FrancophonIA/ELRC3.0 huggingface dataset:
English: Initial daily doses just after transplantation will generally be in the range of
Danish: Startdosis lige efter transplantationen vil sædvanligvis ligge i intervallet
English: Therefore, you should not breast-feed whilst using Advagraf.
Danish: Derfor bør De ikke amme, når De tager Advagraf.
English: A double dose should not be taken on the next morning.
Danish: Der må ikke tages dobbelt dosis den næste morgen.
English: Accordingly, high-risk patients receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at 3 months and then at 9 -12 months).
Danish: Derfor skal patienter i risikogruppen, og patienter i intensiv immunsuppression kontrolleres med f.eks. ekkokardiografi eller EKG før og efter transplantation (f.eks. efter 3 måneder i begyndelsen af behandlingen og igen efter 9-12 måneder).
English: Advagraf contains the active substance tacrolimus.
Danish: Advagraf indeholder det aktive stof tacrolimus.
English: In current clinical practice, whole blood levels are monitored using immunoassay methods.
Danish: I nuværende klinisk praksis måles koncentrationer i fuldblod med immunoassay-metoder.
English: 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).
Danish: Man så obliterativ bronchiolitis hos 21,7 % af patienterne i tacrolimusgruppen sammenlignet med 38,0 % af patienterne i ciclosporingruppen (p=0,025).
English: In comparison to Caucasians, black patients may require higher tacrolimus doses to achieve similar trough levels.
Danish: Sammenlignet med kaukasider, kræver sorte patienter en højere dosis af tacrolimus for at opretholde samme niveau.
English: This is because immunosuppressants could increase the risk of skin cancer.
Danish: Dette skyldes, at immundæmpende behandling kan øge risikoen for ondartede hudlidelser.
English: Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.
Danish: Øgede doser af tacrolimus, supplerende kortikosteroidbehandling og indsættelse af korte behandlingsperioder med mono-/polyklonale antistoffer er blevet benyttet til at behandle afstødningsepisoder.
English: Posterior reversible encephalopathy syndrome (PRES) Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Danish: Det er rapporteret at patienter, der får behandling med tacrolimus, udvikler posterior reversibel encefalopati-syndrom (PRES).
English: Hypersensitivity to tacrolimus, or to any of the excipients listed in section 6.1 Hypersensitivity to other macrolides
Danish: Overfølsomhed over for tacrolimus eller over for et eller flere af hjælpestofferne anført i punkt 6.1 Overfølsomhed over for andre makrolider.
English: Other potential interactions that may increase systemic exposure of tacrolimus include prokinetic agents (such as metoclopramide and cisapride), cimetidine and magnesium-aluminium-hydroxide.
Danish: Andre potentielle interaktioner, som kan medføre en øget systemisk eksponering for tacrolimus, er prokinetiske midler (såsom metoclopramid og cisaprid), cimetidin og magnesium-aluminiumhydroxid.
English: In stable patients converted from Prograf capsules (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.
Danish: Hos stabile patienter, som overførtes fra Prografkapsler (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.
English: Clinically significant interactions have also been observed with phenobarbital.
Danish: Der er også rapporteret klinisk relevante interaktioner med fenobarbital.
English: 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.
Danish: Tacrolimus hæmmer T-celleaktivering og T-hjælpercelleafhængig Bcelleproliferation, samt dannelsen af lymfokiner (såsom interleukin-2 og -3 og γ-interferon) og nedreguleringen af interleukin 2-receptorer.
English: The 1-year patient survival rate was 80.8% in the tacrolimus and 83% in the ciclosporin group.
Danish: 1-års patientoverlevelsesraten var 80,8 % i tacrolimusgruppen og 83 % i ciclosporingruppen.
English: The interim analysis of a recent multicentre study using oral Prograf discussed 110 patients who underwent 1:1 randomisation to either tacrolimus or ciclosporin.
Danish: Interimanalysen af en nyligt afsluttet multicenterundersøgelse med oral Prograf omfatter 110 patienter, der blev randomiseret i forholdet 1:1 til enten tacrolimus eller ciclosporin.
English: - if you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Advagraf (see section 6).
Danish: - hvis De er allergisk over for tacrolimus eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: In patients unable to take oral medicinal products during the immediate post-transplant period, tacrolimus therapy can be initiated intravenously (see Summary of Product Characteristics for Prograf 5 mg/ml concentrate for solution for infusion) at a dose approximately 1/5th of the recommended oral dose for the corresponding indication.
Danish: Til patienter, som ikke kan tage oral medicin i den umiddelbare posttransplanterede periode, kan tacrolimus gives intravenøst (se produktresumeet for Prograf 5 mg/ml koncentrat til infusionsvæske, opløsning) med en dosis på cirka 1/5 af den anbefalede orale dosis til den tilsvarende indikation.
English: Treatment of allograft rejection after kidney or liver transplantation For conversion from other immunosuppressants to once daily Advagraf, treatment should begin with the initial oral dose recommended in kidney and liver transplantation respectively for prophylaxis of transplant rejection.
Danish: Afstødningsbehandling efter nyre- eller levertransplantation Ved overførelse til Advagraf én gang daglig fra andre immunsuppressive midler bør behandlingen påbegyndes med henholdsvis den anbefalede orale startdosis for nyre- og levertransplantater og dosisprofylakse for transplantatafstødning.
English: In rats, female reproductive function including birth was impaired at toxic doses and the offspring showed reduced birth weights, viability and growth.
Danish: Hos hunrotter blev den reproduktive funktion, herunder fødsel, påvirket negativt ved toksiske doser, og der sås lavere fødselsvægt, levedygtighed og vækst hos afkommet.
English: Based on its high molecular weight, poor aqueous solubility, and extensive erythrocyte and plasma protein binding, it is anticipated that tacrolimus will not be dialysable.
Danish: Som følge af den høje molekylvægt, den ringe vandopløselighed og stærke binding til erytrocytter og plasmaprotein vil tacrolimus ikke være dialysabelt.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Danish: Yderligere information om Advagraf findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Advagraf contains lactose, sodium and lecithin (soya)
Danish: Advagraf indeholder lactose, natrium og lecithin (soja)
English: Dose reduction may be necessary in patients with severe liver impairment in order to maintain the tacrolimus blood trough levels within the recommended target range.
Danish: Det kan være nødvendigt at reducere dosis hos patienter med kraftig nedsat leverfunktion for at holde blodkoncentrationerne af tacrolimus inden for de anbefalede grænser.
English: Caution should be exercised in patients with risk factors for QT prolongation, including patients with a personal or family history of QT prolongation, congestive heart failure, bradyarrhythmias and electrolyte abnormalities.
Danish: Der skal udvises forsigtighed hos patienter med risikofaktorer for QT-forlængelse, herunder patienter med en personlig eller familiær disposition for QT-forlængelse, kongestiv hjerteinsufficiens, bradyarytmi eller elektrolytforstyrrelser.
English: In an additional two-centre study, 26 patients were randomised to the tacrolimus versus 24 patients to the ciclosporin group.
Danish: I yderligere en undersøgelse i to centre blev 26 patienter randomiseret til tacrolimus versus 24 patienter til ciclosporin.
English: Patients treated with immunosuppressants, including Advagraf are at increased risk for infections including opportunistic infections (bacterial, fungal, viral and protozoal) such as BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
Danish: Patienter behandlet med immunsuppressiva, herunder Advagraf, har en øget risiko for infektioner, herunder opportunistiske infektioner (bakteriel, fungal, viral og protozoal) såsom BK-virus associeret nefropati og JC-virus associeret progressiv multifokal leukoencefalopati (PML).
English: Another randomised study included 66 patients on tacrolimus versus 67 patients on ciclosporin.
Danish: En anden randomiseret undersøgelse omfattede 66 patienter på tacrolimus og 67 patienter på ciclosporin.
English: The FKBP12tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calciumdependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of cytokine genes.
Danish: FKBP12-tacrolimuskomplekset bindes specifikt, kompetitivt hæmmende til calcineurin, hvilket medfører en calciumafhængig hæmning af T-cellernes signaltransduktion, således at transskriptionen af visse cytokingener forhindres.
English: Grapefruit juice has been reported to increase the blood level of tacrolimus and should therefore be avoided.
Danish: Det er rapporteret, at grape-juice øger koncentrationen af tacrolimus, hvorfor det bør undgås.
English: No specific antidote to tacrolimus therapy is available.
Danish: Der findes ingen specifik modgift til behandling med tacrolimus.
English: Afterwards regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Danish: Herefter vil Deres læge regelmæssigt tage blodprøver for at fastlægge den korrekte dosis og for løbende at justere dosis.
English: By Day 4, systemic exposure as measured by trough levels is similar for both kidney and liver transplant patients with both formulations.
Danish: På dag 4 var den systemiske eksponering for begge formuleringer, målt som dalværdi, sammenlignelig for både nyre- og levertransplanterede patienter.
English: Advagraf capsules contain lactose.
Danish: Advagrafkapsler indeholder lactose.
English: In de novo kidney and liver transplant patients AUC0-24 of tacrolimus for Advagraf on Day 1 was 30% and 50% lower respectively, when compared with that for the immediate release capsules (Prograf) at equivalent doses.
Danish: Hos de novo nyre- og levertransplanterede patienter var AUC0-24 af tacrolimus for Advagraf på dag 1 henholdsvis 30 % og 50 % lavere, når den blev sammenlignet med en tilsvarende dosis af den umiddelbart udløste kapsel (Prograf).
English: Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed.
Danish: Medicineringsfejl, herunder utilsigtet, uforsætlig eller uovervåget substitution af umiddelbart udløsteeller depotformuleringer af tacrolimus, er set.
English: 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).
Danish: En multicenterundersøgelse med oral Prograf, hvori der indgik 205 patienter, der gennemgik simultan pancreas-nyretransplantation blev randomiseret til tacrolimus- (n=103) eller til ciclosporinbehandling (n=102).
English: EXP: Use all the capsules within 1 year of opening the aluminium wrapping and before the expiry date.
Danish: EXP: Brug alle kapslerne inden for 1 år efter åbning af aluminiumsposen og før udløbsdatoen.
English: Do not use Advagraf after the expiry date which is stated on the carton after “Exp”.
Danish: Brug ikke Advagraf efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving Advagraf.
Danish: Da man ikke kan udelukke skadelige virkninger på fosteret, bør kvinder i behandling med Advagraf ikke amme.
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Danish: Behandling af transplantatafstødning, der er resistent for behandling med andre immunsuppressive lægemidler hos voksne.
English: Inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe.
Danish: Utilsigtet, uforsætlig eller uovervåget substitution af umiddelbart udløste- eller depotformuleringer af tacrolimus er farligt.
English: Contents of the pack and other information What Advagraf contains
Danish: Pakningsstørrelser og yderligere oplysninger Advagraf indeholder:
English: Benign and malignant tumours have been reported following Advagraf treatment.
Danish: Der er set godartede og ondartede svulster efter Advagraf-behandling.
English: Other medicines and Advagraf
Danish: Brug af anden medicin sammen med Advagraf
English: The treatment difference was -3.0% (Advagrafciclosporin) (95.2% confidence interval [-9.9%, 4.0%]) for Advagraf vs. ciclosporin and -1.9% (Prografciclosporin) (95.2% confidence interval [-8.9%, 5.2%]) for Prograf vs. ciclosporin.
Danish: 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.
English: Advagraf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below under “Therapeutic drug monitoring”).
Danish: Doseringen af Advagraf bør primært baseres på en klinisk bedømmelse af afstødning og tolerans for hver enkelt patient vejledt af overvågninger af blodkoncentrationer (se nedenfor under ”Terapeutisk lægemiddelovervågning”).
English: The most commonly reported adverse reactions (occurring in > 10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Danish: De mest almindeligt rapporterede bivirkninger (forekommer hos > 10 % af patienterne) er tremor, nyreinsufficiens, hyperglykæmi, diabetes mellitus, hyperkaliæmi, infektioner, hypertension og insomnia.
English: 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).
Danish: 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).
English: If abnormalities develop, dose reduction of Advagraf, or change of treatment to another immunosuppressive agent should be considered.
Danish: Ved tegn på anomalier bør man overveje at reducere doseringen af Advagraf eller skifte til en anden immunsuppressiv behandling.
English: 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.
Danish: 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.
English: A combination of immunosuppressives such as antilymphocytic antibodies (e.g. basiliximab, daclizumab) given concomitantly increases the risk of EBVassociated lymphoproliferative disorders.
Danish: En kombination af immunsuppressiva - såsom antilymfocytiske antistoffer (f.eks. basiliximab, daclizumab) administreret samtidig - øger risikoen for EBV-associerede, lympfoproliferative sygdomme.
English: 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.
Danish: Ved oral overdosering kan maveskylning og/eller indgift af absorberende stoffer (såsom medicinsk kul) forsøges kort tid efter indtagelse.
English: 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).
Danish: 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).
English: Advagraf prolonged-release hard capsules should be taken immediately following removal from the blister.
Danish: Advagrafdepotkapsler, hårde, bør tages umiddelbart efter, at de er fjernet fra blisterkortet.
English: Human data demonstrate that tacrolimus is excreted in breast milk.
Danish: Data viser, at tacrolimus udskilles i human mælk.
English: Red iron oxide (E 172) Hydroxypropylcellulose.
Danish: Rød jernoxid (E 172) Hydroxypropylcellulose.
English: The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC 0-24) is similar between the two formulations Advagraf and Prograf.
Danish: Forholdet mellem tacrolimusniveauerne (C24) og systematisk eksponering (AUC0-24) er sammenligneligt for de to formuleringer Advagraf og Prograf.
English: Following conversion, tacrolimus trough levels should be monitored and if necessary dose adjustments made to maintain similar systemic exposure.
Danish: Efter omstillingen bør tacolimus' dalværdier overvåges, og om nødvendigt justeres dosis for at opretholde den systemiske eksponering.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Skin and subcutaneous tissue disorders common:
Danish: Hud og subkutane væv Almindelig:
English: Tacrolimus has been shown to increase the blood level of phenytoin.
Danish: Tacrolimus øger blodkoncentrationen af fenytoin.
English: Advagraf contains lactose (milk sugar).
Danish: Advagraf indeholder lactose (mælkesukker).
English: Patients treated with tacrolimus have been reported to develop Epstein-Barr-Virus (EBV)-associated lymphoproliferative disorders (see section 4.8).
Danish: Hos patienter, der er blevet behandlet med tacrolimus, er der observeret udvikling af Epstein-BarrVirus (EBV)-associerede lymfoproliferative tilstande (se pkt.
English: The treatment difference (AdvagrafPrograf) was 3.8% (95% confidence interval [-2.1%, 9.6%]).
Danish: Behandlingsforskellen (Advagraf - Prograf) var 3,8 % (95 % konfidensinterval [-2,1 %, 9,6 %]).
English: 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).
Danish: 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).
English: Transparent PVC/PVDC aluminium blister or unit-dose perforated blister wrapped in an aluminium wrapper with a desiccant containing 10 capsules per blister.
Danish: Gennemsigtig PVC/PVDC aluminiumblister eller perforeret enkeltdosisblister, indpakket i en aluminiumpose med et tørremiddel, indeholdende 10 kapsler pr. blister.
English: Do not stop your treatment unless your doctor tells you to do so.
Danish: De må ikke ophøre med behandlingen, uden at have talt med Deres læge.
English: 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.
Danish: 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.
English: Certain combinations of tacrolimus with drugs known to have nephrotoxic or neurotoxic effects may increase the risk of these effects (see section 4.5).
Danish: Samtidig brug af tacrolimus og lægemidler med nefrotoksisk eller neurotoksisk effekt kan øge risikoen for disse bivirkninger (se pkt.