypomagnesaemia, hypophosphataemia, hypokalaemia, hypocalcaemia, hyponatraemia, fluid overload, hyperuricaemia, appetite decreased, anorexia,
Infektioner og parasitære sygdomme Som det er tilfældet ved behandling med andre potente immunsuppressive midler, øger behandlingen med tacrolimus patienternes modtagelighed for infektioner (virus, bakterier, svampe, protozoer).
Infections and infestations As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal).
Forløbet af eksisterende infektionssygdomme kan forværres.
The course of pre- existing infections may be aggravated.
Tilfælde af BK- virus associeret nefropati og JC- virus associeret progressiv multifokal leukoencephalopati (PML) er rapporteret hos patienter, der har fået behandling med immunsuppressorer, inklusiv Advagraf.
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 Advagraf.
Traumer, forgiftning og behandlingskomplikationer Almindelig:
Injury, poisoning and procedural complications common:
Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper) Patienter i immunsuppressiv behandling har en øget risiko for at få maligne lidelser.
Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Benigne og maligne neoplasmatiske lidelser inklusive EBV- associerede lymfoproliferative lidelser og maligne tilstande i huden er blevet rapporteret i forbindelse med behandling med tacrolimus.
Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders and skin malignancies have been reported in association with tacrolimus treatment.
Vaskulære sygdomme Meget almindelig: hypertension Almindelig:
Vascular disorders very common: common:
blødning, tromboemboliske og iskæmiske tilstande, perifere kredsløbsforstyrrelser, vaskulært betinget nedsat blodtryk
hypertension haemorrhage, thromboembolic and ischaemic events, peripheral vascular disorders, vascular hypotensive disorders
infarkt, dyb venetrombose, shock
infarction, venous thrombosis deep limb, shock
Almene symptomer og reaktioner på administrationsstedet Almindelig:
General disorders and administration site conditions common:
asteni, feber, ødem, smerter og ubehag, stigning i basisk fosfatase, vægtøgning, ændret opfattelse af kropstemperatur
asthenic conditions, febrile disorders, oedema, pain and discomfort, blood alkaline phosphatase increased, weight increased, body temperature perception disturbed
multiorgansvigt, influenza- lignende symptomer, temperaturintolerans, trykken for brystet, nervøsitet, fremmedfølelse, øget blod - lactatdehydrogenase, vægttab
multi-organ failure, influenza like illness, temperature intolerance, chest pressure sensation, feeling jittery, feeling abnormal, blood lactate dehydrogenase increased, weight decreased
tørst, svækkelse, trykken for brystet, nedsat bevægelighed, mavesår øget fedtvæv
thirst, fall, chest tightness, mobility decreased, ulcer fat tissue increased
Allergiske og anafylaktoide reaktioner er observeret hos patienter, der fik tacrolimus (se afsnit 4. 4)
Immune system disorders Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section 4.4).
Lever og galdeveje Almindelig:
Hepatobiliary disorders common:
unormale leverenzymtal og leverfunktion, cholestase og gulsot, skade på leverceller og hepatitis, cholangitis
hepatic enzymes and function abnormalities, cholestasis and jaundice, hepatocellular damage and hepatitis, cholangitis
trombose i leverarterie, venokklusiv leversygdom leversvigt, galdevejsstenose
hepatitic artery thrombosis, venoocclusive liver disease hepatic failure, bile duct stenosis
10 Ikke almindelig:
Reproductive system and breast disorders uncommon:
Almindelig:
Psychiatric disorders very common: common:
insomnia angst, konfusion og desorientering, depression, nedtrykthed, følelsesmæssig labilitet, mareridt, hallucinationer, mentale lidelser
insomnia anxiety symptoms, confusion and disorientation, depression, depressed mood, mood disorders and disturbances, nightmare, hallucination, mental disorders
Der er blevet rapporteret adskillige tilfælde af overdosering med tacrolimus som:
psychotic disorder 10
Tremor, hovedpine, kvalme og opkastninger, infektioner, urticaria, letargi, forhøjet blodurinstof samt forhøjet serumkreatinin og øget alanin- aminotransferase.
Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy, increased blood urea nitrogen and elevated serum creatinine concentrations, and increase in alanine aminotransferase levels.
Ved peroral overdosering kan maveskylning og/ eller indgift af absorberende stoffer (såsom medicinsk kul) forsøges kort tid efter indtagelse.
In cases of oral intoxication, gastric lavage and/ or the use of adsorbents (such as activated charcoal) may be helpful, if used shortly after intake.
Calcineurinhæmmere, ATC- kode:
Calcineurin inhibitors, ATC code:
Virkningsmekanisme og farmakodynamisk effekt På molekylært niveau synes virkningen af tacrolimus at være medieret af binding til cytosolprotein (FKBP12), som også er ansvarlig for den intracellulære akkumulering af præparatet.
Mechanism of action and pharmacodynamic effects At the molecular level, the effects of tacrolimus appear to be mediated by binding to a cytosolic protein (FKBP12) which is responsible for the intracellular accumulation of the compound.
FKBP12- tacrolimus- komplekset bindes specifikt, kompetitivt hæmmende til calcineurin, hvilket medfører en calciumafhængig hæmning af T- cellernes signaltransduktion, således at transskriptionen af visse lymfokingener forhindres.
The FKBP12-tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calcium-dependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of lymphokine genes.
Tacrolimus er et meget potent immunsuppressivt middel, der har vist aktivitet i både in vitro - og in vivo- undersøgelser.
Tacrolimus is a highly potent immunosuppressive agent and has proven activity in both in vitro and in vivo experiments.
Tacrolimus hæmmer T- celleaktivering og T- hjælpercelleafhængig B - celleproliferation, samt dannelsen af lymfokiner (såsom interleukin- 2 og - 3 og γ- interferon) og nedreguleringen af interleukin 2- receptorer.
Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ -interferon) and the expression of the interleukin-2 receptor.
Resultater fra kliniske studier udført med Advagraf, tacrolimus en gang daglig Levertransplantation Effektiviteten og sikkerheden af Advagraf og Prograf, begge i kombination med kortikosteroider, blev sammenlignet i 471 de novo levertransplanterede patienter.
Results from clinical trials performed with once-daily tacrolimus Advagraf Liver transplantation The efficacy and safety of Advagraf and Prograf, both in combination with corticosteroids, was compared in 471 de novo liver transplant recipients.
Hyppigheden af biopsibekræftet akut afstødning inden for de første 24 timer efter transplantation var 32, 6% i Advagrafgruppen (N=237) og 29, 3% i Prografgruppen (N=234).
The event rate of biopsy confirmed acute rejection within the first 24 weeks after transplantation was 32.6% in the Advagraf group (N=237) and 29.3% in the Prograf group (N=234).
Overlevelsesraten efter 12 måneder var 89, 2% for Advagraf og 90, 8% for Prograf; i Advagrafgruppen døde 25 patienter (14 kvinder, 11 mænd), og i Prografgruppen døde 24 patienter (5 kvinder, 19 mænd).
The treatment difference (Advagraf – Prograf) was 3.3% (95% confidence interval [-5.7%, 12.3%]). The 12-month patient survival rates were 89.2% for Advagraf and 90.8% for Prograf; in the Advagraf arm 25 patients died (14 female, 11 male) and in the Prograf arm 24 patients died (5 female, 19 male).
Transplantatoverlevelsen efter 12 måneder var 85, 3% for Advagraf og 85, 6% for Prograf.
12-month graft survival was 85.3% for Advagraf and 85.6% for Prograf.
Nyretransplantation Effektiviteten og sikkerheden af Advagraf og Prograf, begge i kombination med mycophenolatmofetil (MMF) og kortikosteroider, blev sammenlignet i 667 de novo nyretransplanterede patienter.
Kidney transplantation The efficacy and safety of Advagraf and Prograf, both in combination with mycophenolate mofetil (MMF) and corticosteroids, was compared in 667 de novo kidney transplant recipients.
Hyppigheden for biopsibekræftet akut afstødning inden for de første 24 timer efter transplantationen
The event rate for biopsy-confirmed acute rejection within the first 24 weeks after transplantation was 18.6% in the Advagraf group (N=331) and 14.9% in the Prograf group (N=336).
Behandlingsforskellen (Advagraf - Prograf) var 3, 8% (95% konfidensinterval [- 2, 1%, 9, 6%]).
The treatment difference (Advagraf-Prograf) was 3.8% (95% confidence interval [-2.1%, 9.6%]).
Overlevelsesraten efter 12 måneder var 96, 9% for Advagraf og 97, 5% for Prograf; i Advagrafgruppen døde 10 patienter (3 kvinder, 7 mænd), og i Prografgruppen døde 8 patienter (3 kvinder, 5 mænd).
The 12-month patient survival rates were 96.9% for Advagraf and 97.5% for Prograf; in the Advagraf arm 10 patients died (3 female, 7 male) and in the Prograf arm 8 patients died (3 female, 5 male).
Transplantatoverlevelsen efter 12 måneder var 91, 5% for Advagraf og 92, 8% for Prograf.
12-month graft survival was 91.5% for Advagraf and 92.8% for Prograf.
Effektiviteten og sikkerheden af Prograf, ciclosporin og Advagraf, alle i kombination med basiliximab antistofinduktion, MMF og kortikosteroider, blev sammenlignet i 638 de novo nyretransplanterede patienter.
11 The efficacy and safety of Prograf, ciclosporin and Advagraf, all in combination with basiliximab antibody induction, MMF and corticosteroids, was compared in 638 de novo kidney transplant recipients.
Hyppigheden af manglende effekt på kliniske endepunkter ved 12 måneder (defineret ved død, tab af transplantat, biopsibekræftet akut afstødning eller ingen opfølgning) var 14, 0% i Advagrafgruppen (N=214), 15, 1% i Prografgruppen (N=212) og 17, 0% i ciclosporingruppen (N=212).
The incidence of efficacy failure at 12 months (defined as death, graft loss, biopsy- confirmed acute rejection, or lost to follow-up) was 14.0% in the Advagraf group (N=214), 15.1% in the Prograf group (N=212) and 17.0% in the ciclosporin group (N=212).
Behandlingsforskellen var - 3, 0% (Advagraf - ciclosporin) (95, 2% konfidensinterval [- 9, 9%, 4, 0%]) for Advagraf vs. ciclosporin og - 1, 9% (Prograf - ciclosporin (95, 2% konfidensinterval [- 8, 9%, 5, 2%]) for Prograf vs. ciclosporin.
The treatment difference was -3.0% (Advagraf-ciclosporin) (95.2% confidence interval [-9.9%, 4.0%]) for Advagraf vs. ciclosporin and -1.9% (Prograf-ciclosporin) (95.2% confidence interval [-8.9%, 5.2%]) for Prograf vs. ciclosporin.
Overlevelsesraten efter 12 måneder var 98, 6% for Advagraf, 95, 7% for Prograf og 97, 6% for ciclosporin; i Advagrafgruppen døde 3 patienter (alle mænd), i Prografgruppen døde 10 patienter (3 kvinder, 7 mænd), og i ciclosporingruppen døde 6 patienter (3 kvinder, 3 mænd).
The 12-month patient survival rates were 98.6% for Advagraf, 95.7% for Prograf and 97.6% for ciclosporin; in the Advagraf arm 3 patients died (all male), in the Prograf arm 10 patients died (3 female, 7 male) and in the ciclosporin arm 6 patients died (3 female, 3 male).
Transplantatoverlevelsen efter 12 måneder var 96, 7% for Advagraf, 92, 9% for Prograf og 95, 7% for ciclosporin.
12-month graft survival was 96.7% for Advagraf, 92.9% for Prograf and 95.7% for ciclosporin.
Resultater fra publicerede data for tacrolimus administreret to gange daglig som Prograf- kapsler ved anden primær organtransplantation Prograf er blevet en accepteret behandling som primært immunsuppressivt lægemiddel i forbindelse med pankreas -, lunge - og intestinaltransplantationer.
Results from published data of tacrolimus administered twice daily as Prograf capsules in other primary organ transplantation Prograf has evolved into an accepted treatment as primary immunosuppressive medicinal product following pancreas, lung and intestinal transplantation.
I publicerede, prospektive undersøgelser var peroral Prograf primært immunsuppressivum hos omkring 175 lungetransplanterede patienter, 475 pankreastransplanterede patienter og 630 intestinaltransplanterede patienter.
In prospective published studies oral Prograf was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
Peroral Progaf- tolerans i disse publicerede undersøgelser svarer til, hvad der blev rapporteret fra store undersøgelser, hvor Prograf blev benyttet til primær behandling efter lever -, nyre - og hjertetransplantationer.
Overall, the safety profile of oral Prograf in these published studies appeared to be similar to what was reported in the large studies, where Prograf was used as primary treatment in liver, kidney and heart transplantation.
Lungetransplantation Interimanalysen af en nyligt afsluttet multicenterundersøgelse med peroral Prograf omfatter 110 patienter, der blev randomiseret i forholdet 1: 1 til enten tacrolimus eller ciclosporin.
Lung transplantation The interim analysis of a recent multicentre study using oral Prograf discussed 110 patients who underwent 1:1 randomisation to either tacrolimus or ciclosporin.
Derpå blev oral tacrolimus administreret i doser på 0, 05 – 0, 3 mg/ kg/ dag.
Tacrolimus was started as continuous intravenous infusion at a dose of 0.01 to 0.03 mg/ kg/ day and oral tacrolimus was administered at a dose of 0.05 to 0.3 mg/ kg/ day.
Det første år efter transplantationen blev der rapporteret en lavere incidens af akutte afstødningsepisoder for tacrolimus - versus ciclosporinbehandlede patienter (11, 5% versus 22, 6%) og en lavere incidens af kronisk afstødning, bronchiolitis obliterans syndromet (2, 86% versus 8, 57%).
A lower incidence of acute rejection episodes for tacrolimus- versus ciclosporin-treated patients (11.5% versus 22.6%) and a lower incidence of chronic rejection, the bronchiolitis obliterans syndrome (2.86% versus 8.57%), was reported within the first year after transplantation.