natgillin/translations-raw huggingface dataset:
1- års patientoverlevelsesraten var 80, 8% i tacrolimusgruppen og 83% i ciclosporingruppen (Treede et al., 3rd ICISan Diego; US, 2004, Abstract 22).
The 1-year patient survival rate was 80.8% in the tacrolimus and 83% in the ciclosporin group (Treede et al., 3rd ICI San Diego, US, 2004; Abstract 22).
Tacrolimus blev startet som kontinuerlig intravenøs infusion med doser på 0, 025 mg/ kg/ dag, oral tacrolimus blev administreret i doser på 0, 15 mg/ kg/ dag med følgende dosisjustering for at nå dalkoncentrationer på 10- 20 ng/ ml.
Tacrolimus was started as continuous intravenous infusion at a dose of 0.025 mg/ kg/ day and oral tacrolimus was administered at a dose of 0.15 mg/ kg/ day with subsequent dose adjustments to target trough levels of 10 to 20 ng/ ml.
1- års patientoverlevelsesraten var 83% i tacrolimusgruppen og 71% i ciclosporingruppen, 2- års patientoverlevelsen var henholdsvis 76% og 66%.
The 1-year patient survival was 83% in the tacrolimus and 71% in the ciclosporin group, the 2-year survival rates were 76% and 66%, respectively.
Akutte afstødningsepisoder per 100 patientdage var numerisk færre i tacrolimusgruppen (0, 85 episoder) mod (1, 09 episoder) i ciclosporingruppen.
Acute rejection episodes per 100 patient-days were numerically fewer in the tacrolimus (0.85 episodes) than in the ciclosporin group (1.09 episodes).
Man så obliterativ bronchiolitis hos 21, 7% af patienterne i tacrolimusgruppen sammenlignet med 38, 0% af patienterne i ciclosporingruppen (p=0, 025).
Obliterative bronchiolitis developed in 21.7% of patients in the tacrolimus group compared with 38.0% of patients in the ciclosporin group (p = 0.025).
Der var signifikant flere patienter i ciclosporingruppen (n=13), som måtte overføres til tacrolimus end tacrolimusbehandlede patienter, der måtte overføres til ciclosporin (n=2) (p=0, 02) (Keenan et al.; Ann Thoracic Surg 1995; 60: 580).
Significantly more ciclosporin-treated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02) (Keenan et al., Ann Thoracic Surg 1995; 60:580).
Tacrolimus startede som kontinuerlig intravenøs infusion med doser på 0, 05 mg/ kg/ dag, hvorefter oral tacrolimus blev administreret i doser på 0, 1 – 0, 3 mg/ kg/ dag med følgende dosisjustering for at nå dalkoncentrationer på 12 – 15 ng/ ml.
Tacrolimus was started as continuous intravenous infusion at a dose of 0.05 mg/ kg/ day and oral tacrolimus was administered at a dose of 0.1 to 0.3 mg/ kg/ day with subsequent dose adjustments to target trough levels of 12 to 15 ng/ ml.
1- års overlevelsesraterne lå på 73, 1% i tacrolimusgruppen versus 79, 2% i ciclosporingruppen.
The 1-year survival rates were 73.1% in the tacrolimus versus 79.2% in the ciclosporin group.
Fraværet af akut afstødning var højere i tacrolimusgruppen ved 6 måneder (57, 7% versus 45, 8%) og 1 år efter lungetransplantationen (50% versus 33, 3%) (Treede et al., J Heart Lung Transplant 2001; 20: 511).
Freedom from acute rejection was higher in the tacrolimus group at 6 months (57.7% versus 45.8%) and at 1 year after lung transplantation (50% versus 33.3%) (Treede et al., J Heart Lung Transplant 2001; 20:511).
12 De 3 undersøgelser viser de samme overlevelsesrater.
The three studies demonstrated similar survival rates.
Incidensen af akut afstødning var numerisk lavere med tacrolimus i alle 3 undersøgelser, og en af undersøgelserne rapporterede signifikant lavere incidens af oblitererende bronchiolitis- syndrom med tacrolimus.
The incidences of acute rejection were numerically lower with tacrolimus in all three studies and one of the studies reported a significantly lower incidence of bronchiolitis obliterans syndrome with tacrolimus.
Pankreastransplantation En multicenterundersøgelse med peroral Prograf, hvori der indgik 205 patienter, der gennemgik simultan pancreas- nyretransplantation blev randomiseret til tacrolimus - (n=103) eller til ciclosporinbehandling (n=102).
Pancreas transplantation A multicentre study using oral Prograf included 205 patients undergoing simultaneous pancreas- kidney transplantation who were randomised to tacrolimus (n = 103) or to ciclosporin (n = 102).
Den initiale perorale per protokol dosis af tacrolimus var 0, 2 mg/ kg/ dag med følgende dosisjustering for at opnå dalkoncentrationer på 8 – 15 ng/ ml på 5. dagen og 5 – 10 ng/ ml efter 6. måned.
The initial oral per protocol dose of tacrolimus was 0.2 mg/ kg/ day with subsequent dose adjustments to target trough levels of 8 to 15 ng/ ml by Day 5 and 5 to 10 ng/ mL after Month 6.
Pancreasoverlevelse var efter 1 år signifikant bedre med tacrolimus end med ciclosporin:
Pancreas survival at 1 year was significantly superior with tacrolimus:
91, 3% versus 74, 5% (p < 0, 0005), mens overlevelsen af nyretransplantater var den samme i de 2 grupper.
91.3% versus 74.5% with ciclosporin (p < 0.0005), whereas renal graft survival was similar in both groups.
I alt 34 patienter skiftede behandling fra ciclosporin til tacrolimus, mens kun 6 tacrolimuspatienter havde behov for alternativ behandling (Bechstein et al., Transplantation 2004; 77: 1221) Intestinal transplantation Publicerede kliniske resultater fra et enkelt center om brug af peroral Prograf som primær behandling efter intestinale transplantationer viste, at overlevelsesraten hos 155 patienter (65 intestinal alene, 75 lever og tarm og 25 multivicerale), der fik tacrolimus og prednisolon, var på 75% efter 1 år, på 54% efter 5 år og på 42% efter 10 år.
Intestinal transplantation Published clinical experience from a single centre on the use of oral Prograf for primary treatment following intestinal transplantation showed that the actuarial survival rate of 155 patients (65 intestine alone, 75 liver and intestine, and 25 multivisceral) receiving tacrolimus and prednisone was 75% at 1 year, 54% at 5 years, and 42% at 10 years.
I de første år var den initiale perorale dosis af tacrolimus 0, 3 mg/ kg/ dag.
In the early years the initial oral dose of tacrolimus was 0.3 mg/ kg/ day.
Forskellige innovationer har bidraget til at forbedre resultaterne ved denne indikation: teknik til tidlig diagnose af Epstein- Bar (EBV) og CMV- infektioner, knoglemarvsforøgelse, samtidig brug af interleukin 2- antagonisten daclizumab, lavere initiale doser af tacrolimus med dalkoncentrationer på 10- 15 ng/ ml og senest bestråling af allotransplantat, (Abu- Elmagd et al., Ann Surg 2001; 234: 404).
A variety of innovations, such as techniques for early detection of Epstein-Barr (EBV) and CMV infections, bone marrow augmentation, the adjunct use of the interleukin-2 antagonist daclizumab, lower initial tacrolimus doses with target trough levels of 10 to 15 ng/ ml, and most recently allograft irradiation were considered to have contributed to improved results in this indication over time (Abu- Elmagd et al., Ann Surg 2001; 234:404).
Absorption Hos mennesker er det vist, at tacrolimus kan absorberes i hele mave- tarmkanalen.
Absorption In man tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract.
2 timer.
Advagraf is a prolonged-release formulation of tacrolimus resulting in an extended oral absorption profile with an average time to Cmax of approximately 2 hours.
Prografformuleringen) ligger mellem 20% - 25% (individuelt hos voksne 6% - 43%).
Absorption is variable and the mean oral bioavailability of tacrolimus (investigated with the Prograf formulation) is in the range of 20% - 25% (individual range in adult patients 6% - 43%).
Den perorale biotilgængelighed af Advagraf var reduceret, hvis det blev indgivet efter et måltid.
The oral bioavailability of Advagraf was reduced when it was administered after a meal.
Galdeflow påvirker ikke absorptionen af tacrolimus, og derfor kan behandling med Advagraf påbegyndes peroralt.
Bile flow does not influence the absorption of tacrolimus and therefore treatment with Advagraf may commence orally.
Der er god korrelation mellem AUC og fuldblodskoncentrationerne ved steady- state for Advagraf.
A strong correlation exists between AUC and whole blood trough levels at steady-state for Advagraf.
Fordeling og elimination Hos mennesker kan tacrolimus farmakokinetik efter intravenøs infusion bedst beskrives med en to - compartment model.
Distribution and elimination In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.
20: 1.
In the systemic circulation, tacrolimus binds strongly to erythrocytes resulting in an approximate 20:1 distribution ratio of whole blood/ plasma concentrations.
I plasma er tacrolimus stærkt bundet (> 98, 8%) til plasmaproteiner, hovedsagelig til serumalbumin og surt alfa- 1- glykoprotein.
In plasma, tacrolimus is highly bound (> 98.8%) to plasma proteins, mainly to serum albumin and α -1-acid glycoprotein.
1300 l.
The steady-state volume of distribution based on plasma concentrations is approximately 1300 l (healthy subjects).
Det tilsvarende tal baseret på fuldblod var 47, 6 l.
Corresponding data based on whole blood averaged 47.6 l.
Hos raske forsøgspersoner var den gennemsnitlige totale body clearance beregnet ud fra koncentrationer i fuldblod 2, 25 l/ time.
In healthy subjects, the average total body clearance estimated from whole blood concentrations was 2.25 l/ h.
Hos voksne lever -, nyre - og hjertetransplanterede, har man set værdier på henholdsvis 4, 1 l/ time, 6, 7 l/ time og 3, 9 l/ time.
In adult liver, kidney and heart transplant patients, values of 4.1 l/ h, 6.7 l/ h and 3.9 l/ h, respectively, have been observed.
Faktorer såsom lav hæmatokrit og lavt serumprotein, der giver en øget ubunden fraktion af tacrolimus, samt kortikoidinduceret øget metabolisme, betragtes som hovedårsagerne til den højere clearance, man finder hos transplanterede.
Factors such as low haematocrit and protein levels, which result in an increase in the unbound fraction of tacrolimus, or corticosteroid-induced increased metabolism are considered to be responsible for the higher clearance rates observed following transplantation.
13 Halveringstiden for tacrolimus er lang og varierer.
The half-life of tacrolimus is long and variable.
43 timer.
In healthy subjects, the mean half-life in whole blood is approximately 43 hours.
Metabolisme og biotransformation Tacrolimus metaboliseres i udstrakt grad i leveren, primært af cytochrom P450- 3A4.
Metabolism and biotransformation Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450-3A4.
Udskillelse Efter peroral og efter intravenøs administration af 14C- mærket tacrolimus blev størstedelen af radioaktiviteten elimineret i fæces.
13 Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
Mindre end 1% af intakt tacrolimus blev fundet i urin og fæces, hvilket indikerer at næsten al tacrolimus metaboliseres før eliminering, idet størstedelen bliver elimineret med galden.
Less than 1% of unchanged tacrolimus was detected in the urine and faeces, indicating that tacrolimus is almost completely metabolised prior to elimination: bile being the principal route of elimination.
Nyrer og pankreas var de primære organer, der blev påvirket i toksicitetsundersøgelser på rotter og bavianer.
The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
Hos hunrotter blev den reproduktive funktion inklusive fødsel nedsat ved toksiske doser, og der sås lavere fødselsvægt, levedygtighed og vækst hos afkommet.
In rats, female reproductive function including birth was impaired at toxic doses and the offspring showed reduced birth weights, viability and growth.
Hypromellose Ethylcellulose Laktosemonohydrat Magnesiumstearat.
Hypromellose Ethylcellulose Lactose monohydrate Magnesium stearate.
Titandioxid (E 171) Gul jernoxid (E172) Rød jernoxid (E172) Gelatine.
Titanium dioxide (E 171) Yellow iron oxide (E 172) Red iron oxide (E 172) Gelatin.
Blæk (Opakode S- 1- 15083):
Printing ink (Opacode S-1-15083):
Shellac Lecitin (soja) Simeticon Rød jernoxid (E 172) Hydroxypropyl cellulose.
Shellac Lecithin (soya) Simethicone Red iron oxide (E 172) Hydroxypropyl Cellulose.
Tacrolimus er ikke forligelig med PVC.
Tacrolimus is not compatible with PVC.
Sonder, kanyler, sprøjter og andet udstyr, som anvendes til at fremstille en suspension af Advagraf kapsler, må ikke indeholde PVC.
Tubing, syringes and other equipment used to prepare a suspension of Advagraf capsule contents should not contain PVC.
14 6. 3 Opbevaringstid
6.3 Shelf life
3 år Efter åbning af aluminiumfolie:
3 years After opening the aluminium wrapper:
Opbevares i den originale yderpakning og på et tørt sted for at beskytte mod fugt.
Store in the original package and in a dry place in order to protect from moisture.
Gennemsigtig PVC/ PVDC aluminiumblister indpakket i en aluminiumpose med et tørremiddel.
14 Transparent PVC/ PVDC aluminium blister wrapped in an aluminium pouch with a desiccant.
Ti kapsler pr. blister.
Ten capsules per blister.
30, 50 og 100 depotkapsler.
30, 50 and 100 prolonged-release capsules.
6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal
Elisabethhof 19 2353 EW Leiderdorp Holland
Elisabethhof 19 2353 EW Leiderdorp Netherlands
< MM/ ÅÅÅÅ >
{MM/ YYYY}
Advagraf 1 mg depotkapsler, hårde
Advagraf 1 mg Prolonged-release hard capsules
Hver depotkapsel indeholder 1 mg tacrolimus.
Each prolonged-release capsule contains 1 mg of tacrolimus.
Hver depotkapsel indeholder 107, 28 mg laktosemonohydrat
Each prolonged-release capsule contains 107.28 mg of lactose monohydrate
Depotkapsler, hårde Hvid- orange gelatinekapsler, indeholdende hvidt pulver, præget med ” 1 mg ” i rødt på den hvide kapseltop og med ”  677 ” på den orange kapselbund.
677” on
Forholdet mellem dalværdierne (C24) og systemisk eksponering (AUC0- 24) af Advagraf ligner det for Prograf.
The relationship between tacrolimus trough levels (C24) and systemic 16 exposure (AUC0-24) for Advagraf is similar to that of Prograf.
17 Doseringsvejledning – Afstødningsbehandling Øgede doser af tacrolimus, supplerende kortikosteroidbehandling og indsættelse af korte behandlingsperioder med mono - / polyklonale antistoffer er blevet benyttet til at behandle afstødningsepisoder.
17 Dose recommendations - Rejection therapy Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/ polyclonal antibodies have all been used to manage rejection episodes.
18 Dalværdierne for tacrolimus- koncentrationer i blod bør måles under den postoperative fase.
Blood trough levels of tacrolimus should be monitored during the post-transplantation period.
Det anbefales at overvåge koncentrationsniveauerne hyppigt de to første uger efter transplantation, og at følge op med periodisk overvågning under vedligeholdelsesbehandlingen.
Frequent trough level monitoring in the initial two weeks post transplantation is recommended, 18 followed by periodic monitoring during maintenance therapy.
19 Ventrikulær hypertrofi eller hypertrofi af septum, rapporteret som kardiomyopati, er blevet observeret hos patienter, som er blevet behandlet med Prograf i enkelte tilfælde, og kan derfor også forekomme i forbindelse med Advagraf.
Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed in Prograf treated patients on rare occasions and may therefore also occur with Advagraf.
Andre faktorer, der kan øge risikoen for disse kliniske tilstande, er tidligere hjertelidelse, behandling med kortikosteroider, hypertension, nedsat nyre - eller leverfunktion, infektion, væskeretention og ødem.
Other factors observed to increase the risk of these clinical 19 conditions included pre-existing heart disease, corticosteroid usage, hypertension, renal or hepatic dysfunction, infections, fluid overload, and oedema.
20 Metabolismehæmmere Det er påvist, at de følgende midler øger tacrolimus´ blodkoncentration:
Inhibitors of metabolism Clinically the following substances have been shown to increase tacrolimus blood levels:
21 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 21 Tacrolimus is extensively bound to plasma proteins.
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 22
23 Det endokrine system Sjælden:
Endocrine disorders rare: hirsutism
24 Ikke almindelig:
Reproductive system and breast disorders uncommon:
psykotiske forstyrrelser
4.9 Overdose
4. 9 Overdosering
psychotic disorder 24
Erfaringerne er begrænsede.
Experience with overdose is limited.
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.
25 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.
26 De 3 undersøgelser viser de samme overlevelsesrater.
The three studies demonstrated similar survival rates.
27 Halveringstiden for tacrolimus er lang og varierer.
The half-life of tacrolimus is long and variable.
Udskillelse Efter peroral og efter intravenøs administration af 14C- mærket tacrolimus blev størstedelen af radioaktiviteten elimineret i fæces.
27 Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
28 6. 3 Opbevaringstid
6.3 Shelf life
Gennemsigtig PVC/ PVDC aluminiumblister indpakket i en aluminiumpose med et tørremiddel.
28 Transparent PVC/ PVDC aluminium blister wrapped in an aluminium pouch with a desiccant.
30, 50, 60 og 100 depotkapsler.
30, 50, 60 and 100 prolonged-release capsules.
Advagraf 5 mg depotkapsler, hårde
Advagraf 5 mg Prolonged-release hard capsules
Hver depotkapsel indeholder 5 mg tacrolimus.
Each prolonged-release capsule contains 5 mg of tacrolimus.
Hver depotkapsel indeholder 536, 4 mg laktosemonohydrat
Each prolonged-release capsule contains 536.4 mg of lactose monohydrate
Depotkapsler, hårde Gråligrød- orange gelatinekapsler, indeholdende hvidt pulver, præget med ” 5 mg ” i rødt på den grå - røde kapseltop og med ”  687 ” på den orange kapselbund.
Greyish red-orange gelatin capsules imprinted in red with “ 5 mg” on the greyish red capsule cap and ” 687” on the orange capsule body, containing white powder.
30 Hos stabile patienter, som overføres fra Prograf (to gange daglig) til Advagraf (en gang daglig) i forholdet 1: 1 (mg: mg) total daglig dosis, var den systemiske eksponering for tacrolimus (AUC0- 24) for Advagraf cirka 10% lavere end for Prograf.
In stable patients converted from Prograf (twice daily) to Advagraf (once daily) on a 1:1 (mg: mg) total daily dose basis the systemic exposure to tacrolimus (AUC0-24) for Advagraf was approximately 10% lower than that for Prograf.
Forholdet mellem dalværdierne (C24) og systemisk eksponering (AUC0- 24) af Advagraf ligner det for Prograf.
The relationship between tacrolimus trough levels (C24) and systemic 30 exposure (AUC0-24) for Advagraf is similar to that of Prograf.
Man bør kontrollere for lave tacrolimus- koncentrationer efter
Following conversion, tacrolimus trough levels should be monitored and if necessary dose adjustments made to maintain similar systemic exposure.
31 omstilling, og om nødvendigt foretage dosisjusteringer for at opretholde tilsvarende systemisk eksponering.
31 Dose recommendations - Rejection therapy Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/ polyclonal antibodies have all been used to manage rejection episodes.
32 Forholdet mellem tacrolimusniveauerne (C24) og systematisk eksponering (AUC0- 24) er sammenligneligt for de to formuleringer Advagraf og Prograf.
The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC 0-24) is similar between the two formulations Advagraf and Prograf.
Dalværdierne for tacrolimus- koncentrationer i blod bør måles under den postoperative fase.
Blood trough levels of tacrolimus should be monitored during the post-transplantation period.
Det anbefales at overvåge koncentrationsniveauerne hyppigt de to første uger efter transplantation, og at følge op med periodisk overvågning under vedligeholdelsesbehandlingen.
Frequent trough level monitoring in the initial two weeks post transplantation is recommended, 32 followed by periodic monitoring during maintenance therapy.
33 Kombinationsbehandling med ciclosporin og tacrolimus bør undgås, og der skal udvises forsigtighed ved behandling med tacrolimus af patienter, som tidligere har fået ciclosporin (se afsnit 4. 2 og 4. 5).
The combined administration of ciclosporin and tacrolimus should be avoided and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.5).
Ventrikulær hypertrofi eller hypertrofi af septum, rapporteret som kardiomyopati, er blevet observeret hos patienter, som er blevet behandlet med Prograf i enkelte tilfælde, og kan derfor også forekomme i forbindelse med Advagraf.
Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed in Prograf treated patients on rare occasions and may therefore also occur with Advagraf.
Andre faktorer, der kan øge risikoen for disse kliniske tilstande, er tidligere hjertelidelse, behandling med kortikosteroider, hypertension, nedsat nyre - eller leverfunktion, infektion, væskeretention og ødem.
Other factors observed to increase the risk of these clinical 33 conditions included pre-existing heart disease, corticosteroid usage, hypertension, renal or hepatic dysfunction, infections, fluid overload, and oedema.
Ved samtidig brug af lægemidler, som kan ændre
Inhibitors of metabolism Clinically the following substances have been shown to increase tacrolimus blood levels:
4. 2 og 4. 4).
34 ritonavir).
35 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.
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 35 Tacrolimus is extensively bound to plasma proteins.
36 Almindelig:
Blood and lymphatic system disorders 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 36
Øjne Almindelig:
Eye disorders
Meget sjælden:
Ear and labyrinth disorders common: uncommon: rare: very rare:
Sjælden:
Endocrine disorders rare: hirsutism
Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper) Patienter i immunsuppressiv behandling har en øget risiko for at få maligne lidelser.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.