natgillin/translations-raw huggingface dataset:
De mest almindeligt rapporterede bivirkninger (forekommer hos > 10 % af patienterne) er tremor, nyreinsufficiens, hyperglykæmi, diabetes mellitus, hyperkaliæmi, infektioner, hypertension og insomnia.
The most commonly reported adverse reactions (occurring in > 10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Fortæl det til Deres læge, hvis De tager eller har brug for at tage ibuprofen (behandling af feber, betændelsestilstande og smerte), amphotericin B (behandling af bakterielle infektioner) eller antivirale midler (behandling af virusinfektioner f.eks. aciclovir).
Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation and pain), amphotericin B (used to treat bacterial infections) or antivirals (used to treat viral infections e.g. aciclovir).
Ved tegn på anomalier bør man overveje at reducere doseringen af Advagraf eller skifte til en anden immunsuppressiv behandling.
If abnormalities develop, dose reduction of Advagraf, or change of treatment to another immunosuppressive agent should be considered.
Pancreasoverlevelse var efter 1 år signifikant bedre med tacrolimus end med ciclosporin: 91,3 % versus 74,5 % (p< 0,0005), mens overlevelsen af nyretransplantater var den samme i de 2 grupper.
Pancreas survival at 1 year was significantly superior with tacrolimus: 91.3% versus 74.5% with ciclosporin (p < 0.0005), whereas renal graft survival was similar in both groups.
En kombination af immunsuppressiva - såsom antilymfocytiske antistoffer (f.eks. basiliximab, daclizumab) administreret samtidig - øger risikoen for EBV-associerede, lympfoproliferative sygdomme.
A combination of immunosuppressives such as antilymphocytic antibodies (e.g. basiliximab, daclizumab) given concomitantly increases the risk of EBVassociated lymphoproliferative disorders.
Ved oral 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.
Man bør derfor tage højde for risikoen for interaktioner med andre aktive stoffer, der har høj affinitet for plasmaproteiner (f.eks. NSAID, orale antikoagulantia og orale antidiabetika).
Possible interactions with other active substances known to have high affinity for plasma proteins should be considered (e.g., NSAIDs, oral anticoagulants, or oral antidiabetics).
Advagrafdepotkapsler, hårde, bør tages umiddelbart efter, at de er fjernet fra blisterkortet.
Advagraf prolonged-release hard capsules should be taken immediately following removal from the blister.
Data viser, at tacrolimus udskilles i human mælk.
Human data demonstrate that tacrolimus is excreted in breast milk.
Rød jernoxid (E 172) Hydroxypropylcellulose.
Red iron oxide (E 172) Hydroxypropylcellulose.
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.
Efter omstillingen bør tacolimus' dalværdier overvåges, og om nødvendigt justeres dosis for at opretholde den systemiske eksponering.
Following conversion, tacrolimus trough levels should be monitored and if necessary dose adjustments made to maintain similar systemic exposure.
Afstødningsbehandling efter andre allotransplantater Selvom der ikke er nogen klinisk erfaring med Advagraf hos lunge-, pancreas- eller intestinaltransplanterede patienter, er Prograf blevet anvendt hos lungetransplanterede patienter med en initial oral dosis på 0,10 - 0,15 mg/kg/dag, i pancreastransplanterede patienter med en initial oral dosis på 0,2 mg/kg/dag og ved intestinaltransplantation med en initial dosis på 0,3 mg/kg/dag.
Treatment of allograft rejection after transplantation of other allografts Although there is no clinical experience with Advagraf in lung-, pancreas- or intestine-transplanted patients, Prograf has been used in lung-transplanted patients at an initial oral dose of 0.10 - 0.15 mg/kg/day, in pancreas-transplanted patients at an initial oral dose of 0.2 mg/kg/day and in intestinal transplantation at an initial oral dose of 0.3 mg/kg/day.
CYP3A4-inducere som potentielt kan nedsætte tacrolimus' blodkoncentrationer Det er påvist klinisk, at de følgende midler nedsætter tacrolimus' blodkoncentrationer: Der er set kraftige interaktioner med rifampicin, fenytoin og perikon (Hypericum perforatum), som kan kræve øget dosering af tacrolimus hos næsten alle patienter.
CYP3A4 inducers potentially leading to decreased tacrolimus blood levels Clinically the following substances have been shown to decrease tacrolimus blood levels: Strong interactions have been observed with rifampicin, phenytoin, St. John's Wort (Hypericum perforatum) which may require increased tacrolimus doses in almost all patients.
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.
Overførsel af patienter behandlet med Prograf til Advagraf Transplanterede patienter på vedligeholdelsesdosis med Prografkapsler 2 gange daglig, som skal overføres til Advagraf én gang daglig, bør overføres på en 1:1 (mg:mg) total daglig basisdosis.
Conversion of Prograf-treated patients to Advagraf Allograft transplant patients maintained on twice daily Prograf capsules dosing requiring conversion to once daily Advagraf should be converted on a 1:1 (mg:mg) total daily dose basis.
Hud og subkutane væv Almindelig:
Skin and subcutaneous tissue disorders common:
Tacrolimus øger blodkoncentrationen af fenytoin.
Tacrolimus has been shown to increase the blood level of phenytoin.
Advagraf indeholder lactose (mælkesukker).
Advagraf contains lactose (milk sugar).
Hos patienter, der er blevet behandlet med tacrolimus, er der observeret udvikling af Epstein-BarrVirus (EBV)-associerede lymfoproliferative tilstande (se pkt.
Patients treated with tacrolimus have been reported to develop Epstein-Barr-Virus (EBV)-associated lymphoproliferative disorders (see section 4.8).
Behandlingsforskellen (Advagraf - Prograf) var 3,8 % (95 % konfidensinterval [-2,1 %, 9,6 %]).
The treatment difference (AdvagrafPrograf) was 3.8% (95% confidence interval [-2.1%, 9.6%]).
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).
Gennemsigtig PVC/PVDC aluminiumblister eller perforeret enkeltdosisblister, indpakket i en aluminiumpose med et tørremiddel, indeholdende 10 kapsler pr. blister.
Transparent PVC/PVDC aluminium blister or unit-dose perforated blister wrapped in an aluminium wrapper with a desiccant containing 10 capsules per blister.
De må ikke ophøre med behandlingen, uden at have talt med Deres læge.
Do not stop your treatment unless your doctor tells you to do so.
Det er påvist in vitro, at de følgende midler er potentielle hæmmere af tacrolimus' metabolisme: Bromocriptin, kortison, dapson, ergotamin, gestoden, lidocain, mephenytoin, miconazol, midazolam, nilvadipin, norethindron, quinidin, tamoxifen, (triacetyl)oleandomycin.
In vitro the following substances have been shown to be potential inhibitors of tacrolimus metabolism: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl)oleandomycin.
Samtidig brug af tacrolimus og lægemidler med nefrotoksisk eller neurotoksisk effekt kan øge risikoen for disse bivirkninger (se pkt.
Certain combinations of tacrolimus with drugs known to have nephrotoxic or neurotoxic effects may increase the risk of these effects (see section 4.5).
• når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
An updated RMP should be submitted: - At the request of the European Medicines Agency, - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Vedligeholdelsesdoser af kortikosteroider reducerer tacrolimus' blodkoncentration.
Maintenance doses of corticosteroids have been shown to reduce tacrolimus blood levels.
Hypromellose Ethylcellulose Lactosemonohydrat Magnesiumstearat.
Hypromellose Ethylcellulose Lactose monohydrate Magnesium stearate.
Tilfælde af BK-virus associeret nefropati og JC-virus associeret progressiv multifokal leukoencephalopati (PML) er rapporteret hos patienter, der har fået behandling med immunsuppressorer, herunder 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.
Virkningen og sikkerheden af Advagraf og Prograf, begge i kombination med kortikosteroider, blev sammenlignet i 471 de novo levertransplanterede patienter.
The efficacy and safety of Advagraf and Prograf, both in combination with corticosteroids, was compared in 471 de novo liver transplant recipients.
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.
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, gangliclovir og aciclovir).
Other interactions leading 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).
Hver kapsel indeholder mindre end 1 mmol (23 mg) natrium.
Each capsule contains less than 1 mmol sodium (23 mg).
- hvis De er allergisk over for sirolimus eller over for makrolidantibiotika (f.eks. erythomycin,
- if you are allergic to sirolimus or to any macrolide-antibiotic (e.g. erythromycin, clarithromycin, josamycin).
Samtidig brug af stoffer, der vides at hæmme eller inducere CYP3A4, kan påvirke tacrolimus' metabolisme og derved nedsætte eller øge tacrolimusblodkoncentrationerne.
Concomitant use of substances known to inhibit or induce CYP3A4 may affect the metabolism of tacrolimus and thereby increase or decrease tacrolimus blood levels.
Patienter bør fastholdes på én lægemiddelform af tacrolimus med det tilsvarende daglige dosisregime; ændringer i lægemiddelform eller regime bør kun ske under nøje supervision fra en transplantationsspecialist (se pkt.
Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.2 and 4.8).
Svagere interaktioner er set med clotrimazol, clarithromycin, josamycin, nifedipin, nicardipin, diltiazem, verapamil, amiodaron, danazol, ethinylestradiol, omeprazol, nefazodon og (kinesisk) naturmedicin indeholdende ekstrakt af Schisandra sphenanthera.
Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, amiodarone, danazol, ethinylestradiol, omeprazole, nefazodone and (Chinese) herbal remedies containing extracts of Schisandra sphenanthera.
Kapselindhold: Hypromellose, ethylcellulose, lactosemonohydrat, magnesiumstearat.
Capsule content: Hypromellose, ethylcellulose, lactose, magnesium stearate.
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.
Forholdet mellem dalværdierne (C24) og systemisk eksponering (AUC0-24) af Advagraf er sammenligneligt med det for Prograf.
The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC0-24) for Advagraf is similar to that of Prograf.
Forsigtighed bør også udvises hos patienter, som er diagnosticeret med eller mistænkes for at have medfødt lang QT-syndrom eller erhvervet QTforlængelse, eller patienter, som samtidig får behandling med lægemidler, som er kendt for at forlænge QT-intervallet, inducere elektrolytforstyrrelser eller øge tacrolimuseksponeringen (se pkt.
Caution should also be exercised in patients diagnosed or suspected to have Congenital Long QT Syndrome or acquired QT prolongation or patients on concomitant medications known to prolong the QT interval, induce electrolyte abnormalities or known to increase tacrolimus exposure (see section 4.5).
Der er blevet rapporteret adskillige tilfælde af utilsigtet overdosering med tacrolimus som: Tremor, hovedpine, kvalme og opkastninger, infektioner, urticaria, letargi og forhøjet blodurinstof, serumkreatinin og alanin-aminotransferase.
Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine and alanine aminotransferase levels.
Benigne og maligne neoplasmatiske lidelser herunder 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.
I den første postoperative periode kontrolleres regelmæssigt med måling af blodtryk, EKG, neurologisk status og synsstatus, fastende blodsukker, elektrolytter (specielt kalium), lever- og nyrefunktion, hæmatologiske parametre, koagulationsstatus og plasmaprotein.
During the initial post-transplant period, monitoring of the following parameters should be undertaken on a routine basis: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly potassium), liver and renal function tests, haematology parameters, coagulation values, and plasma protein determinations.
Deres læge vil beregne den rigtige startdosis for at undgå afstødning af det transplanterede organ ud fra Deres vægt.
The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
pure red cell aplasia, agranulocytose, hæmolytisk anæmi
pure red cell aplasia, agranulocytosis, haemolytic anaemia Immune system disorders
Dette har ført til alvorlige bivirkninger herunder transplantatafstødning eller andre bivirkninger, som mulig konsekvens af enten over- eller undereksponering for tacrolimus.
This has led to serious adverse reactions, including graft rejection, or other adverse reactions which could be a consequence of either under- or over-exposure to tacrolimus.
Ændringer i patientens tilstand efter transplantation kan medføre ændret farmakokinetik for tacrolimus, hvilket kan nødvendiggøre yderligere dosisjusteringer.
Post-transplant changes in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.
Begrænsede data fra organtransplanterede recipienter, der sammenligner tacrolimus med andre immunsuppressive midler, viser ingen tegn på øget risiko for ugunstig indflydelse på graviditetsforløbet eller resultatet heraf ved behandling med tacrolimus.
Limited data from organ transplant recipients show no evidence of an increased risk of adverse reactions on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products.
Til behandling af afstødning af allograf hos voksne patienter, som er resistente over for andre immunsuppressive medicinske produkter, er de kliniske data endnu ikke tilgængelige for Advagraf-depotformuleringen.
For treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients clinical data are not yet available for the prolonged-release formulation Advagraf.
I klinisk praksis har dalværdierne for koncentrationer i fuldblod generelt ligget fra 5 - 20 ng/ml for levertransplanterede og fra 10 - 20 ng/ml for nyre- og hjertetransplanterede i den tidlige postoperative periode.
In clinical practice, whole blood trough levels have generally been in the range 5 - 20 ng/ml in liver transplant recipients and 10 - 20 ng/ml in kidney and heart transplant patients in the early post-transplant period.
Da tacrolimus er et lægemiddelstof med lav clearance, kan det tage adskillige dage efter en dosisjustering af Advagraf, før den ønskede steady state er opnået.
As tacrolimus is a substance with low clearance, following adjustments to the Advagraf dose regimen it may take several days before the targeted steady state is achieved.
Virkningen og sikkerheden af Prograf, ciclosporin og Advagraf, alle i kombination med basiliximab antistofinduktion, MMF og kortikosteroider, blev sammenlignet i 638 de novo nyretransplanterede patienter.
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.
Tacrolimus er kraftigt bundet til erytrocytterne, således at fuldblod/plasmakvotienten er ca. 20:1.
In the systemic circulation, tacrolimus binds strongly to erythrocytes resulting in an approximate 20:1 distribution ratio of whole blood/plasma concentrations.
hovedpine, tremor
Trembling, headache
Advagraf er en oral formulering af tacrolimus, som skal tages en gang daglig.
Advagraf is a once-a-day oral formulation of tacrolimus.
Naturlægemidler, der indeholder perikon (Hypericum perforatum), eller anden naturmedicin bør undgås ved behandling med Advagraf pga. risikoen for interaktioner, som kan medføre enten et fald i blodkoncentrationen af tacrolimus og reduceret terapeutisk effekt af tacrolimus eller en stigning i blodkoncentrationen af tacrolimus og risiko for tacrolimustoksicitet (se pkt.
Herbal preparations containing St. John's Wort (Hypericum perforatum) or other herbal preparations should be avoided when taking Advagraf due to the risk of interactions that lead to either a decrease in blood concentrations of tacrolimus and reduced clinical effect of tacrolimus, or an increase in blood concentrations of tacrolimus and risk of tacrolimus toxicity (see section 4.5).
Fortæl straks Deres læge, hvis De under behandlingen lider af: problemer med Deres syn, såsom sløret syn, ændringer i farvesynet, problemer med at se detaljer eller hvis Deres synsfelt bliver begrænset.
problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Det anbefales kraftigt at monitorere tacrolimus' blodkoncentration såvel som QT-forlængelse (med EKG), nyrefunktionen og andre bivirkninger ved samtidig brug af lægemidler, som kan ændre CYP3A4-metaboliseringen eller på anden vis påvirke tacrolimus' blodkoncentration, og at afbryde eller justere tacrolimusdosis tilsvarende for at vedligeholde en konstant eksponering (se pkt.
It is strongly recommended to closely monitor tacrolimus blood levels, as well as, QT prolongation (with ECG), renal function and other side effects, whenever substances which have the potential to alter CYP3A4 metabolism or otherwise influence tacrolimus blood levels are used concomitantly, and to interrupt or adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and 4.4).
Printblæk: Shellac, lecithin (soja), simeticon, rød jernoxid (E172), hydroxypropylcellulose.
Printing ink: Shellac, lecithin (soya), simeticone, red iron oxide (E 172), hydroxypropylcellulose.
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.
Forbedring i patientens tilstand efter transplantation kan medføre ændret farmakokinetik for tacrolimus, hvilket kan nødvendiggøre yderligere dosisjustering.
Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.
Deres læge skal også vide, om De tager kaliumtilskud eller særlig vanddrivende medicin, som bruges ved hjertesvigt, hypertension og nyresygdom (f.eks. amilorid, triamteren eller spironolacton), nonsteroide anti-inflammatoriske midler (NSAID, f.eks. ibuprofen), som bruges ved feber, betændelsestilstande og smerter, blodfortyndende medicin (antikoagulantia) eller oral medicin mod diabetes (sukkersyge), mens De tager Advagraf.
Your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, hypertension and kidney disease, (e.g. amiloride, triamterene, or spironolactone), nonsteroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes, while you take Advagraf.
Dalværdierne for tacrolimuskoncentrationerne i blodet bør også monitoreres nøje i følgende tilfælde: ved overgang fra Prograf til Advagraf, ved dosisjusteringer, ved ændring i den immunsuppressive behandling samt ved administration sammen med stoffer, som kan ændre koncentrationen af tacrolimus i fuldblod (se pkt.
Blood trough levels of tacrolimus should also be closely monitored following conversion from Prograf to Advagraf, dose adjustments, changes in the immunosuppressive regimen, or co-administration of substances which may alter tacrolimus whole blood concentrations (see section 4.5).
I publicerede, prospektive undersøgelser var oral Prograf primært immunsuppressivum hos omkring 175 lungetransplanterede patienter, 475 pancreastransplanterede patienter og 630 intestinaltransplanterede patienter.
Clinical efficacy and safety of Prograf capsules bid in primary organ transplantation In prospective studies oral Prograf was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
Immunsystemet Allergiske og anafylaktoide reaktioner er observeret hos patienter, der fik tacrolimus (se pkt.
Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section